NLS Pharmaceutics Ltd. announced plans to showcase its global strategic R&D progress and platform, as well as its product candidate and pipeline goals for 2023, with a focus on rare and complex CNS disorders with unmet medical needs. Highlights of NLS' Pipeline: NLS-13 (mazindol): Target indication: Idiopathic hypersomnia (IH): Orphan Drug Designation in the U.S. and Europe; Phase 2 studies with Mazindol ER demonstrated efficacy in narcolepsy patients with Type II disorder, which has strong similarities to IH; Promising results support continued development of NLS-13 (mazindol) for IH; No approved treatment in Europe, 1 approved therapy in the U.S.; Early access program under named-patient program has been initiated in Europe with the potential to generate short-term, non-dilutive revenues for NLSP. NLS-3 (phacetoperane) Target: Attention deficit hyperactivity disorder (ADHD): Preclinical studies for NLS-3 (phacetoperane) show potential for the treatment of ADHD with improved efficacy, safety and tolerability versus methylphenidate; Promising results support continued development of NLS-3 (phacetoperane); NLS has intellectual property (IP) patent protections for NLS-3 in the U.S., Japan, China and Europe.

NLS-4 (lauflumide): Target indication: Chronic fatigue syndrome (CFS) associated with long COVID and cancer patients: Preclinical studies for NLS-4 (lauflumide) show potential for the treatment of chronic fatigue associated with Long-COVID (AKA “Chronic Fatigue caused be COVID-19 infection”) and demonstrated improved recovery from CFS) in rat model; Promising results support continued development of NLS-4 (lauflumide); NLS has intellectual property (IP) patent protections for NLS-4 in the U.S., Canada and Europe. NLS-8 (melafenoxate):Target indication: Amnesia associated with Alzheimer's: Preclinical study for NLS-8 (melafenoxate) focusing on neurodegenerative disorders, specifically on the pathological process of Alzheimer's Disease (AD) demonstrated an improvement on amnesia symptoms associated with neurodegenerative disorders, specifically AD, in mice model; Promising results support continued development of NLS-8 (melafenoxate) to improve memory and reduce cognitive symptoms of AD; The European Patent Office has granted approval for International Patent Application No. PCT/EP2022/069204 including the NLS-11 mechanism of action and its applications as neurological diseases treatment associated with sleep disorders.

NLS-11 (benedin): Target indication: Kleine-Levin Syndrome: Preclinical development of NLS-11 (benedin), an innovative drug targeting the Kleine-Levin Syndrome (KLS), demonstrated a clinical benefit on hypersomnia symptoms and exhaustion associated with KLS in mice models. As of January 12, 2023, there are no approved treatment available world-wide to cure or control KLS; Promising results in addition to extensive historical preclinical data, as well as preliminary clinical data, support continued development of NLS-11 (benedin) in KLS and other rare sleep disorders; The European Patent Office has granted approval for International Patent Application No. PCT/EP2022/069188 including the NLS-11 mechanism of action and its applications as neurological diseases treatment associated with sleep disorders.

NLS-12 (oxafuramine): Target indication: Dementia associated with Lewy Bodies and Parkinson Disease: Preclinical study for NLS-12 (oxafuramine) shows positive results for the treatment of neurological disorders including Dementia with Lewy Bodies, Parkinson Disease and others using the novel object recognition (NOR) test in mice models; NLS-12 specifically targets neurodegenerative diseaseswherecentral muscarinic neurotransmission is compromised; The European Patent Office has granted approval for International Patent Application No. PCT/EP2022/069200 including the NLS-12 mechanism of action on muscarinic M4 and M5 receptors as agonist and its potential role on the modulation of dopamine and its applications thereof for treating neurodegenerative diseases with Lewy Body Disease and/or Alzheimer's Disease.