[ NASDAQ: MEIP ] Cantor Fitzgerald Healthcare Conference July 8, 2015

Transcription

1 [ NASDAQ: MEIP ] Cantor Fitzgerald Healthcare Conference July 8, 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 drug development company with three wholly owned drug candidates in the clinic Pracinostat: Oral HDAC inhibitor with evidence of clinical activity o Improving response rates in ongoing Phase II elderly AML study ME-344: Novel mitochondrial inhibitor with single-agent activity o o Phase Ib study + topotecan enrollment closed; initial survival estimates expected in Q Compelling pre-clinical combination data with VEGFR TK inhibition PWT143: PI3K delta inhibitor with promising pre-clinical activity o First-in-human study initiated in June 2015 Intellectual property protection extending past 2028 in US Strong cash position Management team with proven drug development experience 3

4 Management Team EXECUTIVE MANAGEMENT Daniel Gold, PhD President & Chief Executive Officer Former Chief Scientific Officer & Founder, Favrille Robert Mass, MD Chief Medical Officer Former Head of Medical Affairs, BioOncology, Genentech Thomas Zech Chief Financial Officer Former Chief Financial Officer, Pacira Pharmaceuticals David Urso, JD SVP, Corporate Development & General Counsel Former Principal, Forward Ventures / COO, Tioga Pharmaceuticals Karen Potts, PhD SVP, Regulatory Affairs Former SVP of Regulatory Affairs, Trius Therapeutics BOARD OF DIRECTORS Christine White, MD (Lead Director) Former Head of Global Medical Affairs, Biogen Idec Charles Baltic, JD Co-Head of Healthcare, Needham & Co. Leah Cann, MBA Two-time Wall Street Journal All-Star Analyst Kevan Clemens, PhD Former Head of Global Oncology, Roche Nick Glover, PhD Former President & CEO, YM BioSciences Daniel Gold, PhD President & CEO, MEI Pharma Thomas Reynolds, MD, PhD Former Chief Medical Officer, Seattle Genetics William Rueckert Former Chairman, Novogen Limited 4

5 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 5

6 Pracinostat: Evidence of Clinical Activity in Hematologic Diseases As a single agent in elderly acute myeloid leukemia (AML) 14% (2/14) CR rate in Phase I dose-escalation study 1 As a single-agent in myelofibrosis 36% (8/22) clinical improvement rate in Phase II study 2 Combined with azacitidine in myelodysplastic syndrome (MDS) 89% (8/9) ORR rate in pilot study 3 Combined with azacitidine in newly diagnosed elderly AML 54% (27/50) CR/CRi/MLFS rate in Phase II study Garcia Manero et al ASH Annual Meeting, Abstract Quintás-Cardama et al. Leukemia Research, 2012 Sep;36(9): Quintás-Cardama et al ASH Annual Meeting, Abstract Garcia-Manero et al EHA Annual Congress, Abstract P568

7 Pracinostat: Phase II Study in Front Line MDS Intermediate Risk-2 or High Risk MDS Patients Previously Untreated with HMA Pracinostat + Azacitidine Placebo + Azacitidine 102 evaluable patients at 19 sites in the U.S. One-to-one randomization, double-blind Primary endpoint: CR Secondary endpoints: overall response rate, hematologic improvement, clinical benefit rate, duration of response, progression-free survival, rate of leukemic transformation, overall survival, safety and tolerability 7

8 Pracinostat: Phase II Study in Front Line MDS Top-Line Data No difference in CR rate compared to azacitidine alone Data from event-driven endpoints (duration of response, event and progression free survival and overall survival) immature Longer follow-up required to achieve meaningful conclusions Fatigue, gastrointestinal toxicities and myelosuppresion occurred more frequently in combination group Resulted in higher rate of drug discontinuations compared to azacitidine alone o Discontinuation difference most evident during first 2 cycles 8

9 Pracinostat: Phase II Study in Front Line AML Elderly (Age 65 years) Patients with Newly Diagnosed AML Pracinostat + Azacitidine 50 patients enrolled at 15 sites in the U.S. Last patient in on November 24, 2014 Primary endpoint: CR + CRi + MLFS* Secondary endpoints: overall response rate, complete cytogenetic response, duration of response, event-free survival, overall survival, safety and tolerability Response assessments end of cycle 1 or 2, then every other cycle until CR is achieved or as clinically indicated 9 * Morphologic leukemia-free state (i.e., marrow CR)

10 Pracinostat: Phase II Study in Front Line AML vs. MDS Cycle 1 and 2 Discontinuations 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%) 10 * Includes adverse events, patient decisions/informed consent withdrawals and other

11 Pracinostat: Phase II Study in Front Line AML Data from European Hematology Association (EHA) 54% (27/50) achieved primary endpoint CR rate = 32% (16/50) Most responses occur within first two cycles and continue to improve with ongoing therapy The most common treatment-emergent AEs included febrile neutropenia, thrombocytopenia, nausea and fatigue 60-day mortality rate = 10% (5/50) Median overall survival not yet reached 32 patients (64%) still living While these data are encouraging, longer follow-up is necessary to get an accurate overall survival estimate of the combination 11

12 1 st Line Elderly AML Patients (N=50) Pracinostat: Phase II Study in Front Line AML Duration on Study and Best Response 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

13 Pracinostat: Phase II Study in Front Line AML Overall Survival (OS) by Risk Group* 13 * Patients still living are censored as of the date of last contact to determine survival status on or after May 15, 2015 (CNSR = censored)

14 Pracinostat: Phase II Study in Front Line AML Clinical Update since EHA Patients continue to improve with ongoing therapy CR rate now 42% (21/50) Median overall survival not yet reached 32 patients (64%) still living (range, 8-17 months) 14

15 Phase III Study of Azacitidine Alone in Elderly AML* Conventional Care Regimens (n=247) Azacitidine (n=241) CR 54 (22%) 47 (20%) Overall Survival 6.5 months (95%CI: ) 10.4 months (95%CI: ) 15 * Global, multi-center, randomized, open-label pivotal study, patients at least 65 years old with newly diagnosed or secondary AML with > 30% bone marrow blasts

16 ME-344: Lead Mitochondrial Inhibitor Evidence of single agent activity in Phase I dose-escalation study in refractory solid tumors 1 Generally well tolerated at 10 mg/kg weekly o Dose limiting toxicity of Grade 3 neuropathy at 15 and 20 mg/kg Phase 1b combination study with topotecan in relapsed/refractory ovarian and small cell lung cancers closed to enrollment Initial survival estimates expected by Q Novel mechanism of action directly targeting mitochondrial OXPHOS complex I 2, resulting in rapid loss of cellular energy (ATP) New pre-clinical data shows significantly enhanced anti-tumor activity when combined with VEGFR tyrosine-kinase inhibitor (TKI) 16 1 Cancer 2015 Apr 1;121(7): Am J Cancer Res 2015;5(2):

17 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

18 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

19 PWT143: Highly Selective PI3K Delta Inhibitor Acquired from Pathway Therapeutics in September 2013 Expands drug development pipeline Clinically validated target in hematologic diseases Distinct chemical structure and evidence of improved pre-clinical activity compared to other PI3K delta inhibitors in development First-in-human study initiated in June 2015 PK data anticipated by Q

20 Intellectual Property Pracinostat 3 issued US and 77 issued foreign patents 2 US and 8 foreign applications pending Composition of matter to May 2028 in US, Aug 2026 in EP May 2033 with up to 5 years patent term restoration in US Aug 2031 with up to 5 years Supplementary Protection Certificate in EP ME issued US and 18 issued foreign patents 3 US and 7 foreign applications pending Composition of matter to Sep 2025 in US and EP Sep 2029 with up to 4 years of patent term restoration in US Sep 2030 with up to 5 years Supplementary Protection Certificate in EP PWT143 1 issued US patent 3 US and 29 foreign applications pending Composition of matter to Jan 2031 in US, pending in EP 20

21 Financial Highlights Cash: $70.5 million as of March 31, 2015 Debt: None Shares outstanding: 33.3 million 21

22 Upcoming Clinical Milestones Pracinostat Overall survival estimate from Phase II study in elderly AML (Q4) ME-344 Survival estimate from Phase Ib + topotecan study (Q4) PWT143 Data from first-in-human study (Q4) 22

23 [ NASDAQ: MEIP ] Cantor Fitzgerald Healthcare Conference July 8, 2015