Post on 30-Apr-2020
Puma Biotechnology
Copyright 2015 Puma Biotechnology
Jefferies 2015 Healthcare Conference
June 2015
Copyright 2015 Puma Biotechnology
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the anticipated timing of and plans with respect to our regulatory filings, the potential indications of our drug candidates and the development of our drug candidates, including, but not limited to, the anticipated timing for the commencement and completion of various clinical trials and announcement of data relative to these trials. These statements are often, but not always, made through the use of words or phrases such as ``anticipates,'' ``expects,'' ``plans,'' ``believes,'' ``intends,'' and similar words or phrases. All forward–looking statements included in this presentation involve risks and uncertainties that could cause our actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the fact that we have no product revenue and no products approved for marketing; our dependence on our lead product candidate PB272, which is still under development and may never receive regulatory approval; the challenges associated with conducting and enrolling clinical trials; the risk that results of clinical trials may not support our drug candidate claims; even if approved, the risk that physicians and patients may not accept or use our products; our reliance on third parties to conduct our clinical trials and to formulate and manufacture our drug candidates; our dependence on licensed intellectual property; and the other risk factors disclosed in our periodic reports filed with the Securities and Exchange Commission from time to time, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2014. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. We assume no obligation to update these forward-looking statements except as required by law.
Forward-Looking Safe Harbor Statement
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Copyright 2015 Puma Biotechnology
Company Highlights In-licensing driven business model – mitigates R&D risk
PB272 (neratinib)- clinical stage candidate targeting multiple oncology indications
HER2+ Metastatic Breast Cancer HER2+ Metastatic Breast Cancer with Brain Metastases HER2+ Neoadjuvant Breast Cancer HER2+ Adjuvant Breast Cancer HER2 Mutated Non-Small Cell Lung Cancer HER2 Mutated Breast Cancer HER2 Mutated Solid Tumors
Retained commercial rights to PB272
Strong Phase II and Phase III data for PB272 (single agent and in combination with chemotherapy)
Potential for multiple clinical trial readouts over next 6-12 months 3
Copyright 2015 Puma Biotechnology
Product Pipeline Drug Indication Pre-clinical I II III Registration
PB272 Single agent
Adjuvant Breast Cancer
PB272 Combination w/ Xeloda
Metastatic Breast Cancer
PB272 Combination w/ Paclitaxel
Metastatic Breast Cancer
PB272 Combination w/ Torisel
Metastatic Breast Cancer
PB272 Single agent/ combination
Metastatic Breast Cancer with Brain Mets
PB272 Combination w/ chemotherapy
Neoadjuvant Breast Cancer
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Copyright 2015 Puma Biotechnology
Product Pipeline (cont’d.) Drug Indication Pre-clinical I II III Registration PB272 (oral) Combination and Single agent
HER2 Mutated NSCLC
PB272 (oral) Single agent
HER2 Mutated Breast Cancer
PB272 (oral) Single agent
HER2 Mutated Solid Tumors
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Copyright 2015 Puma Biotechnology
Neratinib (PB272) Safety
Over 3,000 patients treated with neratinib prior to Puma licensing drug
Neratinib - Main Grade 3/4 AE-Diarrhea (previously ~30% Grade 3/4)
Typically a first cycle effect (first 28 days) Historically treated with antidiarrheal agents (loperamide)
after diarrhea occurs Treated with dose reductions after diarrhea occurs
Puma introduced diarrhea prophylaxis with loperamide Given Day 1 with neratinib dose for first cycle High dose of loperamide initially (8-16mg) Taper dose during cycle 1
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Neratinib (PB272) Grade 3 Diarrhea Rates Without Prophylaxis with Loperamide
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Neratinib (PB272) Diarrhea Prophylaxis with Loperamide
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- HER2 positive breast cancer
- Lymph node negative, positive or residual invasive disease after
neoadjuvant treatment
Ran
dom
ize
1:1
Neratinib (1 year)
2800 patients total
Placebo (1 year)
- Completed 1 year prior adjuvant treatment with trastuzumab prior to
randomization
Primary endpoint: Invasive Disease Free Survival (IDFS) Secondary endpoints: Disease Free Survival Including Ductal Carcinoma in Situ (DFS-DCIS), Time to Distant Recurrence, Incidence of CNS recurrence, Overall Survival No loperamide prophylaxis used to prevent neratinib related diarrhea
ExteNET Trial - HER2 Positive Extended Adjuvant Breast Cancer
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ExteNET-HER2+ Extended Adjuvant Breast Cancer Announced trial hit primary endpoint (July 2014)
33% Reduction in Risk of Disease Free Survival (DFS) Hazard ratio: 0.67 p= 0.009
37% Reduction in Risk of Disease Free Survival including DCIS (DFS-DCIS)
Hazard ratio: 0.63 p = 0.002
Presentation and publication of data in 2015
Anticipate Filing for Regulatory Approval (US/Europe) in Q1 2016
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Kaplan-Meier Estimates of Disease Free Survival ITT Population
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Kaplan-Meier Estimates of DFS Centrally Confirmed HER2 Positive Population
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Comparator Adjuvant Registration Studies Study
Design
DFS
DFS-DCIS
Reduction in risk of disease
recurrence
Absolute reduction in risk of disease
recurrence HR p HR p DFS DFS-
DCIS DFS DFS-
DCIS ‘Extended’ adjuvant HER2+ BC ExteNET Local HER2 0.67* 0.009 0.63 0.002 33% 37% 2.3%
(24 mo) 2.9%
(24 mo) Central HER2 0.51 0.002 0.49 <0.001 49% 51%
4.1%
(24 mo) 4.5%
(24 mo) HERA 2 years
Central HER2 0.99 0.86 ND 2.4% (24 mo)
Extended adjuvant HR+ EBC post tamoxifen Rx (HER2+ and HER2-) MA.17 Letrozole
(post 5yrs tamoxifen)
0.62* <0.001 2.8% (24 mo)
Adjuvant treatment HR+ EBC (HER2+ and HER2-) Arimidex 5 yrs Rx 0.83 0.0049 17% 2.8%
(5 yrs)
Aromasin 2-3 yrs tamoxifen → Aromasin
0.69 <0.001 31% 3.4% (5 yrs)
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Kaplan-Meier Estimates of DFS Hormone Receptor Positive Patients ITT Population
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Crosstalk between ER and HER2 Signaling Pathways: Rationale for Dual Neratinib and Hormonal Therapy
Source: Prat and Baselga. Nat Clin Practice Onc 2008;5:531–42
*Inhibition of cross talk not seen in extended adjuvant trials of Herceptin (HERA 2 year) or Tykerb (TEACH)
Copyright 2015 Puma Biotechnology
Phase II Trial of Neratinib in HER2+ Extended Adjuvant Breast Cancer using Loperamide
Prophylaxis Open label Phase II trial of neratinib monotherapy in patients
who have completed trastuzumab in adjuvant setting (n=70)
Patients will be given high dose loperamide prophylaxis (no loperamide prophylaxis used in ExteNET)
Trial initiated in Q1 2015
Primary endpoint: Incidence and severity of diarrhea
Data anticipated in late 2015
Anticipate results will be including in NDA/MAA filings to support ability of high dose loperamide to reduce neratinib related diarrhea in extended adjuvant HER+ breast cancer
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Surgery
Early HER2-positive Breast Cancer, Adjuvant
AC Herceptin + Taxol (NCCTG N9831 + NSABP B-31)
ExteNET Neratinib vs Placebo
AC Taxotere + Herceptin (BCIRG)
Approved APHINITY
Perjeta + Herceptin + Chemotherapy vs Placebo+ Herceptin + Chemotherapy
KAITLIN AC Trastuzumab + Pertuzumab + Taxane vs
AC TDM1 + Pertuzumab
Ongoing
ALTTO Herceptin+/- taxane
Herceptin +/- taxane Tykerb
Tykerb + Herceptin +/- taxane
Chemo
Herceptin (HERA 2 yrs Rx Arm)
Adjuvant (for up to 52 weeks post surgery) Extended adjuvant
Failed
Chemotherapy Herceptin (HERA 1 yr)
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PB272 Extended Adjuvant HER2+ Breast Cancer Market Size
Approximately 36,000 patients (US) with early stage HER2+ breast cancer
Approximately 34,000 patients (EU) with early stage HER2+ breast cancer
Treatment duration: 12 months
Current WW Herceptin adjuvant revenue (year 1) : $4.3 billion Neratinib would be used in year 2 after adjuvant Herceptin
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Treatment Paradigm for HER2+ Metastatic Breast Cancer
Prior HER2+ MBC Rx
T-DM1 (EMILIA)
Tykerb (lapatinib) + Xeloda (capecitabine)
Herceptin + other Chemo Rx
Herceptin + Tykerb
Herceptin (trastuzumab) + Perjeta (pertuzumab)
+docetaxel
Neratinib + Xeloda (capecitabine)
Neratinib + Torisel
No Prior HER2+ Rx
T-DM1 +/- Perjeta (MARIANNE-trial did not
achieve primary endpoint December 2014)
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Neratinib (PB272) Activity in second-line/third-line HER2+ MBC
Response Rate
PFS (weeks)
Tykerb (single agent) 5-7% 8-9
Neratinib (single agent) 24% 22.3
Herceptin plus vinorelbine 37% 24.6
Neratinib plus vinorelbine 57% 44.1
Tykerb plus capecitabine 23.7% 27.1
Neratinib plus capecitabine 64% 40.3
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PB272 Phase III Trial-Third Line HER2+ MBC (PUMA-NER-1301)
Obtained SPA from FDA and review by EMA in February 2013
Performed in patients with HER2+ Metastatic Breast Cancer (MBC) who have been treated with two or more prior treatments (third-line disease)
Trial Design PB272 plus Xeloda (capecitabine) versus Tykerb plus Xeloda
(N=600, 1:1 randomization) Study conducted in North America, Europe, Asia-Pacific Co-primary endpoint: progression free survival/overall survival
Trial initiated June 2013
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Copyright 2015 Puma Biotechnology
PB272 Third-Line HER2+ MBC Market Size
Approximately 5,000-6,000 patients (US) with third-line HER2+ metastatic breast cancer
Tykerb 2013 WW sales - ~$325 M (~$86 M US, ~$239M ex US) Approved in combination with Xeloda In US, Herceptin often substituted for Tykerb in combination with
Xeloda
Opportunity to gain market share from both Xeloda-Tykerb patients and Xeloda-Herceptin patients
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Copyright 2015 Puma Biotechnology
-No Prior Treatment for Metastatic Disease
-Prior taxane/trastuzumab in adjuvant setting allowed R
ando
miz
e 1:
1
Paclitaxel plus Neratinib
Paclitaxel plus Trastuzumab
Primary endpoint: Progression free survival (PFS)
Secondary endpoints: Overall response rate, clinical benefit rate, safety, time to CNS mets
No loperamide prophylaxis used to prevent neratinib related diarrhea �
480 patients total
NEfERTT Trial-First Line HER2 Positive Metastatic Breast Cancer
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PB272 First-Line HER2+ Metastatic Breast Cancer Trial (NEfERTT)
Progression Free Survival: Paclitaxel-Neratinib: 12.9 months Paclitaxel-Herceptin: 12.9 months (p=0.777)
Objective Response Rate: Paclitaxel-Neratinib: 74.8% Paclitaxel-Herceptin: 77.2% (p=0.595)
Incidence of CNS Metastases: Paclitaxel-Neratinib: 7.9% Paclitaxel-Herceptin: 16.0% (p=0.004)
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Comparison of Incidence of CNS Metastases
CLEOPATRA (first line metastatic breast cancer) Taxotere-Herceptin-Perjeta: 13.7% Taxotere-Herceptin: 12.6% (p=NS)
EMILIA (second line metastatic breast cancer) Kadcyla: 2.0% Xeloda-Tykerb: 0.7% (p=NS)
NEfERTT (first line metastatic breast cancer) Taxol-Neratinib: 7.9% Taxol-Herceptin: 16.0% (p=0.004)
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Kaplan Meier Estimates of Incidence of CNS Metastases
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Neratinib (PB272) Combination with Torisel
Temsirolimus
Neratinib
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Source: Company
Copyright 2015 Puma Biotechnology
Neratinib (PB272) Phase II Trial in Combination with Torisel
Neratinib (240 mg) in combination with Torisel (8 mg/wk) Fourth-Line (and Later) HER2+ Metastatic Breast
Cancer 11 of 37 patients with PR (30%) Median duration of response = 7.4 months Progression free survival not yet mature Benefit seen in patients previously treated with
Herceptin, Perjeta, Tykerb, TDM-1 Potential to initiate Phase III trial in 2015
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San Antonio Breast Cancer Symposium 2014
Copyright 2015 Puma Biotechnology
Neratinib (PB272) HER 2+ MBC with Brain Metastases
33% of HER2+ advanced metastatic breast cancer patients develop brain metastases
Phase II trial of Tykerb (lapatinib) in MBC patients with CNS metastases (n=39)
2.6% response rate in CNS metastases (Tykerb naïve)
Phase II trial of Tykerb (lapatinib) in MBC patients with CNS metastases (n=242)
6% response rate in CNS metastases (Tykerb naïve)
Phase II extension trial of Tykerb (lapatinib) plus Xeloda in MBC patients with CNS metastases (n=50) 20% response rate in CNS metastases
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Neratinib (PB272) HER2+ MBC with Brain Metastases
Phase II trial of neratinib in MBC patients with brain metastases
Conducted by Dana Farber Translational Breast Cancer Research
Two cohorts of patients:
Single agent neratinib (n=40) 85% of patients are Tykerb refractory 7.5% response rate in CNS metastases (ASCO, 2014)
Xeloda plus neratinib (n=60) Patients who are Tykerb naïve (n=30) Patients who are Tykerb refractory (n=30)
Potential for results over next 6-12 months
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Neratinib - Neoadjuvant Trials Comparison
pCR rate (breast & lymph)
NeoALTTO Taxol + Herceptin 27.6%
Taxol plus Tykerb 20.0%
Taxol plus Herceptin plus Tykerb 46.8%
NeoSphere
Taxotere plus Herceptin 21.5% Taxotere plus Perjeta 17.7%
Taxotere plus Herceptin plus Perjeta 39.3%
-No doublet (Tax plus single HER2 agent) outperformed Tax plus Herceptin
-Herceptin added ~22-27% to pCR rate for Tax plus single HER2 agent doublet
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Neratinib (PB272)-Neoadjuvant HER2+ Breast Cancer I-SPY2 Trial (Investigation of Serial Studies to Predict Your
Therapeutic Response with Imaging And moLecular Analysis 2)
NIH Funded Trial (n=20 (min) - 120 (max) per arm)
Enrolls patients with higher risk of recurrence (MammaPrint 70 gene signature assay)
Adaptive trial design using Bayesian predictive probability Taxol plus Herceptin Taxol plus Neratinib
Extensive Biomarker analysis (signatures) being performed
Endpoint: pathological complete response (path CR) rate (breast and lymph nodes)
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I-SPY 2 Trial: Neoadjuvant Therapy
AACR 2014
• 80.5% of MammaPrint UltraHigh patients were HER2 negative • Neratinib now eligible for I-SPY3 (Phase III)
(p=0.089)
(p=0.067)
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Neratinib (PB272) Neoadjuvant Studies in HER2+ Breast Cancer NSABP Trial (FB-7) - Neoadjuvant randomized trial of neratinib, Taxol, Herceptin
Funded by NSABP (National Surgical Adjuvant Breast and Bowel Project) Taxol plus Herceptin (n=43) Taxol plus Neratinib (n=43) Taxol plus Herceptin plus Neratinib (n=43)
Endpoint: pathological complete response (path CR) rate (breast and axillary lymph nodes)
Results anticipated H1 2015
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Copyright 2015 Puma Biotechnology
PB272 Neoadjuvant HER2+ Breast Cancer Market Size
Approximately 36,000 patients (US) with newly diagnosed HER2+ breast cancer
Approximately 34,000 patients (EU) with newly diagnosed HER2+ breast cancer
Treatment duration: 3 months
Market opportunity: $1.0 - 2.0 billion
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HER2 Mutated Non-Small Cell Lung Cancer (NSCLC)
Approximately 2-4% of NSCLC have HER2 kinase domain mutation at exon 20 (~4,500-9,000 patients US)
Most common in adenocarcinoma, non-smokers
Mutation narrows ATP binding cleft resulting in increased tyrosine kinase activity
HER2 mutation also results in increased PI3K/mTOR activation
Data suggests patients with HER2 mutated NSCLC do not respond to platinum based chemotherapy or EGFR inhibitors
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Phase II HER2 mutant NSCLC: Study Schema
Prior 1st or subsequent line Stage
IIIb/IV NSCLC w/ documented
ERBB2 mutation
Enroll n = 13 each arm
-expand one arm to 39 total
Neratinib 240mg daily
Neratinib 240mg daily + Temsirolimus 8mg iv weekly
Interim results (ESMO 2014): Neratinib monotherapy (n=13): 4 (31%) patients with clinical benefit Neratinib plus Torisel (n=14): 3 (21%) patients with partial response, 9 (64%) patients with clinical benefit
1:1
PD
PD
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HER2 Negative Breast Cancer with HER2 Mutation
Approximately 2% of all breast cancer patients have mutation in HER2 kinase (~4000-5000 patients US)
Identified in patients with HER2 negative disease
Mutation results in increased HER2 kinase activity
Data first presented at 2012 San Antonio Breast Cancer Symposium and published in Cancer Discovery (December 2012)
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Phase II HER2 mutant MBC: Study Schema
Enroll up to 29 patients
Neratinib 240mg daily
STUDY OBJECTIVES: 1o endpoint: Clinical Benefit Rate (CR + PR + SD ≥ 6 months) 2o endpoints: Correlate HER2 mutations with histology, Grade, Stage, PFS
PD
HER2 mutant, non-HER2 amplified
Stage IV MBC w/ documented
ERBB2 mutation
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Copyright 2015 Puma Biotechnology San Antonio Breast Cancer
Symposium 2014
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Phase II Basket Trial: Study Schema
STUDY OBJECTIVES: 1o endpoint: Objective Response Rate (ORR) 2o endpoints: Clinical Benefit Rate, PFS, Duration of Response
For each cohort: • Enroll n=7 per cohort • If threshold response rate hit
then expand cohort
Bladder & GU carcinoma
Colorectal carcinoma
Gastro-Esoph carcinoma
Ovarian carcinoma
Endometrial carcinoma
Other tumor types
Neratinib 240mg daily PD
ERBB2 mutations
Primary brain tumors EGFR mutation
All tumor types ERBB3 mutation
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Phase II Basket Study - Cohort Expansions
Expanded cohort that included HER2 negative breast cancer with HER2 mutations (May 2014) Enrolled in “other tumor” basket Basket expanded to 18 patients
Expanded cohort that included metastatic non-small cell lung cancer with HER2 mutations (April 2015)
Anticipate announcing additional cohort expansions during 2015
Potential to present initial data in next 6-12 months
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Baseline 4 Months
ERBB2 L755S Non-Small Cell Lung Cancer
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Puma-Expected Milestones
Present/Publish Phase III trial results from ExteNET Trial (extended adjuvant treatment HER2 positive early stage breast cancer) (mid 2015)
Present/publish Phase II results from NEfERTT Trial (first-line HER2 positive metastatic breast cancer) (mid 2015)
Report Phase II neoadjuvant HER2 positive breast cancer trial (H1
2015)
Expand additional cohorts in basket trial (H2 2015) Report Phase II trial in MBC patients with brain metastases (H2 2015) Report Phase II data in patients with HER2 non-amplified breast cancer
that has a HER2 mutation (H2 2015)
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Intellectual Property
Composition of matter patent issued (expires 2025) Can be extended w/ Hatch/Waxman
Use in the treatment of cancer issued (expires 2025)
Two polymorph patents issued (both expire 2028)
Formulation patent allowed (expires 2030)
Additional use patents filed
Covers entire family of in-licensed candidates
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Copyright 2015 Puma Biotechnology
Intellectual Property on EGFR T790M Mutations
Issued claims in Europe, Asia, Australia (expires 2026) Possibility to extend up to 5 years
Pending claims in United States
Patent claims upheld after European Opposition Hearing (February 2014)
Claims for the pharmaceutical composition comprising an irreversible EGFR inhibitor for use in treating cancer having a T790M mutation
Claims for the pharmaceutical composition for use in the treatment of cancer including lung cancer and non-small cell lung cancer
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Experienced Management Team
Alan H. Auerbach Chairman, Chief Executive Officer, President, Founder
-Chief Executive Officer, President, Founder, Cougar Biotechnology Richard Bryce, MD Senior Vice President Clinical Research and Development -Onyx, Roche, ICON Clinical Research Charles R. Eyler Senior Vice President, Finance and Treasurer -Cougar Biotechnology, Hayes Medical Erin Jones Vice President Regulatory Affairs -Genentech, Biomarin
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Board of Directors
Alan H. Auerbach Chairman, Chief Executive Officer, President, Founder Puma Biotechnology, Inc. Tom Malley Portfolio Manager (retired) Janus Global Life Sciences Fund Jay Moyes Former CFO Myriad Genetics Troy Wilson, PhD, JD CEO, Kura Oncology; CEO, Wellspring Biosciences; CEO Avidity
Nanomedicines; Former CEO, President, Intellikine
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Copyright 2015 Puma Biotechnology
Currently Trading on NYSE: PBYI Cash position at March 31, 2015: $310.4 million Adjusted net loss in Q1 2015: $32.4 million Completed $218.5 million Public Offering (January 2015)
Issued 1,150,000 shares at $190.00 per share Shares issued and outstanding: 32.1 million
Puma Biotechnology-Financial
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Copyright 2015 Puma Biotechnology
Company Highlights In licensing driven business model – mitigates R&D risk
PB272 (neratinib)- clinical stage candidate targeting multiple oncology indications
HER2+ Metastatic Breast Cancer HER2+ Metastatic Breast Cancer with Brain Metastases HER2+ Neoadjuvant Breast Cancer HER2+ Adjuvant Breast Cancer HER2 Mutated Non-Small Cell Lung Cancer HER2 Mutated Breast Cancer HER2 Mutated Solid Tumors
Retained commercial rights to PB272
Strong Phase II and Phase III data for PB272 (single agent and in combination with chemotherapy)
Potential for multiple clinical trial readouts over next 6-12 months 51
Puma Biotechnology
Copyright 2015 Puma Biotechnology
Jefferies 2015 Healthcare Conference
June 2015