AM Wake Up: (Nasdaq: NCEL) Aims For Disruption In The T1D Market (7 Potential Catalysts)

Were you on watch for Tuesday's breakout idea? It popped in an impressive manner.

Any content you receive is for information purposes only. Always conduct your own research. *Sponsored AM Wake Up: (Nasdaq: NCEL) Aims For Disruption In The T1D Market (7 Potential Catalysts) Consider Starting Your Own Research On (NCEL)... [ Company Website ] | [ Corporate Communications ] *Click Here To Get Our Alerts Faster Via SMS* July 1st Dear Reader, Were you on watch for Tuesday's breakout idea? It popped in an impressive manner. Surging to a high of $9.73 before the bell, it moved approx. 110% from its prior day close of $4.62. While that run was unfolding, our attention started getting dragged in another direction... You see, there is a particular kind of company that doesn't announce its arrival loudly. It moves through regulatory checkpoints, builds out its science, assembles the right advisors, and one day finds itself standing at the threshold of a First-In-Human clinical trial, pursuing one of the few genuinely differentiated approaches to treating a disease that has resisted a functional cure for over a century. On May 27th, 2026, this company filed a Pre-IND briefing package with the U.S. FDA to support a proposed First-In-Human trial of its lead stem cell-derived islet product, in combination with tegoprubart, developed by Eledon Pharmaceuticals. Furthermore, a Type B meeting with the FDA was scheduled for the final week of June. NewcelX Ltd. (Nasdaq: NCEL) is the product of a merger finalized on October 30th, 2025, between NLS Pharmaceutics Ltd. and Kadimastem Ltd, a cell therapy company. The deal united Kadimastem's validated human pluripotent stem cell platform with a focus on translational regenerative medicine and cell therapy development across metabolic disease and immune-modulated indications. The combined company relisted on Nasdaq under NCEL. The Underlying Science Deserves Attention Type 1 Diabetes is a condition in which the body's own immune system destroys the insulin-producing beta cells in the pancreas. The approach NewcelX is advancing with NCEL-101 is fundamentally different: replace the destroyed islet cells using scalable, off-the-shelf, stem cell-derived islets, and pair those transplanted cells with targeted immune protection. The collaborative framework with Eledon, specifically tegoprubart, evaluated in over 100 transplant recipients across multiple FDA-cleared IND studies, is what makes the immune protection component clinically credible. The company maintains access to a $25Mn Equity Line of Credit and is substantially debt-free. With a market capitalization hovering around $19Mn (6/30/26), the gap between this company's current chart valuation and the scale of the unmet medical need it is targeting may be one of the more striking disconnects in the clinical-stage biopharma space right now. Two Platforms, One Clinical Mission NewcelX Ltd. (Nasdaq: NCEL) is a clinical-stage regenerative medicine company incorporated in Switzerland and headquartered in Zurich, with research and development operations in Ness Ziona, Israel. The company's operating model is built around an allogeneic, off-the-shelf cell therapy manufacturing strategy Rather than producing patient-specific therapies, NewcelX is designing its pipeline to be manufactured from renewable pluripotent cell banks, frozen, and shipped globally, an approach that supports broad patient access and standardized production at scale. “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.” — Ronen Twito, Executive Chairman & CEO, NewcelX Ltd. | April 30th, 2026 Cell Therapy for T1D - Structural Scale, Unsolved Problem The global cell therapy market represents one of the most structurally significant long-cycle themes in heal-thcare. Unlike traditional pharmaceuticals that interact with biochemistry, cell therapies aim to replace or restore biological function at the cellular level, an approach that, in diseases like Type 1 Diabetes, offers the possibility of functional resolution rather than lifelong symptom management. Global T1D Patients - 9.5Mn Children with T1D - 1.8Mn U.S. Annual Diabetes Cost - $640Bn / year Curative Standard of Care - None Currently Exists What gives this market context particular strategic weight right now is the regulatory environment. The FDA has publicly signaled a commitment to streamlining the IND process for Type 1 Diabetes innovations, a point referenced directly by CEO Ronen Twito in the company's May 2026 Pre-IND announcement. The combination of scalable stem cell-derived islets with a calcineurin inhibitor-free immune protection regimen represents a small cohort of programs globally. Recent NCEL Milestones May 27th, 2026 - FDA Pre-IND Package Submitted For NCEL-101 NewcelX filed its Pre-IND briefing package with the FDA to support the proposed First-In-Human trial of NCEL-101 combined with tegoprubart. A Type B pre-IND meeting with the FDA was scheduled for the final week of June 2026. Agenda covers manufacturing, preclinical safety/toxicology planning, and FIH trial design. March 9th, 2026 - Strategic Collaboration Announced With Eledon Pharmaceuticals Formal collaborative research agreement to advance combination strategies pairing NCEL-101 with tegoprubart (AT-1501). Designed to support durable, immune-protected islet replacement and a potential functional cure for Type 1 Diabetes. January 5th, 2026 - Dr. Julien Boisdron (CMO of Roche) Appointed To Scientific Advisory Board Diabetes specialist with 20+ years of global pharmaceutical leadership, currently CMO of a major Swiss multinational pharma company, joins the SAB to advise on NCEL-101 translational strategy, patient adoption, and commercialization frameworks. October 31st, 2025 - Merger Completed As NCEL Takes A Spin On The Nasdaq NLS Pharmaceutics x Kadimastem merger closed; combined company relisted as NewcelX Ltd. (NCEL) on the Nasdaq. Consider Starting Your Own Research On (NCEL)... [ Company Website ] | [ Corporate Communications ] These 7 Potential Catalysts Put (Nasdaq: NCEL) At the Top of Our Watchlist #1. FDA Engagement The Type B pre-IND meeting scheduled with the FDA for the last week of June 2026 puts NCEL in direct regulatory dialogue at a moment when the agency has publicly signaled its commitment to streamlining the IND pathway for Type 1 Diabetes cell therapy innovations. #2. Tight Float With approximately 2.61Mn shares in its float, NCEL carries one of the tighter share structures in the clinical-stage biotech space, a factor that becomes relevant when catalysts arrive and market interest accelerates. #3. Validated Science The human pluripotent stem cell platform underpinning the company's NCEL-101 program has been validated through years of GMP manufacturing development, prior FDA interactions, and preclinical work accumulated during the AstroRx® ALS program, all now applied directly to the flagship diabetes asset. #4. Strategic Alliance The collaborative research agreement between NCEL and Eledon Pharmaceuticals integrates tegoprubart, a next-generation anti-CD40L antibody with safety data from over 100 transplant recipients, into the immune protection layer of NCEL-101, meaningfully reducing a core technical risk in islet cell therapy. #5. Off-the-Shelf Model NCEL's allogeneic manufacturing strategy is designed for scalability and cost efficiency, a structural advantage over autologous approaches that require individualized production and cannot easily be standardized across large patient populations. #6. Bullish Technicals At close on Tuesday, Barchart was reporting at least 8 triggered technical indicators across terms. Furthermore, one of those eight that were triggered was the website's composite "Trend Seeker" indicator. #7. Deep Advisory Bench The scientific advisory board assembled around NCEL includes Dr. Julien Boisdron (CMO at a major Swiss multinational pharma, 20+ years in diabetes care); Prof. Jeremy Shefner, MD, PhD (CMO at Barrow Neurological Institute, co-founder of NEALS ALS consortium, 200+ peer-reviewed papers); and Prof. Tamir Ben-Hur, MD, PhD (neuroimmunology expert at Hadassah and Hebrew University). We Will Have All Eyes On NewcelX (Nasdaq: NCEL) Wednesday Morning. NewcelX Ltd. (Nasdaq: NCEL) is navigating the most consequential stretch of its existence. The merger that created it is less than a year old. Its lead program has just completed its Pre-IND submission to the FDA. A Type B meeting with regulators was scheduled for the end of June. The scientific advisory board has been built with purpose. The manufacturing partner is in place. The immune protection collaborator has clinical data from over 100 transplant recipients. What markets are watching is whether the company can convert that groundwork into a cleared IND and a path to First-In-Human data. The disease it is targeting affects 9.5Mn people globally. The current standard of care is a lifetime of daily management. The approach NewcelX is advancing goes further, it is aimed at the underlying biology. We're kicking off coverage on NewcelX Ltd. (Nasdaq: NCEL). Be on the lookout for updates coming soon. Talk again shortly. Sincerely, FierceAnalyst | Jaks Swift Editorial Writer (Always Remember The St-ock Prices Could Be Significantly Lower Now From The Dates I Provided.) *FierceInvestor (FierceInvestor . com) is owned by SWN Media LLC, a limited liability company. Data is provided from third-party sources and FierceInvestor ("FI") is not responsible for its accuracy. Make sure to always do your own research and due diligence on any day and swing profile I bring to your attention. We do not provide personalized fin-ancial advice, are not finan-cial advisors, and our opinions are not suitable for all in-vest-ors. NewcelX Ltd (NCEL:US) previously changed their company name and symbols from NLS Pharmaceutics AG (NLSP:US) Pursuant to an agreement between SWN Media LLC and TD Media LLC, SWN Media LLC has been hired for a period beginning on 06/30/2026 and ending on 07/01/2026 to publicly disseminate information about (NCEL:US) via digital communications. Under this agreement, TD Media LLC has paid SWN Media LLC twenty thousand USD ("Funds"). To date, including under the previously described agreement, SWN Media LLC has been paid fifty two thousand five hundred USD ("Funds"). These Funds were part of the twenty seven thousand five hundred USD funds that TD Media LLC received from a third party named LFG Equities Corp. who did receive the Funds directly or indirectly from the Issuer and does not own st-ock in the Issuer but the reader should assume that the clients of the third party own shares in the Issuer, which they will liquidate at or near the time you receive this communication and has the potential to hurt share prices. Neither SWN Media LLC, TD Media LLC and their member own shares of (NCEL:US). Please see important disclosure information here: https://fierceinvestor.com/disclosure/ncel-kghgw/#details

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