Investor Presentation

Transcription

1 Investor Presentation June 2017 Joe Turgeon President and Chief Operating Officer

2 Safe Harbor Statement This presentation contains forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management s current beliefs and expectations. These statements include but are not limited to statements that relate to our business and its future, our strategy, the success of our drug candidates, the safety and efficacy of our drug products, product approvals, market potential, product sales, revenue, development, regulatory and approval timelines, product launches, product acquisitions, capital resources and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that price and other competitive pressures may make the marketing and sale of our drugs not commercially feasible, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of sustained revenue history, our limited experience in establishing strategic alliances, our limited marketing experience, our customer concentration, the possibility for fluctuations in customer orders, evolving market dynamics, our dependence on third parties for clinical trials, manufacturing, distribution, information and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this presentation except as required by law. 2

3 About Spectrum An Oncology Focused Biotech Company Listed on NASDAQ: SPPI Advanced-Stage Novel Drugs Poziotinib Lung Cancer o Interim Data Expected this Year Poziotinib Other Tumors ROLONTIS o Top-Line Data Expected from Pivotal Study in 1H 2018 o BLA Filing in Marketed Drugs Revenue Pays for Most of the Development Activities 3

4 Key Milestones POZIOTINIB: Lung Cancer (NSCLC) Exon 20 Insertion Mutation Interim Data Before Year End 2017 ROLONTIS (under SPA): Chemotherapy-Induced Neutropenia Top-Line Data First Half 2018 BLA Filing 2018 QAPZOLA (under SPA): Non Muscle-Invasive Bladder Cancer Phase 3 Initiation 3Q

5 Poziotinib Phase 1 Showed Tumor Size Reductions in Multiple Tumor Types Tumor size reductions in heavily pre-treated patients with diverse tumors 5

6 Lung Cancer Program Targets High Unmet Need Percent Survival Lung Cancer Leading cause of death in both men and women 155,870 deaths estimated in 2017 Genetic mutations are the cause for poor response to many chemotherapy and targeted therapies in lung cancer 6 Exon 20 insertion mutation response to existing treatment is unsatisfactory Progression free survival (% of patients) EGFR Ex20 insertion (N=9) Classical EGFR mut (N=129) Months Time (Months) Robichaux et. al. World Congress on Lung Cancer 2016 Classical EGFR mutations (n=129) Median PFS 2 months 14 months

7 Poziotinib 100X More Potent than other EGFR Inhibitors in Pre-Clinical Studies Benzo-pyrrole (ATP mimetic) Osimertinib Reactive Group Poziotinib Reactive Group Quinazoline core Terminal Group Terminal Group Robichaux et. al. World Congress on Lung Cancer 2016 % Viability % % Viability % Viability Average EGFR of 6 Ba/F3 A763insFQEA EGFR Ex20 Insertion cell lines 125 EGFR Exon20 Insertion Mutations EGFR Exon20 Insertion Mutations Erlotinib EGFR Exon20 Insertion MutationsAfatinib 125 AZD9291 CO EGF816 Poziotinib log[inhibitor], µm Erlo Afa AZ CO EG log[inhibitor], µm µm µm Poziotinib average IC 50 : 1.09nM 7

8 Poziotinib Compassionate Use in NSCLC at MDACC A 65 year old non-smoking female Stage IV adenocarcinoma with HER2 exon 20 insertion mutation History of progression on other drugs Poziotinib - 16mg orally daily 1 week of Therapy: Significant improvement in cough & pain in multiple bone sites 4 weeks of Therapy: PET/CT scans showed significant radiological response Circulating free DNA dropped to undetectable levels 7 months of Therapy: patient is stable Initiated Phase 2 study, number of patients = 30 8

9 Poziotinib Has Shown Strong Early Clinical Data in Breast Cancer POZIOTINIB Neratinib Lapatinib (Tykerb) Spectrum/Hanmi Hanmi Aggregate Phase 1: Im S et al ORR: 60% (n= 10) Prior treatment with: Trastuzumab Lapatinib Pertuzumab* * One patient treated with prior pertuzumab who had PR Puma Biotechnology Phase 2: Burstein et al ORR: 24% (n=63) Prior treatment with: Trastuzumab Glaxo Phase 2: Burstein et al ORR: 6% (n=140) Prior treatment with: Trastuzumab 1 Im S et al. Poziotinib, an oral, irreversible pan-her inhibitor, demonstrates promising clinical activity in metastatic HER2-positive breast cancer patients. Poster presented at the December 2015 San Antonio Breast Cancer Symposium 2 Burstein HJ et al. Neratinib, an irreversible ErbB receptor tyrosine kinase inhibitor, in patients with advanced ErbB2-positive breast cancer. J Clin Oncol Mar 10;28(8): Burstein HJ et al, A phase II study of lapatinib monotherapy in chemotherapy-refractory HER2-positive and HER2-negative advanced or metastatic breast cancer. Ann Oncol Jun;19(6):

10 Poziotinib Breast Cancer Phase 2, open label HER2-positive, metastatic breast cancer patients with at least 2 prior HER2-directed treatments Primary Endpoint: Objective Response Rate (ORR) ~ 75 patients 10

11 Key Milestones POZIOTINIB: Lung Cancer (NSCLC) Exon 20 Insertion Mutation Interim Data Before Year End 2017 ROLONTIS (under SPA): Chemotherapy-Induced Neutropenia Top-Line Data First Half 2018 BLA Filing 2018 QAPZOLA (under SPA): Non Muscle-Invasive Bladder Cancer Phase 3 Initiation 3Q

12 ROLONTIS for the Management of Chemotherapy-Induced Neutropenia A Novel, Long-Acting GCSF Targeting a $6 Billion Market 12

13 ANC (10 9 /L) ROLONTIS Phase 2 Efficacy Median Absolute Neutrophil Count (ANC) Over Time in Cycle ROLONTIS μg/kg ROLONTIS μg/kg ROLONTIS - 45 μg/kg pegfilgrastim - 6 mg Days Chemo Therapy Study Drug 13

14 ROLONTIS Phase 2 Primary Endpoint Days of Severe Neutropenia (DSN) in Cycle 1 ROLONTIS 45 µg/kg (N=39) Days of Severe Neutropenia or DSN (Days) in Cycle 1 ROLONTIS 135 µg/kg (N=36) ROLONTIS 270 µg/kg (N=36) Pegfilgrastim 6 mg (N=36) n Mean SD Difference with Pegfilgrastim N/A Non-inferiority p-value <0.001 N/A Superiority p-value N/A 14

15 Randomization ROLONTIS Phase 3 Program: Expected to File BLA in 2018 Under SPA Topline Results Expected First Half % Patients Enrolled BLA Filing by 2018 Number of Patients = 400 Screening Period Treatment Period Four 21-day Cycles Day 1 Day 2 End of Treatment Visit 30 Days Docetaxel + Cyclophosphamide ROLONTIS (eflapegrastim) Pegfilgrastim ~30 Days after the end of cycle 4 Second International Study Initiated: Similar trial design Additional countries targeted: Canada, EU, Korea, India 15

16 Key Milestones POZIOTINIB: Lung Cancer (NSCLC) Exon 20 Insertion Mutation Interim Data Before Year End 2017 ROLONTIS (under SPA): Chemotherapy-Induced Neutropenia Top-Line Data First Half 2018 BLA Filing 2018 QAPZOLA (under SPA): Non Muscle-Invasive Bladder Cancer Phase 3 Initiation 3Q

17 QAPZOLA (apaziquone) for Intravesical Instillation A Potent Tumor-Activated Drug NMIBC remains an unmet medical need with no new drugs approved in the last 25 years QAPZOLA demonstrated activity in previous studies QAPZOLA is well-tolerated NMIBC 17

18 Bladder Cancer has a High Incidence, Recurrence, Cost and Unmet Need US EU Bladder Cancer Incidence 73, ,500 Bladder Cancer Prevalence >600,000 >1,100,000 Most expensive cancer to treat with worldwide costs of over $5 Billion TURBT surgery is standard of care 60-70% of patients have recurrence after surgery 18

19 QAPZOLA SPA from FDA on New Study Design New study design incorporates learnings from previous studies Study Design ~ 425 patients Single dose: 8mg Intravesical Instillation at 60 +/- 30 minutes post TURBT Double blind, placebo controlled Phase 3 study with 2:1 randomization 19

20 20 Spectrum s Pipeline

21 Proven Track Record to Pave the Path to the Future Currently Marketing 6 Niche Anti-Cancer Drugs Contributing to a Pipeline Targeting Large Markets 21

22 Summary: Key Milestones POZIOTINIB: Lung Cancer (NSCLC) Exon 20 Insertion Mutation Interim Data Before Year End 2017 ROLONTIS (under SPA): Chemotherapy-Induced Neutropenia Top-Line Data First Half 2018 BLA Filing 2018 QAPZOLA (under SPA): Non Muscle-Invasive Bladder Cancer Phase 3 Initiation 3Q

23 Thank you