Tarsus Corporate Presentation - July 2021
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Tarsus Corporate Presentation
July 2021
© 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.
2 © Tarsus Pharmaceuticals 2021
Corporate Highlights
Pipeline with novel API:
Potential for first Saturn-2 Phase 3 study Callisto Phase 1 trial initiated for
FDA-approved therapeutic initiated, with topline results Lyme disease4 and malaria4;
for Demodex blepharitis. expected in Q1 2022, followed initiation of MGD2 Phase 2a and
Significant market opportunity by NDA submission Rosacea3 Phase 1/2 trials planned
with no approved therapies1 by end of 2021
All primary and secondary Two new studies on disease
endpoints met, and prevalence and impact, and
clinically meaningful Chinese out-license
effects demonstrated in validate market opportunity and
Saturn-1 Phase 2b/3 pivotal inform commercial strategy
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. See slide 25
(including the footnotes thereto) for more information.
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. See slide 26 (including the footnotes thereto for
more information).
3 © Tarsus Pharmaceuticals 2021
Tarsus Executive Leadership Team
Bobby Azamian, M.D., Ph.D., President & CEO, Co-Founder Leo Greenstein, J.D., CPA, Chief Financial Officer
• Former CEO/CMO Metavention • Former SVP, Finance & Corporate Controller of Spectrum
• Extensive investment/entrepreneurial experience with Versant and Pharmaceuticals, Inc.
Third Rock Ventures • 20+ years of finance leadership within publicly-traded companies
• Medicine at Brigham, M.D., Harvard, Ph.D. Chemistry, Oxford • Certified Public Accountant and Member of State Bar of California
Michael Ackermann, Ph.D., Chairman, Co-Founder Elizabeth Yeu, M.D., Chief Medical Advisor
• CEO Presidio Medical • Nationally recognized leader in Ophthalmology
• Former Chairman, Oyster Point Pharma • Cornea, Cataract, Refractive and Ocular surface specialist
• Former CEO Oculeve, VP Neurostimulation Allergan • Future President American Society of Cataract and Refractive
Surgeons (ASCRS)
Sesha Neervannan, Ph.D., Chief Operating Officer Dianne Whitfield, MSW, Chief Human Resources Officer
• Former SVP Global Pharmaceutical Development, Allergan • Former VP, Head of HR Evolus
• 25+ years drug development experience, with deep expertise in • 20+ years HR leadership including multiple roles at Allergan
ophthalmic and dermatology products • Extensive experience supporting both commercial and R&D
• Prior drug development experience at Amgen and BMS organizations
Aziz Mottiwala, MBA, Chief Commercial Officer Bryan Wahl, M.D., J.D., General Counsel
• Former CCO Opiant, and Head of Commercial at Avanir • Former Partner, Knobbe Martens LLP
• Former VP Marketing, Allergan Eye Care,(Restasis®, Lumigan®) • Broad legal experience including IP and strategic transactions
• 20+ years of Commercial experience, with 10+ years in eye care • 20+ years practicing internal medicine, most recently at Kaiser
Permanente
4 © Tarsus Pharmaceuticals 2021
Our Mission
Our Vision
To become a leading eye care
pharmaceutical company dedicated
to meeting patient needs through
boundless therapeutic ingenuity.
5 © Tarsus Pharmaceuticals 2021
Major Accomplishments Since IPO That Have Advanced Our Growth
Strategy
1 2
Positive Saturn-1 Saturn-2 Titan Collarette Atlas Disease
Topline Data Enrolling Prevalence Study Impact Study
LianBio TP-05 IND Callisto TP-05 Expanding Board with
Partnership Accepted Phase 1 Trial Biopharma Leadership
Wendy Yarno
Initiated
6 © Tarsus Pharmaceuticals 2021
Blepharitis Is a Large and Underserved Market in Eye Care
Epidemiology of
Demodex Blepharitis
• ~45M unique adult ECP
Estimated visits/yr1
In-Office • ~58% with collarettes2 Titan (collarette clinic prevalence) and Atlas (disease
Epidemiology Large Patient Population
impact) studies demonstrate high prevalence of disease
with Significant Disease Impact
~25M and significant burden on patients
Significant Head Start on Diagnosis 2.1M ICD-10 Blepharitis Dx’s/yr8
Approx. Eyelids to become red, irritated and itchy, with debris on
Blepharitis Routinely Causes
9-25M the eyelashes9
Blurring of vision, missing or misdirected eyelashes, and
U.S. Demodex Blepharitis Can Lead to
inflammation of other eye tissue, particularly the cornea4
Blepharitis
Population Significant overlap in Dry Eye patients. Demodex
Prevalence Current ICD-10 Concomitant Dry Eye
Epidemiology prevalent in ~69% of DE patients5
~9M ~1M Dx/yr
Important factor for maximizing surgical outcomes:
Blepharitis and Surgery
67% of Cataract Patients have Demodex blepharitis6
Studies have shown a direct correlation between
• ~20M with blepharitis3-6 • 2.1M blepharitis Contact Lens Drop-out
Demodex blepharitis and Contact Lens intolerance10
• 45% with Demodex ICD-10-CM Dx’s/yr8
infestation7 • ~1M/yr Demodex7-8 Prescription Treatment None; 81% of patients currently seeking treatment11
• Despite no mkt education
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-Wielgoś J, Młocicki 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
7 © 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
% of Subjects with Demodex
100% • Demodex mites found on 100% of lashes with collarettes2
% of Subjects with Demodex
100%
80% • Collarettes found in ~ 58% of eye care patients3
60% 50%
40%
20% 7%
0%
>1 Collarette No collarettes, No collarettes,
Using lid scrubs No lid scrubs
1. Fromstein 2018
2. Gao et al., Invst Ophth and Vis Sci, September 2005, Vol. 46, No. 3089-3094
3. Tarsus Collarette Prevalence Study
8 © 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 Dry Eye ICD Diagnoses/Year
activated through education of ECPs and 7,000,000
patients
• In 2003, no approved dry eye therapeutics 6,000,000
– With approval of a prescription therapeutic and
Dry Eye Diagnoses per Year
concurrent ECP and patient education, 5,000,000
diagnosis rate increased 12 times Launch
of Rx Ramp in
• Blepharitis already has 2.1 million diagnoses 4,000,000 Dry Eye
Product
DTC
Campaigns
per year, despite no approved therapies
3,000,000
• Focus on Demodex blepharitis growing Blepharitis
amongst ECPs 2.1M/yr
2,000,000
– 78% of literature published in the last 5 years1
– Key topic for recent major meetings and
1,000,000
educational programs
– Increasing awareness amongst both
Ophthalmologists and Optometrists2 0
2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
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.
9 © Tarsus Pharmaceuticals 2021
Titan Study Confirms Collarette Prevalence in ECP Clinic Patients and
Key Patient Segments
Study Overview
IRB-APPROVED
RETROSPECTIVE
LARGE-SCALE
ALL-COMERS
DIVERSE ANTERIOR
SEGMENT
25M
CHART REVIEW (1,032 patients) CLINICS U.S. Demodex Blepharitis Patients
Examined presence Consecutive patients with a Geographically diverse
of collarettes and other wide variety of reasons for (7 US sites) including both 45M Unique Adults visiting an ECP per year;
characteristics MD and OD clinics 58% of patients with collarettes
visit
Key Findings
% of Overall Population Key Patient Groups
% with collarettes within each group
Blepharitis diagnosis 69%
With Collarettes Dry eye diagnosis Dry Eye Rx Treatment* 60%
58% 58% Cataract patients 56%
(n=595) (n=593)
Contact lens users 51%
0% 20% 40% 60% 80% 100%
* 22% of all study patients on Dry Eye Rx treatment
Additional Study at ARVO 2021 by Teo, Jacobson,
Rosenberg showed (n=199):
55% prevalence of Mites,
62% overlap of Blepharitis
68% overlap with Dry Eye
10 © Tarsus Pharmaceuticals 2021Atlas 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
51% 58% 33%
Demodex blepharitis (interim analysis of 311 patients) Experienced signs Never diagnosed with Made at least 2, and
– Presence of Demodex mites (at least 1 mite per lash) and symptoms > 4 yrs blepharitis sometimes more than 6, visits
to a doctor for this condition
– Presence of collarettes (> 10, upper lid)
– At least mild erythema
Most Bothersome Symptoms Functional and Psychosocial Impact
52% experienced these Male Female
symptoms frequently or all the Feels eyes/conscious of eyes all 41%
time day 51%
11% 33%
Difficulty driving at night
55%
9%
17% Additional time needed for daily hygiene 28%
routine 31%
14%
Negative appearance of eyes or 16%
eyelids to others 27%
27% Constantly worrying about your 23%
23% eyes or eyelids 22%
Difficulty wearing make-up 3%
34%
Eyes that itch Dry eyes
Top 1 Top 2 Top 3
11 © Tarsus Pharmaceuticals 2021TP-03 is Designed to Eradicate Demodex Mites and Treat
Demodex Blepharitis
To view video, please click HERE
12 © Tarsus PharmaceuticalsTP-03 is a Novel Therapeutic Designed to Eradicate Demodex Mites
and Treat Demodex Blepharitis
1. TP-03 Product profile based on Saturn-1 Trial Design *BID means twice per day
13 © Tarsus Pharmaceuticals 2021Saturn-1: All Primary and Secondary Endpoints Met and Clinically
Meaningful Effects Demonstrated with TP-03
• Efficacy: All pre-specified primary and secondary endpoints were met
– 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
– Secondary Endpoint: Composite Lid Erythema and Collarette Complete Cure p < 0.0001
– Clinically Meaningful Composite Lid Erythema and Collarette Cure p < 0.0001
– Erythema Cure p = 0.0001 and Erythema Response p = 0.0002
– Rapid Cures: Improvements Seen in 2 Weeks p ≤ 0.0149 in Primary and Secondary Endpoints
• Safety: TP-03 was well-tolerated, with safety profile similar to vehicle
– All TP-03-related AE’s were mild with no treatment related discontinuations
– 92% of patients reported the drop to be neutral to very comfortable
14 © Tarsus Pharmaceuticals 2021Clinically Meaningful Collarette Cure
Clinically Meaningful Collarette Cure Observed by Week 1 Average Baseline (Grade 3)
Over 90% Avg. Reduction in Collarettes (Over 100 to Less than 10 per Lid)
Grade 0 or 1 Collarettes
100%
*pPrimary 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
*pSecondary Endpoint of Mite Eradication Rate Achieved
Complete Mite Eradication Observed by Week 2
68% of Patients Experienced Complete Eradication at Week 6 (Secondary Endpoint)
Average Baseline
Mite Eradication (0 mites) (3 Mites/lash)
Secondary Endpoint
Day 43
80% *pClinically Meaningful Composite Cure
Clinically Meaningful Composite Cure Improvements Observed by Week 2 Grade 2
68% of Patients Experienced a Grade 0 or 1 Collarette and Erythema Score
Grade 0 or 1 Collarette and Erythema Score
*pSecondary Endpoint of Complete Composite Cure Achieved
Endpoint of Complete Composite Cure Observed by Week 2 Grade 2
Composite Cure
(Collarette Cure + Erythema Cure)
20% Secondary Endpoint
Day 43
Average
Erythema + Collarette Cure (Analysis Eye)
baseline 1.5 Grade 1
*pErythema 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
40% baseline
19% 35%
1.5
15%
30%
25% 28%
10%
20%
15%
7% Grade 0
5%
10%
5%
0%
0%
Day 43
Day 43
(N=209,204)
(N=209,204)
TP-03 Vehicle
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.
20 © Tarsus Pharmaceuticals 2021 Ora Calibra® ScaleAdverse Event and Drop Comfort Summary
All TP-03-related AE’s were mild with no treatment related discontinuations
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/stinging
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%)
One moderate AE
AE Severity All Mild
All other AEs mild
21 © Tarsus Pharmaceuticals 2021Improvements 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) Baseline (Day 0) Baseline (Day 0)
Grade 4 Grade 4 Grade 2 Erythema Grade 2
Post Treatment (Day 43) Post Treatment (Day 43) Post Treatment (Day 43) Post Treatment (Day 43)
Grade 0 Grade 1 Grade 1 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.
22 © Tarsus Pharmaceuticals 2021TP-03 Phase 2 Clinical Data Show Recurrence Rate of Clinical-Grade
Demodex Blepharitis Post-Treatment
Post treatment data from Mars & Jupiter trials show recurrence of both collarettes & mite density
>10 Collarettes on Lid Mite Density of 1.0 or More
Post-treatment follow-up Post-treatment follow-up
70% 70% 65.5%
60% 60%
58.6%
50% 48.3% 50%
41.4% 40.6%
Percentage
Percentage
40% 40%
30% 30%
20% 20% 17.6%
13.2% 12.5% 11.8%
9.4% 7.9%
10% 10% 6.3%
0% 0%
28 60 90 180 270 365 28 60 90 180 270 365
(N = 38) (N = 32) (N = 34) (N = 32) (N = 29) (N = 29) (N = 38) (N = 32) (N = 34) (N = 32) (N = 29) (N = 29)
Data account for presence of collarettes or mites on either eye, (upper eyelid for collarette score)
23 © Tarsus Pharmaceuticals 2021Commercial strategy will be focused on unique and innovative
approaches to market education and patient engagement
Positive disruption of existing norms will be at the core of our commercial plan
Elevate eyelid health as a foundation of ocular wellness
• Educate on the importance, prevalence and impact of Demodex blepharitis,
and how disease management can be part of the overall practice routine
• Build a strong scientific platform through KOL engagement, evidence generation,
and data dissemination
• Establish key patient segments: Diagnosed Blepharitis, Cataracts, Dry Eye,
Contact Lens Intolerance
Transcend the annual visit cycle by leveraging compelling disease
visuals and new technologies to drive patients into the ECP office
• Drive patients to seek optimal lid health outside the routine exam or contact lens refill
• Leverage social and other visual 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
through a unique patient experience
• Rapid, complete, and durable cure without hassle or frustration
• Couple broad reimbursement strategy with streamlined patient resources,
discounts, and fulfillment
• Ensure patient touchpoints drive successful outcomes, initially, and for retreatment
24 © Tarsus Pharmaceuticals 2021Encouraging Early Payer Feedback on TP-03 for Demodex Blepharitis*
Payer feedback indicates potential for favorable reimbursement with strong outcomes and lack of current
treatment options
Payers view the potential profile of TP-03 as having a strong value proposition
• Objective clinical outcomes and targeted mechanism of action contribute to positive payer feedback
• Payers acknowledge the clinical relevance of both collarette cure and mite eradication
• No current Rx treatments available, and no clear, established OTC treatment alternatives currently exist
Feedback suggests novel treatment approach may drive compelling pricing with modest discounting
• Pricing could be comparable to branded dry eye products
• Given product profile, and lack of treatment alternatives, discounting and rebating is currently expected to be modest
Payers have indicated a limited need for utilization management
• Assuming 1-2 treatment cycles per year, payers currently view the per member, per month budget impact as reasonable
• Any potential payer restriction would be based on confirmation of diagnosis (i.e., ECP confirms presence of collarettes)
Jupiter Lifesciences Pricing and Payer Analysis, Q4 2020
*Payer feedback based on company sponsored survey including interviews with approximately 15 payers and may not be indicative of actual payer assessments if and when TP-03 is commercialized. Actual coverage and reimbursement outcomes may vary materially from the early payer
feedback. No assurance can be given that we would obtain favorable reimbursement and compelling. See Risk Factors in the Company's Form 10-K for the year ended December 31, 2020 for more information.
25 © Tarsus Pharmaceuticals 2021Out-License in Greater China: Global Market for TP-03 and Significant
Non-Dilutive Proceeds
March 2021 out-license expands patient access to TP-03 in world’s second largest healthcare market1
40M $4.5B
Estimated Demodex Estimated Chinese eye care
blepharitis patients in China2 market size by 2023
• LianBio was founded by Perceptive Advisors, and is focused on developing and accelerating
availability of paradigm-shifting medicines to patients in China and major Asian markets
• LianBio to provide Tarsus up to $200 million in milestones and other proceeds:
– $35 million to be received by June 30, 2021; additional $35 million expected to be received by Q1 2022 for
near-term clinical milestones
– Additional longer-term clinical, regulatory, and sales milestones totaling $130 million
– Tiered double-digit royalties based on LianBio sales of TP-03 in Greater China
– Minority equity stake in LianBio
• LianBio solely responsible for all costs related to China regulatory approval and commercialization
Greater China includes the People’s Republic of China, Hong Kong, Taiwan and Macau.
1. Deloitte 2020 China Life Sciences Healthcare Trends Report
2. Xuguang S. Chin J Exp Ophthalmol. 2016, 34(6): 481-483; LEK interviews and analyses, Frost & Sullivan analyses
26 © Tarsus Pharmaceuticals 2021Pipeline with Different Formulations of Novel API
Current status and anticipated clinical trial events in our programs in the next 12 months
Status and Anticipated Future
Candidate Indication Formulation Preclinical Phase 1 Phase 2 Phase 3 Milestones* Worldwide Rights
2021: Saturn-1 trial met primary and
secondary endpoints;
Demodex blepharitis
Saturn-2 Phase 3 trial initiated in May
(DB)
Q1 2022: Saturn-2 top-line data
2022: NDA filing
Meibomian Gland Q4 2021: Initiate Phase 2a
Disease (MGD) proof of concept**
TP-03
Demodex blepharitis (Eye drop) Bioequivalence
Preservative-free formulation to be tested after NDA submission
(Preservative–Free) studies (US) ***
2021: Initiate pre-clinical work in
Demodex blepharitis China for DB and MGD
(Greater China Rights)
and MGD in China 2022: Initiate Phase 3 DB trial in
China*
TP-04 Rosacea Q4 2021: Initiate Phase 1/2 trial †
(Topical)
2021: IND Accepted
Lyme Disease Callisto Phase 1 trial initiated in June ††
1H 2022: Callisto Phase 1 trial completion
TP-05 2021:
(Oral) Callisto Phase 1 trial initiated in June ††
Malaria 1H 2022: Callisto Phase 1 trial completion
* 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.
27 © Tarsus Pharmaceuticals 2021TP-05 Oral Tablet: Long-Acting Endectocide for Lyme Disease
Prevention and Community Malaria Reduction
Lyme Disease Prevention Represents a TP-05 IND Accepted and Callisto Ph 1
Significant Unmet Need Trial Initiated
Lyme Disease: Over 300k US cases/year IND accepted in May 2021
• Bacterial infection carried by ticks • Callisto trial will assess safety, PK, and tick kill
• >30M people in US at risk of exposure objectives
– ~20M in high incidence geographies – To evaluate the safety and tolerability of TP-05 in
• TP-05 is a non-vaccine based preventative healthy volunteers
therapeutic in development that targets ticks – To evaluate the pharmacokinetics (PK) of TP-05 in
directly blood, skin, renal PK and food effect
– Based on sustained PK levels in the blood, a more – To explore TP-05 treated blood for tick kill (ex-vivo)
predictable approach compared to immunogenicity and human metabolites
– Potential for >95% reduction in Lyme risk • Callisto trial will also inform approach for community
• Kills 70% of ticks within 4 hrs, 99% @ 8 hrs malaria reduction
• Potential to prevent bacterial transmission
(24-72 hrs)
28 © Tarsus Pharmaceuticals 2021TP-03 Eye Drop: Potential Label Expansion Opportunity in
Meibomian Gland Disease
Potential label expansion into Meibomian Gland Disease
• MGD is a primary cause of Dry Eye; MGD has been found to be approximately
two-thirds of the estimated 34 million Dry Eye patient population in the United
States
• TP-03 targets a known cause of MGD, Demodex brevis mites
• Potential to be the first FDA-approved therapeutic with an indication for MGD
Phase 2a planned (Patient selection and endpoints TBD)
29 © Tarsus Pharmaceuticals 2021TP-04 Topical Potential New Treatment for Rosacea
Soolantra®, anti-parasitic drug
• 1% ivermectin cream used once daily
Current Standard
of Care • Targets Demodex mites, but modestly effective,
takes 8–12 weeks to show efficacy
• ~$500 WAC for 30-day supply
• In-vitro studies and pharmacodynamics testing to identify
TP-04 Topical a lead formulation of TP-04 in progress
• Phase 1/2 planned for 2021*
• ~16 million people in the U.S. are affected by rosacea
per U.S. National Rosacea Society
Significant Market
• Prevalence can represent up to 5.4% of the U.S. population**
Opportunity
• Given the role of Demodex, opportunity exists to reframe
disease management and apply a differentiated approach
*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.
**Incidence and Prevalence of Rosacea: a systematic review and meta-analysis, Gether et al, BJ Dermatol, 2018.
30 © Tarsus Pharmaceuticals 2021Key Upcoming Catalysts to Advance our Growth
2
Saturn-2 Topline TP-03 NDA Filing TP-05 Callisto Phase
Results 2022 1 Trial Completion
1Q 2022 1H 2022
TP-03 MGD Phase Topical Rosacea Phase
2a Trial Initiation 1/2 Trial Initiation
4Q 2021 4Q 2021
31 © Tarsus Pharmaceuticals 2021Tarsus Summary
• Saturn-1 Phase 2b/3 pivotal trial results highly positive and further supports TP-03 clinical and
regulatory success
• TP-03 clinical outcomes and disease prevalence and impact studies validate attractive product profile for
potential 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
32 © Tarsus Pharmaceuticals 202133 © Tarsus Pharmaceuticals 2021
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