Vyne Therapeutics Inc. · NASDAQ:VYNE
Vyne Therapeutics — Investor Presentation (January 2022)
30 slides from Vyne Therapeutics's investor presentation, Jan 5, 2022
Slide 1: Investor Presentation January 2022
INVESTOR PRESENTATION January 2022
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 markets (Atopic Dermatitis and I&I) and rare skin diseases with high unmet
Slide 4: Pipeline and Near-Term Catalysts
Target Candidate Selection Preclinical Clinical Trials Near - Term Catalysts FMX114 Mild - to - moderate Atopic Dermatitis Q1:22: Phase 1b/2a top line results Q2:22: Submit U.S. IND VYN201 Topical BD1/BD2 BET Inhibitor for rare skin conditions 1 H1:22: Submit IND Mid:22: Initiate Phase 1 VYN202 Oral
Slide 5: FMX114 Tofacitinib and Fingolimod Topical Gel for Atopic Dermatitis
FMX114 Tofacitinib and Fingolimod Topical Gel for Atopic Dermatitis 5
Slide 6: FMX114 Program Highlights: Mild-to-Moderate Atopic Dermatitis
Treatment of Patients with mild - to - moderate Atopic Dermatitis, ~19MM people (US) Combination drug to address both the source & cause of inflammation: Tofacitinib (JAK - 1): to inhibit cytokine release. Fingolimod (sphingosine 1 - phosphate receptor modulator): to inhibit inflammatory cell migrat
Slide 7: 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 7 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 tho
Slide 8: FMX114: Designed to address both the source & cause of inflammation in AD
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 and Hodge JA, Kawabata TT, Krishnaswami S et al. Clin & Exper Rheum . 2016; 34(2): 318 - 328 1. Schwartz DM, Kanno Y, Villarino A, War
Slide 9: FMX114: Comparable Efficacy to Triamcinolone in Murine Model
FMX114: Comparable Efficacy to Triamcinolone in Drug - Induced Murine Model: Modified Atopic Dermatitis Index* 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 treatment gr
Slide 10: FMX114: Comparable Body Weight Gains to Vehicle Control
10 -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 11: 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 12: FMX114 Phase 1b/2a Proof of Concept Study Design
FMX114 Phase 1b/2a Proof of Concept Study Design 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 der
Slide 13: InhiBET BET Inhibitor Platform
InhiBET ΠBET Inhibitor Platform Bromodomain & Extra - Terminal Domain (BET) Inhibition for Immunology and Inflammatory Diseases 13
Slide 14: InhiBET BET Inhibitor Platform Overview
BD1 BD2 EXT Characterized by 2 bromodomains and 1 extra - terminal domain Innovative, Clinically Validated Therapeutic Target Key regulators of inflammatory and oncogenic genes Significant Market Opportunity • Topical: Broader binding to target multiple, diverse pathways • Oral: Selective BD2 bindin
Slide 15: 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 15
Slide 16: BET Proteins Regulate Gene Transcription via Epigenetic Interaction
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 Acetylated lysine 16 BET proteins: • “read” acetylated lysines on the N - ter
Slide 17: BET Proteins Play a Key Role 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 18: How BET Proteins Fuel 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 19: BET Inhibitors Block BD1/BD2 Binding to Acetylated Lysines
cytokine transcription 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 cytokin
Slide 20: 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 21: VYN201 Composite Inflammation Score 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 22: VYN201 Biomarker Reduction in Th17-Mediated Model
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 23: VYN201: Normal Skin Physiology in Th17 Murine Inflammation 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 24: 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 Interleukin 36 - gamma IL36 γ is implicated in upregulating IL - 17A signaling - related genes and so able to amplify keratinocyte inflammatory respons
Slide 25: 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 (p<0.05) in composite glo
Slide 26: VYN201: Little Residual Swelling in Murine 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 27: 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 28: Seasoned Team, Strong Platform Supported by Scientific Advisors
Seasoned Team, Strong Platform Supported by Well - Respected Scientific Advisors 28 Seasoned R&D team with proven track record of progressing products through the development lifecycle VYNE’s formulation and analytical capabilities coupled with virtual development approach provides for efficient, fl
Slide 29: Pipeline and Near-Term Catalysts
Target Candidate Selection Preclinical Clinical Trials Near - Term Catalysts FMX114 Mild - to - moderate Atopic Dermatitis Q1:22: Phase 1b/2a top line results Q2:22: Submit U.S. IND VYN201 Topical BD1/BD2 BET Inhibitor for rare skin conditions 1 H1:22: Submit IND Mid:22: Initiate Phase 1 VYN202 Oral
Slide 30: Tyler Zeronda, CFO
Tyler Zeronda, CFO E: tyler.zeronda@vynetx.com NASDAQ: VYNE
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