Newcelx Ltd. · NASDAQ:NCEL
Newcelx — NLS Pharmaceutics — Corporate Update (July 2023)
41 slides from Newcelx's corporate update, Jul 20, 2023
Slide 1: Thank you for joining. The presentation will begin shortly.
Thank you for joining. The presentation will begin shortly.
Slide 2: NLS Pharmaceutics Company Update: Redefining Central Nervous System Therapies
NLS Pharmaceutics Company Update July 6, 2023 Re defining Central Nervous System Therapies
Slide 3: Forward-looking statements
This presentation 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 its clinical trials, the expected timing of our future clinical trials; its proposed product pipeline; the r
Slide 4: Alex Zwyer, Chief Executive Officer & Co-Founder
Alex Zwyer, MBA Chief Executive Officer & Co - Founder
Slide 5: Vision, Mission and Values
VISION Awaken a brighter future for patients by overcoming rare and complex CNS diseases MISSION To develop better therapies to safeguard and empower the brain throughout all stages of life VALUES Put Patients First Think Inquisitive & Disruptively Act with Integrity & Scientific Honesty Collaborate
Slide 6: 2023 NLS Strategic Priorities
2023 NLS Strategic Priorities Focus on Rare and Complex CNS Disorders • Leading edge science • Seasoned team with track record of success in CNS • Multiple shots on goal • Flexible & nimble business model Develop Mazindol • Initiate Phase 3 program for treatment in adult patients with narcolepsy • E
Slide 7: Experienced Team Assembled
Marianne Lambertson, MSc, MSW Corporate Communications and Investor Relations Harvey Kushner Biostatistics Tom Curatolo, MBA US Commercial Operations Beat Widler, PhD Quality Hervé Girsault, MBA Business Development & Licensing Christina Allgeier US GAAP Controller Pelin Vatanacan Finance Operations
Slide 8: NLS Pipeline Overview
NLS Pipeline Overview Phase 3 Phase 2 IND enabling Preclinical Compound Indication Therapeutic Area Mazindol ER Narcolepsy NT1 Narcolepsy NT2 Idiopathic Hypersomnia Sleep Disorders NLS - 4 ⇞ Idiopathic Hypersomnia NLS - 11* Kleine - Levin Syndrome NLS - 4 ⇞ CFS/ME Long COVID CNS/Immunology NLS - 8*
Slide 9: Central Disorders of Hypersomnolence
NT1 IH Cataplexy Refreshing naps Disrupted sleep Sleep paralysis Sleep - related hallucinations No cataplexy Excessive daytime sleepiness (e.g., ESS >10) MSLT sleep latency <8 min Sleep inertia May have long sleep (> 11 h/day) May remit spontaneously Circadian dysrhythmia NT1, Narcolepsy type - 1; N
Slide 10: George Apostol, Chief Medical Officer
George Apostol, MD, MS Chief Medical Officer
Slide 11: Multifaceted Impact on Patients
Multifaceted Impact on Patients • Worsened HRQoL • Impaired social life and isolation • Memory Problems • Impaired critical thinking Sleep Disruption Excessive Daytime Sleepiness Cataplexy Hypnogogic Hallucinations Sleep Paralysis • Increase risk of accidents while driving • Poor work/academic perfo
Slide 12: The Narcolepsy Patient Journey
The Narcolepsy Patient Journey Increasing Prevalence In 2022, it was estimated that ~165 K people had narcolepsy in the U.S., likely growing to ~224 K by 2035 Median time to diagnosis 22 months • More than 50% of patients experience a delay >1 year between report of symptoms and diagnosis • Nearly 2
Slide 13: Currently FDA Approved Treatments
Currently FDA Approved Treatment Safety Considerations Common AE’s Dose MOA Medicine May reduce effectiveness of oral contraceptives; may increase HR and BP Anxiety, back pain, diarrhea, dizziness, dyspepsia, headache, insomnia, and nausea 100 - 400mg/ 50 - 250mg Dopamine reuptake inhibitor Modafini
Slide 14: Narcolepsy: Debilitating Disorder; Large and Underserved Population
• Narcolepsy is a chronic neurodegenerative disease caused by a deficiency of orexin - producing neurons in the lateral hypothalamus 1 • No commercially available products target this immune - mediated neuronal destruction; most patients remain unsatisfied with their treatment 2 1. www.ncbi.nlm.nih.
Slide 15: Mazindol ER dual SNDRI/OX2R partial agonist
• Long history of the active ingredient (mazindol) used to treat narcolepsy (“Compassionate Use” Programs) • Novel dual mechanism of action with partial Orexin - 2 receptor activation & triple monoamine reuptake inhibition • Positive Phase 2 results: met most endpoints with high statistical signific
Slide 16: Mazindol: History & Mechanism of Action
Mazindol: History & Mechanism of Action Wakefulness Release of Dopamine Nucleus accumbens Tuberomammilary nucleus (histamine) Ventral tegmental area (dopamine) Raphe nuclei serotonin Locus coeruleus norepinephrine • Mazindol has been commercialized in the US and in Europe during the 1970’s - 2000’s
Slide 17: Overview of NLS-conducted Mazindol Studies
Overview of NLS - conducted Mazindol Studies COMPLETED NONCLINICAL • ADME: Comprehensive in vitro drug interaction studies • Pharmacology: • in vitro OX2R receptor binding studies • in vitro cellular and nuclear receptor functional assays • OX - 2R Agonist Pilot Study in Mice • Safety pharmacology s
Slide 18: POLARIS: Mazindol ER Development Program in Narcolepsy
POLARIS: Mazindol ER Development Program in Narcolepsy The Mazindol ER development program POLARIS consisted of two US clinical trials: • NLS - 1021 Phase 2, A four - week double - blind, placebo controlled, randomized, US multi - center study of Mazindol ER 3 mg once daily vs. placebo (1:1) • NLS -
Slide 19: Reduction of Weekly Cataplexy Episodes
19 Placebo Double - Blind study Open Label Extension study NLS - 1022 Reduction of Weekly Cataplexy Episodes Combined DB and OLE studies: 4 & 24 weeks Mazindol ER 2.0 0.0 4.0 6.0 8.0 10.0 12.0 14.0 16.0 18.0 DB Baseline (Day 1) DB Final (Day 28) OLE Week 4 OLE Week 8 OLE Week 12 OLE Week 16 OLE Week
Slide 20: Tolerability
20 Tolerability Total (n = 52) MZD MZD (n = 24) PBO MZD (n = 28) TEAE 7 (13.5%) 3 (12.5%) 4 (14.3%) Dry Mouth 5 (9.6%) 2 (8.3%) 3 (10.7%) Covid - 19 4 (7.7%) 0 4 (14.3%) Constipation 4 (7.7%) 3 (12.5%) 1 (3.6%) Urinary Tract Infection 3 (5.8%) 1 (4.2%) 2 (7.1%) Nausea Total (n = 52) MZD MZD (n = 24)
Slide 21: Summary of SLEEP 2023
Summary of SLEEP 2023 • Oral presentation: • Clinician and Patient Global Impression in a Phase 2 Study of Mazindol (NLS - 1021) in Adults with Narcolepsy Type 1 & Type 2 • Additional Poster Presentations: • Functional Outcomes of Sleep Questionnaire in a phase 2 study of mazindol ER in narcolepsy •
Slide 22: Phase 3 Program NLS-1031, NLS-1032 and NLS-1033
Phase 3 Program NLS - 1031, NLS - 1032 and NLS - 1033
Slide 23: Phase 3 Narcolepsy Program
Phase 3 Narcolepsy Program Two identical placebo - controlled Phase 3 trials investigating Mazindol ER vs placebo, plus a 12 - month extension study NLS - 1033 • Open - label, one - year extension for participants completing NLS - 1031 and NLS - 1032 NLS - 1031 NLS - 1032 Summer 2023 Fall 2023 20 -
Slide 24: Parallel Design Studies
Parallel Design Studies • Population: ~50 NT1 participants treated with Mazindol ER or PBO for 8 weeks (1:1) • Dose: 3 mg once daily, no titration • Primary endpoint: Weekly Cataplexy Episodes from baseline to week 8 • An electronic diary will be completed daily for the week preceding the study visi
Slide 25: 12-Month OLE Study (NLS-1033)
12 - Month OLE Study (NLS - 1033) • Study Design: A 52 - week, open - label, multi - center study of Mazindol ER 3 mg once daily • Study population: ~100 participants (Completers from studies NLS - 1031 and NLS - 1032) • Rescue narcolepsy/psychiatric medications allowed in the study • Primary object
Slide 26: Clinical Trial At-A-Glance
Clinical Trial At - A - Glance • Who can participate? People who are aged 18 and above who have narcolepsy and are experiencing cataplexy • What medical conditions are being studied? Narcolepsy • What is the clinical trial testing? Mazindol ER, Placebo • How many participants are being enrolled? 100
Slide 27: Mazindol ER May Represent a Convenient Once-Daily Monotherapy Option
If approved, Mazindol ER May Represent a Convenient Once - Daily Monotherapy Option for Narcolepsy Simple, ONCE - DAILY, MONOTHERAPY , 30 - minutes before breakfast Effective on BOTH Cataplexy and Excessive Sleepiness as well as other symptoms of Narcolepsy RAPID onset of action Favorable drug - dru
Slide 28: Alex Zwyer and Tom Curatolo
Alex Zwyer, MBA Chief Executive Officer & Co - Founder Tom Curatolo, MBA Head of US Commercial
Slide 29: Anticipated Development Timeline
*Timelines are subject to change. There is no guarantee as to the success of any clinical trial. In addition, there is inherent risk and variability in the overall regulatory process. Approval by the FDA may not be granted, or the FDA may require different study parameters from those that are intend
Slide 30: Pre-commercial and launch planning
2025 2023 2024 Pre - Pivotal Data (Present through 2024) • Research: Forecasting, Market Access evaluation, Value Proposition • Advocacy Engagement: Collaborating on disease - state outreach and elevating company insight into patient unmet needs • Physician Mapping: Systematically analyzing the mark
Slide 31: NLS Focused Growth in 2023/24
NLS Focused Growth in 2023/24 Continue to build an organization dedicated to rare and complex central nervous system disorders Solidify opportunity for lead product Mazindol ER through rigorous Phase 3 program Realize mazindol franchise full potential across additional rare sleep disorders Progress
Slide 32: Keith Dewedoff, Chief Financial Officer
Keith Dewedoff Chief Financial Officer
Slide 33: AGM 2023 Highlights
AGM 2023 Highlights • The Board of Directors received the highest voting approval in the Company’s history of 99.5% of votes cast in favor of the proposals • 64% percent of the shares entitled to votes were represented • Shareholders approved the financial statements, the compensation report, and th
Slide 34: New Board Members
New Board Members Audrey Greenberg, MBA Co - Founder and Chief Business Officer, Center for Breakthrough Medicines Audrey is the co - founder, Executive Managing Director and Board Member of the Discovery Labs Center for Breakthrough Medicines, an integrated life science innovation hub helping to st
Slide 35: Key Financials
Key Financials YE 2022 Cash And Cash Equivalents $8.9M Total OPEX FY 2022 $15.9M Shares Outstanding as of 12 / 31 / 22 32,428,893 Employees as of 6/30/23 20 Institutional Ownership as of 12/ 31 / 22 19.67% $NLSP Financials
Slide 36: NLSP Financial Strategy
Capital Markets Partnerships Venture Debt BD Assessing multiple paths to advance Pipeline NLSP Financial Strategy
Slide 37: Why invest in NLS?
Why invest in NLS? Focused Growth • Experienced management team across pharmaceuticals, neuroscience, R&D and capital markets with a proven track record of bringing multiple drugs to market • Multiple innovative drug programs targeting rare and complex central nervous system disorders with high unme
Slide 38: Redefining Central Nervous System Therapies
Redefining Central Nervous System Therapies
Slide 39: Questions for Panel
Questions for Panel HOE NisPharmaceutics
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Slide 41: This concludes our presentation. Thank you for joining.
This concludes our presentation. Thank you for joining.