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| Item 7.01 | Regulation FD Disclosure. |
On May 2, 2022, Tarsus Pharmaceuticals, Inc. (the “Company”) issued a press release announcing positive results of the Company’s Saturn-2 pivotal Phase 3 trial evaluating TP-03 for the treatment of Demodex blepharitis.
Additionally, on May 2, 2022, the Company presented a corporate presentation relating to its positive results of the Saturn-2 pivotal Phase 3 trial evaluating TP-03 for the treatment of Demodex blepharitis and posted the corporate presentation to the investor section of the Company’s website. A copy of this presentation is filed as Exhibit 99.1 to this Current Report on Form 8-K (the “Report”).
The information in this Report, including Exhibit 99.1 hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”), or otherwise subject to the liabilities of that Section, and shall not be deemed incorporated by reference in any registration statement or other filing pursuant to the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise expressly stated in such filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
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| 99.1 | Tarsus Pharmaceuticals, Inc. Corporate Presentation. | |
| 104 | Cover Page Interactive Data File (embedded within XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: May 2, 2022 | Tarsus Pharmaceuticals, Inc. | |||||
| By: | /s/ Leo M. Greenstein | |||||
| Leo M. Greenstein | ||||||
| Chief Financial Officer | ||||||
| (Principal Financial Officer and Principal Accounting Officer) | ||||||
May 2022 Saturn-2 Phase 3 Pivotal Trial Topline Data Presentation and Corporate Update © Tarsus Pharmaceuticals 2022 Exhibit 99.1
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 financial trends that we believe may affect our financial condition, results of operations, business strategy, and financial needs. All statements other than statements of historical facts contained in this presentation, including any 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 completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, and our research and development programs; the timing, scope and likelihood of regulatory filings, NDA submissions and approvals; our ability to obtain marketing approvals of our product candidates and to meet existing or future regulatory standards or comply with post-approval requirements; our expectations regarding the potential advantages of our product 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 candidates into, and successfully complete, clinical trials; the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; the commercialization and market acceptance of our product candidates; our marketing and manufacturing capabilities; the pricing of and reimbursement for our product candidates; the implementation of our business model and strategic plans for our business and product candidates; regulatory development in the United States, Europe and other jurisdictions; our ability to effectively manage our anticipated growth; our financial performance and projections relating to our competitors and our industry, including competing therapies are forward-looking statements. The words “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “is/are likely to,” “potential,” “continue” and other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Important factors that could cause our actual results to differ materially are detailed from time to time in the reports we file with the Securities and Exchange Commission, copies of which are posted on our website and are available from us without charge. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. We are currently finalizing our interim financial results as of and for the quarterly period ending March 31, 2022. The results presented in this presentation reflect preliminary estimates. Preliminary estimates represent the most current information available to management and do not present all necessary information for an understanding of our results of operations for such period and have not been reviewed or audited by our independent registered public accounting firm. As a result, final results may vary from these preliminary estimates. We currently expect that final results will be within or near these preliminary estimates. However, it is possible that actual final results may differ materially from these estimates due to the completion of our financial closing procedures, final adjustments, and other developments that may arise and these estimates should be read together with the discussion of forward-looking statements included above as well as the reports we file with the Securities and Exchange Commission, copies of which are posted on our website and are available from us without charge. We have based these forward-looking statements largely on our current expectations, assumptions, estimates and projections as of the date of this presentation. While we believe that these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond our control. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. This presentation also contains estimates and other data made by independent parties and the Company relating to market size and growth and other data related to the industry in which the Company operates. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. Neither the Company nor any other person makes any representation as to the accuracy or completeness of such 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 collarettes
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 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% Responder Rate 54% Responder Rate
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 (0.5%) 3 (1.4%) Dry eye 3 (1.5%) 1 (0.5%) AE Severity Two moderate All others mild One moderate All others mild
Drop Comfort Summary Over 90% Reported the Drop to be Neutral to Very Comfortable © Tarsus Pharmaceuticals 2022 S2 Drop Comfort, All Visits 91% 9%
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 participating in the Saturn-2 trial. Other patients may experience different or less favorable results. Erythema Cure Post Treatment (Day 43) Erythema Grade 0 Collarette Cure Baseline (Day 0) Collarette Grade 4 Post Treatment (Day 43) Collarette Grade 0 Post Treatment (Day 43) Collarette Grade 0 Baseline (Day 0) Collarette Grade 4 Baseline (Day 0) Erythema Grade 1
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 with high statistical significance Clinically and statistically significant effects seen within 2 weeks TP-03 was generally safe and well tolerated, similar to Saturn-1 Saturn-2 Results Position TP-03 for Potential FDA Approval and Ultimate Commercial Success © Tarsus Pharmaceuticals 2022 Saturn-2 Conclusions
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 Collarette Cure (Grade 0 or 1) 81% vs. 23% (p<0.0001) 89% vs. 33% (p<0.0001) 85% vs 28% Mite Eradication 68% vs. 18% (p<0.0001) 52% vs 14% (p<0.0001) 60% vs 16% Lid Erythema Cure 19% vs. 7% (p<0.0001) 31% vs. 9% (p<0.0001) 25% vs 8% Safety Generally safe and well tolerated Generally safe and well tolerated Generally safe and well tolerated N=421 N=412 Anticipated NDA submission of TP-03 for Demodex blepharitis in H2 2022 N=833 Consistency and High Statistical Significance Expected to Result in Definitive Standard of Care Therapy for Demodex Blepharitis N=421 N=412 N=833
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<0.0001) 52% vs 14% (p<0.0001) 60% vs 16% Lid Erythema Cure 19% vs 7% (p<0.0001) 31% vs 9% (p<0.0001) 25% vs 8% N=421 N=412 N=833 Saturn-1 (Pivotal Phase 2b/3) Saturn-2 (Pivotal Phase 3) Combined Data ≤ 10 Collarettes (Grade 0 or 1) 81% vs 23% (p<0.0001) 89% vs 33% (p<0.0001) 85% vs 28% ≥ 1 Collarette Grade Improvement 93% vs 50% (p<0.0001) 96% vs 65% (p<0.0001) 94% vs 57% ≤ 0.5 Mites/Lash 95% vs 36% (p<0.0001) 87% vs 35% (p<0.0001) 91% vs 35% ≥ 1 Erythema Grade Improvement 45% vs 28% (p=0.0002) 54% vs 36% (p<0.0001) 49% vs 32% Complete Cure Rates: 50% or more of patients experienced a cure on key endpoints Clinically Meaningful Response Rates: Approximately 90% of patients1 experienced a clinically meaningful benefit 1. With respect to collarettes, collarette grade improvement, and mites per lash metrics in table
Paul Karpecki OD © Tarsus Pharmaceuticals 2022 Clinical Perspective
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 of dryness, itching, redness and irritation Secondary complaint of eye watering in the mornings and when he goes outside Currently using gels and artificial tears Exam Notes: Loss of lashes, thin lashes, scalloped eyelid margins, and meibomian gland loss Significant redness/erythema and damage to external tissue Some vision loss © Tarsus Pharmaceuticals 2022 Patient images from 2016
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 scrubs, Tea Tree oil scrubs, high concentration in office tea tree oil and hypochlorous acid Microblepharoexfoliation (2 times) Steroid ointment, Combination steroid/antibiotic drops (3 types) Oral Azithromycin and tetracycline © Tarsus Pharmaceuticals 2022 Patient images from April 2022
Aziz Mottiwala, MBA Bobak Azamian, MD, PhD © Tarsus Pharmaceuticals 2022 What’s Ahead
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, Cataracts and Contact Lens intolerance >7M Patients/year visiting ECPs seeking treatment account for +$1Bn Market opportunity Compelling disease visuals allow for simple diagnosis and patient education Collarettes can be seen during a standard eye exam by every Ophthalmologist and Optometrist Patients are motivated by visuals of collarettes, mites and redness Positive initial feedback from payers may enable clear reimbursement pathway Receptivity to targeted MOA High cure and responder rates provide good value to payers Lack of existing treatment alternatives 1. Wilson J Ophthalmology 2015, 435606, 2014; 2. Titan collarette prevalence study; 3. Source: US HCP Quant Research (n=100 OPT and n= 100 OPH) Q4 2020/Q1 2021 Clear reimbursement pathway Clear early market segments Simple and confident diagnosis ~25 Million Patients total addressable market in U.S.1,2 >7M Patients/year visiting ECPs seeking an effective treatment
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 © Tarsus Pharmaceuticals 2022 Scott Youmans, Vice President, Sales Former Director of Sales, Allergan Eye Care Former marketing lead for Allergan’s Dry Eye Franchise 20+ years of sales and marketing experience, with over 14 years in Eye Care Arthur Chan, Ph.D., Vice President, Medical Affairs Former Head of Medical Affairs, Dry Eye at Novartis Previously led all Field Medical Efforts for Alcon 18+ years of experience in Ophthalmic Medical Affairs Matt Rossen, Vice President, Marketing Former VP, Marketing at QED Therapeutics Former marketing head for Jazz Sleep and Hematology products 20+ years of marketing leadership with multiple product launches 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 eye care
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 & Strengthening World-Class Team focused on delivering impactful therapeutics Advance TP-03 for Approval Establish Commercial Awareness and Infrastructure to build momentum for commercial launch of TP-03 Ongoing activities expected to drive value Enrollment Complete 2 Positive Phase 3 Topline Data 2 NDA Submission TP-05 Lyme Callisto Ph1b Topline Advance Pipeline to Clinical POC 1. As of 3/31/22 (unaudited and has not been reviewed by our independent registered public accounting firm). 2. Assumes $30 million from China out-license milestones during 2022, and availability of additional $25 million to be drawn on credit facility upon NDA submission of TP-03, $35 million upon FDA approval of TP-03, and $20 million of currently available draws.
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 Pharmaceuticals 2022 Revolutionizing Treatments for Eye Diseases, Starting with TP-03 1. With respect to collarettes, collarette grade improvement, and mites per lash metrics in lower table on slide 28 1
© Tarsus Pharmaceuticals 2022