[ NASDAQ: MEIP ] Wedbush PacGrow Healthcare Conference August 11, 2015

Transcription

1 [ NASDAQ: MEIP ] Wedbush PacGrow Healthcare Conference August 11, 2015

2 Forward-Looking Statements These slides and the accompanying oral presentation contain forward-looking statements. Actual events or results may differ materially from those projected in any of such statements. Additional information concerning factors that may cause actual events or results to differ from those projected is contained in MEI Pharma s most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other subsequent filings with the SEC. 2

3 MEI Pharma (Nasdaq: MEIP) San Diego-based oncology company with three wholly owned drug candidates All three drug candidates in the clinic with data expected by year end Strong intellectual property protection for all drug candidates Strong cash position: $70.5 million as of March 31, 2015 Experienced management team with proven oncology drug development experience 3

4 SIGNALING PROGRAM CANCER METABOLISM PROGRAM EPIGENETICS PROGRAM Clinical Development Pipeline DRUG CANDIDATE INDICATION / COMBINATION PRE-CLINICAL PHASE I PHASE II PHASE III Acute Myeloid Leukemia Front Line, Elderly Azacitidine (Vidaza ) Pracinostat HDAC Inhibitor ME-344 Mitochondrial Inhibitor Myelodysplastic Syndrome Front Line, Int-2 & High-Risk Azacitidine (Vidaza ) Myelodysplastic Syndrome Refractory to HMA Azacitidine (Vidaza ) or Decitabine (Dacogen ) Myelofibrosis Front Line & Relapsed/Refractory Ruxolitinib (Jakafi ) Small Cell Lung Cancer Advanced or Metastatic Topotecan (Hycamtin ) Ovarian Cancer Advanced or Metastatic Topotecan (Hycamtin ) PWT143 PI3K Delta Inhibitor Hematologic Cancers 4

5 Pracinostat in MDS: What We Learned Evidence of activity in combination with azacitidine in pilot study 1 89% (8/9) overall response rate; combination very well tolerated Top-line data from randomized Phase II study released in March 2015 Addition of Pracinostat to azacitidine did not improve rate of complete remission compared to azacitidine alone Combination of Pracinostat plus azacitidine resulted in high rate of early drug discontinuations, primarily due to tolerability Patients receiving Pracinostat plus azacitidine for > 4 cycles achieve prolonged progression-free & overall survival compared to azacitidine alone (HRs < 0.6); data still maturing o Data submitted for presentation at ASH in December Quintás-Cardama et al. ASH 2012: Abstract 3821

6 North American Intergroup Randomized Phase II MDS Study (SWOG S1117) 1 Azacitidine Azacitidine + Vorinostat CR rate 24% (22/92) 15% (14/91) Off Tx due to toxicity / side effect / complication Relapse-free survival, on Tx > 6 months (median) 9% (8/92) 24% (22/91) 7 months 13 months (P =.11) Conclusions / Opinion: Are combination regimens in MDS too toxic? Or do we need to manage toxicities better? ORR is not the right endpoint for large MDS trials. We need to focus on durable responses, and on OS. 6 1 Sekeres et al. ASH 2014: LBA - 5

7 1 st Line Elderly AML Patients (N=50) Phase II Study of Pracinostat in AML Duration on Study and Best Response 1 Response Based on Clinical Review of Efficacy Data CR CRi MLFS PR/Pri Stable Disease Progressive Disease No On-Study Assessment Time to 1 st Bone Marrow Assessment for Responders Ongoing Months on Study 7 1 Garcia-Manero et al. EHA 2015: Abstract P568

8 Phase II Study of Pracinostat in AML vs. MDS Discontinuations in First Two Cycles Due to Tolerability* MDS (MEI-003) MDS (MEI-003) AML (MEI-004) Azacitidine (n=51) Pracinostat + Azacitidine (n=51) Pracinostat + Azacitidine (n=50) Cycle Cycle Total 4 (8%) 13 (25%) 7 (14%) 8 * Includes adverse events, patient decisions/informed consent withdrawals and other

9 Phase II Study of Pracinostat in AML Overall Survival by Risk Group 1 Patients are censored as of the date of last contact to determine survival status on or after May 15, CNSR, censored. 9 1 Garcia-Manero et al. EHA 2015: Abstract P568

10 International Phase III Study of Azacitidine in Newly Diagnosed AML (AZA-AML-001) Conventional Care Regimens (n=247) AZA-AML MEI Azacitidine (n=241) Pracinostat + Azacitidine (n=50) CR rate 21.9% 19.5% 42% 60-day mortality rate 18.2% 16.2% 10% One-yearsurvival rate 34.2% 46.5% 60% Overall survival 6.5 months 10.4 months (P =.1009)? 10 1 Dombret et al. Blood Jul 16;126(3): As of ASH abstract submission on August 4, 2015

11 ME-344: Novel Mitochondrial Inhibitor Novel mechanism of action directly targets mitochondrial OXPHOS complex I 1, resulting in rapid loss of cellular energy (ATP) Evidence of single agent activity in Phase I dose-escalation study in refractory solid tumors 2 Phase 1b combination study with topotecan in relapsed/refractory ovarian and small cell lung cancers closed to enrollment Initial survival estimates expected in Q New pre-clinical data shows significantly enhanced anti-tumor activity when combined with VEGFR tyrosine-kinase inhibitor (TKI) Lim et al. Am J Cancer Res. 2015;5(2): Bendell et al. Cancer Apr 1;121(7): Manevich et al. AACR 2015: Abstract 5409

12 Spontaneous Breast Tumor Model Nintedanib (VEGFR/PDGFR/FGFR TKI) + ME-344* 1200 Tumor Growth Inhibition Weeks Vehicle ME-344 BIBF ME Nint BIBF+ME Nint + ME * Collaboration with Miguel Quintela-Fandino, MD, PhD, Spanish National Cancer Research Centre, Madrid

13 Human KRas Mutated Lung Xenograft Nintedanib (VEGFR/PDGFR/FGFR TKI) + ME-344* 1400 Tumor Growth Inhibition T0 T1 T2 T3 T4 T5 T6 T7 T8 T9 T10 T11 T12 T13 T14 T15 Weeks Vehicle ME344 Nint BIBF Nint BIBF+ME344 + ME * Collaboration with Miguel Quintela-Fandino, MD, PhD, Spanish National Cancer Research Centre, Madrid

14 PWT143: Highly Selective PI3K Delta Inhibitor First PI3K delta inhibitor (Idelalisib) approved in July 2014 Recommended starting dose: 150 mg orally, twice daily PWT143 has shown superior pre-clinical activity compared to other PI3K delta inhibitors, including Idelalisib First-in-human study initiated in June 2015 Measurable plasma levels as well as significant on target activity observed at 10 mg starting dose level; PK results suggest daily dosing PK/PD data submitted for presentation at ASH in December

15 Upcoming Clinical Milestones Pracinostat Overall survival estimate from Phase II study in AML (Q4 2015) ME-344 Initial survival estimates from Phase Ib study + topotecan (Q4 2015) Initiation of Phase II study + TKI (Q1 2016) PWT143 PK data from first-in-human study (Q4 2015) Initiation of Phase I study in hematologic cancer (Q1 2016) 15

16 [ NASDAQ: MEIP ] Wedbush PacGrow Healthcare Conference August 11, 2015