Tarsus Pharmaceuticals, Inc. · NASDAQ:TARS
Tarsus Pharmaceuticals — Corporate Update (May 2022)
37 slides from Tarsus Pharmaceuticals's corporate update, May 2, 2022
Slide 1: Saturn-2 Phase 3 Pivotal Trial Topline Data Presentation and Corporate Update
May 2022 Saturn-2 Phase 3 Pivotal Trial Topline Data Presentation and Corporate Update © Tarsus Pharmaceuticals 2022 Exhibit 99.1
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
Slide 3: Today's Agenda
Today’s Agenda © Tarsus Pharmaceuticals 2022 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 a
Slide 4: Participants on Today's Call
Participants on Today’s Call © Tarsus Pharmaceuticals 2022 Bobak Azamian, MD, PhD President and CEO Tarsus Elizabeth Yeu, MD Chief Medical Advisor Tarsus Aziz Mottiwala, MBA Chief Commercial Officer Tarsus Paul Karpecki, OD, FAAO Kentucky Eye Institute Lexington, KY
Slide 5: Our Vision is to become a leading eye care pharmaceutical company
© Tarsus Pharmaceuticals 2022 Our Vision is to become a leading eye care pharmaceutical company… …dedicated to addressing important diseases with impactful therapeutics
Slide 6: TP-03 Designed to provide complete resolution of Demodex blepharitis
TP-03 Designed to provide complete resolution of Demodex blepharitis © Tarsus Pharmaceuticals 2022 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 er
Slide 7: Demodex Blepharitis is a Large and Underserved Market in Eye Care
Demodex Blepharitis is a Large and Underserved Market in Eye Care © Tarsus Pharmaceuticals 2022 1. Wilson J Ophthalmology 2015, 435606, 2014; 2. Titan collarette prevalence study; 3.Symphony claims data; 4.Market Scope 2020 Dry Eye Products Report: A Global Market Analysis for 2019 to 2025; 5. AAO/A
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 © Tarsus Pharmaceuticals 2022 *Tarsus Atlas Study – Yeu et al. Psychosocial Impact of Demodex Blep
Slide 9: 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 First-in-class eye drop drug to selectively eradicate Demodex mites © Tarsus Pharmaceuticals 2022 TP-03 Product profile based on Saturn-1 and Saturn-2 results. 1. The patents and patent applications owned
Slide 10: Saturn-2 Phase 3 Topline Data
© Tarsus Pharmaceuticals 2022 Saturn-2 Phase 3 Topline Data Bobak Azamian, MD, PhD Elizabeth Yeu, MD
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 Endpoint:
Slide 12: Patient Enrollment and Follow-up
Patient Enrollment and Follow-up Vehicle (n=209) Randomized (n=412 at 21 sites in USA) TP-03 (n=203) Discontinued (n=9) Discontinued (n=9) Completed 6 Weeks Treatment (n=193) Completed 6 Weeks Treatment (n=200) n = 2 unrelated AEs n = 7 other 6 Week Treatment and Follow-up, Twice Daily Drop Without
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 © Tarsus Pharmaceuticals 2022 Grade 1 Grade 0 Grade 2 Grade 3 Grade 4 0-2 collarettes on the lashes Cure of collarettes 3-10 collarettes on the lashes Between 10 collarettes to 1/3
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 © Tarsus Pharmaceuticals 2022 Step 2 Step 1 Step 3 Step 4 Two or more lashes from each of the upper and lower eyelids, one from each half of each lid, should be twirled with gentle tensioning fo
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 © Tarsus Pharmaceuticals 2022 Grade 3 0 (None) 1 (Mild) 2 (Moderate) 3 (Severe)* Average baseline 1.6 Grade 1 Grade 0 Grade 2 Hosseini K, Bourque LB, Hays
Slide 16: Saturn-2 Baseline Characteristics Similar to Saturn-1
Saturn-2 Baseline Characteristics Similar to Saturn-1 © Tarsus Pharmaceuticals 2022 TP-03 Vehicle Patients 203 209 Age 64 65 Female % 48 49 Collarette Score 2.9 3.0 Mite Density 3.2 3.4 Erythema Score 1.6 1.6 Grade 3 Collarettes 3 Mites/Lash lash mites erythema collarettes
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 1. The primary efficacy endpoint was the proportion of patients achieving collarette cure (0-2 collarettes on the eyelid) as compared to the vehicle control, at day 43. © Tarsus P
Slide 18: Clinically Meaningful Collarette Cure Achieved
Clinically Meaningful Collarette Cure Achieved © Tarsus Pharmaceuticals 2022 Grade 0 or 1 Collarettes (N=196,206) (N=192,201) (N=195,200) (N=193,200) Clinically Meaningful Collarette Cure Observed by Week 2 Over 90% Avg. Reduction in Collarettes (Over 100 to 10 or Less per Lid) Average Baseline (Gra
Slide 19: Secondary Endpoint of Mite Eradication Achieved
Secondary Endpoint of Mite Eradication Achieved © Tarsus Pharmaceuticals 2022 Mite Eradication (0 mites) (N=192,199) (N=195,200) (N=193,199) Secondary Endpoint Day 43 Complete Mite Eradication Observed by Week 2 Over 50% of Patients Experienced Complete Eradication at Week 6 (Secondary Endpoint) Ave
Slide 20: Secondary Endpoint of Erythema Cure Achieved
Secondary Endpoint of Erythema Cure Achieved © Tarsus Pharmaceuticals 2022 Erythema Cure Erythema Cure (Analysis Eye) Secondary Endpoint Day 43 (N=196,206) (N=192,201) (N=195,200) (N=193,200) *p<0.0001 Elevated to Secondary Endpoint in Saturn-2 Complete Erythema Cure Observed by Week 3 Ora Calibra®
Slide 21: Secondary Endpoint of Complete Composite Cure Achieved
Secondary Endpoint of Complete Composite Cure Achieved © Tarsus Pharmaceuticals 2022 Composite Cure (Collarette Cure + Erythema Cure) Erythema + Collarette Cure (Analysis Eye) Secondary Endpoint Day 43 (N=196,206) (N=192,201) (N=195,200) (N=193,200) Complete Composite Cure Observed by Week 2 *p<0.00
Slide 22: Collarette, Mite & Erythema Improvement Responder Rates
Collarette, Mite & Erythema Improvement Responder Rates © Tarsus Pharmaceuticals 2022 ≥1 Grade Erythema Improvement *p = 0.0001 (N=193,200) TP-03 Vehicle Patients Achieving ≤ 0.5 Mites/Lash (N=193,199) ≥1 Grade Collarette Improvement *p < 0.0001 (N=193,200) *p < 0.0001 96% Responder Rate 87% Respond
Slide 23: Adverse Event Summary
Adverse Event Summary Overall Low Rates of Ocular AEs All AEs Were Mild or Moderate © Tarsus Pharmaceuticals 2022 Treatment related ocular AE rates ≥ 1% TP-03 (n=212) Vehicle (n=209) TP-03 (n=203) Vehicle (n=209) Instillation site pain/burning/stinging 16 (7.9%) 14 (6.7%) Visual acuity reduced 1 (0.
Slide 24: Drop Comfort Summary
Drop Comfort Summary Over 90% Reported the Drop to be Neutral to Very Comfortable © Tarsus Pharmaceuticals 2022 S2 Drop Comfort, All Visits 91% 9%
Slide 25: Significant Clinical Impact Seen After Treatment
Significant Clinical Impact Seen After Treatment Consistent Collarette Cure and Erythema Cure Rates Observed © Tarsus Pharmaceuticals 2022 Photos are images taken of patients in Saturn-2. Images demonstrate results which we believe are representative of favorable treatment with TP-03 for patients pa
Slide 26: Saturn-2 Conclusions
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 meaningful cure Strong consistency across all endpoints compared with Saturn-1 All primary and secondary endpoints met
Slide 27: Two Successful Pivotal Trials with Consistency Across Endpoints
Two Successful Pivotal Trials with Consistency Across Endpoints © Tarsus Pharmaceuticals 2022 Saturn-1 (Pivotal Phase 2b/3) Saturn-2 (Pivotal Phase 3) Combined Pivotal Data Primary Endpoint: Complete Collarette Cure 44% vs. 7% (p<0.0001) 56% vs. 13% (p<0.0001) 50% vs. 10% Clinically Meaningful Colla
Slide 28: Combined TP-03 Data Offers A Very Compelling Clinical Value Proposition
Combined TP-03 Data Offers A Very Compelling Clinical Value Proposition © Tarsus Pharmaceuticals 2022 Saturn-1 (Pivotal Phase 2b/3) Saturn-2 (Pivotal Phase 3) Combined Data Primary Endpoint: Complete Collarette Cure 44% vs 7% (p<0.0001) 56% vs 13% (p<0.0001) 50% vs 10% Mite Eradication 68% vs 18% (p
Slide 29: Paul Karpecki OD Clinical Perspective
Paul Karpecki OD © Tarsus Pharmaceuticals 2022 Clinical Perspective
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 has been “dealing with this” for at least 3 years Visited multiple doctors, multiple times before visiting my clinic Primary complaints
Slide 31: Lack of Effective Treatments Lead to Significant Patient Burden
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 is now age 72 and has lid and lash damage from Demodex blepharitis Patient underwent the following additional treatments: Lid
Slide 32: What's Ahead
Aziz Mottiwala, MBA Bobak Azamian, MD, PhD © Tarsus Pharmaceuticals 2022 What’s Ahead
Slide 33: Demodex Blepharitis Market is Primed for Activation
Demodex Blepharitis Market is Primed for Activation © Tarsus Pharmaceuticals 2022 Increasing market awareness & ECP focus on Demodex blepharitis 87% of ECPs surveyed indicate they explicitly look for Demodex as part of blepharitis diagnosis3 Clear market segments for early use: Blepharitis, Dry Eye,
Slide 34: Tarsus Commercial Leadership Team Combines Eye Care and Product Launch Expertise
Tarsus Commercial Leadership Team Combines Eye Care and Product Launch Expertise Neera Clase, Vice President, Market Access Former VP, Market Access, Acadia Pharmaceuticals Established market access team and strategy at Relypsa 20+ years of reimbursement experience spanning multiple product launches
Slide 35: 2022 Key Catalysts Position Tarsus for Growth
2022 1H 2H TP-05 Lyme Initiate Ph2a 2022 Key Catalysts Position Tarsus for Growth © Tarsus Pharmaceuticals 2022 Strong Balance Sheet $175M1 plus China out-license and credit facility provides runway into at least H2 20242 TP-03 MGD Initiate Ersa Ph2a TP-04 Rosacea Initiate Galatea Ph2a Expanding & S
Slide 36: Revolutionizing Treatments for Eye Diseases, Starting with TP-03
US Market: ~25M total addressable patients Effective and Safe: Over 50% cures, and ~90% clinically meaningful outcomes Reimbursement: Expected favorable outlook on pricing and coverage If NDA Approved: Potential to become the definitive standard of care for Demodex blepharitis © Tarsus Pharmaceutica
Slide 37: © Tarsus Pharmaceuticals 2022
© Tarsus Pharmaceuticals 2022