Newcelx Ltd. · NASDAQ:NCEL
Newcelx — NLS Pharmaceutics — Investor Presentation (February 2023)
33 slides from Newcelx's investor presentation, Feb 1, 2023
Slide 1: Thank you for joining. The presentation will begin shortly.
T h a n k y o u f o r j o i n i n g . T h e p r e s e n ta t i o n w i l l be g i n s h o r t l y .
Slide 2: Redefining Central Nervous System Therapies
2 R e d e f i n i n g C e n t r a l N e r v o u s Sys t e m T h e r a p i e s N L S P i p e l i n e G o al s a n d Deve l o p m en t S t r a t e g ies J a n u a r y 31 , 202 3
Slide 3: Forward-Looking Statements
Fo r w a r d - Lo o k i n g S t a t e m e n t s This presentation contains express or implied forward - looking statements within the Private Securities Litigation Reform Act of 1995 and other US Federal securities laws. For example, we are using forward - looking statements when we discuss the resu
Slide 4: Alex Zwyer, Chief Executive Officer & Co-Founder
A l e x Zw y e r C h i e f E x e c u t i v e O ffi ce r & Co - F o u n d er
Slide 5: Business Highlights
* M a r k e t D a t a a s o f Ja n ua r y 12 , 2023 ** ResearchAndMarkets.com press release (January 19, 2022) 5 N A S D A Q : N L S P , N L S P W M ar k e t C a p * : $ 59.02 M S ha r e s O u t s t a n d i n g: 32.43 M A D T V ( 3 m o . ) : 446.3K Bu s i n e s s H i g h l i g h t s NLS develops dru
Slide 6: NLS Strategic Priorities
6 202 3 NL S St r at e g i c P r i o r i t i e s Focus on Rare and Complex CNS Disorders L e a d i ng e d g e s c i e nc e Wel l capitalize d – f u nd e d t h r o u g h e nd o f 2025 S e a s o n e d l e a d e r s hi p t e a m w i t h trac k record o f success M u l t i p l e s ho t s o n g o a l F l
Slide 7: Leadership Team
7 N L S Le a d e r s h i p T e a m A l e x Z w y e r , M B A Chief Executive Officer & Co - Founder A co - f o un d e r of t he co m p a n y w i t h e x t en s i v e o p e r a t i o n a l , C - l e v e l p h a r m a ce u t i c a l e x p er i en c e . A s e r i a l entrepreneur and strong leader with
Slide 8: Experienced Management Team Assembled
E x p e r i e n ce d Ma n a g e m e n t T e a m A ss e m b l e d AVERAGE 30+ YEARS 100+
Slide 9: Pipeline Update
9 R e d e f i n i n g C e n t r a l N e r v o u s Sys t e m T h e r a p i e s N L S P i p e l i n e U p d a te
Slide 10: George Apostol, MD, MS, Chief Medical Officer
G e o r g e A po s t o l , M D , MS C h i e f M e d i c a l O ffi ce r
Slide 11: NLS Guiding Considerations for Evaluating Pipeline Products
11 Hi g h Unm e t M e d i cal Ne e d with Scientific Rationale Favorable Commercial Po t e n t ial w i t h S t ro ng I P Position Well Established Clinical D e v e l op m e nt Pathway NL S G u i d i ng Cons i d e r a t i ons f or E v a l u a t i ng P i pe l i n e P r o d uc t s
Slide 12: Pipeline Overview
12 N L S P i p e l i n e O v e r v i ew *Including Long - COVID, Cancer fatigue, ME/CFS; Additional indications include hypersomnia * * I n c l u d i n g d e m e n t i a i n s y n u cl e op a t h i e s s u c h a s P a r k i ns o n ’ s D i s e a se : Product C a n d i da t e Selection Preclinical IND
Slide 13: Pre-Clinical Programs
13 R e d e f i n i n g C e n t r a l N e r v o u s S y s t e m Therapies P r e - Cl i n i c a l Pro g r a m s
Slide 14: Target Indication: Kleine-Levin Syndrome
14 N L S - 11 N L S - 11 T a r g e t i n d i c a t i o n : Kl e i n e - Le v i n S y n d r o me Previous development (Schering) demonstrated a benefit on hypersomnia symptoms and exhaustion in adults As of today, there are no approved treatment available for KLS Promising results and extensive histo
Slide 15: Target Indication: Chronic Fatigue Syndrome
15 N L S - 4 N L S - 4 T a r g e t i n d i c a t i o n : C h r o n i c F a t i g u e S y n d r o m e (CF S )* I n c l u d e s L o n g - COV I D a nd C a n c e r f a t i g u e Up to 1% of primary - care patients have CFS. No approved pharmacological therapy Additional indications include Idiopathic H
Slide 16: Target Indication: Alzheimer's Disease
16 N L S - 8 N L S - 8 T a r g e t i n d i c a t i o n : Al z h e i m e r’s D i s e a s e Preclinical study focusing on neurodegenerative disorders, specifically on the pathological process of Alzheimer’s Disease (AD) demonstrated an improvement on amnesia symptoms associated with neurodegenerative
Slide 17: Target Indications: Dementias with Lewy Bodies, Parkinson's and Alzheimer's
17 N L S - 12 N L S - 12 Tar g e t i n d i ca t i o n s : D e m e n t i a s a ssoc i a t e d w i t h L e w y B od i e s * , Pa r k i n s o n ’ s a n d A l z h e i m e r ’ s Preclinical study shows positive results for the treatment of neurological disorders including Dementia with Lewy Bodies, Parki
Slide 18: Target Indications: Autism Spectrum Disorders, Substance Use Disorder
18 N L S - 3 N L S - 3 Tar g e t i n d i ca t i o n s : Au t i s m S p e c t r u m D i s o r d e r s ( ASD ) , S u b s t a n c e U s e D i so r der ( SU D) Preclinical studies for NLS - 3 show potential for the treatment of ASD with improved efficacy, safety and tolerability versus MPH NLS has intel
Slide 19: Clinical Program
19 R e d e f i n i n g C e n t r a l N e r v o u s Sys t e m T h e r a p i e s N L S C l i n i cal P r o gr am
Slide 20: POLARIS: Mazindol ER Development Program in Narcolepsy
20 P O L A R I S : M a z i n d o l ER D e v e l o p m e n t P r o g r a m i n N a r c o l e p s y The Mazindol ER development program POLARIS currently consists o f t w o US c l i n i c a l tri a l s b o th a ppr o v e d by F D A/ W I RB * • NLS - 1021 Phase 2, A four - week double - blind, placebo
Slide 21: Reduction of Excessive Daytime Sleepiness
21 D B B L D B W1 D B W2 D B W3 D B W4 W4 W8 W12 Placebo 33 32 32 30 28 23 19 15 M a z i nd ol ER 34 34 34 33 32 27 24 23 6 8 10 12 14 16 18 20 DB B L DB W 1 DB W 2 DB W 3 DB W 4 OL E W 4 OL E W 8 OL E W 1 2 Change from Baseline ESS Total Score N o rma l R an ge Placebo Ma z i nd o l E R • C l i n i
Slide 22: Weekly Cataplexy Episodes
22 0 . 0 8 . 0 6 . 0 4 . 0 2 . 0 1 0 . 0 1 2 . 0 1 4 . 0 1 6 . 0 1 8 . 0 D B W 4 O L E W 1 O L E W 2 O L E W 3 O L E W 4 O L E W 1 0 O L E W 1 1 O L E W 1 2 Av e r a ge W e e k l y C a t a p l e x y E p is o d e s Com b i n e d D B a n d O L E s t u d i e s – 4+1 2 w ee k s Weekly cataplexy episodes
Slide 23: POLARIS: DB + OLE Conclusions - Safety
23 P O LARI S : D B + O L E Co n c l u s i o n s Safety • Mazindol ER was well - tolerated with even the most common AEs (dry mouth, nausea, decreased appetite) being benign in nature and o c c u rr i n g i n l e ss t h an o n e i n f i v e p a t i e n t s • All adverse events where either mild or m
Slide 24: POLARIS: DB + OLE Conclusions - Efficacy
24 P O LARI S : D B + O L E Co n c l u s i o n s Efficacy • Mazindol ER demonstrated rapid, consistent, and clinically meaningful efficacy in the treatment of sleepiness in adult subjects with narcolepsy as well as a strong signal in treating cataplexy episodes • Patients treated with Mazindol ER co
Slide 25: Quilience: 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 26: Mazindol: Idiopathic Hypersomnia
26 N L S - 1 3 ( maz i n d o l ) I d i op a t h i c H y p e r s o m n i a • O r p h a n D r u g D e s i g n a t i o n i n t h e U S an d E u r o p e • Phase 2 studies with Mazindol ER demonstrated efficacy in narcolepsy patients w i t h T y p e II d i s o r de r , w h i c h h a s s t r o n g s i m i
Slide 27: Mazindol: ADHD
27 N L S - 2 0 ( maz i n d o l ) AD H D • NLS - sponsored Phase 2 trial in ADHD demonstrated efficacy comparable to first - line CII stimulants with favorable tolerability • T r i a l v a l i d a t e d o n c e - d a i l y f o r m u l at i o n • Studies suggest ADHD and narcolepsy are genetically rel
Slide 28: Alex Zwyer, Chief Executive Officer & Co-Founder
A l e x Zw y e r C h i e f E x e c u t i v e O ffi ce r & C o - F o u n d e r
Slide 29: Anticipated Milestones
29 A n t i c i p a t e d M i l e s t o n e s • Complete results for Quilience® in narcolepsy Open Label Extension (OLE) s t u d y a v a i l a bl e ( Q 1 / 2 023 ) • F D A E n d - o f - P h a s e 2 M ee t i n g ( Q 1 / 2023) • Potential for accelerated regulatory pathway designations (FastTrack, Br e
Slide 30: Why? Focused Growth in 2023
30 W h y N L S ? F o c u se d G r o w t h i n 2023 • 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 s y s t e m d
Slide 31: Questions for Panel
Questions for Panel NLS Pharmaceutics
Slide 32: NLS Pharmaceutics
2 x _ NLS Pharmaceutics © Connecting Brains ~ 4 9 Brains
Slide 33: This concludes our presentation. Thank you for joining.
T h i s c o n c l u d e s o u r p r e s e n ta t i o n . T h a n k y o u f o r j o i n i n g .
NLS Pharmaceutics — Investor Presentation (February 2023) on 6ix