tarsus corporate presentation
TRANSCRIPT
January 2022
Tarsus Corporate Presentation
© Tarsus Pharmaceuticals 2021
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 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 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; 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; 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; the commercialization and market acceptance of our product candidates; and the implementation of our business model and strategic plans for our business and product candidates 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. Photos in this presentation relating specifically to the Saturn-1 trial will be explicitly denoted as such.
© Tarsus Pharmaceuticals 20212
Corporate Highlights
Potential for firstFDA-approved therapeutic for Demodex blepharitis.
Significant market opportunity with no approved therapies1
and increasing awareness
Saturn-2 Phase 3 study enrolling, with topline results
expected in Q1 2022, followed by NDA submission
All primary and secondary endpoints met, and
complete resolution of Demodex blepharitis signs and high responder rates demonstrated in Saturn-1
Phase 2b/3 pivotal trial
1. 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.2. 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.3. 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.4. 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.
© Tarsus Pharmaceuticals 20213
New studies on disease prevalence and impact
validate market opportunity, inform focused commercial
strategy, and create momentum for launch
Pipeline with novel API:Callisto Phase 1 trial
progressing for Lyme disease4
and malaria4; initiation of MGD2
Phase 2a and Rosacea3 Phase 2a trials planned in H1 2022
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•Board Member and Former 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
4 © Tarsus Pharmaceuticals 2021
Our Mission
To become a leading eye care
pharmaceutical company dedicated
to addressing important diseases
with impactful therapeutics.
Our Vision
© Tarsus Pharmaceuticals 20215
Major Accomplishments Since IPO that have Advanced our Growth Strategy
1
Positive Saturn-1
Topline Data
TP-05 IND
Accepted
LianBio
Partnership
Saturn-2
Enrolling
2
Atlas Disease
Impact Study
Titan Collarette
Prevalence Study
Callisto TP-05
Phase 1 Trial
Initiated
Expanding Board with
Biopharma and
Clinical LeadershipWendy Yarno
Rose Crane
Elizabeth Yeu, MD
© Tarsus Pharmaceuticals 20216
Demodex Blepharitis is a Large and Underserved Market in Eye Care
© Tarsus Pharmaceuticals7
1. Wilson J Ophthalmology 2015, 435606, 2014; 2. Titan collarette prevalence study; 3.Harmon, Market Scope Dry Eye Analyst Report, 2014; 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; each figure represents 250,000 patients
25 Million Demodex Blepharitis Patients in the U.S.
2.2 MillionCataract
Patients
w/Demodex2,5
~18 MillionDemodex
Patients in Visiting
Eye Doctors
2.3 MillionContact Lens
Intolerant Patients with
Demodex2,6
• Demodex blepharitis is caused by infestation of Demodex mites
• Characterized by collarettes leading to eyelid margin inflammation,
redness, and ocular irritation
• Patients suffer from eyelid itching/burning, blurred vision, and negative
impact on daily life
1.5 MillionBlepharitis
w/Demodex1
Diagnosed
1.2 MillionDry Eye Rx
Patients
w/Demodex2,4
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
– 78% of literature published in the last 5 years1
– 7+ Tarsus scientific publications between H2 21 & H1 22
– Key topic for recent major meetings and educational programs
– Increasing awareness amongst both Ophthalmologists and Optometrists2
Dry Eye ICD Diagnoses/Year
0
1,000,000
2,000,000
3,000,000
4,000,000
5,000,000
6,000,000
7,000,000
2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018D
ry E
ye
Dia
gn
os
es
pe
r Y
ea
r
Launchof Rx
Dry Eye Product
Ramp in DTC
Campaigns
Blepharitis2.1M/yr
1.Tarsus Demodex blepharitis literature review2. 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 20218
New Studies Confirm Collarette Prevalence in ECP Clinic Patients and Key Patient Segments
Titan Study Overview
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%
Key Patient Groups
% of Overall Population
Blepharitis diagnosis
Dry Eye Rx Treatment*
Cataract patients
Contact lens users
0% 20% 40% 60% 80% 100%
69%
60%
56%
51%
% with collarettes within each group
With Collarettes
58%
Dry Eye diagnosis
* 22% of all study patients on Dry Eye Rx treatment
© Tarsus Pharmaceuticals 20219
(595) (593)
Independent study confirms Titan key findings*
55%
With Mites
68%
Blepharitis
overlap
62%
Dry Eye
overlap
% of overall population
*Teo, Jacobson, Rosenberg, ARVO 2021 , n=199, 2 clinics, all comers,
Presence of mites confirmed via epilation
• Over the counter eye care treatments can also lead to ocular stinging/burning, driving discontinuation in many patients
• Tea tree oil toxicity may extend to human meibomian gland epithelial cells1
• There are currently no U.S. FDA approved therapeutics for Demodex blepharitis
High percentage of collarettes observed in patient populations using tea tree oil and lid wipes
© Tarsus Pharmaceuticals10
Titan Study Revealed Tea Tree Oil and Lid Wipes Are Ineffective at Treating Demodex Blepharitis
75%
Tea Tree Oil
57%
Lid Wipes(n=51) (n=102)
1. Chen et al., Cornea, December 2020, Vol. 39, 1541-1546
Converting all current Avenova and Cliradex patients
alone would be over $330M in initial TP-03 sales
Atlas Study Reveals Symptomatic and Psychosocial Burden of Demodex Blepharitis: 80% Report Negative Impact on Daily Life
• Data presented at ARVO 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 (redness)
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 ImpactMost Bothersome Symptoms
34%
22%
27%
31%
55%
51%
3%
23%
16%
28%
33%
41%
Male Female
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
27% 23%
17%14%
11%
9%
Eyes that itch Dry eyes
Top 1 Top 2 Top 3
52% experienced these
symptoms frequently or all the
time
© Tarsus Pharmaceuticals 202111
© Tarsus Pharmaceuticals12
TP-03 is Designed to Eradicate Demodex Mites and Treat Demodex Blepharitis
To view video, please click HERE
TP-03 is a Novel Therapeutic Designed to Eradicate Demodex Mites and Treat Demodex Blepharitis
© Tarsus Pharmaceuticals 202113
1. TP-03 Product profile based on Saturn-1 results; Saturn 2 Trial design *BID means twice per day
TP-03 Met All Primary and 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 < 0.0001
– Secondary Endpoint: Mite Eradication p < 0.0001
– Erythema (Redness) Cure p = 0.0001 and Erythema Response p = 0.0002
• Safety: TP-03 was well-tolerated, with safety profile similar to vehicle
– All TP-03-related AE’s were mild
– 92% of patients reported the drop to be neutral to very comfortable
– No significant findings across several safety assessments
© Tarsus Pharmaceuticals 202114
Collarette Cure (0-2 collarettes)*
Primary Endpoint of Complete Collarette Cure Achieved
Regulatory Endpoint of Complete Collarette Cure Observed by Week 2
• 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.
2%
10%
18%
44%
2% 1% 2%
7%
0%
20%
40%
60%
Day 8 Day 15 Day 22 Day 43
Co
llare
tte
Cu
re (
An
aly
sis
Eye
)
TP-03 Vehicle
*p<0.0001
*p<0.0001
*p<0.0001
(N=211:208) (N=204:208) (N=207:206) (N=209:204)
Primary Endpoint
Day 43
Average Baseline (Grade 3)
Grade 0
© Tarsus Pharmaceuticals 202115
Photos are images taken of patients in Saturn-1 with the corresponding collarette grade.
Grade 0 or 1 Collarettes
Clinically Meaningful Collarette CureClinically Meaningful Collarette Cure Observed by Week 1
Over 90% Avg. Reduction in Collarettes (Over 100 to 10 or Less per Lid)
23%
41%
60%
81%
11%16% 18%
23%
0%
20%
40%
60%
80%
100%
Day 8 Day 15 Day 22 Day 43
TP-03 Vehicle
*p<0.0001
*p<0.0001
*p≤0.0001
*p=0.0003
(N=211:208) (N=204:208) (N=207:206) (N=209:204)
© Tarsus Pharmaceuticals 202116
Average Baseline (Grade 3)
Grade 0
Grade 1
Photos are images taken of patients in Saturn-1 with the corresponding collarette grade.Images demonstrate results which we believe are representative of favorable treatment with TP-03 for patients participating in the Saturn-1 trial. Other patients may experience different or less favorable results.
Mite Eradication (0 mites)
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)
33%
40%
68%
9%12%
18%
0%
20%
40%
60%
80%
Day 15 Day 22 Day 43
Mite
Era
dic
atio
n (
An
aly
sis
Eye
)
TP-03 Vehicle
*p<0.0001
*p<0.0001
*p<0.0001
(N=204:208) (N=207:206) (N=209:204)
Secondary Endpoint
Day 43
Average Baseline (3 Mites/lash)
0 Mites/lash
© Tarsus Pharmaceuticals 202117 * Day 43 Vehicle results for secondary efficacy analysis with imputation is 17.3%
46.9%
72.5%
87.9%92.8%
29.3%
38.9%44.2%
50%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
90.0%
100.0%
Day 8 Day 15 Day 22 Day 43
(N=204:208) (N=207:206) (N=209:204)(N=211:208)
*p=0.0001
*p<0.0001*p<0.0001*p<0.0001
TP-03 Vehicle
Patients improving by ≥1 collarette grade
at each timepoint
© Tarsus Pharmaceuticals 202118
Patients achieving ≤0.5 mites / lash
at day 43
94.7%
35.8%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Day 43
*p<0.0001
(N=209:204)
Collarette and Mite Eradication Responder Rates
Erythema (Redness) Cure and Response
© Tarsus Pharmaceuticals 202119
19% of Patients Experienced Complete Erythema Cure at Day 43
45% of Patients Experienced Erythema Improvement at Day 43
TP-03 Vehicle
1 Grade or More
Erythema Improvement
45%
28%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
Day 43
*p = 0.0002
(N=209:204)
Grade 0 Erythema
19%
7%
0%
5%
10%
15%
20%
25%
Day 43
*p < 0.0001
(N=209:204)
Ora Calibra® Scale
Grade 0
Average
baseline
1.5
Grade 1
Grade 2
Average
baseline 1.5
Photos are images taken of patients in Saturn-1 with the corresponding collarette grade.Images demonstrate results which we believe are representative of favorable treatment with TP-03 for patients participating in the Saturn-1 trial. Other patients may experience different or less favorable results.
Adverse Event and Drop Comfort Summary
© Tarsus Pharmaceuticals 202120
Treatment related ocular AEs occurring at rate of ≥ 1% in active group
TP-03 (n=212) Vehicle (n=209)
Instillation site
pain/burning/stinging25 (11.8%) 16 (7.7%)
Instillation site pruritis 3 (1.4%) 7 (3.3%)
Visual acuity reduced 3 (1.4%) 5 (2.4%)
Eye pain 3 (1.4%) 2 (1.0%)
Eye discharge 3 (1.4%) 1 (0.5%)
AE Severity All MildOne moderate AE
All other AEs mild
All TP-03-related AE’s were mild
92% of patients reported the drop to be neutral to very comfortable
* In a subset of 21 patients. Endothelial cell density will be further evaluated in the Saturn-2 Trial
No Significant Findings Across Multiple Safety Assessments:
Corrected Distance Visual Acuity Slit lamp biomicroscopy
Intraocular pressure Fundus exam
Corneal Staining Endothelial cell density*
Improvements Seen Post Treatment Have Significant Clinical Impact
Cure rates and clinically meaningful effects validate the opportunity to benefit a large proportion of patients
Baseline (Day 0)
Grade 4
Post Treatment (Day 43)
Grade 1
Clinically Meaningful Collarette Cure Erythema Response
Post Treatment (Day 43)
Grade 1
Baseline (Day 0)
Grade 2
Post Treatment (Day 43)
Grade 0
Complete Collarette Cure
Baseline (Day 0)
Grade 4
© Tarsus Pharmaceuticals 202121
Baseline (Day 0)
Erythema Grade 2
Post Treatment (Day 43)
Erythema Grade 1
Photos are images taken of patients in Saturn-1. Images demonstrate results which we believe are representative of favorable treatment with TP-03 for patients participating in the Saturn-1 trial. Other patients may experience different or less favorable results.
Elevate eyelid health as a foundation of ocular wellness• Educate on the prevalence and impact of Demodex blepharitis
• Incorporate into Eye Care practice routine
• Establish key patient segments: Diagnosed Blepharitis, Cataracts, Dry Eye,
Contact Lens Intolerance
Transcend the annual visit cycle and drive patients into
the ECP office• Leverage social and digital media to tell a motivating, visual disease story
• Explore telemedicine as a conduit to accelerate patient action and diagnosis
Offer a cure with no barriers to facilitate market building • Establish clear reimbursement pathway with broad access and affordability
• Robust patient services and touchpoints to drive successful outcomes and
retreatment
Positive disruption of existing norms will be at the core of our commercial plan
Focused Commercial Strategy on Unique and Innovative Approaches to Market Education and Patient Engagement
© Tarsus Pharmaceuticals 202122
© Tarsus Pharmaceuticals: Confidential & Proprietary23
Foundation(Pre-NDA Submission)
Disease Education(Post-NDA Submission)
Rapid Trial & Adoption(FDA Approval - Launch)
Phased approach results in robust market development
• KOL engagement across Optometry and Ophthalmology
• Scientific Posters and Publications
• PR and Social Media
• Leadership Hires
• Payer Engagement and Reimbursement Planning
• MSL Team Launch
• Disease Education and Awareness Campaign
• Sales Team Deployment(100-150 sales reps)
• Digital, “Social First” Consumer Engagement
• Robust Patient Services and Coverage with Payers
Building Purposeful, Continuous Momentum for Launch
• LianBio (Nasdaq: LIAN) is a biotechnology company dedicated to bringing paradigm-shifting medicines to patients in China and other major Asian markets
• Economics of the Greater China partnership with LianBio for TP-03:
– $70 million initial proceeds ($55 million received to-date, with $15 million expected H1 2022)
– $30 million of China-based clinical and regulatory milestones
– $100 million of China-based sales threshold milestones
– Tiered double-digit royalties on TP-03 sales in Greater China
– Minority equity stake in LianBio
• LianBio solely responsible for all TP-03 costs in the Greater China territory related to clinical activities, regulatory approval, and commercialization
March 2021 out-license expands patient access to TP-03 in world’s second largest healthcare market1
© Tarsus Pharmaceuticals 202124
Out-License in Greater China: Global Market for TP-03 and Significant Non-Dilutive Proceeds
Greater China includes the People’s Republic of China, Hong Kong, Taiwan and Macau. 1. Deloitte 2020 China Life Sciences Healthcare Trends Report2. Xuguang S. Chin J Exp Ophthalmol. 2016, 34(6): 481-483; LEK interviews and analyses, Frost & Sullivan analyses
40MEstimated Demodex
blepharitis patients in China2
$4.5BEstimated Chinese eye care
market size by 2023
Pipeline with Different Formulations of Novel API
Current status and anticipated clinical trial events in our programs in the next 12 months
* Anticipated milestones are subject to the impact of the ongoing COVID-19 pandemic on our business and those of our partners.** We intend to rely on preclinical studies and clinical safety assessments from the Demodex blepharitis program. We have not conducted and do not intend to conduct any preclinical studies with TP-03 for the treatment of MGD in order to advance to Phase 2a.*** We intend to leverage all preclinical, Phase 2 and Phase 3 data from the TP-03 Demodex blepharitis program. We intend to conduct in vitro or in vivo bioequivalence studies with our preservative-free formulation to compare it to the current preserved formulation of TP-03 in Demodex blepharitis after NDA submission and file a supplement.† 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, which we intend to conduct outside the United States. We may need to address this approach with the FDA if we were to conduct a clinical trial in the United States. We have not conducted any preclinical studies in rosacea with TP-04 to date.†† In relation to Lyme disease prophylaxis and community malaria reduction, 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 prophylaxis or community malaria reduction, respectively(and will not conduct our own preclinical studies for Lyme disease prophylaxis and community malaria reduction). The formulations used in preclinical studies use the common approach of a gavage that is scaled as appropriate for use in animals. However, human administration,while continuing to be oral, will take the form of a tablet or capsule. We have received FDA feedback from our pre-IND meeting and the FDA has accepted our IND application for Lyme disease prophylaxis. We commenced a Phase 1 trial in June 2021,and further intend to conduct additional trials based on these preclinical studies. In relation to community malaria reduction, we may conduct our trials outside the United States.
Candidate Indication Formulation Preclinical Phase 1 Phase 2 Phase 3
Status and Anticipated Future
Milestones* Worldwide Rights
TP-03
Demodex blepharitis
(DB)
(Eye drop)
2021: Saturn-1 trial met primary and
secondary endpoints;
Saturn-2 Phase 3 trial initiated in May
Q1 2022: Saturn-2 top-line data
2022: NDA filing
Meibomian Gland
Disease (MGD)
H1 2022: Initiate Ersa Phase 2a
proof of concept**
Demodex blepharitis
(Preservative–Free)Preservative-free formulation to be tested after NDA submission
Bioequivalence
studies (US) ***
Demodex blepharitis
and MGD in China
2021: Initiate pre-clinical work in
China for DB and MGD
2022: Initiate Phase 3 DB trial in
China*
TP-04 Rosacea
(Topical)
H1 2022: Initiate Galatea Phase 2a
trial †
TP-05
Lyme Disease
(Oral)
2021: IND Accepted
Callisto Phase 1 trial initiated in June ††
2022: Callisto Phase 1 trial completion
Malaria
2021:
Callisto Phase 1 trial initiated in June ††
2022: Callisto Phase 1 trial completion
(Greater China Rights)
© Tarsus Pharmaceuticals 202125
Lyme Disease is the Most Common Vector-Borne Disease in the U.S.
Caused by bacterium Borrelia burgdorferi and transmitted to humans through the bite of infected blacklegged ticks
• Lyme disease has an estimated >$1.3B impact to the U.S.
healthcare system
• ~80M people at risk of infection, primarily in the Northeast and
Upper Midwest– ~33M at high or moderate risk
– >300K cases/year
• Diagnosed based on the possibility of exposure to infected ticks
and symptoms, including:– Fever
– Headache
– Fatigue
– Characteristic skin rash called erythema migrans
• If left untreated the infection can spread to joints, the heart, and
the nervous system leading to long term debilitating effects
• No approved disease prevention therapies
© Tarsus Pharmaceuticals 202126
TP-05
*Corsica Life Sciences Market Assessment 2020; Occasional/Seasonal risk includes low risk populations in endemic states and a portion of those in peri-endemic states; High/Moderate risk includes all patients identified as high/moderate risk across endemic, peri-endemic, and non-endemic states
Potential unique convenient, on-demand, long-acting, safe and effective alternative to vaccines
• Proof of concept obtained in several preclinical studies
– Based on sustained PK levels in the blood, a more predictable
approach compared to immunogenicity
– Potential for >95% reduction in Lyme risk and rapid
onset of action
• Kills 70% of ticks within 4 hrs, 99% @ 8 hrs
• Potential to prevent bacterial transmission (24-72 hrs)
• 30 day half-life in dogs
– Generally understood to take at least 24 hrs for tick to
transmit Borrellia to human
• Other drugs in class labeled to prevent Lyme in dogs
TP-05 is non-vaccine preventative therapeutic that directly targets ticks
© Tarsus Pharmaceuticals 202127
TP-05 Oral Tablet for Lyme Disease Prevention
TP-05
Lotilaner
Dose-normalized mean of lotilaner following intravenous or oral
administration to fed or fasted dogs
Key Upcoming Catalysts to Advance our Growth
Saturn-2 Topline
Results
Q1 2022
2
TP-05 Callisto Phase 1
Trial Completion
2022
TP-03 Ersa MGD
Phase 2a Trial Initiation
H1 2022
TP-04 Galatea Rosacea
Phase 2a Trial Initiation
H1 2022
TP-03 NDA Filing
2022
© Tarsus Pharmaceuticals 202128
Tarsus Summary
• Highly positive Saturn-1 Phase 2b/3 pivotal trial complete results further supports TP-03 clinical and regulatory potential success
• Next major milestone Saturn-2 Phase 3 topline data in Q1 2022, followed by NDA submission
• TP-03 clinical outcomes and disease prevalence and impact studies validate attractive product profile forpotential first FDA-approved Demodex blepharitis therapeutic, if approved
• Tarsus near-term clinical milestones, experienced executive team, and Board additions position company to become an eye care pharmaceutical leader
• Pipeline advancing with TP-05 Callisto Phase 1 trial for Lyme disease prevention initiated and key upcoming clinical milestones in next 12 months
• Detailed commercial strategy and plan with early focus on education and market access
• Strong cash balance with runway into H2 2023, including proof of concept studies on pipeline
© Tarsus Pharmaceuticals 202129