Krystal Biotech, Inc. · NASDAQ:KRYS
Krystal Biotech — Corporate Update (March 2022)
42 slides from Krystal Biotech's corporate update, Mar 22, 2022
Slide 1: A Gene-Based Aesthetics Company
A GENE-BASED AESTHETICS COMPANY March 2022 1 Exhibit 99.2
Slide 2: Forward Looking Statement
Forward Looking Statement 2 This presentation contains forward-looking statements that involve substantial risks and uncertainties. Any statements in this presentation about future expectations, plans and prospects for Krystal Biotech, Inc. and its wholly-owned subsidiary, Jeune Aesthetics, Inc. (co
Slide 3: Agenda
Agenda 3 1 Introduction • Krish Krishnan, Chairman, Jeune Aesthetics 2 PEARL - 1 Clinical Study and Next Steps • Dr. Bhushan Hardas, President, Jeune Aesthetics, Inc. 3 KOL Perspective • Dr. Steve Yoelin, Study Investigator 4 Q&A
Slide 4: Introduction
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Slide 5: The Characteristic Look of Aging is Caused by Declining Levels of Key Proteins
The Characteristic Look of Aging is Caused by Declining Levels of Key Proteins in the Skin’s Extracellular Matrix • Skin aging is a complex process that is caused by intrinsic factors (age) and extrinsic factors (e.g., sun, cigarette smoke, pollutants, diet etc.) • These factors cause dermal matrix
Slide 6: Jeune Aesthetics is Creating a New Category of Aesthetic Medicines
Jeune Aesthetics is Creating a New Category of Aesthetic Medicines Designed to Directly Address Underlying Biology 6 Damage Fill Paralyze Restore and Rebuild Using light and sound waves, energy-based devices damage the skin triggering a wound healing response Whether bovine collagen, hyaluronic acid
Slide 7: KB301 is designed to increase production of type III collagen
KB301 is designed to increase production of type III collagen 7 Presence of COL3 fibrils induces deposition of long-lasting COL1 fibrils • COL3 appears early during collagen fibrillogenesis, and the subsequent replacement of this COL3 by COL1 is a critical step for collagen fibril maturation and ext
Slide 8: KB301 – Mode of Action
KB301 – Mode of Action 8 1 Ready to Use • Shipped on dry ice and stored at below freezing at sites 2 Intradermal Injection • Delivered via 33G needle • Treatment area numbed with ice (no topical anesthesia required) 3 Protein Synthesis • Once in the nucleus, STAR-D gene designed to allow normal cell
Slide 9: KB301
KB301 9
Slide 10: In Vitro Studies Show Aged Fibroblasts Can Produce Comparable COL3
In Vitro Studies Show Aged-Human Fibroblasts can produce comparable amount of COL3 to young human Fibroblast after treating with KB301 10 © Copyright 2022 Jeune Aesthetics, Inc. All rights reserved. 0 0.2 0.4 0.6 0.8 1 1.2 1.4 1.6 Young Fibroblast Control Aged Fibroblast Control Aged Fibroblast KB30
Slide 11: PEARL-1 Cohort – Data Presented at SID 2021
PEARL-1 Cohort 1 – Data Presented at SID 2021 11 • Open label, dose ranging study designed to evaluate safety and repeat dosing after intradermal injections in 7 subjects Design • Subjects received two (day 0 and day 30) intradermal bolus injections dosages (1e8, 2e8 and 4e8) in buttocks region • Bi
Slide 12: PEARL-1 Cohort Safety & POC Efficacy Study Design
PEARL-1 Cohort 2 Safety & POC Efficacy Study Design 12 © C h 2022 J A h I All h d 1. Adapted from Donofrio L, Carruthers A, Hardas B, et al. Development and validation of a photonumeric scale for evaluation of facial skin texture. Dermatol Surg. 2016;42(suppl 1):S219–S226. 2. Adapted from Carruthers
Slide 13: Baseline Characteristics and Disposition
Baseline Characteristics and Disposition 13 Criteria Baseline in PEARL-1 Study Comments Healthy Male and Female Subjects Male: 1 Female: 26 Between 30 and 70 years old at time of written consent Average age: 65.1 years Older age-range than us typical in aesthetic trials due to regulatory feedback Su
Slide 14: Knee
Knee 14
Slide 15: Above the Knee: Treatment Schedule and Outcome Measurements
Above the Knee: Treatment Schedule and Outcome Measurements 15 Visit 1 Evaluation Visit 2 1st Treatment Visit 3 2nd Treatment Visit 4 Visit 5 Efficacy Evaluation Visit 6 Skin above the knee Treatment: 1ml of low dose of KB301 or placebo injected with 33G needle in area above knee ~ 14 days ~ 14 days
Slide 16: Above the Knee: Injection Site Reactions and Adverse Events
16 • 100% of the active adverse events were mild • Injection site reactions minimized following the first injection Injection Site Reactions Above Knee AE Counts KB301 PLACEBO Visit 2 Visit 3 Visit 2 Visit 3 Blisters 1 0 0 0 Bruising 1 1 0 0 Bumps 1 0 0 0 Unspecified 1 0 1 0 Itching 3 0 0 0 Pain 2 1
Slide 17: Above the Knee: Efficacy Assessments
Above the Knee: Efficacy Assessments 17 41.9 20 21.9 0 10 20 30 40 50 60 KB301 Placebo Difference Pe rc en ta ge o f R es po nd er s Subject Satisfaction (binary) Odds Ratio = 2.95 54.8 33.3 21.5 0 10 20 30 40 50 60 KB301 Placebo Difference Pe rc en ta ge o f R es po nd er s Investigator Assessment
Slide 18: Above the Knee: Before and After of Left Knee
18 Above the Knee: Before and After of Left Knee Treated with KB301 Low Dose Baseline Visit 5 Improvement in texture as well as fine lines and softening of the folds
Slide 19: Above the Knee: Before and After of Left Knee
19 Above the Knee: Before and After of Left knee treated with KB301 Low Dose Baseline Visit 5 Improvement in texture as well as fine lines and softening of the folds
Slide 20: Lower Cheek
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Slide 21: Lower Cheek: Treatment Schedule and Outcome Measurements
Lower Cheek: Treatment Schedule and Outcome Measurements 21 Visit 1 Evaluation Visit 2 1st Treatment Visit 3 2nd Treatment Visit 4 3rd Treatment Visit 5 Optional 4th Treatment & Efficacy Evaluation Visit 6 Efficacy Evaluation Below zygomatic arch ~ 14 days ~ 14 days ~ 14 days ~ 14 days ~ 14 days Out
Slide 22: Injection Site Reactions per Visit Below Zygomatic Arch
22 Injection Site Reactions per Visit Below Zygomatic Arch AE Counts KB301 PLACEBO Visit 2 Visit 3 Visit 4 Visit 5 Visit 2 Visit 3 Visit 4 Visit 5 Blisters 1 0 0 0 0 0 0 0 Bruising1 1 1 0 0 1 0 0 0 Bumps 2 0 0 2 0 0 0 0 Erythema 2 0 0 0 0 0 0 0 Unspecified 1 0 0 0 1 0 0 0 Irritated 0 0 1 0 0 0 0 0 I
Slide 23: Lower Cheek: Efficacy Measures - Subject Satisfaction
Lower Cheek: Efficacy Measures - Subject Satisfaction Efficacy Assessment 23 Difference in Mean Change from Baseline between High Dose KB301 and Placebo is Clinically Meaningful 0.8 0.6 0.8 0.8 0.0 0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 1.8 2.0 Visit 5 Visit 6 M EA N C HA N G E FR O M B AS EL IN E Subject
Slide 24: Lower Cheek: Efficacy Measures – JASRS and JAFLS
Lower Cheek: Efficacy Measures – JASRS and JAFLS Scale Assessment 24 Observations by blinded evaluator: Moderate improvement in skin laxity; Improvement in solar dyschromia (redness); Improvement in telangiectasia (microvasculature) Evaluation by Blinded Independent Reviewer Showed No Separation bet
Slide 25: Lower Cheek: Before and After Right Side Treated with KB301 High Dose
Lower Cheek: Before and After Right Side Treated with KB301 High Dose 25 Overall improvement in texture, fine lines and elasticity Baseline Visit 6
Slide 26: Lower Cheek: Before and After, KB301 vs. Placebo
26High Dose KB301 – Visit 6 Lower Cheek: Before and After Same subject Observation on Week 6 KB301 vs. Placebo Placebo – Visit 6
Slide 27: Lower Cheek: Before and After Right Side, High Dose
Lower Cheek: Before and After Right side treated with KB301 High Dose Subject Reported: “Right Cheek Significantly improved from last visit. One wrinkle completely resolved” 27 Baseline Visit 6
Slide 28: Upper Cheek
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Slide 29: Upper Cheek: Treatment Schedule and Outcome Measurements
29 Visit 1 Evaluation Visit 2 Visit 3 1st Treatment Visit 4 2nd Treatment Visit 5 Optional 3rd Treatment Visit 6 Optional 4th Treatment Efficacy Evaluation Above zygomatic arch Treatment: 0.5 mL of low dose of KB301 or placebo injected with 33 G needle in cheeks above the zygomatic arch (upper cheek
Slide 30: Injection Site Reactions per Visit Above Zygomatic Arch
30 Injection Site Reactions per Visit Above Zygomatic Arch AE Counts KB301 PLACEBO Visit 3 Visit 4 Visit 5 Visit 6 Visit 3 Visit 4 Visit 5 Visit 6 Bruising 3 2 0 0 0 0 0 1 Bumps 0 0 2 0 0 0 0 0 Erythema 2 0 0 0 0 0 0 0 Irritated 0 1 1 0 0 0 0 0 Itching 0 0 1 0 0 0 0 0 Redness 3 2 1 0 0 0 0 0 Sorenes
Slide 31: Upper Cheek: Efficacy Measures
Upper Cheek: Efficacy Measures 31 Grading Description Comments Clinical Improvement Performed by Blinded Independent Reviewer using pictures due to lack of scale for skin area No meaningful difference between active and placebo 1.3 1.3 0.5 0.7 0.0 0.2 0.4 0.6 0.8 1.0 1.2 1.4 Visit 5 Visit 6 M ea n C
Slide 32: Upper Cheek: Before and After with Low Dose of KB301
32 Upper Cheek: Before and After with low dose of KB301 Baseline Visit 6 Improvement in fine lines as well as reduction on lateral canthal line because of increased elasticity of the skin
Slide 33: Upper Cheek: Before and After Pictures with Low Dose
33 Baseline Visit 6 Upper Cheek: Before and After Pictures with low dose of KB301 Improvement in fine lines as well as reduction on lateral canthal line because of increased elasticity of the skin
Slide 34: Upper Cheek: Same Subject KB301 vs Placebo
34 KB301 low dose – Visit 6 Upper Cheek: Same Subject KB301 vs Placebo on Visit 6 Placebo - Visit 6 Improvement in fine lines as well as reduction on lateral canthal line because of increased elasticity of the skin
Slide 35: Phase 1 Cohort Summary
Phase 1 Cohort 2 Summary 35 1 Repeat administration of KB301 was well tolerated across subjects with minimal injection site reactions; all injection site reactions resolved within 3-5 days post injection • Systemic Adverse Events (drug or placebo related) included: mild body ache (n=4), mild fatigue
Slide 36: Market Opportunity
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Slide 37: KB301 Has Potential to Provide Differentiated Benefit in Large and Growing Markets
Source: ISAPS International Survey on Aesthetic / Cosmetic Procedures Note: Not all products or indications approved in the US. 1. August 2021 – Grand View Research - Facial Injectable Market Size & Share Report, 2021-2028. 2. November 2020 – Research and Markets - Global Skincare Devices Market (20
Slide 38: Next Steps
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Slide 39: Next Steps: Cohort Durability Trial Protocol Summary
Next Steps: Cohort 2 Durability Trial Protocol Summary Lower and Upper Cheek Only 39 • Cohort 2 subjects will be enrolled at 2 sites • Open label study where subjects that received placebo injection will now receive KB301 on that specific site • Lower Cheek sites will receive KB301 high dose while U
Slide 40: Next Steps: KB301 Clinical Development Plan
Q1 2021 Q2 2021 Q3 2021 Q4 2021 Q1 2022 Q2 2022 Q3 2022 Q4 2022 Q1 2023 Q2 2023 Phase 1 Phase 2 Next Steps: KB301 Clinical Development Plan 40 Cohort 1 - Safety Cohort 2 – POC Efficacy Lower Cheek Upper Cheek Back of the hand Cohort 2 Durability Protocol … … …
Slide 41: Closing and Q&A
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Slide 42: A Gene-Based Aesthetics Company
A GENE-BASED AESTHETICS COMPANY March 2022 42