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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.
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