UNC/Duke Case Competition 2020 - PowerPoint Presentation

1. UNC/Duke Case Competition 2020Blasting away the toughest immune conditions Erin Burgunder ScholzPh.D. CandidateAndrew StengerPharm.D. CandidateJefferson Pike Jr.Pharm.D. CandidateAmy GuisingerMPH, Pharm.D. Candidate

2. Agenda0Executive Summary + IntroductionICompetitionIIMarket sizeIIIValue to stakeholdersIVLikelihood of approvalVConclusion

3. Executive Summary0SituationTNT-Bio should focus on TNT-002 for its strategic expansion into atopic dermatitisKey questionTNT-Bio should focus on TNT-002 for its strategic expansion into atopic dermatitisRecommendationTNT-Bio should focus on TNT-002 for its strategic expansion into atopic dermatitisImpactTNT-Bio should focus on TNT-002 for its strategic expansion into atopic dermatitisTNT Bio should focus on TNT-002 for its strategic expansion into atopic dermatitisTNT Bio is a public, small-to-mid sized biopharma company focused on developing immunology medicinesThey are seeking to expand 1 of 2 existing immunology assets into atopic dermatitis (AD)Which one of these two assets should be entered into phase I clinical development for AD?Achieve $1.13 B peak annual sales in the atopic dermatitis space TNT-013TNT-002

4. Introductory Information0US adult AD prevalenceUS child AD prevalence7.3%10.7%MILD ADMODERATE ADSEVERE ADTopical corticosteroids (TCS)Topical calcineurin inhibitors (TCI)Emollient creamsHigh-strength TCS, TCI, PDE4 inhibitorsPhototherapyEmollient creamsBiologics (inj.)Oral corticosteroidsPhototherapyEmollient creamsSCENARIO: TNT Bio is seeking to expand one of their existing immunology assets into atopic dermatitis (AD)TNT-002Topical TYK2 inhibitorCurrently in Phase I testing for RATNT-013Injectable anti-IL-13 monoclonal antibodyCompleted Phase II testing for asthma GOAL: Evaluate the opportunity for each program and recommend one agent to develop in AD

5. FrameworkTNT Bio should focus on developing TNT-002 for atopic dermatitis based on performance across 4 categories:TNT-013TNT-002ICompetitionIIMarket sizeIIIValue to stakeholdersIVLikelihood of approval0

6. Current competitive dynamics heavily favor TNT-002LaunchedPhase IIIPhase I/IIAnalogsSame classSame Indication*TNT-013 comparator, moderate-to-severe ADTNT-002 comparator, mild-to-moderate AD“Analog” = overlapping indication + mechanism of action* Pipeline drugs without a disease severity focus were excludedDUPIXENT® is an entrenched competitor for TNT-013TNT-013 is threatened by ph. III analogs that boast oral routes of administrationDespite a saturated topical market, TNT-002 does not yet have any launched class competitors6+ active brands; numerous genericsDUPIXENT®Color intensity = threat of competition (illustrative)10+9+7I

7. TNT-002 can achieve >5x the market share of TNT-013Competitor20202021202220232024‘25 – ‘29TNT-013 CompetitionDUPIXENT®Pediatric expansionInfant expansionLebrikizumabApproval (65%)TralokinumabApproval (68%)ASLAN004Approval (16%)Other class comparatorsApproval (68%)Approvals x7(16 – 24%)Indication competitorsApprovals x4(61 – 71%)Approvals x10 (16 – 24%)TNT-002 CompetitionRuxolitinib CreamCompleting ph. IIIApproval (62%)PF-06700841Approval (24%)Other class comparatorsApprovals x3(68 – 71%)Approvals x3 (16 – 27%)Indication competitorsApproval(71%)Approvals x7 (16 – 24%)Projected competition:2 analogs2 class competitors4 other competitorsAdjusted market opportunity for TNT-013: 7.2% market shareProjected competition:1 analog3 class competitors2 other competitorsAdjusted market opportunity for TNT-002: 40.3% market shareData from Informa BioMedTracker and ClinicalTrials.gov (xx%)–likelihood of approval. Analog–overlapping indication + mechanism of action.I

8. TNT-002 has the largest eligible patient populationTNT-00226.4 M9.8 M6.1 M3.6 M355,702TNT-01318.5 M6.9 M2.7 M1.6 M32,189II*Upon indication expansion, TNT-013 could additionally be used in a population of 11,258 children with uncontrolled moderate-to-severe AD

9. TNT-002 offers the largest commercial opportunity*Based on wholesale acquisition cost of leading marketed competitor Dupixent **Based on wholesale acquisition cost of leading marketed competitor EucrisaIIAttributeTNT-013TNT-002Revenue potential per patient $43,542/year*$7,827/year**Patient SegmentMild-to-moderateChildren-355,702 patientsAdults-Moderate-to-severeAdults32,189 patients-Market size$1.4 B/year$2.8 B/yearMarket share7.2%40.3%Peak annual sales$101 M/year$1.13 B/year

10. Across current AD therapies, topical corticosteroids provide greatest valueStakeholderAttributeTopical CorticosteroidsTopical Calcineurin InhibitorsPatientsEase of useAdministrationCostAdherencePatient PreferenceCompositeProvidersDisease severityPatient profileFormulary tierCompositePayersBudget impactPlace in therapyCompositeManufacturerManufacturing costsR&D costsCompositeEUCRISA® (PDE4 inhibitor) topical ointmentDUPIXENT® (anti-IL-13 & anti-IL-4) SQ injectable therapyIIIOkubo Y, et al. J Dermatolog Treat. 2019Schaarschmidt ML, et al. J Eur Acad Dermatol Venereol. 2013 Bass AM, et al. J Clin Med. 2015Feldman SR, et al. Am Health Drug Benefits. 2019Clark R, et al. J Med Econ. 2018

11. TNT-002 may offer slightly more value to stakeholdersStakeholderAttributeTNT-013TNT-002PatientsEase of useAdherenceCostPatient preferenceCompositeProvidersComorbid indicationsDisease severityCompositePayersNovel mechanismBudget impactCompositeManufacturerManufacturing costsR&D costsCompositeIII

12. Regulatory approval odds of co-developing indicationsTNT-013 may allow for greater efficiency in atopic dermatitis launch over TNT-002 TNT-013: Asthma Clinical DevelopmentPhase 1Phase 2Phase 3ApprovalCompleted(100%)Completed(100%)71.1%94.6%TNT-002: Rheumatoid Arthritis Clinical DevelopmentPhase 1Phase 2Phase 3Approval65.7%31.7%62.2%86.0%11.1% chance of approval67.2% chance of approvalBIO Clinical Development Success Rates 2006-2015. 2016.IV

13. Clinical Development LandscapeTNT-002 may align more closely with growing rhetoric in the atopic dermatitis spaceSolimani F, et al. Front Immunol. 2019.Weidinger S, et al. Lancet. 2016.Amano W, et al. J Allergy Clin Immunol. 2015.IV

14. AssumptionsCompetitionMarket sizeValue to stakeholdersLikelihood of approvalThreat of competition is determined by development stage & overlap in MoA, indication, and route of administrationCompetition reduces commercial opportunity by: 70% for analogs with more convenient RoA50% for other analogs5% for class competitors3% for indication competitorsTNT-013 will pursue moderate-to-severe AD indication and TNT-002 will pursue mild-to-moderate indicationAssumptions and statistics are based on scientific literature and market research:37% diagnosis and treatment rate140% of adults have moderate-to-severe AD233% of children have moderate-to-severe AD358.7% of patients’ AD is uncontrolled (on or off treatment)42% adoption rate for TNT-01310% adoption rate for TNT-002Stakeholder values extrapolated from current literature on currently-approved medicinesBoth TNT-013 and TNT-002 gain FDA approval without significant hurdles and/or complications during the drug development process01Hanifin JM, et al. Dermatitis. 20072AD in America PDF. www.aafa.org3Boguniewicz M, et al. Ann Allergy Asthma Immunol. 20184Wei W, et al. J Dermatol. 2018 MoA – mechanism of action, RoA – route of administration, Analog–comparator with overlapping indication + mechanism of action

15. ConclusionNext stepsDetermine optimal pricing with quantitative market researchResearch global market opportunitiesConsider finding a partner with a global immunology commercial team RisksNo discernible market advantage over analogs, so market share capture is not guaranteedPotentially less workforce synergy when pursuing AD indication for TNT-002 instead of TNT-013No commercial roadmap as of yet for medicines in this class in AD Recommendation:TNT Bio should focus on TNT-002 for its strategic expansion into atopic dermatitisRationaleTNT-002 has a more favorable competitive landscapeTNT-002 has a potential blockbuster market opportunityTNT-002 has a novel mechanism of action that brings more value to stakeholdersV

16. UNC/Duke Case Competition 2020Blasting away the toughest immune conditions Erin Burgunder ScholzPh.D. Candidateeburg007@email.unc.eduAndrew StengerPharm.D. Candidateandrew_stenger@unc.eduJefferson Pike Jr.Pharm.D. Candidatejefferson_pike@unc.eduAmy GuisingerMPH, Pharm.D. Candidateaguising@email.unc.edu