EX-99.2 3 a14-17651_1ex99d2.htm EX-99.2

Exhibit 99.2

 

 

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Second-Quarter Results July 24, 2014

 


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Safe Harbor Statement Statements made in this presentation about TESARO, Inc. that are not descriptions of historical facts are forward-looking statements reflecting the current beliefs and expectations of management. Forward-looking statements are sometimes identified by words such as “plan,” “may,” “will,” “expect,” and similar expressions referencing future events, conditions or circumstances. These forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Actual results could differ materially from those expressed or implied by these forward-looking statements as a result of various factors, including, without limitation, the various risks described in our Annual Report on Form 10-K for the year ended December 31, 2013 and our subsequent filings with the SEC. TESARO, Inc. undertakes no obligation to update or revise any forward-looking statement for any reason. Rolapitant, niraparib and TSR-011 are investigational product candidates that have not been approved by any regulatory agency. The most frequently observed adverse events in the oral rolapitant Phase 3 studies were balanced across treatment arms and included fatigue, alopecia and constipation. Phase 1 data indicate that the most frequently observed adverse events for niraparib at a 300 milligram dose included grade 1/2 anemia, fatigue and nausea. Phase 1 data indicate that TSR-011 was well tolerated at therapeutic dose levels, and the most frequently occurring dose limiting toxicities included ECG changes and dysaethesia, both of which were reversible.

 


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Lonnie Moulder Chief Executive Officer

 


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 CINV: Chemotherapy-induced nausea & vomiting A/C: anthracycline/cyclophosphamide. MEC: Moderately emetogenic chemotherapy; HEC: Highly emetogenic chemotherapy. NSCLC: Non-small cell lung cancer. * In collaboration with SARC, the Sarcoma Alliance for Research through Collaboration. A Balanced Portfolio of Product Candidates Compound Indication Discovery Pre-clinical Phase 1 Phase 2 Phase 3 Rolapitant Oral NK-1 receptor antagonist CINV in A/C-breast cancer/ MEC treated patients CINV in cisplatin (HEC) treated patients CINV in cisplatin (HEC) treated patients Rolapitant IV CINV Niraparib PARP Inhibitor Ovarian Cancer BRCA+ Breast Cancer Niraparib + temozolomide Ewing’s sarcoma* TSR-011 ALK and TRK Inhibitor NSCLC, others TSR-042 Anti-PD-1 antibody Various tumor types Anti-TIM-3 antibody Various tumor types Anti-LAG-3 antibody Various tumor types Anti-TIM-3/PD-1 antibody Various tumor types Anti-LAG-3/PD-1 antibody Various tumor types

 


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Tim Pearson Chief Financial Officer

 


Q2 2014 Financial Results Three Months Ended June 30, 2014 Three Months Ended June 30, 2013 Expenses: Research & Development $30,569 $18,177 General & Administrative 5,587 3,412 Acquired In-process R&D 900 - Total Expenses 37,056 21,589 Loss from Operations (37,056) (21,589) Interest Income 5 25 Net Loss ($37,051) ($21,564) Loss per Share ($1.03) ($0.67) As of June 30, 2014: Cash & equivalents balance totaled approximately $151 million Approximately 36.0 million shares outstanding of common stock

 


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Mary Lynne Hedley, Ph.D. President

 


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NDA: New drug application IV: Intravenous SCLC: Small cell lung cancer IND: Investigational new drug application Development Programs Update Each of three pivotal trials successfully achieved its primary endpoint Data was presented at ASCO & MASCC meetings Pre-NDA meeting held; oral NDA on track for submission in approx. 6 weeks Multiple ascending dose (MAD) study of IV rolapitant completed Rolapitant Phase 3 NOVA trial non-gBRCA cohort enrollment expected to complete at year end Phase 3 BRAVO trial enrollment continues Phase 1 trial in Ewing’s sarcoma initiated Planning ongoing for SCLC and first line ovarian trials Niraparib Fractionated doses are being evaluated in the ongoing Phase 1 study Additional ALK+ and TRK+ patients enrolling Controlled release formulation identified TSR-011 Anti-TIM-3 clinical lead and several backup antibody candidates identified Advancing TSR-042 antibody (anti-PD-1) to support IND filing with U.S. FDA in late 2015 Goal to select an anti-LAG-3 antibody for clinical studies in Q3 2014 I-O Platform

 


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NDA: New drug application IV: Intravenous SCLC: Small cell lung cancer IND: Investigational new drug application Development Programs Update Each of three pivotal trials successfully achieved its primary endpoint Data was presented at ASCO & MASCC meetings Pre-NDA meeting held; oral NDA on track for submission in approx. 6 weeks Multiple ascending dose (MAD) study of IV rolapitant completed Rolapitant Phase 3 NOVA trial non-gBRCA cohort enrollment expected to complete at year end Phase 3 BRAVO trial enrollment continues Phase 1 trial in Ewing’s sarcoma initiated Planning ongoing for SCLC and first line ovarian trials Niraparib Fractionated doses are being evaluated in the ongoing Phase 1 study Additional ALK+ and TRK+ patients enrolling Controlled release formulation identified TSR-011 Anti-TIM-3 clinical lead and several backup antibody candidates identified Advancing TSR-042 antibody (anti-PD-1) to support IND filing with U.S. FDA in late 2015 Goal to select an anti-LAG-3 antibody for clinical studies in Q3 2014 I-O Platform

 


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NDA: New drug application IV: Intravenous SCLC: Small cell lung cancer IND: Investigational new drug application Development Programs Update Each of three pivotal trials successfully achieved its primary endpoint Data was presented at ASCO & MASCC meetings Pre-NDA meeting held; oral NDA on track for submission in approx. 6 weeks Multiple ascending dose (MAD) study of IV rolapitant completed Rolapitant Phase 3 NOVA trial non-gBRCA cohort enrollment expected to complete at year end Phase 3 BRAVO trial enrollment continues Phase 1 trial in Ewing’s sarcoma initiated Planning ongoing for SCLC and first line ovarian trials Niraparib Fractionated doses are being evaluated in the ongoing Phase 1 study Additional ALK+ and TRK+ patients enrolling Controlled release formulation identified TSR-011 Anti-TIM-3 clinical lead and several backup antibody candidates identified Advancing TSR-042 antibody (anti-PD-1) to support IND filing with U.S. FDA in late 2015 Goal to select an anti-LAG-3 antibody for clinical studies in Q3 2014 I-O Platform

 


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NDA: New drug application IV: Intravenous SCLC: Small cell lung cancer IND: Investigational new drug application Development Programs Update Each of three pivotal trials successfully achieved its primary endpoint Data was presented at ASCO & MASCC meetings Pre-NDA meeting held; oral NDA on track for submission in approx. 6 weeks Multiple ascending dose (MAD) study of IV rolapitant completed Rolapitant Phase 3 NOVA trial non-gBRCA cohort enrollment expected to complete at year end Phase 3 BRAVO trial enrollment continues Phase 1 trial in Ewing’s sarcoma initiated Planning ongoing for SCLC and first line ovarian trials Niraparib Fractionated doses are being evaluated in the ongoing Phase 1 study Additional ALK+ and TRK+ patients enrolling Controlled release formulation identified TSR-011 Anti-TIM-3 clinical lead and several backup antibody candidates identified Advancing TSR-042 antibody (anti-PD-1) to support IND filing with U.S. FDA in late 2015 Goal to select an anti-LAG-3 antibody for clinical studies in Q3 2014 I-O Platform

 


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Lonnie Moulder Chief Executive Officer

 


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Commercial Organization: Hiring Targeted for Late in NDA Review Process Approximately 120 Total Headcount Opportunity for Significant Leverage: Anticipate Rolapitant P&L to Break Even at Annual Sales of ~$50-60M NDA: New Drug Application

 


CINV: chemotherapy-induced nausea & vomiting ALKi: ALK inhibitor IO: Immuno-oncology KOL: Key opinion leader Market opportunity projections are based upon Company estimates TESARO Is Positioned for Success Cash and equivalents of ~$151M as of 6/30/2014 Well Capitalized Commercial, development and regulatory experience in oncology Relationships with KOLs and national oncology networks Experienced Team Promising Pipeline Rolapitant: Differentiated profile; unmet market need that can be addressed via education and adherence to existing guidelines Niraparib: Two Phase 3 trials; Phase 1 data demonstrated high response rates among heavily pre-treated patients TSR-011: Compelling Phase 1 data in ALKi-resistant patients TSR-042: IND filing targeted for late 2015 Anti-TIM-3 and anti-LAG-3 programs advancing Significant Market Opportunities Rolapitant: $1.5B U.S. CINV market Niraparib: >$3B WW initial indications

 


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[LOGO]

 


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Submit NDA for oral rolapitant to the U.S. FDA Advance IV rolapitant clinical program Continue to advance niraparib Phase 3 NOVA and BRAVO trials Expand the niraparib clinical development program and continue enrolling the combination study in Ewing’s sarcoma Continue to evaluate activity of TSR-011 in ALK+ and TRK+ patients Advance development of TSR-042 (anti-PD-1 antibody) and anti-TIM-3 candidate Select anti-LAG-3 antibody candidate NDA: New drug application FDA: Food & Drug Administration IV: Intravenous 2H 2014 Key Priorities

 


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Second-Quarter Results July 24, 2014