Tarsus Pharmaceuticals, Inc. · NASDAQ:TARS
Tarsus Pharmaceuticals — Corporate Update (June 2021)
36 slides from Tarsus Pharmaceuticals's corporate update, Jun 21, 2021
Slide 1: Saturn-1 Investor Presentation: Pivotal Trial Topline Data and Corporate Update
Exhibit 99.2 Saturn-1 Investor Presentation Pivotal Trial Topline Data and Corporate Update © Tarsus Pharmaceuticals 2021Exhibit 99.2 Saturn-1 Investor Presentation Pivotal Trial Topline Data and Corporate Update © Tarsus Pharmaceuticals 2021
Slide 2: Legal Disclaimer
Legal Disclaimer This presentation contains forward-looking statements that involve risks and uncertainties. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current expectations about future events that we believe may affec
Slide 3: Participants on Today's Call
Participants on Today’s Call Leo Greenstein, J.D., CPA, Chief Financial Officer Bobby Azamian, M.D., Ph.D., President & CEO, Co-Founder •Former SVP, Finance & Corporate Controller of Spectrum •Former CEO/CMO Metavention Pharmaceuticals, Inc. •Extensive investment/entrepreneurial experience with Vers
Slide 4: Demodex Blepharitis Example patient
Demodex Blepharitis Example patient 4 © Tarsus Pharmaceuticals 2021Demodex Blepharitis Example patient 4 © Tarsus Pharmaceuticals 2021
Slide 5: Blepharitis Is a Large and Underserved Market in Eye Care
Blepharitis Is a Large and Underserved Market in Eye Care Epidemiology of Demodex Blepharitis • ~45M unique adult ECP Estimated 1 visits/yr In-Office 2 • ~58% with collarettes Titan (collarette clinic prevalence) and Atlas (disease Epidemiology Large Patient Population impact) studies demonstrate hi
Slide 6: Agenda
Agenda • Saturn-1 topline data presentation • Saturn-2 update • Tarsus corporate update – Corporate vision – TP-03 market opportunity – Pipeline progress update – Upcoming catalysts 6 © Tarsus Pharmaceuticals 2021Agenda • Saturn-1 topline data presentation • Saturn-2 update • Tarsus corporate update
Slide 7: Saturn-1 Topline Data
Saturn-1 Topline Data 7 © Tarsus Pharmaceuticals 2021Saturn-1 Topline Data 7 © Tarsus Pharmaceuticals 2021
Slide 8: TP-03 is a Novel Therapeutic Designed to Eradicate Demodex Mites
TP-03 is a Novel Therapeutic Designed to Eradicate Demodex Mites and Treat Demodex Blepharitis 1. TP-03 Product profile based on Saturn-1 Trial Design *BID means twice per day 8 © Tarsus Pharmaceuticals 2021TP-03 is a Novel Therapeutic Designed to Eradicate Demodex Mites and Treat Demodex Blephariti
Slide 9: Saturn-1 Patient Enrollment and Follow-up
Saturn-1 Patient Enrollment and Follow-up 6 Week Treatment and Follow-up, twice a day drop without any touching or wiping of lid margin Randomized (n=421 at 15 sites in USA) TP-03 Vehicle (n=212) (n=209) Discontinued Discontinued (n=3) (n=5) n = 1 related AE (mild) Completed Completed n = 3 related
Slide 10: Saturn-1: All Primary and Secondary Endpoints Met
Saturn-1: All Primary and Secondary Endpoints Met and Clinically Meaningful Effects Demonstrated with TP-03 • Efficacy: All pre-specified primary and secondary endpoints were met – Primary Endpoint: Complete Collarette Cure p < 0.0001 – Clinically Meaningful Collarette Cure (Grade 0 or 1) p < 0.0001
Slide 11: Collarette Grading Scale Used in Saturn-1
Collarette Grading Scale Used in Saturn-1 Non-linear scale for counting collarettes performed by each site investigator Average baseline Grade 4 Grade 3 Grade 2 Grade 0 Grade 1 • >2/3 of lashes on lid with • Between 1/3-2/3 of lashes on • Between 10 collarettes to 1/3 • 0-2 collarettes on the lashes
Slide 12: Mite Density Determination Used in Saturn-1
Mite Density Determination Used in Saturn-1 Trained mite-counters (CRO) used for consistency across sites Step 3 Step 4 Anatomy of a Mite Step 1 Step 2 Cephalothorax; head Mouth • Two or more lashes from each of • Lashes with collarettes, if • Lashes from each lid are placed on • Using a microscope,
Slide 13: Lid Margin Erythema Scale Used in Saturn-1
Lid Margin Erythema Scale Used in Saturn-1 Established and validated scale used in blepharitis studies, performed by each investigator Average baseline 1.5 Grade 3 Grade 2 Grade 1 Grade 0 3 (Severe)* 2 (Moderate) 1 (Mild) 0 (None) Hosseini K, Bourque LB, Hays RD. Development and evaluation of a meas
Slide 14: Saturn-1 Baseline Characteristics
Saturn-1 Baseline Characteristics Grade 3 Collarettes erythema collarettes TP-03 Vehicle Age 66.1 67.8 Female % 58 56 Collarette Score 2.8 2.8 3 Mites/Lash Mite Density 3.2 3.2 mites lash Erythema Score 1.5 1.5 Photos are images taken of patients in Saturn-1 14 © Tarsus Pharmaceuticals 2021Saturn-1
Slide 15: Clinically Meaningful Collarette Cure
Clinically Meaningful Collarette Cure Clinically Meaningful Collarette Cure Observed by Week 1 Average Baseline (Grade 3) Over 90% Avg. Reduction in Collarettes (Over 100 to Less than 10 per Lid) Grade 0 or 1 Collarettes 100% *p<0.0001 81% Grade 1 80% *p<0.0001 60% 60% *p≤0.0001 41% 40% *p=0.0003 23
Slide 16: Primary Endpoint of Complete Collarette Cure Achieved
Primary Endpoint of Complete Collarette Cure Achieved Regulatory Endpoint of Complete Collarette Cure Observed by Week 2 Collarette Cure (0-2 collarettes)* Average Baseline (Grade 3) Primary Endpoint 60% Day 43 *p<0.0001 43% 40% Grade 0 *p<0.0001 18% *p<0.0001 20% 10% 7% 2% 2% 2% 1% 0% Day 8 Day 15
Slide 17: Secondary Endpoint of Mite Eradication Rate Achieved
Secondary Endpoint of Mite Eradication Rate Achieved Complete Mite Eradication Observed by Week 2 68% of Patients Experienced Complete Eradication at Week 6 (Secondary Endpoint) Average Baseline Mite Eradication (0 mites) (3 Mites/lash) Secondary Endpoint Day 43 *p<0.0001 80% 68% 60% *p<0.0001 0 Mit
Slide 18: Clinically Meaningful Composite Cure
Clinically Meaningful Composite Cure Clinically Meaningful Composite Cure Improvements Observed by Week 2 Grade 2 68% of Patients Experienced a Grade 0 or 1 Collarette and Erythema Score Grade 0 or 1 Collarette and Erythema Score *p<0.0001 80% Average 68% baseline 1.5 *p<0.0001 Grade 1 Average 60% b
Slide 19: Secondary Endpoint of Complete Composite Cure Achieved
Secondary Endpoint of Complete Composite Cure Achieved Endpoint of Complete Composite Cure Observed by Week 2 Grade 2 Composite Cure (Collarette Cure + Erythema Cure) Secondary Endpoint 20% Day 43 Average baseline 1.5 Grade 1 *p<0.0001 Average baseline 15% 13.4% 1.5 10% *p=0.002 *p=0.015 5.3% 4.4% 5
Slide 20: Erythema Cure and Response
Erythema Cure and Response 19% of Patients Experienced Complete Erythema Cure at Day 43 Grade 2 45% of Patients Experienced Erythema Improvement at Day 43 1 Grade or More Grade 0 Erythema Erythema Improvement 25% 50% Average *p = 0.0002 baseline 1.5 45% Grade 1 Average *p < 0.0001 45% 20% 40% baseli
Slide 21: Adverse Event Summary
Adverse Event Summary • Treatment related ocular AEs occurring at rate of ≥ 1% in active group – Summary of Adverse Events occurring at any time during trial TP-03 (n=212) Vehicle (n=209) Instillation site pain/burning/stinging 25 (11.8%) 16 (7.7%) Instillation site pruritis 3 (1.4%) 7 (3.3%) Visual
Slide 22: TP-03 Was Well Tolerated With 92% Reporting Neutral to Very Comfortable Drop
TP-03 Was Well Tolerated With 92% of Patients Reporting TP-03 to Be Neutral to Very Comfortable Drop Comfort, All Visits 92% 60% 55% 55% 40% 8% 19% 18% 18% 20% 17% 9% 7% 1% 1% 0% Very Uncomfortable Slightly Neither Slightly Comfortable Very Comfortable Uncomfortable TP-03 Vehicle 22 © Tarsus Pharmac
Slide 23: Improvements Seen Post Treatment Have Significant Clinical Impact
Improvements Seen Post Treatment Have Significant Clinical Impact Cure rates and clinically meaningful effects validate the opportunity to benefit a large proportion of patients Erythema Response Complete Collarette Cure Clinically Meaningful Collarette Cure Baseline (Day 0) Baseline (Day 0) Baselin
Slide 24: Conclusions
Conclusions Saturn-1 results demonstrate a potentially powerful treatment for Demodex Blepharitis • All primary and secondary endpoints met • Clinically meaningful cures seen in 81% of patients • All endpoints met with high statistical significance • Erythema cure and improvements demonstrated • Eff
Slide 25: Saturn-2 Update
Saturn-2 Update 25 © Tarsus Pharmaceuticals 2021Saturn-2 Update 25 © Tarsus Pharmaceuticals 2021
Slide 26: Saturn-2 Phase 3 Trial Design and Status
Saturn-2 Phase 3 Trial Design and Status • Trial initiated in May 2021 • Substantively similar trial design to Saturn-1 • Expect top-line data to read out in 1Q2022 26 © Tarsus Pharmaceuticals 2021Saturn-2 Phase 3 Trial Design and Status • Trial initiated in May 2021 • Substantively similar trial de
Slide 27: Tarsus Vision & Strategy
Tarsus Vision & Corporate Update 27 © Tarsus Pharmaceuticals 2021Tarsus Vision & Corporate Update 27 © Tarsus Pharmaceuticals 2021
Slide 28: Our Mission and Vision
Our Mission Our Vision To become a leading eye care pharmaceutical company dedicated to meeting patient needs through boundless therapeutic ingenuity. 28 © Tarsus Pharmaceuticals 2021Our Mission Our Vision To become a leading eye care pharmaceutical company dedicated to meeting patient needs through
Slide 29: Major Accomplishments Since IPO That Have Advanced Our Growth Strategy
Major Accomplishments Since IPO That Have Advanced Our Growth Strategy 1 2 Positive Saturn-1 Saturn-2 Titan Collarette Atlas Disease Topline Data Enrolling Prevalence Study Impact Study LianBio TP-05 IND Callisto TP-05 Expanding Board with Partnership Accepted Phase 1 Trial Biopharma Leadership Wend
Slide 30: Titan Study Confirms Collarette Prevalence in ECP Clinic Patients
Titan Study Confirms Collarette Prevalence in ECP Clinic Patients and Key Patient Segments Study Overview IRB-APPROVED LARGE-SCALE DIVERSE ANTERIOR 25M RETROSPECTIVE ALL-COMERS SEGMENT CHART REVIEW (1,032 patients) CLINICS U.S. Demodex Blepharitis Patients Geographically diverse Examined presence Co
Slide 31: Atlas Study Reveals Symptomatic and Psychosocial Burden of Demodex Blepharitis
Atlas Study Reveals Symptomatic and Psychosocial Burden of Demodex Blepharitis: 80% Report Negative Impact on Daily Life • Data presented at ARVO 2021 • Multicenter, observational study of patients pre-screened for the Saturn-1 pivotal trial 51% 58% 33% • Evaluated the clinical and patient reported
Slide 32: Commercial Strategy Focused on Market Education and Patient Engagement
Commercial strategy will be focused on unique and innovative approaches to market education and patient engagement Positive disruption of existing norms will be at the core of our commercial plan Elevate eyelid health as a foundation of ocular wellness • Educate on the importance, prevalence and imp
Slide 33: Pipeline with Different Formulations of Novel API
Pipeline with Different Formulations of Novel API Current status and anticipated clinical trial events in our programs in the next 12 months Status and Anticipated Future Candidate Indication Formulation Preclinical Phase 1 Phase 2 Phase 3 Milestones* Worldwide Rights 2021: Saturn-1 trial met primar
Slide 34: TP-05 Oral Tablet: Long-Acting Endectocide for Lyme Disease Prevention
TP-05 Oral Tablet: Long-Acting Endectocide for Lyme Disease Prevention and Community Malaria Reduction Lyme Disease Prevention Represents a TP-05 IND Accepted and Callisto Ph 1 Significant Unmet Need Trial Initiated Lyme Disease: Over 300k US cases/year IND accepted in May 2021 • Bacterial infection
Slide 35: Key Upcoming Catalysts to Advance our Growth
Key Upcoming Catalysts to Advance our Growth 2 Saturn-2 Topline TP-03 NDA Filing TP-05 Callisto Phase Results 2022 1 Trial Completion 1Q 2022 1H 2022 TP-03 MGD Phase Topical Rosacea Phase 2a Trial Initiation 1/2 Trial Initiation 4Q 2021 4Q 2021 35 © Tarsus Pharmaceuticals 2021Key Upcoming Catalysts
Slide 36: Closing Remarks
Closing Remarks • Saturn-1 Phase 2b/3 pivotal trial results highly positive and further supports TP-03 clinical and regulatory success • TP-03 clinical outcomes and disease prevalence and impact studies validate attractive product profile for potential first FDA-approved Demodex blepharitis therapeu
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