Array BioPharma Jefferies 2016 Global Healthcare Conference. June 9, 2016

Transcription

1 Array BioPharma Jefferies 216 Global Healthcare Conference June 9, 216

2 Safe Harbor Statement 2 Forward-looking statements made in the course of this presentation are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of The audience is cautioned that such forward looking statements involve risks and uncertainties, including those described in our annual report filed on form 1-K for the year ended June 3, 215, and other filings of the Company with the Securities and Exchange Commission, which may cause the Company's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements.

3 Array s Top Priority Binimetinib & Encorafenib Development & Commercialization 3 SIGNIFICANT PROGRESS IN 215 WITH IMPORTANT VALUE DRIVERS AHEAD IN 216 Regained rights to binimetinib and acquired global rights to encorafenib along with $1 million+ net cash value from Novartis; all currently active binimetinib and encorafenib clinical trials remain substantially funded through completion by Novartis Completed Pierre Fabre collaboration including $3 million upfront, $425 million potential milestones and robust, tiered, double-digit royalties Array retains exclusive rights in key markets including U.S. & Japan Pierre Fabre has exclusive rights in other geographies, including Europe, Asia & Latin America Phase 3 (NEMO) trial achieved primary endpoint Published clinical results for BRAF-mutant colorectal cancer Phase 1/2 BRAF-mutant melanoma Phase 2 (LOGIC2) NRAS-mutant melanoma Phase 1/2 (CDK 4/6 combo) SECOMBIT trial will address sequential use of MEK+RAF with PD-1+CTLA4 in BRAF-mutant melanoma Phase 3/NRAS-mutant melanoma Results at ASCO 216 File for regulatory approval in June 216 Phase 3 Part 1/BRAF-mutant melanoma Provide top-line results 3 rd Quarter 216 BRAF-mutant colorectal cancer Data, including OS, from Phase 2 expansion at ASCO 216 Initiate Phase 3 BEACON trial in 216 Array is making significant progress on development and commercialization of targeted small-molecule cancer treatment therapies in populations with significant unmet need

4 NEMO Meets Primary Endpoint NRAS-mutant Melanoma

5 Binimetinib Phase 3 Study NEMO Results 5 Progression Free Survival (PFS) Binimetinib n=269 Dacarbazine (DTIC) n= (95% CI,.47-.8, p value <.1) 1.5 Pre-Specified Sub-Group of Patients Who Received Prior Immunotherapy (N=85) NEMO study met its primary endpoint of improving PFS compared with dacarbazine treatment Median PFS on the binimetinib arm 2.8 months versus 1.5 months on the dacarbazine arm [hazard ratio (HR)=.62 (95% CI.47-.8), p<.1] Improvement in median PFS on the binimetinib arm was observed in the pre-specified sub-group of patients who received prior treatment with immunotherapy PFS Confirmed Overall Response Rate (ORR) Disease Control Rate (DCR) Overall Survival (OS) 5.5 (95% CI, ) 1.6 Binimetinib n=269 15% (95% CI, 11-2%) 58% (95% CI, 52-64%) Dacarbazine (DTIC) n=133 7% (95% CI, 3-13%) 25% (95% CI, 18-33%) 11. [(HR) = 1. (95% CI.75;1.33), p=.499] 1.1 Median PFS on the binimetinib arm 5.5 months of median PFS (95% CI, ), versus 1.6 months on the dacarbazine arm (95% CI, ) While there was no statistically significant difference demonstrated in overall survival, the median overall survival (mos) favored the binimetinib arm About NRAS-Mutant Melanoma NRAS mutations are present in up to 2% of patients with metastatic melanoma Treatment options for this population remain limited beyond immunotherapy, and patients face poor clinical outcomes and high mortality.

6 Progression-Free Survival Binimetinib significantly improves progression-free survival 1 Progression-Free Survival (%) Hazard ratio:.62 (95% CI,.47.8; P<.1) PFS Binimetinib Dacarbazine Median (95% CI), mo 2.8 ( ) 1.5 ( ) Time (mo) Number still at risk Time (mo) Binimetinib Dacarbazine Stratified log-rank test and stratified Cox model using strata defined by AJCC stage, prior line immunotherapy, and ECOG performance status AJCC=American Joint Committee on Cancer; ECOG=Eastern Cooperative Oncology Group; PFS=progression-free survival Censoring times Binimetinib (n/n=179/269) Dacarbazine (n/n=88/133) 6

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8 Progression-Free Survival by Prior Immunotherapy Progression-Free Survival (%) Months BINI DTIC Prior immunotherapy Number still at risk BINI=binimetinib; DTIC=dacarbazine Kaplan-Meier medians, mo Binimetinib: 5.5 (95% CI, ) Dacarbazine: 1.6 (95% CI, ) Time (mo) Censoring times Binimetinib (n/n=32/57) Dacarbazine (n/n=2/28) Progression-Free Survival (%)1 No prior immunotherapy Time (mo) Number still at risk Kaplan-Meier medians, mo Binimetinib: 2.8 (95% CI, ) Dacarbazine: 1.5 (95% CI, ) Censoring times Binimetinib (n/n=147/212) Dacarbazine (n/n=68/15)

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10 Metastatic Colorectal Cancer (mcrc) Phase 2 Results & Phase 3 Trials

11 Encorafenib Phase 2 BRAF-Mutant mcrc Encouraging Clinical Activity & Good Tolerability 11 Encorafenib + Cetuximab n=5 Encorafenib + Alpelisib (PI3K) + Cetuximab (EGFR) n=52 Overall Survival (OS) Progression Free Survival (PFS) Confirmed Overall Response Rate (ORR) 4.2 (95% CI, ) 22% (95% CI, 12-36%) All Cause Adverse Events (>32% in either treatment group) 5.4 (95% CI, ) 27% (95% CI, 16-41%) Diarrhea 28% 54% Nausea 46% 54% Vomiting 32% 5% Fatigue 5% 46% Abdominal Pain 42% 38% Decreased Appetite 34% 37% Weight Decrease 34% 37% Hyperglycemia 1% 37% Rash 16% 33% Arthralgia 34% 27% Phase 2 trial Includes BRAF-mutant CRC patients who have progressed after one or more prior therapies Historical Published Results after First-Line Treatment OS results range between 4 to 6 months PFS range between 1.8 to 2.5 months ORR range between 6% to 8% Key Point Median OS for the Phase 2 study exceed 1 year which is substantial when compared to historical published benchmarks for this population, which range between 4 to 6 months About CRC CRC is 3 rd most common cancer in the U.S., with approximately 134, new cases and nearly 5, deaths from the disease projected in 216 In the U.S., BRAF mutations occur in 8 to 15% percent of patients with CRC and predict for a poor response to standard therapies and an overall poorer prognosis relative to patients without these mutations

12 Encorafenib-Containing Regimens Improve Overall Survival in 2 nd Line+ BRAFm CRC Over Historical Controls 12 Median OS in 2 nd Line+ BRAFm mcrc Studies Median OS in Months cetuximab + chemo 1 2 nd Line+ n = 24 cetuximab + chemo 2 2 nd Line+ n = 12 FOLFIRI 3 2 nd Line n = 23 FOLFIRI + panitumamab 3 2 nd Line n = 22 cetuximab + chemo 4 2 nd Line+ n = 22 cetuximab + irinotecan 5 2 nd Line+ n = 13 encorafenib + cetuximab 6 2 nd Line+ n = 5 encorafenib + cetuximab+ alpelsib 6 2 nd Line+ n = De Roock et al., Lancet Oncol, Ulivi et al., J Transl Med Peeters et al., ASCO Saridaki et al., PLoS One Loupakis et al., Br J Cancer Tabernero et al., ASCO 216

13 Encorafenib-Containing Regimens Improve ORR and PFS in 2nd Line+ BRAFm CRC Over Historical Controls 13 ORR & PFS in 2 nd Line+ BRAFm mcrc 3% 27% ORR PFS 25% 2% 22% % 1% 5% 8% 6% Months % Encorafenib +Cetuximab +Alpelsib 1 2 nd Line+ Encorafenib +Cetuximab 1 2 nd Line+ Cetuximab + Chemo 2 2 nd Line+ Irinotecan 3 2 nd Line+ Encorafenib +Cetuximab +Alpelsib 1 2 nd Line+ Encorafenib +Cetuximab 1 2 nd Line+ Cetuximab + Chemo 2 2 nd Line+ FOLFIRI 4 2 nd Line Panitumumab + FOLFIRI 4 2 nd Line 1. Tabernero et al., ASCO De Roock et al., Lancet Oncol, Seymour et al., Lancet Oncol, 213 (supplementary appendix) 4. Peeters et al., ASCO 214

14 Published BRAF in BRAF-Mutant Metastatic Colorectal Cancer Safety Profile & Clinical Activity 14 Doublet Therapy Panitumumab + Dabrafenib a Novartis Phase 2 n=2 Triplet Therapy Panitumumab + Dabrafenib + Trametinib a Novartis Phase 2 n=35 No Doublet Included Triplet Therapy Cetuximab + Vemurafenib + Irinotecan b Roche Phase 1 n=18 ORR (CR + PR)* 1% 26% 35% Fatigue 45% 51% 94% Select Adverse Events of Interest Nausea 4% 49% 83% Diarrhea 45% 77% 89% Rash 3% 37% 78% Pyrexia 4% 46% Not reported a ESMO GI 215; b ASCO 215; Panitumumab: EGFR inhibitor, dabrafenib: RAF inhibitor, trametinib: MEK inhibitor Cetuximab: EGFR inhibitor, vemurafenib: RAF inhibitor, irinotecan: Cytotoxic *ORR (CR + PR) Overall response rate (complete response rate + partial response rate)

15 Encorafenib + Binimetinib ± Cetuximab Phase 3 BRAF-Mutant Colorectal Cancer Study Design 15 SAFETY LEAD-IN Safety and tolerability will be assessed in patients receiving binimetinib, encorafenib and cetuximab for the treatment of BRAF V6E-mutant metastatic colorectal cancer n=3 RANDOMIZED PORTION Patient population BRAF V6E mutant 1-2 prior regimens in metastatic setting n=615 Randomization Arm A - Triplet Therapy Binimetinib + Encorafenib + Cetuximab n=25 Arm B - Doublet Therapy Encorafenib + Cetuximab n=25 Arm C - Control Arm FOLFIRI + Cetuximab or irinotecan + Cetuximab n=25 DISEASE PROGRESSION DISEASE PROGRESSION DISEASE PROGRESSION Continued follow-up for evaluation of OS Primary Endpoint: Overall survival (OS) of the triplet therapy compared to the control arm. Secondary Endpoints: Address efficacy of the doublet therapy compared to the control arm, and the triplet therapy compared to the doublet therapy. Other Secondary Endpoints: Progression-free survival (PFS), objective response rate (ORR), duration of response, safety and tolerability. Health related quality of life data will also be assessed. The trial will be conducted at over 25 investigational sites in North America, South America, Europe and the Asia Pacific region. Patient enrollment is expected to be completed in 218.

16 BEACON Collaboration Array BioPharma, Pierre Fabre & Merck KGaA, Darmstadt, Germany 16 Array is the owner of binimetinib and encorafenib and will act as the global sponsor of the study. Pierre Fabre has elected to co-fund 4% of the cost of the BEACON CRC trial. Pierre Fabre licensed commercial rights to binimetinib and encorafenib for Europe and other global markets from Array in December 215. Merck KGaA, Darmstadt, Germany, is the owner of Erbitux outside the United States and Canada, and will supply Erbitux to all trial sites outside the United States and Canada as part of the collaboration. If successful, BEACON results would support regulatory submissions for all three parties.

17 BRAF-Mutant Melanoma COLUMBUS & LOGIC2

18 Binimetinib Phase 3 Study: COLUMBUS Top-Line Results Expected in 3Q Patient Enrollment: Complete PART 1 (1:1:1 Randomization) Complete PART 2 (3:1 Randomization) Patients with BRAF V6E/V6K, advanced, unresectable or metastatic melanoma n~9 Randomization Stratification Stage Performance Status Prior Immunotherapy Arm A Binimetinib + Encorafenib (45mg) Arm B Vemurafenib Arm C Encorafenib (3mg) Arm D Binimetinib + Encorafenib (3mg) Arm C Encorafenib (3mg) Primary Endpoint For Part 1: Progression free survival comparison of Arm A vs. Arm B Secondary Endpoint: Overall survivial Part 2 Rationale: Demonstrates contribution of binimetinib to combination

19 LOGIC2 Binimetinib + Encorafenib + Third Agent BRAF-Mutant Melanoma Study Design 19 Patient Enrollment on-going n=14 Part 1 n=89 as of 7/1/15 Part 2 n=2 as of 7/1/15 GROUP A BRAF- and MEK-naïve patients GROUP A Binimetinib + Encorafenib Binimetinib + Encorafenib + LEE11 (CDK 4/6 inhibitor) GROUP B Patients with any BRAF/MEK combo or single agents (non-naïve) GROUP C Patients previously in COLUMBUS, LOGIC1, CMEK162X211, or Group A (non-naïve) GROUP B Run-in Binimetinib + Encorafenib GROUP C Optional Binimetinib + Encorafenib After progressive disease, genetic assessment performed to determine combination Binimetinib + Encorafenib + BGJ398 (pan FGFR inhibitor) Binimetinib + Encorafenib + BKM12 (pan PI3K inhibitor) Binimetinib + Encorafenib + INC28 (c-met inhibitor) Primary Endpoint: Overall response rate (ORR) (Part 2) Secondary Endpoint: Safety After Progressive Disease in Part 1: Tumor biopsy genetic assessment performed to determine combination treatment in Part 2 Part 2 Third Agent: LEE11 (CDK 4/6 inhibitor), BGJ398 (pan FGFR inhibitor), BKM12 (pan PI3K inhibitor) or INC28 (c-met inhibitor)

20 LOGIC2 Binimetinib + Encorafenib Part 1 Encouraging Preliminary Clinical Activity 2 Combination of binimetinib and encorafenib demonstrated encouraging preliminary clinical activity in BRAFi/MEKi naïve patients Phase 2 (as of 7/1/15) Group A (MEKi + BRAFi Naïve) Encorafenib 45mg QD* + Binimetinib 45mg BID n=45 AE, n (%) Binimetinib 45mg BID/Encorafenib 45mg QD BRAFi/MEKi Naïve Patients n=4 Overall Response Rate (ORR) 2,3 68% Disease Control Rate (DCR) 2,4 95% 79% 6-Month Median Progression Free Survival (PFS) (Note: 96% of patients continued to receive study treatment as of 1 ECC/ESMO 215: LOGIC2: Phase 2, multi-center, open-label study of sequential encorafenib/binimetinib combination followed by a rational combination with targeted agents after progression, to overcome resistance in adult patients with locally-advanced or metastatic BRAF V6 melanoma (Abstract #331); 2 Includes confirmed/unconfirmed responses; 3 ORR=CR/PR, 4 DCR=CR/PR or SD * QD Once Daily; BID Twice Daily Clinical trial number NCT data cutoff) Complete Response (CR) 2 3% (1) Partial Response (PR) 2 65% (26) Stable Disease (SD) 28% (11)

21 LOGIC2 Binimetinib + Encorafenib Part 1 Good Tolerability 21 Differentiated Safety: 12% pyrexia, 7% rash and no photosensitivity Phase 2 (as of 7/1/15) Group A (MEKi + BRAFi Naïve) Encorafenib 45mg QD + Binimetinib 45mg BID n=45 Group B (Prior BRAFi and/or MEKi) Encorafenib 45mg QD + Binimetinib 45mg BID n=43 All Patients n=89 AE, n (%) All Grades n (%) Grade 3/4 n (%) All Grades n (%) Grade 3/4 n (%) Data cutoff date: July 1, 215. *CPK Creatine phosphokinase; QD Once Daily; BID Twice Daily Clinical trial number NCT All Grades n (%) Grade 3/4 n (%) Total 42 (93) 16 (36) 39 (91) 21 (49) 82 (92) 37 (42) Nausea 12 (27) 3 (7) 12 (28) 2 (5) 24 (27) 5 (6) Diarrhea 14 (31) 8 (19) 23 (26) Fatigue 9 (2) 1 (2) 12 (28) 2 (5) 22 (25) 3 (3) Retinopathy 14 (31) 7 (16) 21 (24) Vomiting 7 (16) 1 (2) 7 (16) 15 (17) 1 (1) Blood CPK increased 11 (24) 1 (2) 3 (7) 14 (16) 1 (1) Pyrexia 5 (11) 1 (2) 6 (14) 11 (12) 1 (1) Abdominal Pain 7 (16) 3 (7) 1 (11) Anemia 4 (9) 1 (2) 6 (14) 3 (7) 1 (11) 4 (5) Vision blurred 5 (11) 4 (9) 9 (1)

22 Published MEK/BRAF Data in BRAF-Mutant Melanoma Safety Profile & Clinical Activity 22 Novartis COMBI-D Trametinib + Dabrafenib 1 n=29 Novartis COMBI-V Trametinib + Dabrafenib 2 n=35 Roche cobrim Cobimetinib + Vemurafenib 3 n=247 Fever 57% 55% 28% Rash 42% 24% 16% Select Adverse Events of Interest Diarrhea 3% 34% 6% Chills 31% 33% 1% Hypertension 25% 29% 15% Photosensitivity NR (<1%) 4% 46% NR = Not Reported COMBI-D n=211 COMBI-V n=251 cobrim 4 n=247 1 Long et al ASCO Oral 215; 2 ESMO/ECC 215; 3 Product label; 4 Larkin et. al. ASCO Oral 215 *ORR = Overall Response Rate (Complete Response (CR) + Partial Response Rate (PR) ORR* (CR + PR) BRAFi-Naïve 66% 66% 7%

23 Pyrexia Often Leads to Dose Modification or Discontinuation of Dabrafenib + Trametinib (D + T) Combination 23 Pyrexia in BRAF Melanoma Patients Treated with D+T in Clinical Trials % of Patients Experiencing Pyrexia Grade 2+ (> 12.2 F) Grade 3+ (> 14. F) Median Duration Phase I/II Trials 1 n = 21 Phase III Trial 2 n = 29 59% 51% 35% 29% 6% 6% First Event: 9 days Subsequent: 4-5 days 3 days Pyrexia caused by D + T: Occurs frequently more than half of patients experience pyrexia Recurs often approx. half of patients with pyrexia have 3+ episodes 5 Can be severe a third have a temperature > 12.2 F Negatively impacts patients quality of life Requires physician intervention Is not easily controlled with acetaminophen and may require ongoing management with corticosteroids 4 Causes dose interruptions/reductions or treatment discontinuation Prevents patients from receiving a full, optimal dose of therapy % of Pyrexia Patients w/ 3+ Events % of Pyrexia Patients w/ Dose Modifications 34% 47% Dose Reduction: 49% 3 Dose Interruption: 63% Discontinuation: 5% 3 Dose Reduction: 25% Discontinuation: 5% Importantly, a review of D+T trials revealed that half of patients with pyrexia experienced three or more events, and at least half of patients required dose modifications 5 (interruptions, reductions, or discontinuation) due to pyrexia Source: 1 Menzies et al, Annals of Oncology, Long et al, NEJM, Figures from Part C of Phase II 4 Lee et al, Journal of Clinical Oncology, Dabrafenib & Trametinib Package Insert

24 CoBRIM - Photosensitivity is Frequent, Persistent & Sometimes Severe Side Effect of Vemurafenib + Cobimetinib (V+C) Treatment 24 Among patients treated with Vemurafenib + Cobimetinib in CoBRIM: Nearly half of patients treated with V+C in the Phase 3 CoBRIM trial experienced photosensitivity reactions, many of which were persistent for several months 47% experienced a photosensitivity reaction of any grade 1,2 4% suffered a Grade 3 photosensitivity reaction 1,2 defined as a blistering sunburn covering more than 3% of the body with indications for pain medication or oral corticosteroids 3 Median duration of photosensitivity was 3 months and lasted as long as 14 months for some patients Only 63% of patients with photosensitivity reactions experienced resolution while on study Source: 1 Center for Drug Eval. and Res. Cotellic Medical Review, Cotellic Prescribing Information 3 NCI CTCAE v4.

25 PFS Increased Between Initial and Final Results in Prior Phase 3 BRAF Melanoma Trials 25 PFS Increases between Initial and Final Results in BRAF Melanoma Trials 14 Initial Report Final Mature Data PFS Increase Months of PFS months 12.3 months months 11. months * months 12.6 months * COMBI-V trial was powered for mos as its primary endpoint; therefore, initial data readout occurred later than in COMBI-D or cobrim, which had mpfs as primary endpoints 2 Vemurafenib+ Cobimetinib (cobrim) 1 Dabrafenib+ Tremetinib (COMBI-D) 2 Dabrafenib+ Tremetinib (COMBI-V) 3 In prior BRAF Melanoma trials, reported PFS at first readout is 9-11 months, while mature PFS, reported about a year later, is about 2 months longer at months. 1. Larkin et al., ASCO Long et al., ASCO Robert et al., ESMO 215

26 Value Drivers

27 Array Product Portfolio 216 Value Drivers 27 Indication(s) Status 1H 216 2H 216 Binimetinib & Encorafenib BRAF Melanoma (COLUMBUS) (binimetinib+encorafenib) NRAS Melanoma (NEMO) (binimetinib) Phase 3 Phase 3 Regulatory Submission Full results June 6 at ASCO COLUMBUS Pt 1 Top-Line Results 3Q BRAF Colorectal Cancer (BEACON) (Encorafenib, binimetinib+cetuximab) Phase 2/3 Phase 2 Update June 4 at ASCO BEACON Ongoing Selumetinib KRAS NSCLC (SELECT-1) Thyroid Cancer (ASTRA) NF1 Phase 3 Registration trial Enrollment Ongoing Enrollment Ongoing SELECT-1 Top-Line Results ARRY-797 LMNA-related DCM Phase 2 Publication Aug. 3 at ESC NEMO: NRAS melanoma and MEK inhibitor; COLUMBUS: Combination of LGX818 used with MEK162 in BRAF mutant unresectable skin cancer; ASTRA: Pivotal trial in differentiated thyroid cancer; SELECT-1: selumetinib + docetaxel in patients with KRAS NCSLC

28 Thank You arraybiopharma.com