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

Cantor Fitzgerald Healthcare Conference July 8, 2015filecache.drivetheweb.com/mr5ir_meipharma/129/download...Acute Myeloid Leukemia Front Line, Elderly Azacitidine (Vidaza ®) Myelodysplastic

Embed Size (px)

Citation preview

Page 1: Cantor Fitzgerald Healthcare Conference July 8, 2015filecache.drivetheweb.com/mr5ir_meipharma/129/download...Acute Myeloid Leukemia Front Line, Elderly Azacitidine (Vidaza ®) Myelodysplastic

[ NASDAQ: MEIP ]

Cantor Fitzgerald Healthcare Conference

July 8, 2015

Page 2: Cantor Fitzgerald Healthcare Conference July 8, 2015filecache.drivetheweb.com/mr5ir_meipharma/129/download...Acute Myeloid Leukemia Front Line, Elderly Azacitidine (Vidaza ®) Myelodysplastic

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.

Page 3: Cantor Fitzgerald Healthcare Conference July 8, 2015filecache.drivetheweb.com/mr5ir_meipharma/129/download...Acute Myeloid Leukemia Front Line, Elderly Azacitidine (Vidaza ®) Myelodysplastic

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 Phase Ib study + topotecan enrollment closed; initial survival

estimates expected in Q4 2015

o 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

Page 4: Cantor Fitzgerald Healthcare Conference July 8, 2015filecache.drivetheweb.com/mr5ir_meipharma/129/download...Acute Myeloid Leukemia Front Line, Elderly Azacitidine (Vidaza ®) Myelodysplastic

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

Page 5: Cantor Fitzgerald Healthcare Conference July 8, 2015filecache.drivetheweb.com/mr5ir_meipharma/129/download...Acute Myeloid Leukemia Front Line, Elderly Azacitidine (Vidaza ®) Myelodysplastic

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

Page 6: Cantor Fitzgerald Healthcare Conference July 8, 2015filecache.drivetheweb.com/mr5ir_meipharma/129/download...Acute Myeloid Leukemia Front Line, Elderly Azacitidine (Vidaza ®) Myelodysplastic

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 study1

• As a single-agent in myelofibrosis

36% (8/22) clinical improvement rate in Phase II study2

• Combined with azacitidine in myelodysplastic syndrome (MDS)

89% (8/9) ORR rate in pilot study3

• Combined with azacitidine in newly diagnosed elderly AML

54% (27/50) 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. 2015 EHA Annual Congress, Abstract P568

Page 7: Cantor Fitzgerald Healthcare Conference July 8, 2015filecache.drivetheweb.com/mr5ir_meipharma/129/download...Acute Myeloid Leukemia Front Line, Elderly Azacitidine (Vidaza ®) Myelodysplastic

7

Intermediate Risk-2 or High Risk MDS Patients

Previously Untreated with HMA

Pracinostat

+

Azacitidine

Placebo

+

Azacitidine

Pracinostat: Phase II Study in Front Line MDS

• 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

Page 8: Cantor Fitzgerald Healthcare Conference July 8, 2015filecache.drivetheweb.com/mr5ir_meipharma/129/download...Acute Myeloid Leukemia Front Line, Elderly Azacitidine (Vidaza ®) Myelodysplastic

8

Pracinostat: Phase II Study in Front Line MDSTop-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

Page 9: Cantor Fitzgerald Healthcare Conference July 8, 2015filecache.drivetheweb.com/mr5ir_meipharma/129/download...Acute Myeloid Leukemia Front Line, Elderly Azacitidine (Vidaza ®) Myelodysplastic

9

Elderly (Age ≥ 65 years) Patients with Newly Diagnosed AML

Pracinostat: Phase II Study in Front Line 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

* Morphologic leukemia-free state (i.e., marrow CR)

Page 10: Cantor Fitzgerald Healthcare Conference July 8, 2015filecache.drivetheweb.com/mr5ir_meipharma/129/download...Acute Myeloid Leukemia Front Line, Elderly Azacitidine (Vidaza ®) Myelodysplastic

10

MDS (MEI-003) MDS (MEI-003) AML (MEI-004)

Azacitidine

(n=51)

Pracinostat +

Azacitidine

(n=51)

Pracinostat +

Azacitidine

(n=50)

Cycle 1 4 5 3

Cycle 2 0 8 4

Total 4 (8%) 13 (25%) 7 (14%)

Pracinostat: Phase II Study in Front Line AML vs. MDS

Cycle 1 and 2 Discontinuations Due to Tolerability*

* Includes adverse events, patient decisions/informed consent withdrawals and “other”

Page 11: Cantor Fitzgerald Healthcare Conference July 8, 2015filecache.drivetheweb.com/mr5ir_meipharma/129/download...Acute Myeloid Leukemia Front Line, Elderly Azacitidine (Vidaza ®) Myelodysplastic

11

Pracinostat: Phase II Study in Front Line AMLData 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

Page 12: Cantor Fitzgerald Healthcare Conference July 8, 2015filecache.drivetheweb.com/mr5ir_meipharma/129/download...Acute Myeloid Leukemia Front Line, Elderly Azacitidine (Vidaza ®) Myelodysplastic

12

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Response Based on Clinical

Review of Efficacy Data

CR

CRi

MLFS

PR/Pri

Stable Disease

Progressive Disease

No On-Study Assessment

Time to 1st Bone Marrow

Assessment for Responders

Ongoing

Months on Study

1stLin

e E

lderly A

ML P

atients

(N

=50)

Pracinostat: Phase II Study in Front Line AMLDuration on Study and Best Response

Page 13: Cantor Fitzgerald Healthcare Conference July 8, 2015filecache.drivetheweb.com/mr5ir_meipharma/129/download...Acute Myeloid Leukemia Front Line, Elderly Azacitidine (Vidaza ®) Myelodysplastic

13

Pracinostat: Phase II Study in Front Line AMLOverall Survival (OS) by Risk Group*

* Patients still living are censored as of the date of last contact to determine survival status

on or after May 15, 2015 (CNSR = censored)

Page 14: Cantor Fitzgerald Healthcare Conference July 8, 2015filecache.drivetheweb.com/mr5ir_meipharma/129/download...Acute Myeloid Leukemia Front Line, Elderly Azacitidine (Vidaza ®) Myelodysplastic

14

Pracinostat: Phase II Study in Front Line AMLClinical 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)

Page 15: Cantor Fitzgerald Healthcare Conference July 8, 2015filecache.drivetheweb.com/mr5ir_meipharma/129/download...Acute Myeloid Leukemia Front Line, Elderly Azacitidine (Vidaza ®) Myelodysplastic

15

Conventional Care

Regimens

(n=247)

Azacitidine

(n=241)

CR 54 (22%) 47 (20%)

Overall Survival6.5 months

(95%CI: 5.0-8.6)

10.4 months

(95%CI: 8.0-12.7)

Phase III Study of Azacitidine Alone in Elderly AML*

* 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

Page 16: Cantor Fitzgerald Healthcare Conference July 8, 2015filecache.drivetheweb.com/mr5ir_meipharma/129/download...Acute Myeloid Leukemia Front Line, Elderly Azacitidine (Vidaza ®) Myelodysplastic

16

• 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 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 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 VEGFR 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

Page 17: Cantor Fitzgerald Healthcare Conference July 8, 2015filecache.drivetheweb.com/mr5ir_meipharma/129/download...Acute Myeloid Leukemia Front Line, Elderly Azacitidine (Vidaza ®) Myelodysplastic

17

Spontaneous Breast Tumor ModelNintedanib (VEGFR/PDGFR/FGFR TKI) + ME-344*

0

200

400

600

800

1000

1200

0 1 2 3 4 5 6 7 8 9 10

Weeks

Vehicle BIBF ME BIBF+MENint

Tumor Growth Inhibition

ME-344 Nint + ME-344

* Collaboration with Miguel Quintela-Fandino, MD, PhD, Spanish National Cancer

Research Centre, Madrid

Page 18: Cantor Fitzgerald Healthcare Conference July 8, 2015filecache.drivetheweb.com/mr5ir_meipharma/129/download...Acute Myeloid Leukemia Front Line, Elderly Azacitidine (Vidaza ®) Myelodysplastic

18

0

200

400

600

800

1000

1200

1400

T0 T1 T2 T3 T4 T5 T6 T7 T8 T9 T10 T11 T12 T13 T14 T15

Vehicle ME344 BIBF BIBF+ME344Nint Nint + ME-344

Weeks

Human KRas Mutated Lung XenograftNintedanib (VEGFR/PDGFR/FGFR TKI) + ME-344*

Tumor Growth Inhibition

* Collaboration with Miguel Quintela-Fandino, MD, PhD, Spanish National Cancer

Research Centre, Madrid

Page 19: Cantor Fitzgerald Healthcare Conference July 8, 2015filecache.drivetheweb.com/mr5ir_meipharma/129/download...Acute Myeloid Leukemia Front Line, Elderly Azacitidine (Vidaza ®) Myelodysplastic

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 Q4 2015

Page 20: Cantor Fitzgerald Healthcare Conference July 8, 2015filecache.drivetheweb.com/mr5ir_meipharma/129/download...Acute Myeloid Leukemia Front Line, Elderly Azacitidine (Vidaza ®) Myelodysplastic

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-344

• 2 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

Page 21: Cantor Fitzgerald Healthcare Conference July 8, 2015filecache.drivetheweb.com/mr5ir_meipharma/129/download...Acute Myeloid Leukemia Front Line, Elderly Azacitidine (Vidaza ®) Myelodysplastic

21

Financial Highlights

• Cash: $70.5 million as of March 31, 2015

• Debt: None

• Shares outstanding: 33.3 million

Page 22: Cantor Fitzgerald Healthcare Conference July 8, 2015filecache.drivetheweb.com/mr5ir_meipharma/129/download...Acute Myeloid Leukemia Front Line, Elderly Azacitidine (Vidaza ®) Myelodysplastic

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)

Page 23: Cantor Fitzgerald Healthcare Conference July 8, 2015filecache.drivetheweb.com/mr5ir_meipharma/129/download...Acute Myeloid Leukemia Front Line, Elderly Azacitidine (Vidaza ®) Myelodysplastic

[ NASDAQ: MEIP ]

Cantor Fitzgerald Healthcare Conference

July 8, 2015