Full Press Release Details
May 2022 Saturn-2 Phase 3 Pivotal Trial
Topline Data Presentation and Corporate Update Tarsus Pharmaceuticals 2022 Exhibit 99.1
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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
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statements regarding our expectations of the potential market opportunity and patient populations for our product candidates, including TP-03, TP-04, and TP-05 if approved for commercial use, including comparisons between the market for treating
blepharitis and the market for treating dry eye disease; the inability to grow the market in a similar way to the dry eye market may occur due to differences in the underlying diseases, different eye care professionals or patient attitudes towards
the diseases, symptoms or treatment, regulatory approval, market dynamics, differences in company strategy, marketing or operations and differences in key assumptions which we have not taken into account in our analysis; the ability of our clinical
trials to demonstrate acceptable safety and efficacy of our product candidates, and other positive results; the timing, progress and results of clinical trials for our product candidates, including statements regarding the timing of initiation and
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candidates over existing therapies; the impact of COVID-19 on our business, clinical development programs and operations; the receipt by Tarsus of payments and achievement and timing of milestones under the terms of the LianBio collaboration, the
ability of LianBio to commercialize TP-03 in the Greater China territory; our potential to enter into new collaborations; our expectations with regard to our ability to develop additional product candidates or product candidates for other
indications; our ability to identify additional products, product candidates or technologies with significant commercial potential that are consistent with our commercial objectives; our ability to develop, acquire and advance additional product
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data. In light of the foregoing, you are urged not to rely on any forward-looking statement or third-party data in reaching any conclusion or making any investment decision about any securities of the Company. Tarsus Pharmaceuticals 2022
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 and Bobby Azamian Q&A All
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
Tarsus Pharmaceuticals 2022 Our
Vision is to become a leading eye care pharmaceutical company dedicated to addressing important diseases with impactful therapeutics
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 eradication in 52% of patients Lid erythema (redness) cure in 31% of patients Lid erythema (redness) improvements in 54% of patients Consistent cures and responses demonstrated in two pivotal trials involving > 800 patients
Generally safe and well tolerated, similar to Saturn-1 NDA submission expected in 2H 2022
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/ASCRS Statement on Cataract Surgery, July 2021; 6. Refractive Surgery Council August 2021; 7. White et al, Clin Opthalmology 2019: 13 2285-2292; each figure represents 250,000 patients. 2.2 Million Cataract Patients w/Demodex2,5
~18 Million Demodex Patients Visiting Eye Doctors 2.3 Million Contact Lens Intolerant Patients with Demodex2,6 > 7 Million proactively seeking an effective treatment 1.5 Million Diagnosed Blepharitis w/Demodex3 1.2 Million Dry Eye Rx Patients
w/Demodex2,4,7 ~25 Million Demodex Blepharitis Patients in the U.S.1,2
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 Blepharitis. Abstract presented at ARVO 2021, Abstract #3544849 Diagnosed by collarettes, a waxy, cylindrical plaque at the base of the eyelashes, composed of mite waste, and a sure sign of DB DB patients suffer from eyelid margin
inflammation, redness and ocular irritation 80%* of DB patients report a negative impact on daily life including itching/burning and blurred vision No approved therapeutics
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 by or licensed to us worldwide include approximately 40 issued patents and approximately 38 pending patent applications. The licensed-in portfolio includes approximately 38 issued patents and approximately 3 pending patent
applications the issued patents and at least some of the pending patent applications include composition of matter claims. *BID means twice per day 1
Tarsus Pharmaceuticals 2022
Saturn-2 Phase 3 Topline Data Bobak Azamian, MD, PhD Elizabeth Yeu, MD
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: Erythema Cure p < 0.0001 Secondary Endpoint: Erythema/Collarette Composite Cure p < 0.0001 Safety: Generally safe and well tolerated, similar to Saturn-1 Low rates of TP-03 related AE's, vast majority were mild
91% of patients reported the drop to be neutral to very comfortable Tarsus Pharmaceuticals 2022
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 any Touching or Wiping of Lid Margin n = 1 unrelated AE n = 8 other Tarsus Pharmaceuticals 2022 n = 1 missed visit
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 of lashes on lid with collarettes Approximately 50 collarettes/lid Between 1/3-2/3 of lashes on lid with collarettes Approximately 100 collarettes/lid >2/3 of lashes on lid with collarettes Approximately 150
collarettes/lid Photos are images taken of patients in Saturn-1 with the corresponding collarette grade. Average baseline
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 for at least 10 seconds and removed using fine forceps Lashes with collarettes, if present, should be selected Occasionally, tails of mites can be observed in slit lamp examination Lashes from each lid are placed on a separate
glass slide resulting in eight lashes on four slides An artificial tear with an emulsifier (Refresh Optive Advanced or Refresh Optive Mega 3 ) should be applied prior to the placement of the lashes and then a coverslip is placed The
sample is allowed to sit for approximately 15 minutes to allow the drop to penetrate the collarettes and let the mites disperse Using a microscope, the number of Demodex observed and the number of lashes epilated are counted for each eye Mite
density is determined by dividing the number of Demodex observed by the number of lashes epilated for each eye Mouth Cephalothorax; head Abdomen/body; tail Anatomy of a Mite
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 RD. Development and evaluation of a measure of patient-reported symptoms of blepharitis. Health and Quality of Life Outcomes 2018;16:11 May 2018. Drug Design, Development and Therapy Volume 12:1269-1279 *Image reproduced with
permission from Jiang et al. Efficacy of intra-meibomian gland injection of the anti-VEGF agent bevacizumab for the treatment of meibomian gland dysfunction with lid-margin vascularity, Drug Design, Development and Therapy 2018:12 1269-1279,
Dove Medical Press Limited. Grades 0, 1, and 2 images are from patients in 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
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 Pharmaceuticals 2022 Collarette Cure (0-2 collarettes)1 Primary Endpoint Day 43 (N=196,206) (N=192,201) (N=195,200) (N=193,200) Average Baseline (Grade 3) Grade 0
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 (Grade 3) Grade 0 Grade 1
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) Average Baseline (3 Mites/lash) 0 Mites/lash
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 Scale Grade 0 Average baseline 1.5 Grade 1 Grade 2 Average baseline 1.6
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<0.0001
Collarette, Mite & Erythema