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[ NASDAQ: MEIP ]
Bank of America Merrill Lynch
Health Care Conference
May 12-14, 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.
3
MEI Pharma (Nasdaq: MEIP)
• San Diego-based oncology drug development company with three
wholly owned drug candidates
Pracinostat: Oral HDAC inhibitor with evidence of clinical activity
o Full data from Phase II study in elderly AML at EHA in June 2015
ME-344: Novel mitochondrial inhibitor with single-agent activity
o Data from Phase Ib study expected in Q4 2015
PWT143: PI3K delta inhibitor with compelling pre-clinical activity
o First-in-human study expected to initiate in mid-2015
• Strong intellectual property protection extending past 2028 in US
• Cash sufficient to fund operations to 2017
• Management team with proven drug development experience
4
Management Team
EXECUTIVE MANAGEMENT
Daniel Gold, PhD
President & Chief Executive OfficerFormer Chief Scientific Officer & Founder, Favrille
Robert Mass, MD
Chief Medical OfficerFormer Head of Medical Affairs, BioOncology, Genentech
Thomas Zech
Chief Financial OfficerFormer Chief Financial Officer, Pacira Pharmaceuticals
David Urso, JD
SVP, Corporate Development & General CounselFormer Principal, Forward Ventures / COO, Tioga Pharmaceuticals
Karen Potts, PhD
SVP, Regulatory AffairsFormer SVP of Regulatory Affairs, Trius Therapeutics
BOARD OF DIRECTORS
Christine White, MD (Lead Director)Former Head of Global Medical Affairs, Biogen Idec
Charles Baltic, JDCo-Head of Healthcare, Needham & Co.
Leah Cann, MBATwo-time Wall Street Journal All-Star Analyst
Kevan Clemens, PhDFormer Head of Global Oncology, Roche
Nick Glover, PhDFormer President & CEO, YM BioSciences
Daniel Gold, PhDPresident & CEO, MEI Pharma
Thomas Reynolds, MD, PhDFormer Chief Medical Officer, Seattle Genetics
William RueckertFormer Chairman, Novogen Limited
5
DRUG CANDIDATE INDICATION / COMBINATION PRE-CLINICAL PHASE I PHASE II PHASE III
EP
IGE
NE
TIC
SP
RO
GR
AM
PracinostatHDAC Inhibitor
Acute Myeloid LeukemiaFront Line, ElderlyAzacitidine (Vidaza®)
Myelodysplastic SyndromeFront Line, Int-2 & High-RiskAzacitidine (Vidaza®)
Myelodysplastic SyndromeRefractory to HMAAzacitidine (Vidaza®) or
Decitabine (Dacogen®)
MyelofibrosisFront Line & Relapsed/RefractoryRuxolitinib (Jakafi®)
CA
NC
ER
ME
TA
BO
LIS
M
PR
OG
RA
M
ME-344Mitochondrial Inhibitor
Small Cell Lung CancerAdvanced or MetastaticTopotecan (Hycamtin®)
Ovarian CancerAdvanced or MetastaticTopotecan (Hycamtin®)
SIG
NA
LIN
G
PR
OG
RA
M
PWT143PI3K Delta Inhibitor
Hematologic Cancers
Clinical Development Pipeline
6
Pracinostat: Demonstrated Evidence of Clinical
Activity in Hematologic Diseases
• Single-agent activity in elderly acute myeloid leukemia (AML)
14% (2/14) CR rate in Phase I dose-escalation study1
• Moderate single-agent activity in myelofibrosis
36% (8/22) clinical improvement rate in Phase II study2
• Encouraging activity w/ azacitidine in myelodysplastic syndrome (MDS)
89% (8/9) ORR rate in pilot study3
• Significant activity w/ azacitidine in front-line elderly AML
45% (15/33) CR/CRi/MLFS rate in Phase II study4
1 Garcia‐Manero et al. 2010 ASH Annual Meeting, Abstract 32922 Quintás-Cardama et al. Leukemia Research, 2012 Sep;36(9):1124-73 Quintás-Cardama et al. 2012 ASH Annual Meeting, Abstract 38214 Garcia-Manero et al. 2014 ASH Annual Meeting, Abstract 947
7
Intermediate Risk-2 or High Risk MDS Patients
Previously Untreated w/ HMA
Pracinostat
+
Azacitidine
Placebo
+
Azacitidine
Phase II Study in Front Line MDS (MEI-003)
• 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 & tolerability
8
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 &
progression free survival and overall survival) still immature
Longer follow-up required to achieve meaningful conclusions
• Fatigue, gastrointestinal toxicities & 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
9
Placebo + Azacitidine
(n=51)
Pracinostat + Azacitidine
(n=51)
Cycle 1 4 5
Cycle 2 0 8
Total 4 (8%) 13 (25%)
Phase II Study in Front Line MDS (MEI-003)Cycle 1 & 2 Discontinuations Due to Tolerability*
* Includes adverse events, patient decisions/informed consent withdrawals and “other”
10
Elderly (Age ≥ 65 years) Patients with Newly Diagnosed AML
Phase II Study in Front Line AML (MEI-004)
Pracinostat
+
Azacitidine
• 50 patients enrolled between December 2013 - December 2014 at
15 sites in the U.S.
• Primary endpoint: CR + CRi + MLFS*
Secondary endpoints: overall response rate, complete cytogenetic
response, duration of response, event-free survival, overall survival,
safety & tolerability
• Response assessments end of cycle 1 or 2, then every other cycle
until CR is achieved or as clinically indicated
* Morphologic leukemia-free state (i.e., marrow CR)
11
Phase II Study in Front Line AML: Interim DataDuration on Study & Response – ASH 2014
0 50 100 150 200 250 300
Days on Study
1stLin
e E
lderly A
ML P
atients
(N
=33) Response Based on Clinical
Review of Efficacy Data
CR
CRi
MLFS
PR/PRi
Stable Disease
Progressive Disease
Clinical Benefit –
AE/Withdrew
No Clinical Benefit –
AE/Withdrew
Time to 1st BM
Assessment for
Responders
Remains on treatment
12
Phase II Study in Front Line AML: Interim DataDuration on Study & Response – March 2015*
0 1 2 3 4 5 6 7 8 9 10 11 12 13
Response Based on Clinical
Review of Efficacy Data
CR
CRi
MLFS
PR/PRi
Stable Disease
Progressive Disease
Clinical Benefit –
AE/Withdrew
No Clinical Benefit –
AE/Withdrew
Time to 1st BM
Assessment for
Responders
Remains on treatment
Months on Study
1stLin
e E
lderly A
ML P
atients
(N
=33)
*
**
*
*
* Patients with improved response since presentation at ASH 2014
13
Phase II Study in Front Line AML: Interim Data
• Significant clinical activity in elderly patients w/ newly diagnosed AML
• 52% (17/33) achieved primary endpoint as of March 2015
CR = 33% (11/33)
• Majority of bone marrow responses occur within first two cycles
• Observed response rate continues to increase with longer follow-up
• 60-day mortality rate = 9% (3/33)
Do data support development of Pracinostat + azacitidine in AML?
14
MDS (MEI-003) AML (MEI-004)
Pracinostat + Azacitidine
(n=51)
Pracinostat + Azacitidine
(n=50)
Cycle 1 5 3
Cycle 2 8 4
Total 13 (25%) 7 (14%)
Phase II Study in Front Line AML vs. MDSCycle 1 & 2 Discontinuations Due to Tolerability*
* Includes adverse events, patient decisions/informed consent withdrawals and “other”
15
• Evidence of single agent activity in Phase I dose-escalation study in
refractory solid tumors1
Generally well tolerated at 10 mg/kg weekly
o Dose limiting toxicity of Grade 3 neuropathy at 15 & 20 mg/kg
• Phase 1b combination study with topotecan in relapsed refractory
ovarian & small cell lung cancers ongoing
Ovarian cancer data expected in Q4 2015
• Novel mechanism of action directly targeting mitochondrial OXPHOS
complex I2, resulting in rapid loss of cellular energy (ATP)
• New pre-clinical data shows significantly enhanced anti-tumor
activity when combined with a tyrosine-kinase inhibitor (TKI)
ME-344: Lead Mitochondrial Inhibitor
1 Cancer 2015 Apr 1;121(7):1056-632 Am J Cancer Res 2015;5(2):689-701
16
ME-344: First-in-Human Clinical StudyDuration of Prior Therapy Compared to ME-344*
* Patients achieving partial remission or stable disease
Small Cell Lung Cancer
Carcinoid of the Ileum
Urothelial
Cervical
Cervical Leiomyosarcoma
Non-Small Cell Lung
Ovarian
Non-Small Cell Lung
0 13 26 39 52 65 78 91
9104
1288.5+
40
12
10
51
50+
242+
18
915
11
12
Weeks
Duration of Last Prior Therapy Duration of ME-344
104
18
ME-344: Sensitive vs. Naturally Resistant Cells
Sensitive Human Lung Cancer Cells: IC50 > 100nM
Resistant Human Lung Cancer Cells: IC50 < 50uM
19
Effect of ME-344 on Mitochondria Stress Tests
Lung Cancer Cells
20
Tumor Growth Inhibition Following Single
Agent or Combination Therapy
0
200
400
600
800
1000
1200
0 1 2 3 4 5 6 7 8 9 10
Weeks
Vehicle BIBF ME BIBF+METKI
Tumor Growth
ME-344 TKI + ME-344
21
Impact of ME-344 on Disease Progression
Following Treatment with TKI*
0
200
400
600
800
1000
1200
1400
1600
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14
Weeks
BIBF - BIBF BIBF - BIBF+METKI → TKI + ME-344
* When tumors reached 100mm3, mice were treated with TKI for 10 weeks; mice were then
randomized to receive continued TKI or TKI + ME-344
Tumor Growth
TKI → TKI
22
PWT143: Highly Selective PI3K Delta Inhibitor
• Acquired from Pathway Therapeutics in September 2013
• Expands drug development pipeline
Clinically validated target in hematologic diseases
Potential synergies with Pracinostat
• Distinct chemical structure & evidence of improved pre-clinical
activity compared to other PI3K delta inhibitors in development
• IND-enabling 2-species tox studies & scale manufacturing methods
completed
• First-in-human study expected to initiate in June 2015
23
Intellectual Property
Pracinostat
• 3 issued US & 77 issued foreign patents
2 US & 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-344
• 2 issued US & 18 issued foreign patents
3 US & 7 foreign applications pending
• Composition of matter to Sep 2025 in US & 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 & 29 foreign applications pending
• Composition of matter to Jan 2031 in US, pending in EP
24
Financial Highlights
• Cash: $70.5 million (as of March 31, 2015)
Sufficient to fund operations to 2017
• Debt: None
• Shares outstanding: 33.3 million
25
2015 Clinical Milestones
Pracinostat
Full data from Phase II study in front line elderly AML (June)
ME-344
Data from ovarian cancer cohort in Phase Ib study (Q4)
PWT143
Initiation of first-in-human study (mid-2015)
[ NASDAQ: MEIP ]
Bank of America Merrill Lynch
Health Care Conference
May 12-14, 2015