NLS Pharmaceutics Announces Completion of Open Label Extension Study with Quilience (Mazindol ER) for the Treatment of Narcolepsy Six-month Open Label Extension (OLE) study for patients that completed the POLARIS Phase 2

Pharmaceutics Announces Completion of Open Label Extension Study with Quilience (Mazindol ER) for the Treatment of

Z rich, Switzerland,

January 30, 2023 - NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW) ("NLS" or the "Company"), 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, today announced the completion of the POLARIS six-month open-label extension study (NLS-1022) with Mazindol

ER in patients with narcolepsy.

POLARIS NLS-1022 OLE

is an open-label extension clinical study of Mazindol ER in patients with narcolepsy type 1 (NT1) or narcolepsy type 2 (NT2) who completed

participation in the previously reported POLARIS NLS-1021 Phase 2 clinical study, a four-week, randomized, double-blind, placebo-controlled,

multi-center U.S. clinical study in 67 patients with NT1 or NT2. All patients who completed the POLARIS Phase 2 study were eligible to

participate in the OLE and continue once-a-day treatment with Mazindol ER for up to six months as monotherapy (no concomitant wake-promoting

or anti-cataplexy treatments). The objectives of the NLS-1022 study are to evaluate the long-term safety and tolerability of Mazindol

ER and to evaluate its long-term therapeutic effect in the treatment of Excessive Daytime Sleepiness (EDS) and cataplexy.

this extension study further validates the potential for Mazindol ER to significantly improve EDS and cataplexy, with improved efficacy

over time," said Eric Konofal, MD, PhD, Chief Scientific Officer of NLS. "The unique mechanism of action of Mazindol ER sets

it apart from agents currently used, potentially filling an unmet need and allowing for once-daily monotherapy with a low-incidence of

Previously shared interim

OLE data showed that patients treated with Mazindol ER in the randomized double-blind Phase 2 study continued to improve after rolling

into the OLE study and that patients treated with placebo in the randomized Phase 2 study who received Mazindol ER in the OLE study achieved

comparable results to patients treated with active drug in the Phase 2 study. Those results demonstrated further improvement in efficacy

of Mazindol ER in the treatment of EDS and cataplexy with longer treatment duration as a potential first in class monotherapy. Safety

and tolerability of Mazindol ER were shown to be similar between the double-blind and OLE studies. NLS Pharmaceutics plans to have the

complete results of the OLE study in the first quarter of 2023 and to present these results at a future scientific meeting.

these studies can be found at https://polaris.nlspharma.com/ or www.clinicaltrials.gov,

Narcolepsy is a chronic

neurological disorder that affects the brain's ability to regulate sleep-wake cycles. People with narcolepsy may wake up in the

morning feeling well-rested, but they're unable to sustain that alertness throughout the day. As a result, people with narcolepsy

often feel excessively fatigued and frequently fall asleep during daytime hours, even when they're engaged in conversation, work,

or other activities. The most common symptom of narcolepsy is Excessive Daytime Sleepiness (EDS) which refers to an inability to stay

alert during normal daytime hours. Other symptoms may include cataplexy (a brief but sudden loss of muscle tone, slurred speech, muscle

weakness, or even collapse), hypnagogic dreams or hallucinations and sleep paralysis, and Disrupted Nighttime Sleep (DNS). Narcolepsy

affects 1 in every 2,000 individuals. Typical onset of narcolepsy occurs between the ages of 10 and 20; but can also occur in young children.

About NLS Pharmaceutics

NLS Pharmaceutics Ltd.

(Nasdaq: NLSP) is a global development-stage biopharmaceutical company, working with a network of world-class partners and

internationally recognized scientists, focused on the discovery and development of innovative therapies for patients with rare and complex

central nervous system, or CNS, disorders, who have unmet medical needs. Headquartered in Switzerland and founded in 2015, NLS is led

by an experienced management team with a track record of developing and commercializing product candidates. For more information,

please visit www.nlspharma.com.

The Company's lead product

candidate, Quilience , is a proprietary extended-release formulation of Mazindol (Mazindol ER) and is being developed for

the treatment of narcolepsy, and potentially other sleep-wake disorders such as Idiopathic Hypersomnia (IH), for which NLS recently obtained

Orphan Disease Designation (ODD) from the U. S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Mazindol is

a triple monoamine reuptake inhibitor and partial Orexin-2 Receptor agonist, which was used for many years to treat patients diagnosed

with narcolepsy in compassionate use programs. A Phase 2 multi-center U.S. clinical study evaluating Quilience

in adult patients suffering from narcolepsy met its primary endpoint with high statistical significance and demonstrated a favorable safety

and tolerability profile. NLS also successfully completed a Phase 2 study in the U.S. evaluating Nolazol

(Mazindol Controlled-Release) in adult patients suffering from ADHD. The study met all primary and secondary endpoints and Nolazol

was well-tolerated. Quilience has received Orphan Drug Designations both in

the U.S. and in Europe for the treatment of narcolepsy. Up to 1/3 of narcoleptic patients are also diagnosed with ADHD.

Safe Harbor Statement

This press release contains

expressed or implied forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS is using forward-looking statements

when it discusses the Company's potential funding runway, the potential benefits in the use of Mazindol ER for the treatment of

EDS, that the OLE study further validates the potential for Mazindol ER to significantly improve EDS and cataplexy, with improved efficacy

over time and the expected timing of the complete results of the OLE study. These forward-looking statements and their implications are

based on the current expectations of the management of NLS only and are subject to a number of factors and uncertainties that could cause

actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could

cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements;

NLS may encounter delays or obstacles in launching and/or successfully completing its clinical trials; NLS' products may not be approved

by regulatory agencies, NLS' technology may not be validated as it progresses further and its methods may not be accepted by the scientific

community; NLS may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen

scientific difficulties may develop with NLS' process; NLS' products may wind up being more expensive than it anticipates; results in

the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with

the results of human clinical trials; NLS' patents may not be sufficient; NLS' products may harm recipients; changes in legislation may

adversely impact NLS; inability to timely develop and introduce new technologies, products and applications; and loss of market share

and pressure on pricing resulting from competition, which could cause the actual results or performance of NLS to differ materially from

those contemplated in such forward-looking statements. Except as otherwise required by law, NLS undertakes no obligation to publicly release

any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence

of unanticipated events. More detailed information about the risks and uncertainties affecting NLS is contained under the heading "Risk

Factors" in NLS' annual report on Form 20-F for the year ended December 31, 2021 filed with the Securities and Exchange Commission

(SEC), which is available on the SEC's website, www.sec.gov, and in subsequent filings made by NLS with the SEC.

For additional information:

Marianne Lambertson (investors & media)

NLS Pharmaceutics Ltd.