ZURICH and NESS ZIONA, Israel, Sept. 10, 2025 /PRNewswire/ -- NLS Pharmaceutics Ltd. (Nasdaq: NLSP) (Nasdaq:Â NLSPW) ("NLS"), a Swiss clinical-stage biopharmaceutical company focused on central nervous system ("CNS") disorders, and Kadimastem Ltd. (TASE: KDST) ("Kadimastem"), an advanced clinical-stage cell therapy company progressing treatments for neurodegenerative diseases and diabetes, today announced that the U.S. Securities and Exchange Commission (the "SEC") has declared effective the registration st ...

About NLS Pharmaceutics According to Kadimastem, the Hong Kong patent adds to previously granted patents in Europe, the United States and India, further strengthening the global protection around IsletRx. The patented process enables the selection and enrichment of highly functional islet cells from differentiated cell populations to help maximize therapeutic effect. Alexander Zwyer, Chief Executive Officer of NLS Pharmaceutics, commented: "We congratulate Kadimastem on this important intellectual property ...

Revenue and Payments - The company received a non-refundable upfront payment of $2.5 million in 2019 under the EF License Agreement and is eligible for milestone payments of up to $16 million based on regulatory achievements [874]. - As of December 31, 2023, the company had long-term deferred revenues of $2.5 million related to the Nolazol product candidate, which will be recognized upon completion of development services and regulatory approval in Latin America [874]. - The EF License Agreement with Eurofarma will be terminated effective September 30, 2024, with the company recognizing $2.5 million as other income due to this termination [875]. - The company’s revenue recognition follows ASC 606, which requires the identification of promised goods or services and the measurement of transaction prices [872]. Pension and Tax Liabilities - As of December 31, 2024, the company has no net pension-related liability or associated pension expense recognized on its balance sheet, as all obligations related to the prior pension plan have been settled [876]. - The company incurs tax loss carryforwards generating deferred tax assets, but a full valuation allowance is recognized as it is not likely that the tax benefits can be realized [877]. - The company has a single fully insured collective pension plan, with no active employees participating as of December 31, 2024 [876]. Foreign Currency Exposure - Approximately 59.3% of the company's expenses for the year ended December 31, 2024, were denominated in CHF, 6.4% in EUR, and 0.1% in GBP, indicating significant foreign currency exposure [865]. - Changes of 5.0% and 10.0% in the U.S. dollar/CHF exchange rate would have increased/decreased operating expenses by 3.0% and 6.0%, respectively [865]. - The company does not hedge its foreign currency exchange risk but may consider formal currency hedging transactions in the future [867].

Core Insights - NLS Pharmaceutics Ltd. announced positive preclinical results for Mazindol, indicating its potential as a non-opioid treatment for fentanyl use disorder, which is a significant contributor to opioid-related overdose deaths in the U.S. [1][2] Industry Overview - The U.S. opioid and substance use disorder treatment market was valued at over $35 billion in 2021 and is projected to exceed $60 billion by 2029, driven by the urgent demand for safer alternatives to traditional opioid therapies [2]. Study Design and Findings - Study KO-943 utilized a validated conditioned place preference (CPP) paradigm in mice to assess the effects of Mazindol on fentanyl-induced behavior [3]. - Fentanyl significantly increased place preference, confirming its rewarding effect, while Mazindol at 0.5 mg/kg significantly reduced this effect, indicating a dose-dependent response [4]. Mechanism of Action - Mazindol acts as a pan-monoamine reuptake inhibitor with multiple pharmacological effects, including partial mu-opioid receptor modulation, serotonin 5-HT1A receptor interaction, and orexin-2 receptor activity, positioning it as a differentiated alternative to current opioid therapies [6][7]. Strategic Developments - NLS Pharmaceutics recently raised up to $3 million and signed a $25 million equity facility agreement as part of a strategic merger with Kadimastem Ltd., which will support the development of both companies' clinical assets [5][8].

Company Overview - NLS Pharmaceutics Ltd. is a Swiss clinical-stage biopharmaceutical company focused on developing innovative therapies for central nervous system (CNS) disorders [1] - The company is positioned for a transformative future in the biotechnology sector [1] Strategic Merger - NLS Pharmaceutics announced a definitive merger agreement with Kadimastem Ltd., a clinical-stage cell therapy company specializing in "off-the-shelf" allogeneic cell products for neurodegenerative diseases and diabetes [2] - The merger aims to create a Nasdaq-traded biotechnology company with a robust portfolio of advanced therapies, with both boards of directors unanimously approving the transaction [2] - The merger is anticipated to close in the second quarter of 2025, pending regulatory approvals and customary closing conditions [2][3] Regulatory Filings - A Registration Statement on Form F-4 has been filed with the SEC, detailing the proposed merger with Kadimastem [3] - An application has been submitted to list the merged company on Nasdaq under the name "NucelX Ltd." with the future ticker of NCEL [3] Advancements in Diabetes Treatment - Kadimastem has completed a pre-Investigational New Drug meeting with the FDA for iTOL-102, a potential breakthrough therapy for Type 1 Diabetes [4] - The innovative approach combines Kadimastem's IsletRx cells with iTolerance's immunomodulator, aiming to cure Type 1 Diabetes without lifelong immune suppression [4] - The diabetes treatment landscape has seen significant growth, highlighted by notable mergers and acquisitions in the sector [5] Expansion of Treatment Strategies - The company is expanding its diabetes treatment strategies beyond GLP-1 therapies to address challenges in diabetes management, including neuroinflammation and metabolic resilience [6] Advancements in Neurodegenerative Disease Treatment - Post-merger, NLS Pharmaceutics plans to initiate a Phase IIa multi-site clinical trial of AstroRx®, a product candidate for Amyotrophic Lateral Sclerosis (ALS) [7] Leadership and Expertise - Kadimastem contributes an experienced international leadership team, including key figures with a track record in developing medicines from laboratory to market [8][9] Research and Development Initiatives - The company is advancing its Dual Orexin Receptor Agonist platform, with promising results from preliminary studies on compounds AEX-41 and AEX-2 for sleep-wake disorders [10] - A preclinical program evaluating Mazindol ER as a treatment for fentanyl dependence has been launched [14] Financial Position - NLS Pharmaceutics has zero long-term debt and raised approximately $4.2 million through private placements, extending its operational runway to approximately 18 months [14] - This financial stability allows the company to accelerate clinical development and pursue strategic partnerships [14]

Core Viewpoint - The completion of the pre-IND meeting with the FDA is a significant milestone for the clinical development of iTOL-102, a collaborative research initiative between iTolerance and Kadimastem aimed at treating Type 1 Diabetes [1][3][4]. Company Overview - Kadimastem is a clinical stage cell therapy company developing proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional cells [8]. - iTolerance is a regenerative medicine company focused on developing technologies for tissue, organoid, or cell therapy without requiring life-long immunosuppression [10]. Product Development - iTOL-102 is being evaluated as a potential breakthrough transplantation approach for Type 1 Diabetes, combining a tolerance-inducing agent with human stem cell-derived islets [2][4]. - iTOL-100, developed by iTolerance, is an immunomodulatory microgel technology designed to reduce or eliminate the need for chronic systemic immunosuppression after transplantation [5]. - Kadimastem's IsletRx consists of human pancreatic islet-like cells capable of secreting insulin, providing a scalable source of insulin-producing cells to address donor islet shortages [6][9]. FDA Interaction - Prior to the pre-IND meeting, Kadimastem and iTolerance received critical feedback from the FDA, which is essential for updating their plans for safety toxicology studies and preparing for a First-in-Human clinical trial [3][7]. - The feedback from the FDA is viewed as a validation of the companies' commitment to developing a transformative therapy for Type 1 Diabetes [7]. Market Potential - The collaboration between Kadimastem and iTolerance is seen as a potentially transformative step in diabetes treatment, with the aim of developing a potential cure for Type 1 Diabetes [4][7].

Core Insights - GLP-1 receptor agonists, while effective for diabetes management, do not address systemic and neurological complications, necessitating alternative therapeutic strategies [1] - The DOXA platform by NLS aims to provide a multi-target approach to diabetes treatment, integrating orexin receptor agonism and neuroprotective pathways [2][6] - The merger between NLS and Kadimastem is expected to enhance their capabilities in diabetes treatment through combined expertise in cell therapy and pharmaceutical innovation [4][5] Company Developments - NLS is pioneering the DOXA therapeutic approach, which targets multiple pathways to manage diabetes holistically, including neuroinflammation and metabolic resilience [2][6] - The anticipated merger with Kadimastem is designed to create a stronger entity in the diabetes treatment landscape, leveraging both companies' strengths [4][5] - The DOXA platform is expected to outperform existing treatments, particularly when combined with Islet transplantation, setting a new standard in diabetes care [3] Industry Trends - There is a growing recognition of diabetes as a multi-systemic disease, leading to increased research into its connections with neurodegeneration and sleep disorders [1][7] - Multi-target therapies are emerging as a transformative approach in diabetes treatment, moving beyond traditional glucose regulation to address broader health impacts [6][7] - The integration of neuroscience, metabolism, and regenerative medicine is seen as crucial for developing comprehensive diabetes therapies [8]

Company Overview - NLS Pharmaceutics Ltd. is a global development-stage biopharmaceutical company focused on innovative therapies for rare and complex central nervous system disorders [3] - Kadimastem is a clinical stage cell therapy company developing proprietary cell products for various medical conditions, including ALS and diabetes [4][5] Merger Details - NLS is planning a shareholder meeting for final approval of the merger with Kadimastem, highlighting their commitment to addressing unmet medical needs in the biopharmaceutical sector [1] - Kadimastem's shareholders have approved the merger, indicating confidence in the anticipated value creation from the combined strengths of both companies in biotechnology [2] - Both companies aim to align their efforts to become a leading force in developing therapies for critical health challenges as the merger process progresses [2] Leadership Statements - Ronen Twito, CEO of Kadimastem, expressed optimism about the merger, emphasizing the expected value creation and growth opportunities [2] - Alex Zwyer, CEO of NLS, noted the significance of receiving approval from Kadimastem's shareholders and the commitment to collaborative efforts in biotechnology [2]

Core Insights - NLS Pharmaceutics Ltd. has submitted three research abstracts to the 2025 Annual Meeting of the American Society of Clinical Psychopharmacology, focusing on innovative therapies for CNS disorders [1][5] Group 1: Research Abstracts - The first study evaluates the effects of Mazindol ER on fentanyl dependence, demonstrating its potential as a non-opioid alternative for managing addiction [8] - The second study presents preclinical findings on AEX-41 and AEX-2, two novel dual orexin receptor agonists, showing their wake-promoting properties in a mouse model of narcolepsy [4][8] - The third study introduces a comprehensive multitarget strategy for managing diabetes-associated neurological and sleep disorders, integrating various therapeutic approaches [4] Group 2: Event Details - The ASCP Annual Meeting will take place from May 27 to May 30, 2025, in Scottsdale, Arizona, serving as a key platform for advancements in neuropsychopharmacology [2] - This event is recognized globally for its focus on neuropsychiatric drug development and innovative therapeutic approaches [2] Group 3: Company Overview - NLS Pharmaceutics is a Swiss clinical-stage biopharmaceutical company dedicated to developing therapies for rare and complex CNS disorders, collaborating with leading scientists and pharmaceutical partners [6]

Core Viewpoint - NLS Pharmaceutics Ltd. has launched a preclinical program to evaluate Mazindol ER as a novel treatment for fentanyl dependence, addressing a significant global health crisis related to opioid addiction [1][2][3] Company Overview - NLS Pharmaceutics is a Swiss clinical-stage biopharmaceutical company focused on developing therapies for rare and complex central nervous system disorders [11] - The company was founded in 2015 and is headquartered in Switzerland, led by an experienced management team with a history of developing and commercializing product candidates [11] Preclinical Program Highlights - The preclinical program aims to assess the safety and efficacy of Mazindol ER in models of fentanyl dependence, with a study expected to be completed within 12-18 months [5][9] - Mazindol ER is designed to provide a non-opioid alternative for treating fentanyl addiction, targeting neurochemical imbalances and supporting recovery through its multimodal action on neurotransmitter systems [4][6] Mechanism of Action - Mazindol ER acts on multiple neurotransmitter pathways, including: - Modulation of 5-HT1A receptors to regulate mood and anxiety [7] - Interaction with mu-opioid receptors to reduce cravings and withdrawal symptoms without reinforcing addiction [8] - Partial agonist activity at orexin-2 receptors to aid in sleep-wake cycle restoration [7][8] Future Outlook - NLS aims to leverage initial findings from the preclinical study to expand research and pursue commercialization opportunities for Mazindol ER in treating fentanyl dependence [11] - The company has secured patents for Mazindol ER, which strengthens its intellectual property position and supports ongoing development [10][14] Merger Information - NLS has filed a Registration Statement with the SEC regarding a proposed merger with Kadimastem, a clinical-stage cell therapy company [11][12] - Following the merger, both companies expect to continue developing NLS's Dual Orexin Agonist platform [12]