[ NASDAQ: MEIP ] Stifel Healthcare Conference November 15-16, 2016

Transcription

1 [ NASDAQ: MEIP ] Stifel Healthcare Conference November 15-16, 2016

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 The Year in Review Announced plans to proceed to Phase III registration study of Pracinostat + azacitidine in AML following presentation of Phase II data at ASH in Dec 2015 Reached agreement w/ FDA on proposed Phase III study design Granted Breakthrough Therapy Designation from FDA based on Phase II data Median overall survival: 19.1 months Complete response (CR) rate: 42% Entered strategic partnership for Pracinostat worth up to $464 million Long-term survival & response data from Phase II study in AML accepted for oral presentation at ASH in Dec 2016 Initiated Phase Ib study of ME-401 in relapsed/refractory CLL & fnhl Investigator study of ME Avastin initiated in HER2 - breast cancer 3

4 Late-Stage Development Landscape in AML Patients with newly diagnosed AML who are unfit for treatment with intensive chemotherapy Drug Candidate Sponsor Phase III Study Combo Azacitidine 1 Celgene Completed Pracinostat 2 MEI Pharma Q Aza Vadastuximab talirine 3 (SGN-CD33A) Venetoclax 4 (ABT-199) Guadecitabine 5 (SGI-110) Seattle Genetics Ongoing HMA AbbVie H HMA Astex Ongoing CR Rate 19.5% (47/241) 42% (21/50) 41% (20/49) 27% (12/45) 37% (19/51) Last Reported Clinical Data Median OS 10.4 months (95%CI: ) 19.1 months (95%CI: ) Estimate on first 25 patients: months (Median follow-up: months) N/A 10.5 months Patients with secondary AML who are suitable for treatment with intensive chemotherapy VYXEOS 6 (CPX-351) Celator Completed 37% 9.6 months 4 1 Blood Jul 16;126(3):291-9; 2 ASH 2015: 453; 3 EHA 2016: S503; 4 ASCO 2016: 7009; 5 ASH 2015: 458; 6 ASCO 2016: 7000

5 Pracinostat: Proposed Phase III Study Design* Newly Diagnosed AML Patients Unfit to Receive Induction Therapy (N~500) Group A: Pracinostat + Azacitidine Group B: Placebo + Azacitidine Primary Objective: To compare the overall survival (OS) of Pracinostat in combination with azacitidine versus placebo in combination with azacitidine Inclusion Criteria: 18 years w/ previously untreated AML, intermediate or high-risk cytogenetics Age years requires at least 1 co-morbid medical condition Age 75 years 5 * Anticipate dosing first patient in Q1 2017

6 Pracinostat: A Phase III-Ready Asset Criteria for evaluating partnering opportunities: Financial capabilities to support Phase III development costs Commitment to rapidly advance the program Strong operational and commercial capabilities, ideally in hematologic cancer, to complement our development capabilities Commitment to MDS as well as AML 6

7 Pracinostat: Helsinn an Ideal Strategic Partner Swiss pharmaceutical group focused on quality cancer care products Stated commitment to expand into oncology therapeutics Strong commercial presence in the U.S. Network of 70 commercial partners in 90 countries Aloxi a market leader, often used by patients receiving azacitidine 7

8 Pracinostat: Terms of the Deal Exclusive licensing, development and commercialization agreement for Pracinostat in AML and other hematologic diseases Helsinn responsible for funding global development and commercialization $20 million in near-term cash payments $15 million upfront + $5 million on Mar 1, 2017 or upon dosing of first patient in Phase III study Up to $444 million in regulatory and sales-based milestones Tiered royalty payments in U.S. and selected territories Agree to share cost of Phase II study to explore optimal dosing regimen of Pracinostat + azacitidine in high and very high risk MDS MEI responsible for study conduct, expected to start in 1H 2017 $5 million equity investment from Helsinn 8

9 CANCER METABOLISM PROGRAM SIGNALING PROGRAM EPIGENETICS PROGRAM Clinical Development Pipeline DRUG CANDIDATE INDICATION / COMBINATION PRE-CLINICAL PHASE I PHASE II PHASE III Acute Myeloid Leukemia Newly diagnosed, 75 years or unfit Azacitidine (Vidaza ) Pracinostat* HDAC Inhibitor Myelodysplastic Syndrome High & very high risk Azacitidine (Vidaza ) Myelofibrosis** Front line & relapsed/refractory Ruxolitinib (Jakafi ) ME-401 PI3K Delta Inhibitor B-Cell Malignancies Recurrent CLL or follicular NHL Single agent, dose escalation ME-344 Mitochondrial Inhibitor HER2-Negative Breast** Bevacizumab (Avastin ) 9 * Partnered with Helsinn Healthcare, SA ** Investigator-sponsored studies

10 ME-401: Potential Best-in-Class PI3Kd Inhibitor Potent and highly selective oral PI3K delta inhibitor Superior pre-clinical activity compared to the approved drug Zydelig On-target binding affinity (K D ) >30 times greater First-in-human, single ascending dose study completed Superior PK/PD profile to Zydelig PK confirms once-daily dosing Potential for wide therapeutic window 10

11 ME-401: PK/PD Data Suggest Large Therapeutic Window Biomarker for inhibition of PI3K delta: Inhibition of basophil activation by FceR1 antibody PK/PD data was fit to E max Model EC50 = 0.6 ng/ml (1.0nM) EC90 = 5.2 ng/ml (8.9nM) Daily dosing of > 60 mg expected to afford continuous plasma concentrations above the EC 90 11

12 ME-401: Differentiated Biological Activity vs. Zydelig Compound EC 50 (nm) EC 90 (nm) ME-401 ~1 8.9 Idelalisib 150 >500 12

13 Exposure Margin ME-401: Exposure Margins vs. Zydelig * Exposure Margin = Preclinical AUC / Clinical AUC 13 * Data reported in Zydelig CHMP assessment report

14 ME-401: Phase Ib Dose-Escalation Study Early cohort data expected mid-2017 Patients 18 w/ Relapsed/Refractory Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma (CLL/SLL) or Follicular Lymphoma (FL) Dose Escalation Start at 60 mg to establish mbed Cohort Expansion If no DLTs and 2 or more responses in 6 patients, then expand cohort to 12 Dose Escalate to MTD Phase II Combination Studies 14 Primary objectives: Determine Minimum Biologically Effective Dose (mbed) Determine Maximally Tolerated Dose (MTD) Determine Dose Limiting Toxicities (DLTs) Key eligibility: No prior therapy w/ PI3K delta inhibitors No prior therapy w/ BTK inhibitors unless patient was intolerant of BTK therapy

15 ME-344: Lead Mitochondrial Inhibitor 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 Exciting pre-clinical data demonstrating interplay between tumor cell glycolysis and mitochondrial metabolism in combination with VEGF inhibitors 3,4 Investigator-sponsored study in combination with Avastin in HER2 - breast cancer now open for enrollment 15 1 Lim et al. Am J Cancer Res. 2015;5(2): Bendell et al. Cancer Apr 1;121(7): Manevich et al. J Pharmacol Exp Ther Aug;358(2): Navarro et al. Cell Rep Jun 21;15(12):

16 Intellectual Property Pracinostat 4 issued U.S. and 77 issued foreign patents 2 U.S. and 8 foreign applications pending Composition of matter to May, 2028 in U.S. May, 2033 with up to 5 years patent term restoration in U.S. ME-401 (formerly PWT143) 2 issued U.S. patent 1 U.S. and 21 foreign applications pending Composition of matter to Dec in U.S., excluding patent term restoration ME issued U.S. and 18 issued foreign patents 3 U.S. and 7 foreign applications pending Composition of matter to March, 2027 in U.S. March, 2032 with up to 5 years of patent term restoration in U.S. 16

17 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, MBA 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 Richard Ghalie, MD SVP, Clinical Development Former CMO, Denovo, HemaQuest, Novalar & Favrille BOARD OF DIRECTORS Christine White, MD (Chair) Former Head of Global Medical Affairs, Biogen Idec Charles Baltic, JD Co-Head of Healthcare, Needham & Co. Kevan Clemens, PhD Former Head of Global Oncology, Roche Nick Glover, PhD President & CEO, ProNAi Therapeutics Daniel Gold, PhD President & CEO, MEI Pharma Thomas Reynolds, MD, PhD Former Chief Medical Officer, Seattle Genetics William Rueckert Former Chairman, Novogen Limited 17

18 Financial Highlights $58.9 million in cash as of September 30, 2016 Net loss of $4.5 million for three months ended September 30, 2016 No debt 36.8 million shares outstanding 18

19 Near-Term Clinical Milestones Pracinostat ME-401 Presentation of long-term survival & response data from Phase II study in AML (ASH - Dec 2016) Initiation of Phase III study in newly diagnosed AML, 75 years or unfit for intensive chemotherapy (Q1 2017) Initiation of Phase II dose optimization study in high & very high risk MDS (1H 2017) Phase Ib study in CLL & fnhl open for enrollment Early cohort data from Phase Ib study in CLL & fnhl (Q2 2017) ME-344 HER2-negative breast cancer study open for enrollment Results from HER2-negative breast cancer study (Q4 2017) 19

20 [ NASDAQ: MEIP ] Stifel Healthcare Conference November 15-16, 2016