Z rich, Switzerland

Z rich, Switzerland, August 28, 2023 - NLS Pharmaceutics

Ltd. (Nasdaq: NLSP, NLSPW) ("NLS" or the "Company"), a Swiss late-stage biopharmaceutical company focused on the

discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, today announced

that its Chief Executive Officer, Alex Zwyer, has issued the following letter to shareholders:

NLS Pharmaceutics CEO Issues Letter to Shareholders

To our Shareholders and Friends,

Though we may have been quiet recently, I wanted

to assure you that the team here at NLS has been very busy behind the scenes ensuring that we realize our vision of awakening a brighter

future for patients. Your investment and support to advance our pipeline in rare sleep disorders and other rare and debilitating Central

Nervous System (CNS) disorders is our driving force as we put patients first to develop better therapies to safeguard and empower the

brain throughout all stages of life. I am pleased to report on the progress that we have made towards achieving both our short and our

the outset of 2023, we outlined a number of objectives including:

addition to making significant progress on our objectives, we have advanced in our overall efforts by participating in global medical

conferences, building investor relations and partaking in discussions regarding promising opportunities. As we are at the precipice of

beginning our Phase 3 program for Mazindol ER, I wanted to take the opportunity to share the promises that we have kept and the advances

that we have made, which we could not have achieved without your help.

In late 2022, we completed

a $10 million private placement with BVF Partners L.P., a prestigious life sciences investor. The

offering and shared vision reinforced our confidence in our development program, which has the potential to benefit more than three million

people across the globe challenged with narcolepsy.

are now in the process of assessing different options to initiate our Phase 3 program as well as our strategic plan, which includes: the

potential need for capital, partnerships, venture debt opportunities and business development opportunities. We have significantly reduced

our monthly expenditures to extend our cash runway while finalizing our efforts. At this time we have received several non-binding term

sheets for a potential partnership agreement within the pharmaceutical industry. The Company is still in negotiations, has not executed

a definitive agreement, and no party is under any obligation to enter into or continue negotiations regarding a definitive agreement related

In May of this year, we announced the appointment

of Keith Dewedoff to the position of Interim Chief Financial Officer (CFO). Mr. Dewedoff's depth of expertise in finance within

biotech, and his experience in executing growth capital initiatives, as well as corporate development and equity research, brought crucial

talents into the Company at the right time. Mr. Dewedoff's contributions have been significant.

Following Mr. Dewedoff's appointment and

after an exhaustive international search, in May we engaged Elena Thyen-Pighin, an experienced finance executive, to transition into the

role of permanent CFO & Head of Finance / Human Resources. Ms. Thyen-Pighin's positions will be effective on September 1, 2023.

Ms. Thyen-Pighin holds extensive experience in leadership and management functions as both head of finance and human resources across

a number of industries, including organizations similar to NLS. Based in Switzerland, Ms. Thyen-Pighin speaks 5 languages and has a strong

and successful track record, most notably in accounting for both private and publicly listed enterprises. Her responsibilities will include

oversight of all financial operations as well as those related to human resources. We are thrilled to welcome her to the leadership team.

In July of 2023, NLS

announced that the Phase 3 clinical trial (which we call the AMAZE Program) protocol to evaluate the safety and efficacy of Mazindol ER

in patients with narcolepsy type 1 received approval from the independent Institutional Review Board ("IRB"). The AMAZE Program

encompasses two almost-identical double-blind Phase 3 studies (N=50 each) investigating Mazindol ER versus placebo in adult patients with

narcolepsy commencing this summer at multiple sites exclusively in the U.S. Based on the U.S. Food and Drug Administration's (FDA)

recommendations, both Phase 3 trials will measure the weekly cataplexy episodes as the primary endpoint over 8 weeks of treatment and

excessive daytime sleepiness as a secondary objective using the Patient-Reported Outcomes Measurement Information System (PROMIS-SRI)

and the Epworth Sleepiness Scale (ESS).

Along with IRB approval

and the green light from the FDA, NLS has retained a contract research organization (CRO) and has enrolled a number of sites for the phase

3 studies. Once suitable capital has been secured, the phase 3 program will immediately commence as the sites are ready to begin enrolling

On August 25, 2023, NLS

submitted a fast-track designation application for Mazindol ER for the treatment of narcolepsy to the FDA. Fast track is a designation

by the FDA of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening

condition and fill an unmet medical need. A drug may be granted Fast Track Designation if it is believed to have an impact on patient

survival, day-to-day functioning, or if it is believed that the condition will progress in severity if left untreated. Standard reviews

by the FDA for drug approval generally take about one year. A medicine that receives Fast Track Designation can be on the market within

six months of the regulatory application.

Medical Congress Activities

At SLEEP 2023, the annual

meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS), NLS presented our findings highlighting

data from the recently completed Phase 2 multi-center U.S. clinical study evaluating Mazindol ER, a triple monoamine reuptake inhibitor

and partial Orexin-2 Receptor agonist, in adult patients suffering from narcolepsy, which study met its primary endpoint with high statistical

significance and demonstrated a favorable safety and tolerability profile. We believe that these results confirm the efficacy of Mazindol

ER, as well as the safety and tolerability profile established in over 40 years of on-label and off-label use. Additional data from our

Open Label Extension study (NLS-1022) further validated the positive results from our Phase 2 double-blind trial for Mazindol ER in narcolepsy

and demonstrate the potential long-term efficacy, tolerability, and safety of the treatment.

In addition to presenting our findings, we spoke

to hundreds of clinicians at our booth as well as presented to a packed room in our symposium

entitled, Mazindol ER: Pioneering the Combination of SNDRI and OX2R in the Treatment of Narcolepsy, in which we, along with internationally

renowned key opinion leaders (KOLs) in sleep medicine, Bruce Corser, M.D., Medical Director, Sleep Management Institute, Cincinnati,

and Clete Kushida, MD, PhD, Chief and Medical Director, Division of Sleep Medicine, Stanford School of Medicine, presented on:

NLS current pipeline bridges the present to the future, providing a holistic approach and further strengthening the Company's vision

to awaken a brighter future for patients by overcoming rare and complex CNS diseases. We believe that our pipeline products are well

positioned as we gain ground in establishing future market positions through patents for lauflumide (NLS-4) and other new chemical entities

and assets. With extensive intellectual property (IP) coverage in the U.S., Japan and Europe, and promising pre-clinical data, we anticipate

that our wake-promoting agent, lauflumide (NLS-4), could also offer a new option for the treatment of chronic fatigue, including fatigue

associated with cancer treatment and long-COVID symptoms. We anticipate that clinical trials with lauflumide (NLS-4) will begin in 2024.

As we strive to develop

better therapies to safeguard and empower the brain throughout all stages of life, these compounds, including Mazindol ER for the treatment

of narcolepsy, along with NLS-4 focused on idiopathic hypersomnia and chronic fatigue, and NLS-11, addressing Kleine-Levin Syndrome and

neurodegenerative diseases (e.g. Lewy body dementia), would offer much-needed treatment options to fill the gaps for patients with

Current NLS pipeline products focused on Sleep disorders:

May of this year, NLS presented new and compelling preclinical data on four of our pipeline compounds at the annual meeting of the American

Society of Clinical Psychopharmacology (ASCP), in Miami, Florida. NLS' Chief Scientific Officer, Eric Konofal, MD, PhD, presented

data highlighting the Company's focus on and investment in therapeutic areas of rare hypersomnia disorders and complex neurologic

will continue to explore opportunities and execute on possibilities based on key factors such as unmet medical needs, biological rationales,

safety profiles, feasibility of clinical development, potential for leveraging accelerated development pathways for regulatory

approval, strong IP positions, favorable competitive landscapes and attractive commercial potential.

The NLS discovery platform

continues to focus on single molecules that function through multiple mechanisms designed to target the complexity of the CNS disease

state. Our goal remains building a differentiated global pharmaceutical company that is patient-centered and dedicated to the development

of transformative therapies addressing critical unmet needs. As we navigate the competitive landscape of our industry while focusing on

the development of our product candidates, we are poised to maximize the therapeutic potential of our current pipeline while still pursuing

new candidates that will continue to broaden our product portfolio.

At our Annual General

Meeting (AGM) in July, NLS shareholders approved all of the Board of Directors' proposals for the AGM that took place in Z rich,

Switzerland on June 30, 2023. This included the election of Audrey Greenberg and Dr. Anthony Walsh to the Board of Directors, shareholder

approval of financial statements, the compensation report and the balance sheet results of the Company for the fiscal year 2022. Shareholders

also approved the total compensation budgets for NLS' Board of Directors and Executive Management for the financial year 2024. PricewaterhouseCoopers

AG was re-elected as NLS' independent auditors for another term. Other key highlights from the meeting include 64% percent

of the shares entitled to votes being represented and the Board of Directors receiving the highest voting approval in the Company's

history with 99.5% of votes cast in favor of the proposals.

More than ever, we at NLS are committed and passionate