[ NASDAQ: MEIP ] Wedbush PacGrow Healthcare Conference August 16-17, 2016

Transcription

1 [ NASDAQ: MEIP ] Wedbush PacGrow Healthcare Conference August 16-17, 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 MEI Pharma (Nasdaq: MEIP): Why Invest? Oncology drug development company w/ pipeline of three clinicalstage drug candidates Lead drug candidate Pracinostat granted Breakthrough Therapy Designation Pracinostat Phase III program fully funded via partnership Strong financial position Management team w/ proven oncology drug development experience 3

4 Pracinostat: Overview Potential best-in-class, oral HDAC inhibitor Breakthrough Therapy Designation (BTD) granted by FDA in combination w/ azacitidine (Aza) for treatment of patients w/ newly diagnosed AML 75 years of age or unfit for intensive chemotherapy BTD supported by data from Phase II study of Pracinostat + Aza Median overall survival: 19.1 months Complete response (CR) rate: 42% (21/50) Combination generally well tolerated, no unexpected toxicities Agreement reached w/ FDA on proposed Phase III study design 4

5 Partnering 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 5

6 Helsinn an Ideal Strategic Partner for Pracinostat 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 6

7 Terms of the Deal Exclusive licensing, development and commercialization agreement for Pracinostat in AML and other hematologic diseases $20 million in near-term cash payments 7 $15 million upfront and $5 million 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 $5 million equity investment from Helsinn Collaborate to explore optimal dosing regimen of Pracinostat + Aza in MDS Helsinn & MEI to share cost of Phase II MDS study, expected to start in 1H 2017 Helsinn responsible for funding global development and commercialization of Pracinostat

8 MEI-004 vs. Aza-001: Overall Population Conventional Care Regimens AZA Azacitidine MEI-004 Azacitidine + Pracinostat Overall Population n=247 n=241 n=50 CR rate 21.9% 19.5% 42.0% 60-day mortality rate 18.2% 16.2% 10.0% 1-year survival rate 34.2% 46.5% 62.0% Median overall survival 6.5 months (95%CI: ) 10.4 months (95%CI: ) 19.1 months (95%CI: ) 8 1 Dombret et al. Blood Jul 16;126(3):291-9

9 MEI-004 vs. AZA-001: High-Risk Population Conventional Care Regimens AZA MEI Azacitidine Azacitidine + Pracinostat High-Risk Population n=85 n=85 n=21 1-year survival estimate 14% 30.9% 57.0% Median overall survival 3.2 months 6.4 months 13.3 months 9 1 Döhner et al. ASH 2014: Garcia-Manero et al. ASH 2015: 453

10 MEI-004 vs. AZA-001: Baseline Characteristics MEI-004 AZA Azacitidine + Pracinostat (n=50) Azacitidine (n=241) Age, Years Median AML classification (by WHO) Not otherwise specified Myelodysplasia-related changes/therapy-related myeloid neoplasms Prior MDS Median BM blasts ECOG PS Cytogenetic risk group Intermediate Intermediate, cytogenetically abnormal Poor Dombret et al. Blood Jul 16;126(3):291-9

11 Market Research: Clinically Meaningful OS Minimum level of OS improvement considered meaningful for a new product vs. current drugs for newly diagnosed AML patients 65 not suited for induction therapy / U.S. & EU (87 responses) 92% 13% 48% 31% 7% 1% 5-10% Improvement 11-20% Improvement 21-30% Improvement 31-40% Improvement >40% Improvement 11

12 Market Research: Potential Prescribing Behavior Prescribing percentages (weighted averages) for Product X of eligible newly diagnosed AML patients 65 years of age not suited for induction therapy / U.S. & EU (20 responses) Target Product Profile: 35% improvement in median overall survival over Aza + placebo 100% 90% 87% 80% 70% 60% 74% 69% 50% 45% 40% 30% 20% 10% 0% U.S. Weighted Avg - Prescribing % Year 1 EU Weighted Avg - Prescribing % Peak Year Years to peak: U.S. = 1.3 years / EU = 1.4 years 12

13 Proposed Phase III Study Design (MEI-009)* Elderly (Age 65 years) Patients with Newly Diagnosed Intermediate or High-Risk AML Not Suited for Intensive Chemotherapy (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 13 * Anticipate dosing first patient in Q1 2017

14 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 Pracinostat 1 MEI Pharma Q Aza Vadastuximab talirine 2 (SGN-CD33A) Venetoclax 3 (ABT-199) Guadecitabine 4 (SGI-110) Sapacitabine 5 (CYC682) Seattle Genetics Ongoing HMA AbbVie H HMA Astex Ongoing Cyclacel Ongoing Dac CR Rate 42% (21/50) 41% (20/49) 38% (13/34) 37% (19/51) 25% (5/20) Last Reported Clinical Data Median OS 19.1 months Estimate on first 25 patients: months (Median follow-up: months) N/A 10.5 months 7.6 months Patients with secondary AML who are suitable for treatment with intensive chemotherapy VYXEOS 6 (CPX-351) Celator Completed 37% 9.6 months 14 1 ASH 2015: 453; 2 EHA 2016: S503; 3 ASCO 2016: 7009; 4 ASH 2015: 458; 5 Lancet Oncol. Nov 2012; 6 ASCO 2016: 7000

15 Pracinostat + Aza in MDS: Summary Pilot study of Pracinostat + Aza in higher risk MDS showed encouraging CR/CRi rate of 89% 1 Randomized Phase II study of Pracinostat + Aza in higher risk MDS failed to improve clinical complete remissions compared to Aza alone Pracinostat resulted in more toxicity when added to Aza, leading to more, and earlier, drug discontinuation in the Pracinostat group Exploratory analyses of patients able to tolerate combination for at least 4 cycles confirm activity of Pracinostat + Aza 15 1 Quintás-Cardama et al. ASH 2012: 3821

16 Pracinostat + Aza: Management of Toxicities in AML Compared to MDS Patients Phase II studies of Pracinostat: Discontinuations in first two cycles due to tolerability MDS (MEI-003) MDS (MEI-003) AML (MEI-004) 1 Azacitidine (n=51) Azacitidine + Pracinostat (n=51) Azacitidine + Pracinostat (n=50) Cycle Cycle Total 4 (8%) 13 (26%) 4 (8%) 16 1 Garcia-Manero et al. ASH 2015: 453

17 Pracinostat + Aza in MDS: Duration of Response for All Patients on Study HR = As of data lock on June 30, 2015

18 Pracinostat + Aza in MDS: Duration of Response for Patients on Study for 4 or More Cycles 1 HR = 0.48 HR = As of data lock on June 30, 2015

19 Pracinostat + Aza in MDS: Overall Survival for Patients on Study for 4 or More Cycles 1 HR = As of data lock on June 30, 2015

20 Market Opportunity for Pracinostat in AML & MDS Global Addressable Market* $450 Million AML ~ $250M MDS ~ $750M $1.35 Billion MDS AML 20 * AML = unfit for intensive chemotherapy; MDS = intermediate-2 and high-risk

21 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 Intermediate-2 & 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 ) 21 * Investigator-sponsored studies

22 ME-401: Potential Best-in-Class PI3Kd Inhibitor A potent and highly selective oral PI3Kd inhibitor with best-in-class potential Superior pre-clinical activity compared to 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 large therapeutic window 22

23 ME-401: PK/PD Data Suggests 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 23

24 Exposure Margin ME-401 vs Zydelig: Exposure Margins* Exposure Margin = Preclinical AUC / Clinical AUC 24 * Data reported in Zydelig CHMP assessment report

25 ME-401: Phase 1b Clinical Study Objective: Demonstrate therapeutic window in cancer patients RSD = 145 mg, but will start lower to establish MED and will dose escalate to MTD Dose-escalation study in recurrent chronic lymphocytic leukemia (CLL) or follicular non-hodgkin s lymphoma (fnhl) Naïve to phosphatidylinositol-4,5-biphosphate 3 kinase p110d subunit (PI3Kd) therapy Starting dose = 60 mg q.d. Expect to dose first patient by September

26 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- negative breast cancer now open for enrollment 26 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):

27 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. 27

28 Financial Highlights $49.4 million in cash as of March 31, 2016 $20 million in near-term cash payments from Helsinn $5 million equity investment from Helsinn No debt 36.8 million shares outstanding 28

29 Near-Term Clinical Milestones Pracinostat 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-risk MDS (1H 2017) ME-401 First patient dosed in Phase Ib study in CLL & fnhl (Q3 2016) Interim data from Phase Ib study in CLL & fnhl (Q2 2017) ME-344 First patient dosed in HER2-negative breast cancer study (Q3 2016) Results from HER2-negative breast cancer study (Q4 2017) 29

30 [ NASDAQ: MEIP ] Wedbush PacGrow Healthcare Conference August 16-17, 2016