1. Investment Snapshot
2. Thesis
3. Valuation & Price Target
4. Business & Product Moat
5. People & Governance
6. Market & Macro
7. Financial Quality
8. Risk Register
9. Prediction Market
10. 𝕏 Posts
Discussion
1. Investment Snapshot
2. Thesis
3. Valuation & Price Target
4. Business & Product Moat
5. People & Governance
6. Market & Macro
7. Financial Quality
8. Risk Register
9. Prediction Market
10. 𝕏 Posts
Discussion
1. Investment Snapshot
2. Valuation
Discussion
Symbol
NLSP
Event Date
2020-11-20
Sector
Health Care
Subsector
Pharmaceuticals
Offer Range
—
Shares Offered
4.82M
10.6M
$28.9M
45.5%
Implied Upside vs Midpoint
Description
We are a clinical-stage pharmaceutical company 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. Our lead compound mazindol, in a proprietary controlled release, or CR, formulation, is being developed for the treatment of narcolepsy (lead indication) and Attention Deficit Hyperactivity Disorder, or ADHD (follow-on indication), and is a triple monoamine reuptake inhibitor and partial orexin receptor 2 agonist. We believe that this mechanism of action will also give mazindol CR the potential for therapeutic benefit in other rare and complex CNS disorders. CNS disorders are a diverse group of conditions that include neurological, psychiatric, and substance use disorders. According to the World Health Organization and based on data from the Global Burden of Disease Report, CNS disorders result in a socio-economic burden of more than $317 billion annually in the United States alone. Additionally, CNS disorders were expected to account for approximately 15% of the global disease burden in 2020, the largest of any disease area. However, treatment options for these conditions are often limited, inadequate or nonexistent, and the development of new CNS treatments generally trails behind other therapeutic areas. We are pursuing the development of the next generation of CNS therapies with high medical impact to address this critical and growing unmet need. Our dual development strategy is designed to optimize the outcome of our clinical programs by developing new chemical entities, or NCEs, from known molecules with strong scientific rationale, and also by re-defining previously approved molecules with well-established tolerability and safety profiles, as determined by applicable regulatory agencies. We believe that our streamlined clinical development approach has the potential to advance our product candidates rapidly through early-stage clinical trials, while carrying an overall lower development risk. A lower development risk, we believe, exists with respect to the development of our lead product candidate, Quilience, and follow-on product candidate, Nolazol, due to their use of mazindol as the active molecule, which was previously approved and marketed in the United States, Japan and Europe to manage exogenous obesity (obesity caused by overeating). Our discovery platform currently focuses on single molecules that operate through multiple mechanisms designed to target the complexity of the CNS disease state, and, we believe this may potentially offer new treatment options for patients, including for those patients who are refractory to currently available treatments. Our current focus is in the therapeutic areas of rare hypersomnia disorders (conditions highlighted by excessive daytime sleepiness, or EDS) and complex neurodevelopmental disorders, and includes our lead product candidate: Quilience, for the treatment of EDS and cataplexy associated with narcolepsy, and our follow-on candidate Nolazol, for the treatment of ADHD. We have not yet conducted sponsored clinical studies for Quilience and, subject to the completion of this offering, we intend to initiate our clinical development with a Phase 2 clinical trial in the second quarter of 2021, followed by a Phase 3 program, in adult patients with narcolepsy, subject to authorization from the FDA and other applicable regulatory agencies. We expect to have top line results from our Phase 2 clinical trial during the third quarter of 2021. We also intend to apply for entrance into expedited development program(s) facilitated by the U.S. Food and Drug Administration, or the FDA, such as Breakthrough Therapy and/or Fast Track designations and by the European Medicines Agency, or EMA, such as Priority Medicine, or PRIME. We have completed a Phase 2 clinical trial evaluating the safety and efficacy of Nolazol in adults with ADHD in the U.S. and, given the positive outcome of this trial, we may initiate Phase 3 clinical trials after we receive approval to commercialize Quilience. We intend to seek FDA and other regulatory approval for Nolazol for use in children with ADHD, which requires additional nonclinical work, as well as staged clinical work in determining safe dosing and monitoring. In addition, following our current focus on the development of Quilience for narcolepsy in adults, and if approved for marketing, we intend to seek a label expansion for the treatment of narcolepsy in pediatric patients, which may require additional nonclinical and clinical studies. Quilience and Nolazol both contain mazindol as the active molecule in a proprietary CR formulation developed for a once-a-day dosing. Mazindol has a well-established safety record from its extended history of clinical use across the United States and several countries in Europe, where mazindol was previously approved in an immediate release formulation for the short-term management of exogenous obesity. It was marketed for nearly 30 years, into the early 2000s, before being voluntarily withdrawn from the market for commercial reasons and is no longer available nor marketed in these regions. In addition to the 30-year period in which it was marketed, mazindol was also widely used off-label and prescribed under compassionate use for the treatment of narcolepsy for approximately four decades, during which time it demonstrated a well-tolerated safety profile in patients over long-term, chronic use of the drug. --- NLS-1 and NLS Pharma were incorporated in June 2015 and NLS-0 was incorporated in April 2016, each in Switzerland. In March 2019, and pursuant to Swiss law, effective as of January 1, 2019, NLS-0 and NLS Pharma each merged with and into NLS-1. We refer to these transactions throughout the prospectus included in this registration statement collectively as the “Reorganization.” As part of the Reorganization, all assets and liabilities of NLS-0 and NLS Pharma were transferred to NLS-1 by way of universal succession (pursuant to which, under Swiss law, assets and liabilities are transferred as a whole and in one act), and NLS-1 was renamed NLS Pharmaceutics Ltd. Our registered office and principal executive offices are located at Alter Postplatz 2, CH-6370 Stans, Switzerland. Our telephone number in Switzerland is +41.41.618.8000. Our website address is nlspharma.com.
NewcelX Ltd. annual income statement and balance sheet, FY 2021 to FY 2025, as reported in SEC filings.
| Metric | FY 2021 | FY 2023 | FY 2024 | FY 2025 |
|---|---|---|---|---|
| Operating income | ($11.9M) | ($3.0M) | ($2.1M) | ($2.6M) |
| Net income | ($11.9M) | ($3.3M) | ($7.2M) | ($8.3M) |
| Metric | FY 2021 | FY 2023 | FY 2024 | FY 2025 |
|---|---|---|---|---|
| Total assets | $5.8M | — | $903K | $11.4M |
| Total liabilities | $5.2M | — | $8.9M | $4.2M |
| Total equity | $542K | ($1.2M) | ($8.0M) | $7.3M |
| Cash & equivalents | $5.4M | $1.1M | $650K | $2.2M |