Kadimastem Stock Price, News & Analysis

NLS Pharmaceutics (NASDAQ:NLSP) and its merger partner Kadimastem have secured a significant patent in Hong Kong for their cell selection and enrichment technology used in developing IsletRx, a stem cell-derived therapy targeting insulin-dependent diabetes. The patent complements existing protections in Europe, the United States, and India.

The technology enables the selection of highly functional islet cells from differentiated cell populations to maximize therapeutic effect. Hong Kong represents a strategic market with approximately 706,000 adults living with diabetes (8.2% prevalence) and an estimated economic impact of $90 billion, based on average lifetime healthcare expenditures of $125,000 per patient.

NLS Pharmaceutics (NASDAQ:NLSP) announced that the BIRD Foundation has approved an additional milestone payment of $166,000 to Kadimastem and iTolerance for their iTOL-102 diabetes program. This brings total BIRD Foundation support to $882,352.

The milestone follows a successful Pre-IND meeting with the FDA regarding iTOL-102, a potential cure for Type 1 diabetes that combines Kadimastem's IsletRx technology with iTolerance's iTOL-100 immunomodulatory platform. The therapy aims to eliminate the need for life-long immunosuppression drugs.

Preclinical studies at the University of Miami's Diabetes Research Institute have shown promising results, demonstrating functional insulin secretion and disease reversal in diabetic animal models. The companies are now preparing for safety toxicology studies and clinical trial submissions.

NLS Pharmaceutics (NASDAQ: NLSP) has announced significant progress in Q1 2025, including successful financing events totaling $2.5M at premium share prices and a $25M equity facility commitment. The company completed two equity financings at $3.10 and $1.65 per share, representing 48% and 10% premiums respectively. A transformative merger with Kadimastem (TASE: KDST) is expected to close in early Q3 2025, creating NewcelX, a combined entity focusing on neurodegenerative diseases and diabetes treatments. The company reported positive preclinical data for AEX-2 and encouraging results for Mazindol ER in fentanyl-related studies. Post-merger plans include initiating a Phase IIa trial for AstroRx in ALS treatment, Phase I study for IsletRx in Type I diabetes, and advancing preclinical development of AEX-2/AEX-41 for narcolepsy and neurodegeneration. The company has converted all outstanding liabilities to equity, achieving a debt-free status.

NLS Pharmaceutics (NLSP) has announced positive results from Study KO-943, evaluating Mazindol's effectiveness in reducing fentanyl-induced reward in mice. The preclinical study demonstrated that Mazindol at 0.5 mg/kg significantly reduced fentanyl-induced conditioned place preference (CPP), bringing behavior close to baseline.

The study utilized four test groups: vehicle control, fentanyl-only, and two fentanyl with Mazindol co-treatment groups. Key findings showed that fentanyl increased place preference (p ≤ 0.05 vs. vehicle), while Mazindol demonstrated a dose-dependent effect in reducing this preference.

Mazindol's mechanism of action includes:

• Partial mu-opioid receptor modulation
• 5-HT1A receptor interaction
• OX2R activity

This development follows the company's recent $3 million fundraising and $25 million committed equity facility agreement as part of a planned merger with Kadimastem

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.

Kadimastem Ltd. announced a financing round raising 10 million NIS ($3.2 million) from ILEX Medical. This private investment was executed at a price of 4.26 NIS ($1.35) per share, about 5% above the previous closing price. The funding will support the clinical development of AstroRx® for ALS and initiate trials for IsletRx, aimed at curing diabetes. Kadimastem has raised over 50 million NIS ($15.9 million) in 2021 and plans for a NASDAQ listing to enhance visibility and attract investors.

Kadimastem Ltd. has appointed Asaf Shiloni as its new CEO, bringing over 20 years of biotech experience, including 13 years at PeproTech Inc. His expertise in cell therapy and partnerships with US firms is expected to drive the company's initiatives in ALS and diabetes treatment. This management change follows the recent appointment of Ronen Twito as Co-Chairperson, alongside new board members Doron Birger and Ron Mayron. The new leadership aims to enhance business value and foster collaborations in the burgeoning cell therapy sector.