Accessibility StatementSkip Navigation In his role on the SAB of NewcelX, Prof. Shefner will provide strategic guidance on the Company's programs in ALS, including the clinical development of AstroRx®, and will support the integration of neuromuscular and neurodegenerative disease expertise into the Company's broader platform of cell therapy and neuroscience innovation. ZURICH and NESS ZIONA, Israel, Nov. 17, 2025 /PRNewswire/ -- NewcelX Ltd. (Nasdaq: NCEL) ("NewcelX" or "the Company"), a clinical-stage bio ...

Core Viewpoint - NewcelX Ltd. is at a critical juncture, with significant scientific advancements and opportunities expected to redefine patient outcomes and shareholder value in the next 12 months [1][3]. Group 1: Company Overview - NewcelX is a Swiss clinical-stage biopharmaceutical company focused on developing cell-based and small-molecule therapies for neurodegenerative and metabolic diseases [1]. - The company integrates regenerative medicine and neuroscience expertise within a unified platform, aiming to deliver transformative therapies [2]. Group 2: Strategic Focus and Pipeline - NewcelX's mission is to provide disease-modifying therapies for severe neurodegenerative and metabolic diseases, guiding all decision-making processes [4]. - The company has multiple clinical and preclinical assets, with a strong foundation supported by validated technologies and collaborations [3]. - Key programs include: - **AstroRx® for ALS**: Preparing for a Phase 2a study in the U.S. after promising Phase 1/2 results in Israel [5]. - **IsletRx – iTOL-102 for Diabetes**: Advancing towards preclinical safety testing and a U.S. Phase 1 trial [5]. - **DOXA Neuroscience and Metabolic Platform**: Targeting the orexin pathway, with potential applications across CNS and metabolic disorders [5]. Group 3: Financial Position and Outlook - Following the merger between NLS Pharmaceutics and Kadimastem, NewcelX raised approximately $9 million in equity financing, enhancing its cash position [8]. - The company's projected shareholders' equity as of June 30, 2025, is approximately $20 million, reinforcing its financial stability as it approaches key development milestones [9]. - NewcelX is well-capitalized to support operations for the next 12 months, with an existing $25 million Equity Line of Credit [8]. Group 4: Upcoming Milestones - The company plans to launch a U.S. Phase 2a clinical study in ALS and initiate a U.S. Phase 1 clinical study in IsletRx [11]. - Expansion of the AstroRx® platform into additional indications such as Multiple Sclerosis is also on the agenda [11]. - Progressing the DOXA platform toward lead-candidate selection is a priority [11].

Core Viewpoint - NLS Pharmaceutics Ltd. and Kadimastem Ltd. are set to merge, creating a new entity named NewcelX Ltd., with significant ownership stakes for Kadimastem shareholders [1][2][5]. Merger Details - The merger is expected to close on October 30, 2025, with trading under the new name starting on October 31, 2025, pending customary closing conditions [3]. - Kadimastem's ordinary shares will be delisted from the TASE on October 31, 2025, following the merger [4]. - The final exchange ratio was determined to be approximately 6.92 NLS shares for each Kadimastem share pre-reverse stock split, translating to about 0.62 NLS shares per Kadimastem share post-split [5][6]. Ownership Structure - Post-merger, Kadimastem shareholders will own approximately 84.4% of the combined company, while NLS shareholders will hold about 15.6% [5][8]. Clinical and Development Programs - NewCelX will advance its clinical programs, including AstroRx® for Amyotrophic Lateral Sclerosis (ALS) and IsletRx for insulin-dependent diabetes, following successful technology transfer and clinical manufacturing agreements [9].

Core Viewpoint - The merger between NLS Pharmaceutics Ltd. and Kadimastem Ltd. has been approved by NLS shareholders, paving the way for the formation of NewCelX Ltd., which will be listed on Nasdaq under the ticker "NCEL" [1][6][7]. Group 1: Merger Details - The merger will create a Nasdaq-listed company named NewCelX, with governance and capital structure approvals completed [2]. - Kadimastem shareholders will own 84.4% of the combined company, while NLS shareholders will own 15.6%, reflecting the relative value contributions of each party [5][6]. - The combined company will integrate Kadimastem's advanced cell therapy programs with NLS's expertise in CNS small-molecule therapies [2][7]. Group 2: Leadership and Governance - The leadership team will be headed by Ronen Twito as Executive Chairman and CEO, with Prof. Michel Revel serving as Chief Scientific Officer and Director [3][6]. - A new Board of Directors will be elected, and various committees will be newly constituted to enhance governance and execution [6]. Group 3: Clinical Programs and Pipeline - The merger will unite Kadimastem's clinical programs, including a Phase 2a ALS trial of AstroRx® and the IsletRx diabetes product candidate, with NLS's CNS therapies [7]. - The combined company aims to build a diversified biotechnology portfolio with the potential to deliver transformative therapies to patients worldwide [7].

Core Insights - The U.S. Securities and Exchange Commission (SEC) has declared effective the registration statement on Form F-4 for the merger between NLS Pharmaceutics Ltd. and Kadimastem Ltd., marking a significant milestone in the merger process [1][3][5] Company Overview - NLS Pharmaceutics Ltd. is a Swiss clinical-stage biopharmaceutical company focused on developing innovative therapies for central nervous system disorders [5][6] - Kadimastem Ltd. is an advanced clinical-stage cell therapy company developing treatments for neurodegenerative diseases and diabetes [6] Merger Details - The merger will create a new entity named NewCelX Ltd., which will be publicly traded on Nasdaq under the ticker "NCEL" [3][5] - This merger combines Kadimastem's cell therapy platforms with NLS's expertise in small-molecule therapies, aiming to enhance the therapeutic scope in CNS disorders and metabolic diseases [7] Clinical and Strategic Highlights - Kadimastem is preparing to initiate a Phase 2a clinical trial of AstroRx® for ALS treatment, with global trial site selection and regulatory preparations underway [7] - The IsletRx diabetes program, developed in collaboration with iTolerance, has received support from the BIRD Foundation following a successful Pre-IND meeting with the FDA [7] - The merger is expected to strengthen the global position of the combined company and provide access to U.S. capital markets [5][7]

Core Insights - The announcement highlights the successful completion of a Type B Pre-IND meeting with the FDA, allowing NLS and Kadimastem to advance towards First-in-Human clinical trials of iTOL-102 [1][3] - The BIRD Foundation has approved a milestone payment of approximately NIS 564,400 ($166,000 USD), increasing total support to nearly NIS 3 million ($882,352 USD) [2] - The collaboration between Kadimastem and iTolerance is seen as promising, with the potential of iTOL-102 to redefine treatment for Type 1 diabetes [3] Company Developments - Kadimastem is developing IsletRx technology, which is a scalable, stem cell-derived source of insulin-producing islet-like cells, combined with iTolerance's iTOL-100 platform in iTOL-102 [3] - NLS Pharmaceutics is preparing for safety toxicology studies and clinical trial submissions based on FDA guidance [4] - Dr. Eric Konofal from NLS has been recommended for the Prix Galien, recognizing his contributions to pediatric sleep medicine [5] Industry Context - iTolerance is focused on developing immunomodulatory technologies to enable transplantation without chronic systemic immunosuppression, with iTOL-102 as its lead program [8] - Kadimastem is a clinical-stage biotechnology company with a focus on allogeneic cell therapies, including potential treatments for Type 1 diabetes [6] - NLS Pharmaceutics is a development-stage biopharmaceutical company targeting rare and complex central nervous system disorders [9]