Tarsus Pharmaceuticals, Inc. · NASDAQ:TARS

Tarsus Pharmaceuticals — Investor Presentation (2021)

36 slides from Tarsus Pharmaceuticals's investor presentation, 2021

  1. Slide 1: Saturn-1 Investor Presentation

    Saturn-1 Investor Presentation Pivotal Trial Topline Data and Corporate Update © Tarsus Pharmaceuticals 2021

  2. 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

  3. Slide 3: Participants on Today's Call

    Participants on Today’s Call Bobby Azamian, M.D., Ph.D., President & CEO, Co-Founder Leo Greenstein, J.D., CPA, Chief Financial Officer • Former CEO/CMO Metavention • Former SVP, Finance & Corporate Controller of Spectrum • Extensive investment/entrepreneurial experience with Versant and Pharmaceuti

  4. Slide 4: Demodex Blepharitis

    Demodex Blepharitis Example patient 4 © Tarsus Pharmaceuticals 2021

  5. 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 visits/yr1 In-Office • ~58% with collarettes2 Epidemiology Titan (collarette clinic prevalence) and Atlas (disease Large Patient Population impact) studies demonstrate high

  6. 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 2021

  7. Slide 7: Saturn-1 Topline Data

    Saturn-1 Topline Data 7 © Tarsus Pharmaceuticals 2021

  8. Slide 8: TP-03 is a Novel Therapeutic Designed to Eradicate Demodex Mites and Treat Demodex Blepharitis

    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 2021

  9. 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) n = 3 related to COVID Completed C

  10. Slide 10: Saturn-1: All Primary and Secondary Endpoints Met and Clinically Meaningful Effects Demonstrated with TP-03

    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

  11. 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 1 Grade 0 • >2/3 of lashes on lid with • Between 1/3-2/3 of lashes on • Between 10 collarettes to 1/3 • 3-10 collarettes on the lashe

  12. 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 1 Step 2 Step 3 Step 4 Anatomy of a Mite Cephalothorax; head Mouth • Two or more lashes from each of • Lashes with collarettes, if • Lashes from each lid are placed on • Using a microscope,

  13. 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

  14. 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 lash mites Erythema Score 1.5 1.5 Photos are images taken of patients in Saturn-1 14 © Tarsus Pharmaceuticals 2021

  15. 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 10 or Less 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%

  16. 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% Collarette Cure (Analysis Eye) 40% Grade 0 *p<0.0001 20% *p<0.0001 18% 10%

  17. 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 80% *p<0.0001 Mite Eradication (Analy

  18. 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% 68% Average baseline 1.5 Grade 1 *p<0.0001 Average 60% b

  19. 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) 20% Secondary Endpoint Day 43 Average Erythema + Collarette Cure (Analysis Eye) baseline 1.5 Grade 1 *p<0.0001 Average 15% baseline 1

  20. 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 45% baseline 1.5 Grade 1 20% *p < 0.0001 45% Average 40% baseli

  21. 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

  22. Slide 22: TP-03 Was Well Tolerated With 92% of Patients Reporting Neutral to Very Comfortable

    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% % of Patients Report 40% 8% 19% 20% 18% 17% 18% 9% 7% 1% 1% 0% Very Uncomfortable Slightly Neither Slightly Comfortable Very Comfortable Uncomfortable TP-03 Vehicl

  23. 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 Complete Collarette Cure Clinically Meaningful Collarette Cure Erythema Response Baseline (Day 0) Baseline (Day 0) Baselin

  24. 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

  25. Slide 25: Saturn-2 Update

    Saturn-2 Update 25 © Tarsus Pharmaceuticals 2021

  26. 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 1Q 2022 26 © Tarsus Pharmaceuticals 2021

  27. Slide 27: Tarsus Vision & Corporate Update

    Tarsus Vision & Corporate Update 27 © Tarsus Pharmaceuticals 2021

  28. Slide 28: Our Mission

    Our Mission Our Vision To become a leading eye care pharmaceutical company dedicated to meeting patient needs through boundless therapeutic ingenuity. 28 © Tarsus Pharmaceuticals 2021

  29. 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

  30. Slide 30: Titan Study Confirms Collarette Prevalence in ECP Clinic Patients and Key Patient Segments

    Titan Study Confirms Collarette Prevalence in ECP Clinic Patients and Key Patient Segments Study Overview IRB-APPROVED RETROSPECTIVE LARGE-SCALE ALL-COMERS DIVERSE ANTERIOR SEGMENT 25M CHART REVIEW (1,032 patients) CLINICS U.S. Demodex Blepharitis Patients Examined presence Consecutive patients with

  31. 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 • Evaluated the clinical and patient reported impact of 51

  32. Slide 32: Commercial strategy will be focused on unique and innovative approaches to 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

  33. 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

  34. Slide 34: TP-05 Oral Tablet: Long-Acting Endectocide for Lyme Disease Prevention and Community Malaria Reduction

    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

  35. 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 2021

  36. 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

Tarsus Pharmaceuticals — Investor Presentation (2021) on 6ix