Vyne Therapeutics Inc. · NASDAQ:VYNE
Vyne Therapeutics — Investor Presentation (November 2021)
32 slides from Vyne Therapeutics's investor presentation, Nov 10, 2021
Slide 1: Investor Presentation November 2021
INVESTOR PRESENTATION November 2021
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation includes forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 , including, but not limited to statements regarding the development of VYNE’s product candidates and other statements regarding the future ex
Slide 3: Investment Highlights
3 Investment Highlights (NASDAQ: VYNE) VYNE is focused on developing proprietary, innovative, and differentiated therapies for the treatment of immuno - inflammatory conditions Innovative Pipeline • Pipeline focused on major immuno - inflammatory conditions and rare skin diseases with high unmet med
Slide 4: Novel Pipeline for Immuno-Inflammatory Conditions
Novel Pipeline for Immuno - Inflammatory Conditions FMX114: Mild to moderate Atopic Dermatitis VNY202: Oral BD2 BET inhibitor for major I&I conditions 1 VYN201: Topical BD1/BD2 BET Inhibitor for rare skin conditions 1 Preclinical Candidate Selection Status IND - enabling studies underway Development
Slide 5: Targeted Clinical Milestones through 2023
Targeted Clinical Milestones through 2023 Driving Pipeline to Proof - of - Concept • Q4: 2021: Phase 1b/2a initiated • Q1:2022: Phase 1b/2a Top - line results • Q2: 2022: Submit IND FMX114 (tofacitinib & Fingolimod gel) • 1H:2022: Submit IND • Mid - 2022: Initiate Phase 1 • Phase 1 results 6 to 12 m
Slide 6: FMX114 Tofacitinib and Fingolimod Topical Gel for Atopic Dermatitis
FMX114 Tofacitinib and Fingolimod Topical Gel for Atopic Dermatitis 6
Slide 7: Program Highlights
Program Highlights Target Market Treatment of Patients with mild - to - moderate Atopic Dermatitis, ~19MM people (US) Preclinical Safety • Demonstrated preclinical tolerance, with no evidence of skin atrophy • Skin barrier function recovered Next Milestone Topline results of Phase 1b/2a Trial: Q1 20
Slide 8: FMX114 Atopic Dermatitis Market Opportunity
FMX114 Atopic Dermatitis Market Opportunity >85% of treated patients are categorized as mild - to - moderate disease severity Source: Data on file. *Prescription numbers from 2019 30 Million people in the U.S. have a diagnosis of atopic dermatitis (AD) 0 10M 20M 30M 0 10M 20M 30M 22 Million of those
Slide 9: FMX114 Designed to Address Both Source & Cause of Inflammation in AD
Intracellular space Extracellular space Activated STATs Inactive STATs Nucleus Activated JAK Inactive JAK Receptor Cytokines Phosphate FMX114 Designed to address both the source & cause of inflammation in AD Image Sources: Leung DY, Guttman - Yassky E. J Allergy Clin Immunol . 2014;134(4):769 - 779
Slide 10: FMX114: Comparable Efficacy to Triamcinolone in Murine Model
FMX114: Comparable Efficacy to Triamcinolone in Drug - Induced Murine Model: Modified Atopic Dermatitis Index ( mADI *) Dorsal depilated BALB - C mice were dosed for 39 days with 100µl topical DNCB solution (Day 1 - 32 induction phase, Day 32 - 38 treatment phase). N=8 animals were assigned to 7 tre
Slide 11: Body Weight Comparison in Murine Model
11 -15 -14 -13 -12 -11 -10 -9 -8 -7 -6 -5 -4 -3 -2 -1 0 1 2 3 4 5 6 7 8 9 10 0 1 2 3 4 5 6 7 Mean percent change in body weight Post - induction treatment day Non-induced, healthy vehicle control DNCB control Tofacitinib 0.3%, Fingolimod 0.02% gel Tofacitinib 0.6%, Fingolimod 0.01% gel Triamcinolone
Slide 12: FMX114: Normal Skin Physiology in Murine Atopic Dermatitis Model
DNCB - 2,4 - Dinitrochlorobenzene FMX114 Dose 2: Tofacitinib 0.6%, Fingolimod 0.01% Gel DNCB Control Triamcinolone 0.1% Cream • No appreciable improvement in clinical signs • Substantial resolution of clinical signs • Skin presents with normal physiology with no evidence of striae rubrae (stretch ma
Slide 13: FMX114 Phase 1b/2a Proof of Concept Study
FMX114 Phase 1b/2a Proof of Concept Study Randomized, double - blinded, vehicle - controlled Phase 1b/2a trial with separate open - label active treatment phase evaluating the safety, pharmacokinetics & efficacy of FMX114 gel vs. vehicle gel in the treatment of mild - to - moderate atopic dermatitis
Slide 14: InhiBET BET Inhibitor Platform
InhiBET ΠBET Inhibitor Platform Bromodomain & Extra - Terminal Domain (BET) Inhibition for Immunology and Inflammatory Diseases 14
Slide 15: InhiBET BET Inhibitor Platform Overview
BD1 BD2 BRD4 is the most well - characterized BET Protein EXT Characterized by 2 bromodomains and 1 extra - terminal domain InhiBET ΠBET Inhibitor Platform Overview Platform includes global rights to a library of NCEs for any indication Innovative, Clinically Validated Therapeutic Target: Key regul
Slide 16: BET Background: Epigenetic Regulation via Histone Modification
BET Background: Epigenetic regulation of gene expression occurs via histone modification Chromosome DNA Chromatin Inactive gene Histone tail Histone DNA inaccessible Inactive gene Epigenetic Factor DNA accessible Active gene Active gene Acetylated lysine 16
Slide 17: BET Proteins Regulate Gene Transcription
Gene transcription stimulated N - terminal tail of histone Gene transcription silenced Nucleosome Transcription factors BET Proteins: a Family of Nuclear Proteins that Regulate Gene Transcription via Epigenetic Interaction BET proteins: • “read” acetylated lysines on the N - terminal tail of a histo
Slide 18: BET Proteins in Inflammatory and Oncogenic Genes
BET Proteins Play a Key Role in the Regulation of Inflammatory and Oncogenic Genes involved in Several Diseases Gene transcription stimulated Histones N - terminal of histones BRD4 Oncogenic genes, leading to: • Increased cell proliferation/survival • An increase in solid tumors and hematologic mali
Slide 19: BET Proteins and the Vicious Cycle of Cytokine Production
How BET Proteins Fuel the “Vicious Cycle” of Pro - Inflammatory Cytokine Production in Autoimmune Diseases Pro - inflammatory cytokines Cytokines bind to cytokine receptors 1 Activation of NF - kb kinase complex 2 Nuclear translocation 3 Recruitment of transcription factors 4 5 6 BRD4 active cytokin
Slide 20: BET Inhibitors Block BD1/BD2 Binding
BET Inhibitors Block BD1/BD2 Binding to Acetylated Lysines and Stall Pro - inflammatory Protein Transcription BET INHIBITOR Binds BD1 and/or BD2 of BRD4 protein making it unable recognize acetylated histones, recruit transcription factors and release pro - inflammatory cytokines Pro - inflammatory c
Slide 21: VYN201 Program Highlights
VYN201 Program Highlights Potential Target Market: Clinical indication selection following preclinical program evaluation • Treatment of rare skin diseases, <200,000 patients • Systemic exposure mitigation via topical application and “soft” approach Broad activity: • Binds to BD1 and BD2 domains of
Slide 22: VYN201 Dose-Dependent Efficacy in Murine Model
IMI – Imiquimod. *Composite Inflammation Severity Score is a composite mean score of erythema and peeling severity scored on a 4 - point ordinal sc ale per domain (0=none, 1=mild, 2=moderate and 3=severe for a maximum score of 6), data expressed as a mean percentage change from initiation of treatme
Slide 23: VYN201 Biomarker Reduction
IMI – Imiquimod. Dorsal depilated BALB - C mice were dosed topically for 14 days with 100mg topical IMI cream (Day 1 - 7: induction phase, Day 8 - 14: treatment phase). N=4 animals were assigned to each treatment group with each group receiving 100mg of allocated treatment on Day 8 - 14 once daily •
Slide 24: VYN201: Normal Skin Physiology in Th17 Murine Model
VYN201 0.1% VYN201 Vehicle Clobetasol Cream 0.05% • No appreciable improvement in clinical signs • Substantial resolution of clinical signs • Skin presents with normal physiology with no evidence of striae rubrae or atrophy • No evidence suggestive of intolerance • Substantial resolution of clinical
Slide 25: VYN201 Reduced Pro-Inflammatory Proteins in Human Tissue
VYN201 Significantly Reduced Expression of Several Key Pro - Inflammatory Proteins Relevant to Th17 - mediated Autoimmune Diseases in Human Tissue 1 0 20 40 60 80 100 120 Percent inhibition (IL - 17 α ) Interleukin 36 - gamma IL36 γ is implicated in upregulating IL - 17A signaling - related genes an
Slide 26: VYN201 Murine Wound Healing Study
Female hairless mice (n=4/group) had two identical 10mm incisions made either side of the flank. Animals were topically dosed 1X daily with 100mg VYN201 vehicle, VYN201 1% or a hydroalcoholic gel* until each wound had completely healed • Statistically significant difference in composite global exter
Slide 27: VYN201: Little Residual Swelling in Skin Healing Model
VYN201 1% VYN201 Vehicle Hydroalcoholic gel • Still evidence of minor swelling around incision sites • Little evidence of residual swelling • Wound appears more macular in nature compared to VYN201 vehicle or the hydroalcoholic gel • Incision sites appear less distinct and leave a more aesthetic out
Slide 28: VYN202 Program Highlights
Potential Target Market 1 : • Immuno - inflammatory indications such as rheumatoid arthritis, systemic lupus erythematosus, ulcerative colitis/Crohn's and multiple sclerosis; additional potential in myeloproliferative neoplastic disorders 2 Focused activity: • Highly selective inhibition of BD2 doma
Slide 29: Divestiture Process for Topical Minocycline Franchise
Divestiture Process for Topical Minocycline Franchise Discussions ongoing with potential counterparties MST TM Franchise Portfolio Based on Proprietary Foam Platform to Optimize Topical Minocycline Delivery Product Indication / Function Status Moderate - to - severe Acne Vulgaris NDA Approved, Launc
Slide 30: Seasoned Team, Strong Platform Supported by Scientific Advisors
30 Seasoned Team, Strong Platform Supported by Well - Respected Scientific Advisors Leadership team has developed or commercialized >25 FDA - Approved products Complemented by an Expert I&I Scientific Advisory Board Seasoned R&D team with proven track record of progressing products through the devel
Slide 31: Targeted Clinical Milestones through 2023
Targeted Clinical Milestones through 2023 Driving Pipeline to Proof - of - Concept • Q4: 2021: Phase 1b/2a initiated • Q1:2022: Phase 1b/2a Top - line results • Q2: 2022: Submit IND FMX114 (tofacitinib & Fingolimod gel) • 1H:2022: Submit IND • Mid - 2022: Initiate Phase 1 • Phase 1 results 6 to 12 m
Slide 32: a THERAPEUTICS
rd a THERAPEUTICS
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