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[ NASDAQ: MEIP ] Bank of America Merrill Lynch Health Care Conference May 12-14, 2015

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Page 1: Bank of America Merrill Lynch Health Care …filecache.drivetheweb.com/mr5ir_meipharma/128/download...Bank of America Merrill Lynch Health Care Conference May 12-14, 2015 2 Forward-Looking

[ NASDAQ: MEIP ]

Bank of America Merrill Lynch

Health Care Conference

May 12-14, 2015

Page 2: Bank of America Merrill Lynch Health Care …filecache.drivetheweb.com/mr5ir_meipharma/128/download...Bank of America Merrill Lynch Health Care Conference May 12-14, 2015 2 Forward-Looking

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.

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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

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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

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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

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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

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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

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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

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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”

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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)

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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

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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

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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?

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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”

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• 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

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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

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18

ME-344: Sensitive vs. Naturally Resistant Cells

Sensitive Human Lung Cancer Cells: IC50 > 100nM

Resistant Human Lung Cancer Cells: IC50 < 50uM

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19

Effect of ME-344 on Mitochondria Stress Tests

Lung Cancer Cells

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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

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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

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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

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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

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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

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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)

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[ NASDAQ: MEIP ]

Bank of America Merrill Lynch

Health Care Conference

May 12-14, 2015