Tetralogic Pharmaceuticals Corp · OTC:TLOG
Tetralogic Pharmaceuticals — Investor Presentation (April 2015)
27 slides from Tetralogic Pharmaceuticals's investor presentation, Apr 30, 2015
Slide 1: Corporate Presentation
=> Tetralogic’ Corporate Presentation
Slide 2: Forward-Looking Statements
Forward-Looking Statements Given these risks Forward-looking future events or otherwise. “"Tetralogic Pharmaceuticals” is a registered trademark and “Tetralogic” and the “TetraLogic Pharmaceuticals” logo are the property of their i ely for ence, the trademark in thi
Slide 3: Experienced Management Team with Proven Track Record
Experienced Management Team with Proven Track Name Title Prior Experience J, Kevin Buchi President, Chief Executive Officer Cephalon peteAuNvievers Gis Financial Officer and Deutsche Bank reasurer Chief Scientific Officer and SVP, b The Royal "SS Watters ElizalHall Research & Development AMGEN = Net
Slide 4: TetraLogic Focus
TetraLogic Focus We are a clinical-stage biopharmaceutical company with a focus on cancer and chronic infectious diseases >» ONCOLOGY = Ovarian Cancer = Multiple Myeloma = @TeL > INFECTIOUS DISEASES = Chronic Hepatitis B
Slide 5: Near Term Value Drivers
Near Term Value Drivers Later this year we plan to have: > INFECTIOUS DISEASE: = Data with birinapant in chronic HBV >» ONCOLOGY: Interim data with oe in MDS Data with SHAPE Commenced a cial trial of KEYTRUDA® (Merck’s recently approved PD-1 antibody) and birinapant
Slide 6: Birinapant's Novel Mechanism of Action
Birinapant’s Novel Mechanism of Action > Mimics the Endogenous Protein SMAC = SMAC antagonizes IAPs and enables TNF to. ae damaged cells to self- apoptosis destru signaling to pro-survival snl 4 fm gg SMAC or ad Birinapant By " 4 = @ om-m Birinapant aA nd APOPTOSIS: "ABNORMAL CELL’ SURVIVAL
Slide 7: Currently There is No Cure for Hepatitis B
Currently There is No Cure for Hepatitis B » ~2 Billion people in tt 1 infected with hepatitis B (1 in 3 people), including 12 million in US » ~ 400 Millio Idwid hronicall including > A million i in US y infected, » Loss of £. tigen (HBsAg) and A £ wpe £. . aA 1 antibodies to p y molecul: the HBV su
Slide 8: Birinapant's Differentiated Mechanism of Action
Birinapant’s Differentiated Mechanism of Ai ANTIVIRAL AGENTS: Retroviral inhibitors RNAi INDUCTION OF HOST APOPTOSIS: Birinapant Replication inhibitors
Slide 9: Birinapant in Infectious Disease
Birinapant in Infectious Disease
Slide 10: Birinapant Clears HBV in Mice
Birinapant Clears HBV in Mice HBV-DNA Loss of HBV-DNA in circulation and liver 14 5 ; =e —— 108 ® Entecavir (n=6) a @ Birinapant (n=6) (n=5) 107 x 10: p<.05 a My 3 08 E = 3 3 ® 10° an : g ry = 04: 10° 03 10? an Liver at Day 35 Time post first dose (days) Pellegrini etal. PNAS 2015
Slide 11: Death of Infected Hepatocytes Causes Transient Elevation of Liver Enzymes
Death of Infected Hepatocytes Causes Transient Elevation of Liver Enzymes ALT AST 1500 2000 Ml Untreated B® vehicle B® Birinapant IU/ml 250 750 1000 1250 500 1000 1500 12 24 48 Time post birinapant treatment (hours)
Slide 12: Birinapant Cures HBV in Mice
Birinapant Cures HBV in Mice 20. i *P <0.05 unpaired © Vehicle (n=6) —— two-tailed test ‘@ Entecavir (n=6) 10¢ © Birinapant (n=6) 0G & 10? ‘ 5) Wi vehicle a 10: @® birinapant 2 _ 10 oe SE = as € ao 5 n= 35 per group 10 + meanss.em + 2independent experiments nd 0. a2 Day 42 oO 4 28 Time post first do
Slide 13: Single and Multiple Ascending Dose Trials
Single Ascending Dose Trial Multiple Ascending Dose Trial DNA and HBsAg Study Population: Safety and tolerability increases in ALT/AST pieent or entecavir with measurable sAg Primary Objectives: = Safety and tolerability Secondary Objectives: Single dose of birinapant at 18: “gme/m? Dose and Schedul
Slide 14: Potential Applicability in Other Viral and Mycobacterial Infections
Potential Applicability in Other Viral and Mycobacterial tions Infecti HIV Assays: Normal PBMC samples infected in-vitro TB Assays: in-vivo mouse model 6.0 g 2 < 55 ee 2 = so 5 5 NT 01 1 10 & Birinapant (uM) 45 4 T T Control Birinapant (n=15) (n=17) (0.33 Log, CFU/lung; p = 0.012) @ Tarot eT wroaa 3
Slide 15: Birinapant in Oncology
Birinapant in Oncology
Slide 16: TetraLogic Oncology Pipeline
TetraLogic Oncology Pipeline BIRINAPANT STATUS Myelodysplastic Syndromes (MDS) inati: i IDAZA\ Randomized Phase 2 Ongoing Vv Solid Tumors Phase 1/2 Target 4Q15 v Multiple Myeloma Combination with VELCADE? ———-->_ Phase 1/2 Target 1H16 Ovarian Cancer ‘dLine ——» Phase 1/2 Ongoing ————» ‘Phase 2 Target
Slide 17: Birinapant Safety and Pharmacodynamics
Birinapant Safety and Pharmacodynamics » Well-tolerated at pharmacologically active doses = Tested in ~ 350 subjects with solid and hematological cancers = Several subjects have continued >12 months = Dose-limiting toxicities: & li Bell’s Palsy = Safely combined with multiple chemotherapeutic regime
Slide 18: Responses to Birinapant Plus Azacitidine in Higher Risk MDS
Responses to Birinapant Plus Azacitidine in Higher Risk MDS Bone Marrow Blast (%) 30.0 + 586 -=Patient #12-005 -=-Patient #11-004 —-=t-Patient #11-001 Pass mn i “”— Screening End of Cycle 1 End of Cycle 2 End of Cycle 3 #12-005 CR 5-AZA Naive i #11004 cR Refractory to 5-AZA Died due to sepsis in Cyc
Slide 19: Randomized Phase 2 Trial Design: 1st Line Higher Risk MDS
zed Phase 2 Trial Design: 1%t Line Higher Risk MDS » Birinapant + azacitidine vs. azacitidine 4:1 randomization (n= 148) birinapant + azacitidine Ea ——8 J rN yN yN ‘Commenced trial Interim Review Data Expected 12014 2H 2015 1H 2016 Assumptions: = Primary Endpoint: Response Rate (RR) ae:
Slide 20: Collaboration with Merck: Birinapant Plus KEYTRUDA
Collaboration with Merck: Birinapant Plus KEYTRUDA® = > Phase 1/2 study of the combination of birinapant plus UDA® » Dose escalation ie two of three weeks, re KEYTRUDA® 200mg every dines Weds » Dose expansion phase a TA : Pp types = NSCLC = Bladder cancer = Ovarian cancer = Colorectal cancer
Slide 21: Birinapant Plus Carboplatin More Effective In Vivo in Serous Ovarian Cancer
Birinapant Plus Carboplatin is More Effective In Vivo Than Either Agent Alone in Serous Ovarian Cancer With IAP Over-expression apoptosis ow = Grbopatin —™ Birin. Tumor volume (mm?) 1 2 3 4 5 6 7 Weeks
Slide 22: Combination of Birinapant Plus Bortezomib in Multiple Myeloma
Combination of Birinapant Plus Bortezomib in Multiple Myeloma » Enhanced activity of IAP-inhibitors plus bortezomib versus either agent alone 12 > eu eas plus bortezomib showed efficacy in model of BanIEBle myeloma greater than aInEn: ase alone 2 = Tumor 1 after cessation of drugs at day 73 = Eviden
Slide 23: SHAPE is Differentiated from Currently-Marketed HDAC Inhibitors
SHAPE is eae from Currently-Marketed HDAC Inhibito matter patent through 2028 (plus PTA) the skin but limit systemic exposure acetylation in keratinocytes food vs. Human Skin Homogenate g “© Skin +B Blood = 2 z 2 § i & E
Slide 24: One Month Treatment with SHAPE in Early-Stage CTCL
One Month Treatment with SHAPE in Early-Stage CTCL Treatment duration: i 1 Dosing frequency: BID (twice daily) Results: Four subjects ( from baseline at Days 28 or 42 DLTS. it i i i erythema)
Slide 25: Randomized Phase 2 Trial Design
lomized Phase 2 Trial Desi 0.5% SHAPE BID | | 1:1:1 randomization 1% SHAPE QD (n=60) Ea —® J rN rN Commence trial Data Expected 4Q.2014 End-2015, = Evaluate dose, VALCHLOR®)
Slide 26: Investment Highlights
Investment Highlights » Highly experienced management team > Later this year we will have randomized clinical data in: = Chronic HBV = MDS = rel > Birinapant is the only molecule that has generated antibodies to the HBV surface antigen in preclinical models
Slide 27: Thank you
=> Tetralogic’ Thank you
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