Palisade Bio, Inc. · NASDAQ:PALI
Palisade Bio — Neuralstem — Investor Presentation (November 2019)
25 slides from Palisade Bio's investor presentation, Nov 4, 2019
Slide 1: Seneca Biopharma (NASDAQ: SNCA)
1 Seneca Biopharma (NASDAQ: SNCA) NASDAQ listed company dedicated to developing reduced - risk innovative biopharmaceuticals for the treatment of human immunological diseases
Slide 2: Disclaimer and Safe Harbor Statement
2 DISCLAIMER The following slides and information contained therein are based upon Seneca Biopharma successfully : ( i ) entering into a royalty and milestone free, perpetual, non - cancelable, exclusive worldwide, other than in Greater China (which includes Hong Kong, Macau and Taiwan and certain o
Slide 3: Introduction: Opportunity, Team and Pipeline
3 INTRODUCTION Opportunity, Team and Pipeline
Slide 4: Rapid, differentiated platform: rabbit mAb drug development engine
4 Rapid, differentiated platform: rabbit mAb drug development engine • Humanized rabbit monoclonal antibody platform with rich and deep repertoire • Differentiated: Better mAb’s ; novel, patentable epitopes • Rapid: Speed to market • Product Engine: Evergreen source of new mAb clinical candidates Se
Slide 5: New Pipeline and Legacy Assets
5 New Pipeline • New pipeline of biologics for immunological disease and engine for future product candidates • 6 novel drugs; plus at least one additional candidate per year from platform • Lead drugs address multi - billion dollar markets Legacy Assets • NSI - 566: cell therapy for treatment of AL
Slide 6: Lead programs
6 Lead programs • SNC005: Asthma and Atopic Dermatitis ▪ Anti - IL4R ▪ “Second Mover” to Dupixent ® • SNC006: Systemic Lupus Erythematosus SLE ▪ Anti - IFNR ▪ “Second Mover” to Anifrolumab Current Status of AutoImmune Pipeline • 2 Novel mAbs entering Phase 1 in China • 4 products in research/preclin
Slide 7: Immunological Disease Pipeline for the Global Market (Planned)
7 Immunological Disease Pipeline for the Global Market (Planned) SENECA BIO
Slide 8: QYuns: A Regional Partner Developing World-class Drugs
8 • Deep pipeline of biologics being developed for China and regional market • Successful US - trained team with deep experience in mAb drug development • Robust pre - clinical and manufacturing capabilities to US Standards • Pipeline Partnership: Seneca developing novel pipeline for Global market •
Slide 9: QYuns' Novel Rabbit mAb Platform and Product Engine
9 Broader range of antigens • 50 - fold more B - cells for screening due to larger spleen compared to mouse • Additional mechanisms (somatic gene conversion of rearranged VDJ genes) • Rabbit CDRs possess greater diversity than mouse CDRs Ideal for fast - follower “second mover advantage” strategy •
Slide 10: Seneca Biopharma Management & Key Advisors
10 Seneca Biopharma Management & Key Advisors Kenneth Carter, Ph.D. Executive Chairman • 20+ years as CEO/Chairman of public and private companies • Multiple successful biotechnology companies • Broad pharma, R&D and Business networks Mathew Kalnik, Ph.D. Senior Operations Consultant • 20+ years exe
Slide 11: SNC005 Lead Program
11 SNC005 LEAD PROGRAM
Slide 12: SNC005: Anti-IL4R Second Mover to Dupixent: Asthma & Atopic Dermatitis
12 Target: Anti - IL4R mAb with affinity and preclinical efficacy comparable to or better than Dupixent ( dupilumab ) Blockbuster market: $5.8 billion Dupixent peak sales forecast 1 : $2.5 billion in Asthma (43%) Robust sales trajectory: $931 million across the first six months of 2019 and is on its
Slide 13: SNC005 Targets IL-4Rα Subunit, Inhibiting IL-4 & IL-13
13 SNC005 Targets IL - 4R α Subunit, Inhibiting IL - 4 & IL - 13 Type 2 Inflammatory R esponse Atopic dermatitis, Asthma, Nasal polyposis, Chronic Obstructive Pulmonary Disease SNC005 (anti - IL4R α ) Dupixent Casele , TB, J Allergy Clin Immunol 2017;139:1411 - 21 Th2 cytokines IL - 4, IL - 5, IL -
Slide 14: SNC005 Inhibits IL-4/IL-13 Induced Signal Transduction, Similar To Dupixent
14 SNC005 Inhibits IL - 4/IL - 13 Induced Signal Transduction – Similar To Dupixent in vivo x axis 0.01 0.1 1 10 100 1000 10000 0 0.2 0.4 0.6 0.8 1 1.2 4-P Fit: y = (A - D)/( 1 + (x/C)^B ) + D: A B C D R^2 Dupilumab (Group01: Concentration vs Values) 1.05 1.25 3.8 0.0561 0.997 QX005N (Group02: Conce
Slide 15: SNC005 Better Than Or Comparable To Dupixent In In Vitro Assays
15 SNC005 Is Better Than Or Comparable To Dupixent In Extensive Battery Of in vitro Binding & Functional Assays Assay SNC005 Dupixent Ratio Method Bioactivity （ i n vitro ） Blocking IL - 4 binding to IL - 4R α ( ELISA) IL - 4 30.2 27.5 0.91 ELISA （ IC50 : ng/ml ） Inhibiting IL - 4/IL - 13 induced HE
Slide 16: SNC005: Comparable Efficacy to Dupixent in Asthma Model
16 SNC005: Demonstrates Comparable Efficacy to Dupixent in Human Transgenic B - hIL4/IL4R Asthma Model (Mouse) Eosinophil count
Slide 17: SNC005: Few Early-Stage Anti-IL4R Competitors Beyond Dupixent
17 SNC005: Few Early - Stage Anti - IL4R Competitors Beyond Dupixent Phase 2 Atopic Dermatitis • Dupixent + REGN - 3500: IL4R & IL33 (Regeneron/Sanofi) ▪ Recent study results indicated that combo was no more effective than Dupixent alone Phase 1 Asthma • AZD - 1402/PRS - 060: IL4R (AstraZeneca/ Pier
Slide 18: SNC005: Key Atopic Dermatitis and Asthma Competitors Beyond IL4R
18 SNC005: Key Atopic Dermatitis and Asthma Competitors Beyond IL4R Late Stage Asthma Pipeline • Fevipriprant (CRTH2 inhibitor/Novartis – oral) Phase 3 program (6 trials) across different asthma endotypes (incl. moderate to severe) • Tezepelumab (anti - TSLP/ Astrazeneca ) Phase 3 program targets br
Slide 19: Global Sales For Asthma Biologics
19 • Share shifting rapidly between drugs • Fasenra launched 2017 • Xolair came off patent in 2018 • Dupixent approved in Asthma in 2019 • Dupixent peak sales forecast in Asthma $2.5 Billion $3.5B+ Global Sales For Asthma Biologics *Sources : • Fasenra : Astrazeneca Q 1 2019 investor presentation, H
Slide 20: SNC005 Positioned as Fast-Follower to Dupixent
20 • SNC005 Positioned as “Fast - Follower” to Dupixent • Order of magnitude peak sales opportunity for SNC005 estimated at between $1 to $2B USD for Asthma alone Peak Market Sales Estimate for SNC005 (Targeting IL4Ra) SNC005 Opportunity $ Millions
Slide 21: Robust In-Licensed IP on Novel Rabbit mAbs
21 Robust In - Licensed IP on Novel Rabbit mAbs • Multiple Chinese patent applications on humanized lead selection for all products • Several upcoming PCT filings on one - year anniversary • Issued Claims in China & Published Patent Application SNC002 “Anti - human interleukin 17A monoclonal antibod
Slide 22: Summary
22 SUMMARY
Slide 23: Beyond Lead Programs: Leveraging Future Potential of QYuns Platform
23 8 mAbs developed in 5 years: 4 in Phase 1 in China Beyond Lead Programs: Leveraging Future Potential of High Efficiency QYuns Platform Evergreen source of new mAb Phase 1 candidates (1/ yr ) Biosimilars Novels
Slide 24: Summary: Seneca Biopharma; De-risked Drug Development
24 Multi Billion Dollar Global Peak Sales Opportunity • Second Mover Advantage: SNC005 “Fast - Follower” to Dupixent • Follow - on Global opportunities: SNC002 (Asthma, anti - IL17A) & SNC006 (SLE, anti - IFNR) Rapid differentiated drug - development platform • Better mAbs binding novel patentable e
Slide 25: Thank You
25 THANK YOU Contact Information: Kenneth Carter, PhD Executive Chairman kcarter@senecabio.com Thank you