Full Press Release Details
April 2021 Tarsus Corporate
Presentation Tarsus Pharmaceuticals 2021 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. Tarsus Pharmaceuticals 2021
Corporate Highlights Potential for
first-ever FDA-approved therapeutic for Demodex blepharitis. Significant market opportunity with no approved therapies Pivotal clinical trials in 2021: Saturn-1 Phase 2b/3 enrollment complete and top line data expected in Summer, Saturn-2 Phase 3
initiation planned for Q2 Completed four clinical trials, including two Phase 2b randomized control trials. Consistently met safety and efficacy endpoints The market for Demodex blepharitis may not be similar based on differences in the underlying
disease, different ECP and patient attitudes, and treatment and/or key assumptions we have not taken into our analysis. We intend to rely on preclinical studies for Demodex blepharitis and clinical safety assessments from the Demodex blepharitis
program in order to advance to Phase 2a for MGD. We have not conducted and we do not intend to conduct any preclinical studies with TP-03 for the treatment of MGD. We intend to leverage systemic preclinical data from our TP-03 program and augment
with additional dermal preclinical studies to select formulation in order to advance to Phase 1/2. We have not conducted any preclinical studies in rosacea with TP-04 to date. See slide 25 (including the footnotes thereto) for more information. In
relation to Lyme disease and malaria, we intend to leverage oral systemic preclinical data from our TP-03 program as well as third-party oral systemic preclinical studies for Lyme disease or community malaria reduction, respectively. See slide 26
(including the footnotes thereto for more information) Tarsus Pharmaceuticals 2021 Two new studies on disease prevalence and impact, and Chinese license validate market opportunity and inform commercial strategy Pipeline with novel API
advancing to Phase 2a proof of concept in MGD2, and Phase 1/2 trials in rosacea3, Lyme disease and malaria4
Tarsus Executive Leadership Team Bobby
Azamian, M.D., Ph.D., President & CEO, Co-Founder Former CEO/CMO Metavention Extensive investment/entrepreneurial experience with Versant and Third Rock Ventures Medicine at Brigham, M.D., Harvard, Ph.D. Chemistry, Oxford Michael Ackermann,
Ph.D., Chairman, Co-Founder CEO Presidio Medical Former Chairman, Oyster Point Pharma Former CEO Oculeve, VP Neurostimulation Allergan Sesha Neervannan, Ph.D., Chief Operating Officer Former SVP Global Pharmaceutical Development, Allergan 25+ years
drug development experience, with deep expertise in ophthalmic and dermatology products Prior drug development experience at Amgen and BMS 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 Leo Greenstein, J.D., CPA, Chief Financial Officer Former SVP, Finance & Corporate Controller of Spectrum
Pharmaceuticals, Inc. 20+ years of finance leadership within publicly-traded companies Certified Public Accountant and Member of State Bar of California Elizabeth Yeu, M.D., Chief Medical Advisor Nationally recognized leader in Ophthalmology Cornea,
Cataract, Refractive and Ocular surface specialist Future President American Society of Cataract and Refractive Surgeons (ASCRS) Dianne Whitfield, MSW, Chief Human Resources Officer Former VP, Head of HR Evolus 20+ years HR leadership including
multiple roles at Allergan Extensive experience supporting both commercial and R&D organizations Bryan Wahl, M.D., J.D., General Counsel Former Partner, Knobbe Martens LLP Broad legal experience including IP and strategic transactions 20+ years
practicing internal medicine, most recently at Kaiser Permanente Tarsus Pharmaceuticals 2021
Pharmaceuticals 2021 Focusing on unmet needs, we apply proven science and new technology to revolutionize treatment for patients, starting with eye care. Our Mission A future in which patient needs are met through boundless therapeutic ingenuity.
Blepharitis Is a Large and Underserved
Market in Eye Care Large Patient Population with Significant Disease Impact Titan (collarette clinic prevalence) and Atlas (disease impact) studies demonstrate high prevalence of disease and significant burden on patients Significant Head Start on
Diagnosis 2.1M ICD-10 Blepharitis Dx's/yr8 Blepharitis Routinely Causes Eyelids to become red, irritated and itchy, with debris on the eyelashes.9 Blepharitis Can Lead to Blurring of vision, missing or misdirected eyelashes, and inflammation
of other eye tissue, particularly the cornea4 Concomitant Dry Eye Significant overlap in Dry Eye patients. Demodex prevalent in ~69% of DE patients5 Blepharitis and Surgery Important factor for maximizing surgical outcomes: 67% of Cataract Patients
have Demodex blepharitis6 Contact Lens Drop-out Studies have shown a direct correlation between Demodex blepharitis and Contact Lens intolerance10 Prescription Treatment None; 81% of patients currently seeking treatment11 1. Wilson J Ophthalmology
2015, 435606, 2014; 2. Titan collarette prevalence study; 3. MGD Report IOVS, Special Issue 2011, Vol. 52, N. 4; 4. American Optometric Association; 5.Cheng Cornea Sept 2020; 6. IOVS June 2020; 7. Zhao - Ophthalmic Epidemiology, 19(2), 95-102,
2012; 8. Symphony Claims Data Analysis; 9. Harmon, Market Scope Dry Eye Analyst Report, 2014 10. Tarkowski W, Moneta-Wielgo J, M ocicki D. Demodex sp. as a Potential Cause of the Abandonment of Soft Contact Lenses by Their Existing
Users. Biomed Res Int. 2015;2015:259109 11.Atlas pre-screening study ~45M unique adult ECP visits/yr1 ~58% with collarettes2 Estimated In-Office Epidemiology ~25M Approx. 9-25M U.S. Demodex Blepharitis Prevalence Current ICD-10 ~1M Dx/yr
Population Epidemiology ~9M 2.1M blepharitis ICD-10-CM Dx's/yr8 ~1M/yr Demodex7-8 Despite no mkt education ~20M with blepharitis3-6 45% with Demodex infestation7 Epidemiology of Demodex Blepharitis Tarsus Pharmaceuticals 2021
Blepharitis has Potential Similarities
to Dry Eye Market 15 Years Ago Potential Large Latent Demand for a New Therapy Large untapped patient population that was activated through education of ECPs and patients In 2003, no approved dry eye therapeutics With approval of a prescription
therapeutic and concurrent ECP and patient education, diagnosis rate increased 12 times Blepharitis already has 2.1 million diagnoses per year, despite no approved therapies Focus on Demodex blepharitis growing amongst ECPs 80% of literature
published in the last 5 years1 Key topic for recent major meetings and educational programs Increasing awareness amongst both Ophthalmologists and Optometrists2 Dry Eye ICD Diagnoses/Year Launch of Rx Dry Eye Product Ramp in DTC Campaigns
Blepharitis 2.1M/yr 1.Tarsus Demodex blepharitis literature review 2. Corsica Lifesciences Market Research n=200 *The market for Demodex blepharitis may not be similar based on differences in the underlying disease, different ECP and patient
attitudes, and treatment and/or key assumptions we have not taken into our analysis. Tarsus Pharmaceuticals 2021
Collarettes Are Pathognomonic Sign of
Demodex Infestation 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 Eye Exam Demodex mites found on 100% of lashes with collarettes2 Collarettes found in ~ 58% of eye care patients3 % of Subjects with Demodex % of Subjects with Demodex Fromstein 2018 Gao et al., Invst Ophth and Vis Sci, September 2005, Vol.
46, No. 3089-3094 Tarsus Collarette Prevalence Study Tarsus Pharmaceuticals 2021
Tarsus Pharmaceuticals 2021
Titan Study Confirms Widespread Collarette Prevalence in ECP Clinic Patients and Key Patient Segments Study Overview Key Findings IRB-APPROVED RETROSPECTIVE CHART REVIEW Examined presence of collarettes and other characteristics LARGE-SCALE
ALL-COMERS (1,032 patients) Consecutive patients with a wide variety of reasons for visit DIVERSE ANTERIOR SEGMENT CLINICS Geographically diverse (7 US sites) including both MD and OD clinics 58% (n=598) Key Patient Groups % of Overall Population
Blepharitis diagnosis Dry Eye Rx Treatment* Cataract patients Contact lens users 69% 60% 56% 51% % with collarettes within each group With Collarettes 59% (n=609) Dry eye diagnosis * 22% of all study patients on Dry Eye Rx treatment
Atlas Study Reveals Symptomatic and
Psychosocial Burden of Demodex Blepharitis Tarsus Pharmaceuticals 2021 Multicenter, observational study of patients pre-screened for the Saturn-1 pivotal trial Evaluated the clinical and patient reported impact of Demodex blepharitis (interim
analysis of 311 patients) Presence of Demodex mites (at least 1 mite per lash) Presence of collarettes (> 10, upper lid) At least mild erythema 51% Experienced signs and symptoms > 4 yrs 58% Never diagnosed with blepharitis 33% Made at least
2, and sometimes more than 6, visits to a doctor for this condition Functional and Psychosocial Impact Most Bothersome Symptoms Q7. Does your blepharitis affect any of the following aspects of your daily life (if applicable or how you feel about
your life?) Difficulty wearing make-up Constantly worrying about your eyes or eyelids Negative appearance of eyes or eyelids to others Additional time needed for daily hygiene routine Feels eyes/conscious of eyes all day Difficulty driving at night
52% experienced the top 3 symptoms frequently or all the time
Tarsus Pharmaceuticals 2021
TP-03 is Designed to Eradicate Demodex Mites and Treat Demodex Blepharitis
TP-03 is a Novel Therapeutic
Designed to Eradicate Demodex Mites and Treat Demodex Blepharitis TP-03 is designed to paralyze the mite nervous system through parasite-specific GABA inhibition Lotilaner Potent non-competitive antagonist of insect and
arachnid GABA-Cl channels Highly lipophilic molecule, which may promote its uptake in the oily sebum of the hair follicle, where the mites reside Tarsus has licensed worldwide rights to lotilaner for all human uses Projected Orange Book
Exclusivity to at least 2038 Tarsus Pharmaceuticals 2021
Product Form Multi-dose eye drop
solution bottle, preserved Targeted Use Treatment of Demodex blepharitis MOA Paralysis and death of Demodex mites Diagnosis Collarettes identified in standard eye examination Dosing BID* for 6 weeks Efficacy Goal 1o collarette cure rate, 2o mite
eradication, 2o redness + collarette cure rate Safety Goal Well-tolerated safety profile TP-03 Is a Novel Drug Designed to Treat Demodex Blepharitis by Eradicating Mites and Collarettes1 Tarsus Pharmaceuticals 2021 *BID means twice per day 1.
TP-03 Product profile based on Saturn-1 Trial Design
Trial / Study Design Endpoints
Results Achieved Status PoC: Mercury Ex-vivo mite testing on 80 mites Ex-vivo mite death count 100% mites dead within 24 hours (p < 0.001) Clinical Trials Collarette Cure Rate** Mite Eradication Rate P2a: Mars* 28-day BID dosing, single arm
(n=15) Pilot formulation Collarette grade Mite density Safety 86% at 28 days (p < 0.05) 57% at 28 days (p < 0.05) P2b: Jupiter* 28-day BID dosing, randomized 1:1 (n=60) Pilot formulation 1o - Mite density 2o - Collarette grade
Safety 88% at 28 days (p < 0.001) 67% at 28 days (p < 0.005) P2a: Io** 42-day BID dosing, single arm (n=18) Current formulation 1o - Collarette cure rate 2o - Mite eradication Safety 72% at 42 days (p < 0.05) 78% at 42 days (p
< 0.05) P2b: Europa** 42-day BID dosing, randomized 1:1 (n=54) Current formulation 1o - Collarette cure rate 2o - Mite eradication 2o - Redness Composite Safety 80% at 42 days (p < 0.001) 73% at 42 days (p = 0.003) P2b/3:
Saturn-1** 42-day BID dosing, randomized 1:1 (n 350) Current formulation 1o - Collarette cure rate 2o - Mite eradication 2o - Redness Composite Safety Trial fully enrolled Q1 2021, top line data expected Summer 2021
P3: Saturn-2** 42-day BID dosing, randomized 1:1 (n=350) Current formulation 1o - Collarette cure rate 2o - Mite eradication 2o - Redness Composite Safety Initiate trial in Q2 2021 Extensive Clinical Trial Program for
TP-03 Tarsus Pharmaceuticals 2021 Two Pivotal Trials Represents pivotal trial Same formulation of TP-03 as expected in the Saturn trials * The Mars and Jupiter trials used collarette grade as an endpoint, which has been translated into a
collarette cure (defined as <10 collarettes). This is different from the collarette cure (defined as 2 collarettes) endpoint used in Io, Europa, Saturn-1 and the planned Saturn-2 trials. The Mars and Jupiter trials also used mite density
as an endpoint, which is different from mite eradication. Mite density is translated into mite eradication, which is defined as zero mites per lash consistently throughout trials. ** Primary endpoint in Io, Europa, Saturn-1 and intended in Saturn-2
is collarette cure based on collarette grade. In connection with our IND application, a "no-objection" letter was received from the FDA regarding the trial design of the Saturn-1 trial. Saturn-2 design is highly
comparable to that of Saturn-1 with respect to which the FDA raised no objection and we expect to update the IND protocol prior to commencing Saturn-2.
Baseline Cure of Collarettes with
BID Use of TP-03 Post Treatment Tarsus Pharmaceuticals 2021
Europa Phase 2b: Efficacy Endpoints
of Collarette Cure Rate and Mite Eradication Rate Both Achieved Primary and secondary efficacy endpoints same as Saturn-1 trial Collarette Cure (0-2 collarettes)* Mite Eradication (0 mites) Tarsus Pharmaceuticals 2021 * The primary efficacy
endpoint was the proportion of patients experiencing a cure based on collarette grade of two or fewer collarettes on the eyelid, or collarette cure, as compared to the vehicle control, at day 42. (N=22,20) (N=23,20) (N=18,18) (N=15,19) (N=23,20)
Europa Phase 2b: Statistically