Tetralogic Pharmaceuticals Corp · OTC:TLOG
Tetralogic Pharmaceuticals — Investor Presentation (September 2015)
28 slides from Tetralogic Pharmaceuticals's investor presentation, Sep 28, 2015
Slide 1: Corporate Presentation September 2015
Corporate Presentation September 2015
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward looking statements, These statements are not guarantees of future performance and involve a number of unknown risks, assumptions, trends, uncertainties and factors that are beyond our control. Given these risks, assumptions and uncertaint
Slide 3: Summary Financial Metrics
Summary Financial Metrics NASDAQ: TLOG Founded : 2003 Cash) : $35mm Basic Shares Outstanding® : 23mm 1H2015 Cash Burn’) : $18mm (1) As of June 30, 2015. (2) Net cash used in operating activities, six months ended June 30, 2015.
Slide 4: Targeting Significant Improvements in Standards of Care
Targeting Significant Improvements in Standards of Care We are a Clinical-stage biopharmaceutical company with a focus on cancer and chronic infectious diseases » Birinapant could meaningfully improve MDS standard of care = Objective responses in 5 of 9 high risk MDS patients including 3 complete re
Slide 5: Experienced Management Team with Proven Track Record
Experienced Management Team with Proven Track Rec Name Title Prior Experience J. Kevin Buchi President, Chief Executive Officer Cephalon J teinsue | and Dirertor we) Ges a> Chief Financial Officer and Deutsche Bank I] CreprrSuisst™ ition Read! & Co. Pete A. Meyers lee Chief Scientific Officer and SV
Slide 6: Pipeline
PRE-CLINICAL PHASE 1 PHASE 2 Myelodysplastic Syndromes (MDS) Birinapant plus VIDAZA® Cutaneous T-Cell Lymphoma (CTCL) SHAPE HBV Birinapant Solid Tumors Birinapant plus KEYTRUDA® Multiple Myeloma Birinapant plus bortezomib HIV Birinapant
Slide 7: Birinapant is a SMAC Mimetic that Enhances Apoptosis in Cancer and Viral Infection
Birinapant is a SMAC Mimetic that Enhances Apoptosis in Cancer and Virall = Birinapant and SMAC antagonize IAPs and thereby enable TNF to drive damaged cells to self-destruct SMAC or > Birinapant s SMAC or S>> Birinapant APOPTOSIS: Infected Cells = Cancerous cells avoid TNF driven apoptosis by upreg
Slide 8: SHAPE is a Novel Approach to T-Cell Skin Diseases
to T-Cell Skin Diseases roa SHAPE is a Novel A » SHAPE is a topical HDAC inhibitor designed for more tolerable treatment of Stage I-lla CTCL Systemic HDAC inhibitors are effective and used in Stage Ilb-IV CTCL, but side effects prevent their use in early stage disease Activity in the skin demonstrat
Slide 9: Birinapant in Myelodysplastic Syndromes
Birinapant in Myelodysplastic Syndromes
Slide 10: Birinapant in MDS
Birinapant in MDS » Myelodysplastic Syndromes (MDS) = ~ 15,000 new diagnoses of MDS every year in US = ~ 40% are higher-risk (RAEB1 and RAEB2) = RAEB1 median survival is 18 months = RAEB2 median survival is 10 months = Current therapies include azacitidine and decitabine = Only ~ 30% of higher-risk
Slide 11: Phase 2 Trial Design: 1st Line Higher Risk MDS
Phase 2 Trial Design: 15‘ Line Higher Risk MDS birinapant + azacitidine Phase 2a Safety Run-in (n=9) Phase 2b Randomized (n =148) azacitidine a a a ‘Commenced trial Interim Review Data Expected 1H2014 January 2016 Mid 2016 = 67 sites across 4 countries = Primary Endpoint: Response Rate (RR) = Study
Slide 12: Promising Efficacy in Phase 2a (n=9)
Promising Efficacy in Phase 2a (n=9) > Objective responses in 5 of 9 high risk MDS patients including 3 CRs Pare one | pom bUSTS (FTCA areca) |e we " Baseline 12.5 9.9 599 29 c4aw4 2 13.2 1200 60 cR Baseline 16 74 900 52 . "2 c4aw4 2 174 3000 157 cR Baseline 8 ii7 400 29 . iia c4aw4 2 11.5 1900 231
Slide 13: Summary of Adverse Events of Patients in Phase 2a
Summary of Adverse Events 22 of Patients in Phase 2a Term All Grades Grade23 Fatigue 6 2 Neutropenia [Thrombocytopenia Pyrexia [Constipation Nausea Rash lAnemia Diarrhea Ichilts IMyalgia [Dyspnea lAmylase increased lipase increased jeight decreased lAbdominal pain Decreased appetite [Dehydration lar
Slide 14: SHAPE: Cutaneous T-Cell Lymphoma
SHAPE Cutaneous T-Cell Lymphoma
Slide 15: Cutaneous T-Cell Lymphoma
Cutaneous T-Cell L » CTCL affects > 30,000 patients in North America » Early-stage disease (Stages IA-IIA) represents ~75% of all CTCL cases » Chronic disease with 5 year survival rate ¥ 88% » Current therapies for early-stage disease include: Topical Corticosteroids, Topical Retinoids, Topical Nitr
Slide 16: One Month Treatment with SHAPE in Early-Stage CTCL
One Month Treatment with SHAPE in Early-Stage CTCL Treatment duration: Maximum 28 days, 2 week follow up Dosing frequency: BID (twice daily) Phase 1 Results: = Four subjects (~27%) demonstrated PRs by 50% reduction in CAILS score from baseline at Days 28 or 42 = Subjects on placebo demonstrated no s
Slide 17: Randomized Phase 2 Trial Design (Stage IA-IIA)
domized Phase 2 Trial Desig: (Stage IA-IIA) 0.5% SHAPE BID | | 1:1:1 randomization 1% SHAPE QD (n =60) 1% SHAPE BID | | Evaluate dose, efficacy at 6 months (vs 1 month), time to response and tolerability of treatment of >2% body surface area = Primary end-point: Response Rate by CAILS and mSWAT = De
Slide 18: Additional Opportunities
Additional Opportunities
Slide 19: Broad Applicability for Birinapant
Broad Applicability for Birinapan are Amplified Across Human Cancer: 000 200 _ mo # 700 5 0 ta “oa fo ito oo AE ret SEES? 3 = ee ee ge A TPRITTTETTT TUITE LEEPER ee ges dena FS $ 2 Gee 8 3 z oF ay a 3 228 id 33 & gs 6&8 4 3 :* eg é TAP Genes igs how Oncogenes IAPs protect cells, including cancer cel
Slide 20: Birinapant Plus KEYTRUDA®
Birinapant Plus KEYTRUDA® » Birinapant and KEYTRUDA® enable the immune system to kill cancer cells in complementary fashion = KEYTRUDA® acts against the T-cell suppressor PD-1 = SMAC mimetics enhance T and NK cell responses and unblock IAP suppression of the immune system mediated apoptosis » Collab
Slide 21: Birinapant Plus Carboplatin More Effective In Vivo Than Either Agent Alone
Birinapant Plus Carboplatin is More Effective In Vivo Than Either Agent Alone in Serous Ovarian Cancer With IAP Over-expression A. Human serous tumor with high levels of inhibitor of apoptosis proteins Vehicle 40 “= Birinapant 351 ~~ Carboplatin “™ Birinapant+Catboglatin Tumor volume (mm?) 1 2 3 4 s
Slide 22: Birinapant Plus Bortezomib is Effective In Vivo in Multiple Myeloma
Birinapant Plus Bortezomib is Effective In Vivo in Multiple Myeloma: Sustained Tumor Suppression After Treatment Cessation 2500 | 8 8 Tumor volume (mm?) 3 even mt Btz 0.5 ~a-Bt207 TL 15 ~OnTL+ Bt 0.5 ~O-TL+ 8120.7 Day post tumor cell inoculation I ‘Treatment ceased ‘Treatment: 15 mg/kg Birinapant (i
Slide 23: Birinapant in Infectious Disease
Birinapant in Infectious Disease
Slide 24: HBV Adopts a Similar Apoptosis Defense as Cancer
HBV Adopts a Similar Apoptosis Defense as Cancer » Birinapant cures HBV in Mice 20: * ® Vehicle (n=6) — *P <0.05 unpaired © Entecavir (n=6) bata a @ Birinapant (n=6) aS: £ 10° 3) i vehicle é 10: WB birinapant pe 102 3 + n=3-5 per group ae = + mean £s.e.m, x2 oR + 2 independent experiments. 10! nd :
Slide 25: Chronic Hepatitis B Proposed Phase 1/2
ic Hepatitis B Proposed Phase 1/2 » Study Objective = Safety and tolerability = Identify dose that is active (based on elevation in LFT’s and/or decline in HBV DNA) and tolerable = Determine multiple dose efficacy and safety of birinapant at that dose » Study Population: = Subjects with chronic hepa
Slide 26: Potential Applicability in Other Viral and Mycobacterial Infections
Potential Applicability in Other Viral and Mycobacterial Infections HIV Assays: Normal PBMC Samples Infected In-vitro Induced Apoptosis in HIV-infected CD4+ Cells Reduction in Lung Burden After 3 Doses 120 100 +— — 6.0 g 80 +— — <= 2 = 55) 40 +— -L — = 5 a = = 50 ots | __ >) NT O01 1 10 6 Birinapant
Slide 27: Upcoming Milestones
Upcoming Milestones » MDS Interim Phase 2 Data » CTCL Phase 2 Data » Birinapant plus KEYTRUDA® Phase 1 Start >» HBV Phase 1/2 Start
Slide 28: Thank you
Thank you
TetraLogic Pharmaceuticals — Investor Presentation (September 2015) on 6ix