Non-opioid, multi-mechanism profile positions Mazindol as a differentiated asset in addiction therapeutics

Favorable results support potential expansion into high-value markets beyond ADHD and narcolepsy

ZURICH, April 15, 2025 /PRNewswire/ -- NLS Pharmaceutics Ltd. (Nasdaq: NLSP) (NASDAQ: NLSPW) ("NLS" or the "Company"), a Swiss clinical-stage biopharmaceutical company focused on developing innovative therapies for central nervous system (CNS) disorders, today announced positive results from Study KO-943, a preclinical investigation evaluating the efficacy of Mazindol in mitigating fentanyl-induced conditioned place preference (CPP) in mice. The study, conducted by Key-Obs SAS, a leading preclinical CRO, provides evidence that Mazindol may offer a novel, non-opioid approach for the treatment of fentanyl use disorder — a condition contributing to over 75% of opioid-related overdose deaths in the United States.

ZURICH, March 10, 2025 /PRNewswire/ -- NLS Pharmaceutics Ltd. (NASDAQ: NLSP), a Swiss clinical-stage biopharmaceutical company focused on developing innovative therapies for central nervous system (CNS) disorders, today issued a letter to its shareholders.

Dear Shareholders,

We are thrilled to share the significant progress and strategic milestones NLS Pharmaceutics has achieved, positioning our company for a transformative future in the biotechnology sector.

ZÜRICH, Switzerland, Feb. 27, 2025 /PRNewswire/ -- NLS Pharmaceutics Ltd. (Nasdaq: NLSP) (Nasdaq: NLSPW) ("NLS" or the "Company"), in collaboration with Aexon Labs Inc. ("Aexon Labs"), is pleased to announce new preclinical findings on AEX-2, reinforcing its potential as a first-in-class non-sulfonamide dual orexin receptor agonist ("DOXA") for narcolepsy and related neurological disorders. These results build upon the Company's multi-target neurodegenerative strategy, which also includes AEX-41, demonstrating a novel and promising approach to addressing sleep disorders, neuroinflammation, and metabolic dysfunction.

Companies Advance Collaborative Clinical Development of iTOL-102: A Potential Cure for Diabetes Without the Need for Chronic Life-long Immune Suppression

ZURICH and NESS ZIONA, Israel, Feb. 25, 2025 /PRNewswire/ -- NLS Pharmaceutics Ltd. (Nasdaq: NLSP) ("NLS") and Kadimastem Ltd. (TASE: KDST) ("Kadimastem"), a clinical-stage company specializing in "off-the-shelf" allogeneic cell therapy products for neurodegenerative diseases and diabetes, in collaboration with iTolerance Inc. ("iTolerance"), a U.S. based regenerative medicine company, announced today the result from the  Type B pre-IND meeting held by Kadimastem and iTolerance with a committee of the U.S Food and Drug Administration ("FDA") on February 24, 2025, regarding the development of iTOL-102, a potential cure for diabetes that would not require life-long chronic immune system suppression. iTOL-102 is an investigational biologic for the treatment and potential cure of Type 1 Diabetes consisting of Kadimastem's allogenic human stem cell-derived pancreatic islets (IsletRx cells) combined with iTolerance's immunomodulator (iTOL-100).

ZURICH and NESS ZIONA, Israel, Feb. 10, 2025 /PRNewswire/ -- NLS Pharmaceutics Ltd. ("NLS") (Nasdaq: NLSP), a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for rare and complex central nervous system disorders, and Kadimastem Ltd. ("Kadimastem") (TASE: KDST), a clinical-stage cell therapy company developing and manufacturing "off-the-shelf" allogeneic cell products for the treatment of neurodegenerative diseases and potential cure for diabetes, are on a mission to create a leading biotechnology entity. The upcoming expected merger aims to transform the treatment landscape for complex conditions such as diabetes. By uniting the core competencies of both organizations, NLS and Kadimastem believe that this merger is positioned to potentially create a holistic solution that addresses the multifaceted challenges of diabetes management.

ZURICH and NESS ZIONA, Israel, Jan. 31, 2025 /PRNewswire/ -- NLS Pharmaceutics Ltd. ("NLS") (Nasdaq: NLSP), a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for rare and complex central nervous system disorders, and Kadimastem Ltd. ("Kadimastem") (TASE: KDST), a clinical-stage cell therapy company developing and manufacturing "off-the-shelf" allogeneic cell products for the treatment of neurodegenerative diseases and potential cure for diabetes, are pleased to announce that in a special general meeting of shareholders held yesterday, Kadimastem's shareholders approved the merger with NLS (the "Merger"). This key milestone brings NLS and Kadimastem one step closer to creating a combined Nasdaq-traded biotechnology company with a robust portfolio of advanced therapies for neurodegenerative diseases and diabetes.

ZURICH, Jan. 28, 2025 /PRNewswire/ -- NLS Pharmaceutics Ltd. (NASDAQ: NLSP) (NASDAQ: NLSPW) ("NLS" or the "Company"), a Swiss clinical-stage biopharmaceutical company dedicated to developing therapies for rare and complex central nervous system disorders, is proud to announce the launch of a preclinical program evaluating Mazindol ER (Extended-Release) as a novel treatment for fentanyl dependence. Fentanyl dependence is a major global health crisis and was recently declared a national public health emergency by the new Trump administration. In 2023, the CDC reported 105,007 drug overdose deaths with 90% involving synthetic opioids like fentanyl.

Kadimastem Approaches Final Steps for Securing Merger Completion

ZURICH and NESS ZIONA, Israel, Jan. 16, 2025 /PRNewswire/ -- NLS Pharmaceutics Ltd. ("NLS") (Nasdaq: NLSP), a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for rare and complex central nervous system disorders, and Kadimastem Ltd. ("Kadimastem") (TASE: KDST), a clinical-stage cell therapy company developing and manufacturing "off-the-shelf" allogeneic cell products for the treatment of neurodegenerative diseases and potential cure of diabetes, announces that Kadimastem has issued a notice to convene a special general meeting of Kadimastem's shareholders to approve the merger transaction with NLS. The Central District Court in Israel has approved that this meeting may occur within a reduced time frame of only 14 days from the date of publication of the meeting notice. This meeting is needed to secure Kadimastem's shareholder approval which are critical to completing the merger process.

ZURICH and NESS ZIONA, Israel, Jan. 8, 2025 /PRNewswire/ -- NLS Pharmaceutics Ltd. ("NLS") (Nasdaq: NLSP), a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for rare and complex central nervous system disorders, and Kadimastem Ltd. ("Kadimastem") (TASE: KDST), a clinical-stage cell therapy company developing and manufacturing "off-the-shelf" allogeneic cell products for the treatment of neurodegenerative diseases and potential cure of diabetes, announce the successful completion of the initial closing of $500,000 of the previously announced $1 million financing between NLS and an accredited investor under a securities purchase agreement dated December 4, 2024, with the approval of certain items in NLS's extraordinary general meeting on January 7, 2025. As previously detailed in NLS's Report on Form 6-K submitted to the Securities and Exchange Commission on December 4, 2024, this agreement involved no warrants and was executed at a share price of $3.10, representing 48% above the NLS market closing share price as of Jan 6, 2025, the last trading day prior to the date of the NLS's extraordinary general meeting.

The proposed transaction will create a Nasdaq-traded, biotechnology company with product candidates in advanced stages of clinical development and a focus on advancing its allogeneic cell therapy platform

ZURICH and NESS ZIONA, Israel, Dec. 30, 2024 /PRNewswire/ -- NLS Pharmaceutics Ltd. ("NLS") (Nasdaq: NLSP), a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, and Kadimastem Ltd. ("Kadimastem") (TASE: KDST), a clinical-stage cell therapy company developing and manufacturing "off-the-shelf" allogeneic cell products for the treatment of neurodegenerative diseases and potential cure of diabetes, announced today that NLS has filed a Registration Statement on Form F-4 ("Registration Statement") with the U.S. Securities and Exchange Commission ("SEC") regarding the previously announced merger between NLS and Kadimastem.