Nls Pharmaceutics Ltd - NLSP STOCK NEWS

NLS Pharmaceutics (NASDAQ: NLSP) announced significant developments in their shareholder letter dated March 10, 2025. The company highlighted its planned merger with Kadimastem (TASE: KDST), expected to close in Q2 2025, creating a Nasdaq-traded biotechnology company under the name 'NucelX ' (future ticker: NCEL).

Key developments include a successful pre-IND meeting with the FDA for iTOL-102, a potential Type 1 Diabetes treatment developed in collaboration with iTolerance Inc. The company plans to initiate a Phase IIa multi-site clinical trial of AstroRx® for ALS post-merger.

Financially, NLSP maintains zero long-term debt and raised approximately $4.2 million through private placements in October and December 2024, extending their operational runway to approximately 18 months. The company is advancing its Dual Orexin Receptor Agonist (DOXA) platform with AEX-41 and AEX-2 compounds for sleep-wake disorders, and launched a preclinical program evaluating Mazindol ER for fentanyl dependence treatment.

NLS Pharmaceutics (NLSP) has announced new preclinical findings for AEX-2, their non-sulfonamide dual orexin receptor agonist (DOXA). The research demonstrates promising results in treating narcolepsy and related neurological disorders.

Key findings from preclinical studies show that AEX-2 (20 mg/kg, IP) significantly enhanced wakefulness while maintaining stable wake architecture, preserved REM sleep patterns, and effectively reduced cataplexy episodes in narcolepsy type 1.

The company is expanding its therapeutic potential beyond sleep disorders, with AEX-2 and AEX-41 showing promise in treating neuroinflammation, ALS, Parkinson's disease, and diabetes-associated neurological disorders through Sigma-1 receptor modulation. NLS plans to advance both compounds into IND-enabling studies in 2025, targeting first-in-human clinical trials by 2026.

NLS Pharmaceutics (NLSP) and Kadimastem announced successful completion of a pre-IND meeting with the FDA for iTOL-102, a potential diabetes treatment. iTOL-102 combines Kadimastem's IsletRx cells (stem cell-derived pancreatic islets) with iTolerance's immunomodulator iTOL-100, aiming to cure Type 1 Diabetes without requiring life-long immune suppression.

The treatment was evaluated at the Diabetes Research Institute at the University of Miami School of Medicine, where it demonstrated functional insulin release and disease reversal in animal models. Based on FDA feedback, the companies are updating plans for safety toxicology studies and First-in-Human clinical trials.

IsletRx is a clinical-grade product comprising human pancreatic islet-like cells capable of secreting insulin, offering a scalable source of insulin-producing cells to address donor islet shortages. The technology can detect glucose levels and produce required amounts of insulin and glucagon.

NLS Pharmaceutics (NLSP) and Kadimastem have announced their planned merger to revolutionize diabetes treatment through a multi-targeted approach. The companies are introducing DOXA (Dual Orexin and Multi-Pathway Modulation), a next-generation therapeutic platform that goes beyond traditional GLP-1 therapies by addressing both metabolic and neurological aspects of diabetes.

DOXA targets multiple pathways including orexin signaling, sigma-1 receptor modulation, cathepsin inhibition, SGLT2 modulation, and adiponectin receptor activation. Preclinical studies, to be presented at ASCP 2025, show DOXA's ability to restore orexinergic function, reduce inflammation, and enhance β-cell survival.

The merger combines Kadimastem's cell therapy expertise with NLS's pharmaceutical innovation, particularly focusing on Diabetes-Associated Neurological and Sleep Disorders (DANS). The companies believe their combined approach, especially when DOXA is paired with Islet transplantation, could set new standards in diabetes care.

NLS Pharmaceutics (NLSP) and Kadimastem have achieved a significant milestone in their merger process as Kadimastem's shareholders approved the merger during a special general meeting. The merger aims to create a combined Nasdaq-traded biotechnology company focusing on advanced therapies for neurodegenerative diseases and diabetes.

NLS, a Swiss clinical-stage biopharmaceutical company specializing in rare and complex central nervous system disorders, plans to convene its own shareholder meeting for final merger approval. Kadimastem, a clinical-stage cell therapy company, develops 'off-the-shelf' allogeneic cell products for neurodegenerative diseases and diabetes treatment.

Both companies view this merger as an opportunity to leverage their combined biotechnology strengths and advance innovative solutions in the biopharmaceutical sector.

NLS Pharmaceutics (NASDAQ: NLSP) has submitted three research abstracts to the 2025 Annual Meeting of the American Society of Clinical Psychopharmacology (ASCP), scheduled for May 27-30, 2025, in Scottsdale, Arizona. The submissions include:

1. A study on Mazindol ER for fentanyl dependence, exploring its potential as a non-opioid alternative for addiction treatment.

2. Research on AEX-41 and AEX-2, novel dual orexin receptor agonists (DOXA), showing promising results for narcolepsy treatment without traditional stimulants' adverse metabolic effects.

3. A comprehensive study on managing diabetes-associated neurological and sleep disorders using dual orexin receptor agonists, neuropeptide-based preconditioning, and metabolic modulators.

NLS Pharmaceutics (NASDAQ: NLSP) has launched a preclinical program to evaluate Mazindol ER as a treatment for fentanyl dependence. The program, designated Study KO-943, comes amid a major global health crisis, with CDC reporting 105,007 drug overdose deaths in 2023, 90% involving synthetic opioids like fentanyl.

Mazindol ER, protected by patents until September 2038, offers a non-opioid alternative through multiple mechanisms: 5-HT1A receptor modulation, mu-opioid receptor interaction, and orexin-2 receptor partial agonist activity. The preclinical study will evaluate safety, efficacy, and pharmacokinetics, with completion expected within 12-18 months.

The company holds key patents, including US Patent No. 11,207,271 for oral formulations and No. 11,596,622 for heroin dependence treatment. The development program aims to address the limitations of traditional treatments like methadone and buprenorphine.

Kadimastem has called for a special general meeting of shareholders to approve its merger with NLS Pharmaceutics (NASDAQ: NLSP). The Central District Court in Israel has approved an expedited 14-day timeframe for the meeting from the notice publication date.

This development follows NLS's recent successful initial closing of $500,000 from a planned $1 million fundraising round at $3.10 per share, representing a 48% premium above market price. This funding, combined with a previous $3.2 million investment from October 2024, supports the proposed merger to create a combined Nasdaq-traded biotechnology company.

NLS has filed an F-4 Registration Statement with the SEC detailing the merger proposal. The combined entity aims to focus on rare and complex central nervous system disorders, neurodegenerative diseases, and diabetes treatments through cell therapy solutions.

NLS Pharmaceutics (NLSP) announced the initial closing of $500,000 from a previously announced $1 million financing agreement with an accredited investor. The shares were priced at $3.10, representing a 48% premium above the market closing price as of January 6, 2025. This financing, combined with a previous $3.2 million investment from October 2024, supports the proposed merger with Kadimastem

The financing agreement, dated December 4, 2024, involves no warrants and received approval at NLS's extraordinary general meeting on January 7, 2025. NLS has filed an F-4 Registration Statement with the SEC detailing the proposed merger with Kadimastem, which aims to create a combined Nasdaq-traded biotechnology company focusing on advanced clinical-stage product candidates.