Tarsus Pharmaceuticals, Inc. · NASDAQ:TARS
Tarsus Pharmaceuticals — Corporate Update (February 2022)
39 slides from Tarsus Pharmaceuticals's corporate update, Feb 8, 2022
Slide 1: Revolutionizing Treatment for Demodex Blepharitis Patients
Revolutionizing Treatment for Demodex Blepharitis Patients February 8, 2022 © Tarsus Pharmaceuticals 2022
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: Our Vision
Our Vision To become a leading eye care pharmaceutical company dedicated to addressing important diseases with impactful therapeutics. 3 © Tarsus Pharmaceuticals 2022
Slide 4: Participants on Today's Call
Participants on Today’s Call Bobak Azamian, MD, PhD Eric Donnenfeld, MD Paul Karpecki, OD Elizabeth Yeu, MD President and CEO OCLI Vision Kentucky Eye Institute Virginia Eye Consultants Tarsus Garden City, NY Lexington, KY Norfolk, VA 4 © Tarsus Pharmaceuticals 2022
Slide 5: Agenda
Agenda • Tarsus: Positioned for a Transformational Year • Prevalence and Impact of Demodex Blepharitis • Diagnosis and Unmet Need • Real World Demodex Blepharitis Case Studies • TP-03 Clinical Data Review • What’s Ahead • Questions and Answers 5 © Tarsus Pharmaceuticals 2022
Slide 6: Corporate Highlights
Corporate Highlights Pioneering TP-03 for Positive Saturn-1 Enrollment Complete Demodex Blepharitis Pivotal Data in Saturn-2 Pivotal 1 2 Phase 3 Trial of TP-03 First potential FDA Met all primary & approved therapeutic secondary endpoints, Topline results for Demodex blepharitis complete resolution
Slide 7: Prevalence and Impact of Demodex Blepharitis
Prevalence and Impact of Demodex Blepharitis Eric Donnenfeld, MD 7 © Tarsus Pharmaceuticals 2022
Slide 8: 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. • Demodex blepharitis is caused by infestation of Demodex mites • Characterized by collarettes leading to eyelid margin inflammation, redness, and ocular irritation • Patients suffer
Slide 9: New Studies Confirm Collarette Prevalence in ECP Clinic Patients and Key Patient Segments
New Studies Confirm Collarette Prevalence in ECP Clinic Patients and Key Patient Segments Titan Study Overview % of Overall Population IRB-APPROVED LARGE-SCALE DIVERSE ANTERIOR RETROSPECTIVE ALL-COMERS SEGMENT CHART REVIEW (1,032 patients) CLINICS Examined presence Consecutive patients with a Geogra
Slide 10: Lid Health Directly Impacts Overall Ocular Wellness
Lid Health Directly Impacts Overall Ocular Wellness1-3 Examples of Demodex blepharitis and conjunctival/corneal disease1-3 Erythema Hordeola/Chalazia Corneal Scarring Pterygia References: 1. Amescua G, Akpek EK, Farid M, et al. Blepharitis preferred practice pattern ®. Ophthalmology. 2019;126(1):56-
Slide 11: Demodex Blepharitis Takes a Heavy Toll on Patients
Demodex Blepharitis Takes a Heavy Toll on Patients The Atlas study was the first multicenter observational analysis of adults with Demodex blepharitis* to evaluate the impact of the disease (N=296)1: 80% of patients say that Demodex blepharitis negatively affects their life.1 Itching and dryness wer
Slide 12: A Serious Burden to Patients and Health Care Systems
A Serious Burden to Patients and Health Care Systems The Atlas study also showed that patients with Demodex blepharitis reported the following about their experience with identifying their disease1: Experienced signs and Never diagnosed symptoms >4 years1 with blepharitis1 51% 58% N=306 N=303 Over 1
Slide 13: Diagnosis and Unmet Need
Diagnosis and Unmet Need Paul Karpecki, OD 13 © Tarsus Pharmaceuticals 2022
Slide 14: Demodex Blepharitis May Be Hiding in Plain Sight
Demodex Blepharitis May Be Hiding in Plain Sight Simple ECP Education Can Unlock New Perspective • The way an ECP examines their patients’ eyelids can impact what they can and cannot see What do you see here? • Collarettes are the pathognomonic sign of Demodex blepharitis and can easily be seen on t
Slide 15: Demodex Blepharitis May Be Hiding in Plain Sight
Demodex Blepharitis May Be Hiding in Plain Sight Simple ECP Education Can Unlock New Perspective • The way an ECP examines their patients’ eyelids can impact what they can and cannot see What do you see here? • Collarettes are the pathognomonic sign of Demodex blepharitis and can easily be seen on t
Slide 16: Collarettes Are Pathognomonic Sign of Demodex Blepharitis
Collarettes Are Pathognomonic Sign of Demodex Blepharitis Collarettes Are Composed of Mite Waste Products and Eggs1 • Regurgitated undigested material combined with epithelial cells, keratin, and mite eggs • Contain digestive enzymes, which cause irritation Easily and Rapidly Diagnosed with Standard
Slide 17: Titan Study Revealed Tea Tree Oil and Lid Wipes Are Ineffective
Titan Study Revealed Tea Tree Oil and Lid Wipes Are Ineffective at Treating Demodex Blepharitis High percentage of collarettes observed in patient populations using tea tree oil and lid wipes 75% 57% Tea Tree Oil (TTO) Lid Wipes (n=51) (n=102) • Over the counter eye care treatments can also lead to
Slide 18: Case Studies
Case Studies Paul Karpecki, OD Eric Donnenfeld, MD 18 © Tarsus Pharmaceuticals 2022
Slide 19: Case Study: Recalcitrant Dry Eye Patient
Case Study: Recalcitrant Dry Eye Patient 19 © Tarsus Pharmaceuticals 2022
Slide 20: Case Study: Demodex blepharitis with Recalcitrant Dry Eye
Case Study: Demodex blepharitis with Recalcitrant Dry Eye Presentation: • 73 y/o Caucasian male complains of dry eye • Secondary complaint of itching and tearing, mild in severity • Condition has been present for 3 years and has seen two previous doctors History/Exam: • Slightly high osmolarity in b
Slide 21: Case Study: Demodex blepharitis with Recalcitrant Dry Eye
Case Study: Demodex blepharitis with Recalcitrant Dry Eye Treatment: • In-office, microblepharoexfoliation (MBE) and TTO lid scrubs twice daily, followed by in- office MBE every 2-3 months • Most recent visit (4 years later) still complains of dry eyes, blurred vision and tearing • Vision still not
Slide 22: Case Study: Cataract Patient
Case Study: Cataract Patient Presentation: • 66 y/o male patient presents for a cataract evaluation with history of chronic ocular irritation • Vision overall pretty good, but glare is worsening • Complains of foreign body sensation and itching. (+) Redness upon awakening. 22 © Tarsus Pharmaceutical
Slide 23: Case Study: Cataract Patient
Case Study: Cataract Patient History/Exam: • Has seen multiple optometrists and ophthalmologists • Treated in past for ocular allergy with topical antihistamines and corticosteroids • Treated for dry eye with Restasis and Xiidra • Treated for meibomian gland disease with hot compresses, oral omega-3
Slide 24: TP-03 Clinical Data Review
TP-03 Clinical Data Review Elizabeth Yeu, MD 24 © Tarsus Pharmaceuticals 2022
Slide 25: 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 results; Saturn 2 Trial design *BID means twice per day 25 © Tarsus Pharmaceuticals 2022
Slide 26: TP-03 Met Primary and All Secondary Endpoints in Saturn-1
TP-03 Met Primary and All Secondary Endpoints and Complete Resolution of Demodex Blepharitis in Saturn-1 • Efficacy: Met all pre-specified primary and secondary endpoints, including: – Primary Endpoint: Complete Collarette Cure p < 0.0001 – Clinically Meaningful Collarette Cure (Grade 0 or 1) p < 0.
Slide 27: 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 Collarette Cure (Analysis Eye) 44% 40% *p<0.0001 Grade 0 20% *p<0.0001 18% 10%
Slide 28: 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%
Slide 29: 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) Mite Eradication (0 mites) Average Baseline (3 Mites/lash) Secondary Endpoint Day 43 80% *p<0.0001 68% Mite Eradication (A
Slide 30: Collarette and Mite Eradication Responder Rates
Collarette and Mite Eradication Responder Rates Patients improving by ≥1 collarette grade Patients achieving ≤0.5 mites / lash at each timepoint at day 43 100.0% 92.8% 87.9% 100% 90.0% *p<0.0001 90% 94.7% 80.0% 72.5% 80% *p<0.0001 *p<0.0001 *p<0.0001 70.0% 70% 60.0% *p=0.0001 50% 60% 50.0% 46.9% 44.
Slide 31: Erythema (Redness) Cure and Response
Erythema (Redness) 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
Slide 32: 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
Slide 33: Adverse Event and Drop Comfort Summary
Adverse Event and Drop Comfort Summary All TP-03-related AE’s were mild 92% of patients reported the drop to be neutral to very comfortable Treatment related ocular AEs occurring at rate of ≥ 1% in active group TP-03 (n=212) Vehicle (n=209) Instillation site 25 (11.8%) 16 (7.7%) pain/burning/stingin
Slide 34: What's Ahead
What’s Ahead Bobak Azamian, MD, PhD President & CEO 34 © Tarsus Pharmaceuticals 2022
Slide 35: Enrollment Complete in the TP-03 Saturn-2 Pivotal Phase 3 Trial
Enrollment Complete in the TP-03 Saturn-2 Pivotal Phase 3 Trial Saturn-1 Saturn-2 (Pivotal Phase 2b/3) (Pivotal Phase 3) Size 421 412 U.S. Sites 15 211 Complete Collarette Cure (Grade 0) Primary Endpoint 44% vs. 7% (p<0.0001) Complete Collarette Cure (Grade 0) Mite Eradication 68% vs. 18% (p<0.0001)
Slide 36: $175 Million Credit Facility Provides Availability of Non-dilutive Capital
$175 Million Credit Facility Provides Availability of Non-dilutive Capital • Extends cash runway well into the anticipated commercialization of TP-03 • Executed February 2022 • The $175 million is available as follows – $40 million at closing with $20 million drawn, $25 million at TP-03 NDA submissi
Slide 37: 2022 Key Catalysts Position Tarsus for Growth
2022 Key Catalysts Position Tarsus for Growth Advance TP-03 for Approval 2 Enrollment 2 Phase 3 NDA Complete Topline Data Submission 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 Topline
Slide 38: Q&A
Q&A 38 © Tarsus Pharmaceuticals 2022
Slide 39: © Tarsus Pharmaceuticals 2022
39 © Tarsus Pharmaceuticals 2022
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