Tarsus Pharmaceuticals, Inc. · NASDAQ:TARS

Tarsus Pharmaceuticals — Corporate Update (May 2022)

38 slides from Tarsus Pharmaceuticals's corporate update, May 2022

  1. Slide 1: Saturn-2 Phase 3 Pivotal Trial Topline Data Presentation and Corporate Update

    Saturn-2 Phase 3 Pivotal Trial Topline Data Presentation and Corporate Update May 2022 © Tarsus Pharmaceuticals 2022 Strictly Confidential

  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 and projections about future events and finan

  3. Slide 3: Today's Agenda

    Today’s Agenda Welcome and Introductions Bobby Azamian Tarsus – Revolutionizing Treatment for Demodex Blepharitis Bobby Azamian Saturn-2 Phase 3 Topline Data Bobby Azamian and Elizabeth Yeu Patient Journey – Clinical Perspective Paul Karpecki Conclusion Aziz Mottiwala and Bobby Azamian Q&A All 3 © T

  4. Slide 4: Participants on Today's Call

    Participants on Today’s Call Bobak Azamian, MD, PhD Paul Karpecki, OD, FAAO President and CEO Kentucky Eye Institute Tarsus Lexington, KY Elizabeth Yeu, MD Aziz Mottiwala, MBA Chief Medical Advisor Chief Commercial Officer Tarsus Tarsus 4 © Tarsus Pharmaceuticals 2022

  5. Slide 5: Our Vision

    Our Vision is to become a leading eye care pharmaceutical company… …dedicated to addressing important diseases with impactful therapeutics 5 © Tarsus Pharmaceuticals 2022

  6. Slide 6: TP-03 for Demodex Blepharitis

    TP-03 for Demodex Blepharitis Standard of Care Potential • Strong and consistent Saturn-2 data • Complete collarette cure in 56% of patients • Clinically meaningful collarette cure in 89% of patients • Mite eradication in 52% of patients TP-03 • Lid erythema (redness) cure in 31% of patients Designe

  7. Slide 7: Demodex Blepharitis is a Large and Underserved Market in Eye Care

    Demodex Blepharitis is a Large and Underserved Market in Eye Care ~25 Million Demodex Blepharitis Patients in the U.S.1,2 > 7 Million proactively seeking an effective treatment 1.5 Million 1.2 Million 2.2 Million 2.3 Million ~18 Million Diagnosed Blepharitis Dry Eye Rx Patients Cataract Patients Con

  8. Slide 8: Demodex Blepharitis is a Pervasive and Damaging Eye Disease

    Demodex Blepharitis is a Pervasive and Damaging Eye Disease Demodex blepharitis (DB) is caused by an infestation of Demodex mites, which leads to collarettes, can carry bacteria and induce inflammation • Diagnosed by collarettes, a waxy, cylindrical plaque at the base of the eyelashes, composed of m

  9. Slide 9: 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 First-in-class eye drop drug to selectively eradicate Demodex mites 1 TP-03 Product profile based on Saturn-1 and Saturn-2 results. 1. The patents and patent applications owned by or licensed to us worldwi

  10. Slide 10: Saturn-2 Phase 3 Topline Data

    Saturn-2 Phase 3 Topline Data Bobak Azamian, MD, PhD Elizabeth Yeu, MD 10 © Tarsus Pharmaceuticals 2022

  11. Slide 11: TP-03 Met All Primary and Secondary Endpoints Again in Saturn-2

    TP-03 Met All Primary and Secondary Endpoints Again in Saturn-2, with a Complete Resolution of Demodex Blepharitis • Efficacy: Met all pre-specified primary and secondary endpoints – Primary Endpoint: Complete Collarette Cure p < 0.0001 – Secondary Endpoint: Mite Eradication p < 0.0001 – Secondary E

  12. Slide 12: Patient Enrollment and Follow-up

    Patient Enrollment and Follow-up 6 Week Treatment and Follow-up, Twice Daily Drop Without any Touching or Wiping of Lid Margin Randomized (n=412 at 21 sites in USA) TP-03 Vehicle (n=203) (n=209) Discontinued Discontinued (n=9) (n=9) n = 2 unrelated AEs Completed Completed n = 1 unrelated AE n = 7 ot

  13. Slide 13: Collarette Grading Scale Used in Saturn-2

    Collarette Grading Scale Used in Saturn-2 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

  14. Slide 14: Mite Density Determination Used in Saturn-2

    Mite Density Determination Used in Saturn-2 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,

  15. Slide 15: Lid Margin Erythema (Redness) Scale Used in Saturn-2

    Lid Margin Erythema (Redness) Scale Used in Saturn-2 Established and Validated Scale Used in Blepharitis Studies, Performed by Each Investigator Average baseline 1.6 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

  16. Slide 16: Saturn-2 Baseline Characteristics

    Saturn-2 Baseline Characteristics Similar to Saturn-1 Grade 3 Collarettes erythema collarettes TP-03 Vehicle Patients 203 209 Age 64 65 Female % 48 49 3 Mites/Lash Collarette Score 2.9 3.0 lash mites Mite Density 3.2 3.4 Erythema Score 1.6 1.6 16 © Tarsus Pharmaceuticals 2022

  17. Slide 17: 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)1 Average Baseline (Grade 3) Primary Endpoint 80% Day 43 *p<0.0001 60% 56% Collarette Cure (Analysis Eye) 40% *p<0.0001 Grade 0 28% *p<0.0001 20%

  18. Slide 18: Clinically Meaningful Collarette Cure Achieved

    Clinically Meaningful Collarette Cure Achieved Clinically Meaningful Collarette Cure Observed by Week 2 Average Baseline (Grade 3) Over 90% Avg. Reduction in Collarettes (Over 100 to 10 or Less per Lid) Grade 0 or 1 Collarettes *p<0.0001 100% 89% Grade 1 *p<0.0001 80% 74% 60% *p<0.0001 45% 40% 33% 2

  19. Slide 19: Secondary Endpoint of Mite Eradication Achieved

    Secondary Endpoint of Mite Eradication Achieved Complete Mite Eradication Observed by Week 2 Over 50% of Patients Experienced Complete Eradication at Week 6 (Secondary Endpoint) Average Baseline Mite Eradication (0 mites) (3 Mites/lash) Secondary Endpoint 80% Day 43 *p<0.0001 Mite Eradication (Analy

  20. Slide 20: Secondary Endpoint of Erythema Cure Achieved

    Secondary Endpoint of Erythema Cure Achieved Elevated to Secondary Endpoint in Saturn-2 Grade 2 Complete Erythema Cure Observed by Week 3 Erythema Cure Secondary Endpoint 40% Day 43 Average *p<0.0001 baseline 1.6 Grade 1 35% Average 31.1% baseline Erythema Cure (Analysis Eye) 30% 1.5 25% 20% *p=0.00

  21. Slide 21: Secondary Endpoint of Complete Composite Cure Achieved

    Secondary Endpoint of Complete Composite Cure Achieved Complete Composite Cure Observed by Week 2 Composite Cure (Collarette Cure + Erythema Cure) Secondary Endpoint 25% Day 43 Erythema + Collarette Cure (Analysis Eye) *p<0.0001 20% 19.2% 15% *p=0.0001 *p=0.0013 10% 7.7% 5.7% 5% 4.0% 0.5% 0.5% 0.5%

  22. Slide 22: Collarette, Mite & Erythema Improvement Responder Rates

    Collarette, Mite & Erythema Improvement Responder Rates ≥1 Grade ≥1 Grade Patients Achieving Collarette Erythema ≤ 0.5 Mites/Lash Improvement Improvement *p < 0.0001 100% *p = 0.0001 100% *p < 0.0001 60% 96% 90% 96% Responder 90% 87% 87% 50% 54% 54% 80% 80% Responder Responder 70% Rate 70% 60% Rate

  23. Slide 23: Adverse Event Summary

    Adverse Event Summary Overall Low Rates of Ocular AEs All AEs Were Mild or Moderate Treatment related ocular AE rates ≥ 1% TP-03 (n=203) Vehicle (n=209) Instillation site 16 (7.9%) 14 (6.7%) pain/burning/stinging Visual acuity reduced 1 (0.5%) 3 (1.4%) Dry eye 3 (1.5%) 1 (0.5%) Two moderate One mode

  24. Slide 24: Drop Comfort Summary

    Drop Comfort Summary Over 90% Reported the Drop to be Neutral to Very Comfortable Drop Comfort, All Visits S2 91% 60% 52% 53% % of Patients Report 40% 9% 23% 20% 20% 16% 17% 9% 7% 1% 0% 0% Very Uncomfortable Slightly Neither Slightly Comfortable Very Comfortable Uncomfortable TP-03 Vehicle 24 © Tars

  25. Slide 25: Significant Clinical Impact Seen After Treatment

    Significant Clinical Impact Seen After Treatment Consistent Collarette Cure and Erythema Cure Rates Observed Collarette Cure Baseline (Day 0) Post Treatment (Day 43) Collarette Grade 4 Collarette Grade 0 Erythema Cure Baseline (Day 0) Post Treatment (Day 43) Erythema Grade 1 Erythema Grade 0 Baselin

  26. Slide 26: Saturn-2 Conclusions

    Saturn-2 Conclusions Saturn-2 Results Position TP-03 for Potential FDA Approval and Ultimate Commercial Success • 56% of patients met primary endpoint of complete collarette cure • Very high responder rate to TP-03 – 96% of patients improved at least one collarette grade, 89% achieved a clinically m

  27. Slide 27: Two Successful Pivotal Trials with Consistency Across Endpoints

    Two Successful Pivotal Trials with Consistency Across Endpoints Consistency and High Statistical Significance Expected to Result in Definitive Standard of Care Therapy for Demodex Blepharitis N=421 N=412 N=833 Saturn-1 N=421 Saturn-2 N=412 Combined N=833 (Pivotal Phase 2b/3) (Pivotal Phase 3) Pivota

  28. Slide 28: Combined TP-03 Data Offers A Very Compelling Clinical Value Proposition

    Combined TP-03 Data Offers A Very Compelling Clinical Value Proposition Complete Cure Rates: 50% or more of patients experienced a cure on key endpoints Saturn-1 N=421 Saturn-2 N=412 N=833 Combined Data (Pivotal Phase 2b/3) (Pivotal Phase 3) Primary Endpoint: Complete Collarette Cure 44% vs 7% (p<0.

  29. Slide 29: Clinical Perspective

    Clinical Perspective Paul Karpecki OD 29 © Tarsus Pharmaceuticals 2022

  30. Slide 30: Clinical Case Study of a Patient Significantly Impacted by Demodex Blepharitis

    Clinical Case Study of a Patient Significantly Impacted by Demodex Blepharitis Initial presentation of 66-year-old male patient diagnosed via slit lamp exam Patient images from 2016 • Patient has been “dealing with this” for at least 3 years – Visited multiple doctors, multiple times before visiting

  31. Slide 31: Lack of Effective Treatments Lead to Significant Patient Burden and Worsening of Disease

    Lack of Effective Treatments Lead to Significant Patient Burden and Worsening of Disease Six years later all management options have been exhausted with poor results Patient images from April 2022 • Patient is now age 72 and has lid and lash damage from Demodex blepharitis • Patient underwent the fo

  32. Slide 32: What's Ahead

    What’s Ahead Aziz Mottiwala, MBA Bobak Azamian, MD, PhD 32 © Tarsus Pharmaceuticals 2022

  33. Slide 33: Demodex Blepharitis Market is Primed for Activation

    Demodex Blepharitis Market is Primed for Activation ~25 Million Patients total addressable market in U.S.1,2 >7M Patients/year visiting ECPs seeking an effective treatment Clear early market segments • Increasing market awareness & ECP focus on Demodex blepharitis • 87% of ECPs surveyed indicate the

  34. Slide 34: Tarsus Commercial Leadership Team Combines Eye Care and Product Launch Expertise

    Tarsus Commercial Leadership Team Combines Eye Care and Product Launch Expertise Aziz Mottiwala, MBA, Chief Commercial Officer • Former CCO Opiant, and Head of Commercial at Avanir • Former VP Marketing, Allergan Eye Care (Restasis®, Lumigan®) • 20+ years of Commercial experience, with 10+ years in

  35. Slide 35: 2022 Key Catalysts Position Tarsus for Growth

    2022 Key Catalysts Position Tarsus for Growth Advance TP-03 for Approval Positive 2 Enrollment 2 NDA Phase 3 Complete Submission Topline Data 2022 1H 2H Advance Pipeline to Clinical POC TP-03 MGD TP-05 Lyme TP-04 Rosacea TP-05 Lyme Initiate Ersa Ph2a Initiate Ph2a Initiate Galatea Ph2a Callisto Ph1b

  36. Slide 36: Revolutionizing Treatments for Eye Diseases, Starting with TP-03

    Revolutionizing Treatments for Eye Diseases, Starting with TP-03 US Market: ~25M total addressable patients Effective and Safe: 1 Over 50% cures, and ~90% clinically meaningful outcomes Reimbursement: Expected favorable outlook on pricing and coverage If NDA Approved: Potential to become the definit

  37. Slide 37: Q&A

    Q&A All 37 © Tarsus Pharmaceuticals 2022

  38. Slide 38: © Tarsus Pharmaceuticals 2022

    38 © Tarsus Pharmaceuticals 2022

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