Spectrum Pharmaceuticals

Size: px
Start display at page:

Download "Spectrum Pharmaceuticals"

Transcription

1 Spectrum Pharmaceuticals Joe Turgeon President and CEO June 2018 Investor Presentation 1

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 Spectrum s Mission At Spectrum Pharmaceuticals, Inc., we bring the expertise and passion for excellence of our team to acquire, develop and commercialize pharmaceuticals for unmet medical needs while building value for our shareholders.

4 POZIOTINIB Irreversible Tyrosine Kinase Inhibitor 4

5 Poziotinib is a Novel EGFR Tyrosine Kinase Inhibitor Orally available Demonstrated activity in a variety of tumors Recent data in exon 20 insertion mutations on NSCLC was promising 5

6 Poziotinib s Lung Cancer Program Targets High Unmet Need Leading cause of cancer death in both men and women 155,870 deaths estimated in 2017 Exon 20 insertion mutation response to existing treatment is unsatisfactory There are no FDA approved drugs for this indication Percent Survival HR = 12.3 p < Time (Months) EGFR Ex20 insertion (N=9) Classical EGFR mut (N=129) Median PFS 2 months 14 months 6

7 Poziotinib Found Significantly More Potent than other EGFR Inhibitors Benzo pyrrole (ATP mimetic) Osimertinib Reactive Group Poziotinib Terminal Group Reactive Group Quinazoline core Terminal Group % Viability Average of 6 Ba/F3 EGFR Ex20 Insertion cell lines Erlotinib Afatinib AZD9291 CO-1686 EGF816 Poziotinib log[inhibitor], µm Poziotinib average IC 50 : 1.09nM 7 Robichaux et. al. World Congress on Lung Cancer 2016

8 Exon 20 Mutations in EGFR and HER2 Constrict the TKI Binding Pocket Exon 20 Insertion Mutation leads to structural alterations restricting the size of the binding pocket TKI The bulk and rigidity of first, second, and third generation TKIs prevent access to the restricted binding pocket 8

9 Poziotinib Binds in the Active Site and Blocks ATP Poziotinib Even with the restricted binding pocket of exon 20 insertion mutations, poziotinib is able to overcome steric hindrance allowing for irreversible binding 9

10 MD Anderson Phase II Study of Poziotinib NSCLC Patients with EGFR or HER2 Exon-20 Mutations Study Design Key Eligibility Criteria EGFR or HER2 exon 20 mutation One or more prior systemic therapies Brain metastases permitted if asymptomatic and stable, without escalating steroids or anticonvulsants Cohort 1 EGFR exon 20 mutant NSCLC (N = 50) fully enrolled Cohort 2 HER2 exon 20 NSCLC (N = 30) Primary Endpoint Objective response rate (ORR, RECIST 1.1) Secondary Endpoints PFS OS Disease control rate Duration of response Safety 10

11 Preliminary Evidence of Poziotinib Activity Maximum Response from Baseline S V769insGSV H773dupPR H773insAH Blue: Stable Disease Grey: Un confirmed Response Green: Confirmed Partial Response N771insHH Poziotinib A,P D770del insgy D770insY H773Y D770insG A767dupASV S768dupSVD E,A S768I Prior Therapy: P = AP32788 S = ASP 8273 E = Erlotinib A =Afatinib P772insDNP Most of previously reported PRs have been confirmed October 2017: 8/11 patients had PR (World Lung Conference in Japan) January 2018 : 7/11 patients had Confirmed PR (Nature Medicine Publication) 11 Robichaux et al., Nature Medicine, April 23, 2018

12 CT Scans of Patients Before & After Treatment with Poziotinib EGFR S768I 7/8/2017 9/4/2017 EGFR D770del insgy 8 weeks after poziotinib treatment Patient previously treated with erlotinib & afatinib 8 weeks after poziotinib treatment 8/4/ /10/2017 EGFR S768dupSVD 16 weeks after poziotinib treatment 12 3/28/2017 7/18/2017 Robichaux et al., Nature Medicine, April 23, 2018

13 Poziotinib Activity in NSCLC Patient with HER2 Exon 20 insertion Radiological response with PET Scan Circulating cfdna below detection level 13 Robichaux et al., Nature Medicine, April 23, 2018

14 Publication of Poziotinib Data in Nature Medicine Poziotinib demonstrated a confirmed objective response rate in 7 of 11 patients (64%) with EGFR Exon 20 mutations Activity: 7/11 patients with EGFR Exon 20 mutations demonstrated a confirmed partial response At the time of the publication, median PFS had not been reached following a median follow up of 6.6 months Evidence of CNS activity in patient with CNS metastasis and another with LMD Additional patient treated on compassionate use IND (CIND) also had PR Safety: AE profile similar to EGFR TKIs: Rash and Diarrhea most common AEs AE related dose reduction in 55% of patients 14

15 Spectrum Phase 2 Poziotinib Study Multicenter Trial Enrolling NSCLC Patients We have initiated and are enrolling patients in a Phase 2 multi center study at several leading cancer institutions in the U.S. The study is enrolling up to 87 lung cancer patients with EGFR exon 20 insertion mutations and up to 87 lung cancer patients with HER2 exon 20 insertion mutations The study will evaluate Objective Response Rate (ORR) as the primary endpoint and PFS and OS as secondary endpoints 15

16 Poziotinib Could Address a Significant Unmet Need NSCLC Exon 20 Patient Population United States Europe Japan Advanced Lung Cancer patients ~155,000 Advanced NSCLC patients ~131,000 Advanced Lung Cancer patients ~272, % 80 85% 80 85% Advanced NSCLC patients ~224,000 Advanced Lung Cancer patients ~83,000 Advanced NSCLC patients ~68, % 2 4% 10 15% 2 4% 40 45% 2 4% EGFR cases ~16,300 HER2 cases ~3,900 EGFR cases ~28,000 HER2 cases ~6,700 EGFR cases ~29,100 HER2 cases ~2, % ~96% 9 11% ~96% 9 11% ~96% Exon 20 cases 3,500 7,200 Exon 20 cases 6,100 12,700 Exon 20 cases 3,700 6, % of Advanced NSCLC % of Advanced NSCLC % of Advanced NSCLC 16 Note: Epidemiology is based on multiple data sources; please refer to appendix for more details; Range calculated using low and high end of inputs

17 The Pan-Tumor Landscape of HER2 Exon 20 Mutant Tumors 17 Robichaux et al, AACR 2018

18 Ongoing Poziotinib Studies MD Anderson Phase 2 Study Lung Cancer ~50 NSCLC patients with EGFR EXON 20 mutations ~30 NSCLC patients with HER2 EXON 20 mutations Spectrum Phase 2 Multi Center Study Lung Cancer Up to 87 NSCLC patients with EGFR EXON 20 mutations Up to 87 NSCLC patients with HER2 EXON 20 mutations Spectrum Phase 2 in Patients Breast Cancer ~70 patients with HER2+ metastatic breast cancer patients Additional investigator sponsored studies being conducted by Hanmi Pharmaceuticals Planned: Basket study to study Poziotinib in EXON 20 mutations in solid tumors beyond lung cancer 18

19 ROLONTIS for the Management of Chemotherapy Induced Neutropenia 19

20 ROLONTIS for the Management of Chemotherapy-Induced Neutropenia A Novel, Long Acting GCSF 20

21 ROLONTIS Met Primary Endpoint in ADVANCE Study ADVANCE Registrational Study (n= 406): The ADVANCE study met the primary efficacy endpoint of noninferiority in Duration of Severe Neutropenia between ROLONTIS and pegfilgrastim Secondary endpoints of non inferiority in DSN for Cycles 2 to 4 were also met Adverse event profile was similar between the two treatment arms RECOVER International Study (n= 237): Similar study design Enrollment completed February 2018 Expect to file U.S. BLA in 4Q 2018 and file with EMA in

22 ROLONTIS ADVANCE Phase 3 Study Met Primary Endpoint Days of Severe Neutropenia (DSN) in Cycle 1 ROLONTIS N=196 Pegfilgrastim N=210 DSN (days) Mean (SD) Median (Range) 0.19 (0.478) 0 (0, 2) 0.34 (0.668) 0 (0, 3) Difference in mean DSN (ROLONTIS pegfilgrastim) Percentile Method: Confidence Interval* Non-inferiority p-value** (-0.260, ) < *95% CI was calculated using bootstrap resampling of the data; Non-inferiority met as the upper bound of 95% CI is <0.62 day. ** p-value is based on the calculated t-statistic from bootstrapped sample mean and standard error 22

23 Recent Developments Poziotinib Nature Medicine publication AACR Poster: promise in multiple solid tumors Methods of use agreement with MD Anderson potentially extends IP to 2037 Partnership with Thermo Fisher Scientific to develop next generation sequencing companion diagnostic Rolontis ADVANCE study met the primary efficacy endpoint of noninferiority in DSN Detailed Data at ASCO & MASCC RECOVER, the second Phase 3 study fully enrolled Corporate Corporate governance and BOD changes Guidance raised to $95 million $105 million 23

24 Thank You

Investor Presentation

Investor Presentation Investor Presentation June 2017 Joe Turgeon President and Chief Operating Officer Safe Harbor Statement This presentation contains forward-looking statements regarding future events and the future performance

More information

Oncology Therapeutics without Compromise APRIL 2011

Oncology Therapeutics without Compromise APRIL 2011 Oncology Therapeutics without Compromise APRIL 2011 Forward Looking Statements This presentation contains forward-looking statements that involve substantial risks and uncertainties, including among other

More information

IMMUNOMEDICS, INC. November Advanced Antibody-Based Therapeutics. Oncology Autoimmune Diseases

IMMUNOMEDICS, INC. November Advanced Antibody-Based Therapeutics. Oncology Autoimmune Diseases IMMUNOMEDICS, INC. Advanced Antibody-Based Therapeutics Oncology Autoimmune Diseases November 2017 Forward-Looking Statements This presentation, in addition to historical information, contains certain

More information

33 rd Annual J.P. Morgan Healthcare Conference. January 2015

33 rd Annual J.P. Morgan Healthcare Conference. January 2015 33 rd Annual J.P. Morgan Healthcare Conference January 2015 Forward-looking Statements This presentation contains forward-looking statements, which express the current beliefs and expectations of management.

More information

IMMUNOMEDICS, INC. Advanced Antibody-Based Therapeutics

IMMUNOMEDICS, INC. Advanced Antibody-Based Therapeutics IMMUNOMEDICS, INC. Advanced Antibody-Based Therapeutics Oncology Autoimmune Diseases Rodman & Renshaw 19 th Annual Global Investment Conference Michael R. Garone, Principal Executive Officer and CFO Forward-Looking

More information

VeriStrat Poor Patients Show Encouraging Overall Survival and Progression Free Survival Signal; Confirmatory Phase 2 Study Planned by Year-End

VeriStrat Poor Patients Show Encouraging Overall Survival and Progression Free Survival Signal; Confirmatory Phase 2 Study Planned by Year-End AVEO and Biodesix Announce Exploratory Analysis of VeriStrat-Selected Patients with Non-Small Cell Lung Cancer in Phase 2 Study of Ficlatuzumab Presented at ESMO 2014 Congress VeriStrat Poor Patients Show

More information

ARIAD Pharmaceuticals, Inc.

ARIAD Pharmaceuticals, Inc. ARIAD Pharmaceuticals, Inc. June 8, 2016 David Sachs Non-small cell lung cancer 1 ARIAD clinical trial patient Some of the statements in this presentation constitute forward looking statements under the

More information

AVEO and Astellas Announce Positive Findings from TIVO-1 Superiority Study of Tivozanib in First-Line Advanced RCC

AVEO and Astellas Announce Positive Findings from TIVO-1 Superiority Study of Tivozanib in First-Line Advanced RCC FOR IMMEDIATE RELEASE AVEO and Astellas Announce Positive Findings from TIVO-1 Superiority Study of Tivozanib in First-Line Advanced RCC - Tivozanib is the First Agent to Demonstrate Greater than One Year

More information

AVEO and Astellas Announce TAURUS Patient Preference Clinical Study Comparing Tivozanib with Sunitinib in First-Line Kidney Cancer

AVEO and Astellas Announce TAURUS Patient Preference Clinical Study Comparing Tivozanib with Sunitinib in First-Line Kidney Cancer FOR IMMEDIATE RELEASE AVEO and Astellas Announce TAURUS Patient Preference Clinical Study Comparing Tivozanib with Sunitinib in First-Line Kidney Cancer Study designed to build upon safety profile demonstrated

More information

Third Quarter 2015 Earnings Call. November 9, 2015

Third Quarter 2015 Earnings Call. November 9, 2015 Third Quarter 2015 Earnings Call November 9, 2015 Forward-Looking Statements All of the statements in this presentation that are not statements of historical facts constitute forward-looking statements

More information

Path to Value and Profitability

Path to Value and Profitability Path to Value and Profitability June 4, 2015 Tim Clackson, Ph.D. President of R&D, Chief Scientific Officer ARIAD Pharmaceuticals, Inc. Elsa So Non-small cell lung cancer ARIAD clinical trial patient Some

More information

Savolitinib Global Phase II Trial Initiated in EGFR Mutant Non-Small Cell Lung Cancer

Savolitinib Global Phase II Trial Initiated in EGFR Mutant Non-Small Cell Lung Cancer Savolitinib Global Phase II Trial Initiated in EGFR Mutant Non-Small Cell Lung Cancer Initiation of expanded Phase II trials in NSCLC triggers US$10 million milestone from AstraZeneca to Chi-Med New study

More information

Building a Premier Oncology Biotech

Building a Premier Oncology Biotech Corporate Deck Building a Premier Oncology Biotech Dr. Helen Torley, President and CEO November 2018 Forward-Looking Statements All of the statements in this presentation that are not statements of historical

More information

July, ArQule, Inc.

July, ArQule, Inc. July, 2012 Safe Harbor This presentation and other statements by ArQule may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to clinical

More information

Improving outcomes for NSCLC patients with brain metastases

Improving outcomes for NSCLC patients with brain metastases Improving outcomes for NSCLC patients with brain metastases Martin Schuler West German Cancer Center, Essen, Germany In Switzerland, afatinib is approved as monotherapy for patients with non-small cell

More information

ARQ 087 Overview. FGFR Inhibitor. March 2017

ARQ 087 Overview. FGFR Inhibitor. March 2017 ARQ 087 Overview FGFR Inhibitor March 2017 Safe Harbor This presentation and other statements by ArQule contain forward-looking statements within the meaning of the Private Securities Litigation Reform

More information

Clovis Oncology Announces Q Operating Results and Corporate Update. November 3, :05 PM ET

Clovis Oncology Announces Q Operating Results and Corporate Update. November 3, :05 PM ET Clovis Oncology Announces Q3 2016 Operating Results and Corporate Update November 3, 2016 4:05 PM ET Rucaparib New Drug Application (NDA) accepted for Priority Review in the treatment of advanced BRCA-mutant

More information

B I ABOUT BI DISEASE AREA & MECHANISM OF ACTION. For journalists outside UK/US/Canada only B A C K G R O U N D E R

B I ABOUT BI DISEASE AREA & MECHANISM OF ACTION. For journalists outside UK/US/Canada only B A C K G R O U N D E R For journalists outside UK/US/Canada only B I 1 4 8 2 6 9 4 1. About BI 1482694 2. Disease area & mechanism of action 3. Development status 4. Data overview 1. ABOUT BI 1482694 BI 1482694* (HM61713**)

More information

Investor Call. May 19, Nasdaq: IMGN

Investor Call. May 19, Nasdaq: IMGN Investor Call May 19, 2017 Nasdaq: IMGN Forward-Looking Statements This presentation includes forward-looking statements based on management's current expectations. These statements include, but are not

More information

Building a Premier Oncology Biotech

Building a Premier Oncology Biotech Wells Fargo Securities Healthcare Conference Building a Premier Oncology Biotech Dr. Helen Torley, President and CEO September 2018 Forward-Looking Statements All of the statements in this presentation

More information

Prostate Cancer Panel. June 2018

Prostate Cancer Panel. June 2018 Prostate Cancer Panel June 2018 Forward Looking Statements Certain of the statements made in this presentation are forward looking, such as those, among others, relating to future spending, future cash

More information

Liquid Biopsies. Next Generation Cancer Molecular Diagnostics

Liquid Biopsies. Next Generation Cancer Molecular Diagnostics Liquid Biopsies Next Generation Cancer Molecular Diagnostics Forward Looking Statements 2 Statements pertaining to future financial and/or operating results, future research, diagnostic tests and technology

More information

PSMA-617 License Transaction. October 2, 2017

PSMA-617 License Transaction. October 2, 2017 PSMA-617 License Transaction October 2, 2017 Forward Looking Statements Certain of the statements made in this presentation are forward looking, such as those, among others, relating to future spending,

More information

Osimertinib Activity in Patients With Leptomeningeal Disease From Non-Small Cell Lung Cancer: Updated Results From the BLOOM Study

Osimertinib Activity in Patients With Leptomeningeal Disease From Non-Small Cell Lung Cancer: Updated Results From the BLOOM Study Osimertinib Activity in Patients With Leptomeningeal Disease From Non-Small Cell Lung Cancer: Updated Results From the BLOOM Study Abstract 9002 Yang JC, Kim DW, Kim SW, Cho BC, Lee JS, Ye X, Yin X, Yang

More information

FOURTH QUARTER AND FULL YEAR 2018 FINANCIAL RESULTS AND BUSINESS UPDATE. Thursday, February 7, 2019

FOURTH QUARTER AND FULL YEAR 2018 FINANCIAL RESULTS AND BUSINESS UPDATE. Thursday, February 7, 2019 FOURTH QUARTER AND FULL YEAR 2018 FINANCIAL RESULTS AND BUSINESS UPDATE Thursday, February 7, 2019 Today s Speakers Overview and Key Highlights Clay Siegall, President & CEO Financial Results and Guidance

More information

AVEO and Astellas Report Final Overall Survival Results from TIVO-1

AVEO and Astellas Report Final Overall Survival Results from TIVO-1 AVEO and Astellas Report Final Overall Survival Results from TIVO-1 - Median Overall Survival of 28.8 Months Reported for Tivozanib in Patients with Advanced Kidney Cancer - CAMBRIDGE, Mass. and TOKYO,

More information

Third Quarter 2018 Financial Results. November 1, 2018

Third Quarter 2018 Financial Results. November 1, 2018 Third Quarter 2018 Financial Results November 1, 2018 Agios Conference Call Participants Prepared Remarks Introduction RENEE LECK, Associate Director, Investor Relations Business Highlights & 2018 Key

More information

For analyst certification and disclosures please see page 5

For analyst certification and disclosures please see page 5 Conference Update June 7, 2017 ASCO 2017 Detailed Presentation Notes Day 5 As part of our ongoing coverage of the 2017 American Society of Clinical Oncology (ASCO) conference, we attended multiple oral

More information

Afatinib in patients with EGFR mutation-positive NSCLC harboring uncommon mutations: overview of clinical data

Afatinib in patients with EGFR mutation-positive NSCLC harboring uncommon mutations: overview of clinical data Afatinib in patients with EGFR mutation-positive NSCLC harboring uncommon mutations: overview of clinical data Oscar Arrieta, 1 Pedro De Marchi, 2 Nobuyuki Yamamoto, 3 Chong-Jen Yu, 4 Sai-Hong I Ou, 5

More information

AVEO Oncology Announces Strategic Restructuring. AVEO to Host Conference Call Wednesday, June 5 at 8:30 a.m. ET

AVEO Oncology Announces Strategic Restructuring. AVEO to Host Conference Call Wednesday, June 5 at 8:30 a.m. ET NEWS RELEASE FOR IMMEDIATE RELEASE AVEO Oncology Announces Strategic Restructuring AVEO to Host Conference Call Wednesday, June 5 at 8:30 a.m. ET CAMBRIDGE, Mass., June 4, 2013 AVEO Oncology (NASDAQ: AVEO)

More information

Business Update & Financial Results for Q1 2018

Business Update & Financial Results for Q1 2018 Business Update & Financial Results for Q1 2018 May 15, 2018 Disclaimer The statements made in this presentation may include forward-looking statements regarding the future operations of ERYTECH Pharma

More information

ArQule CorporateUpdate

ArQule CorporateUpdate ArQule April 2015 1 ArQule CorporateUpdate Safe Harbor This presentation and other statements by ArQule may contain forwardlooking statements within the meaning of the Private Securities Litigation Reform

More information

Analyst/Investor Call

Analyst/Investor Call Analyst/Investor Call November 20 th, 2018 Forward-looking Statements Except for historical information, this presentation contains forward-looking statements, which reflect IMV s current expectations

More information

ArQule Jefferies Global Healthcare Conference June 2015

ArQule Jefferies Global Healthcare Conference June 2015 ArQule Jefferies Global Healthcare Conference June 2015 1 ArQule Corporate Update Safe Harbor This presentation and other statements by ArQule may contain forward-looking statements within the meaning

More information

First Phase 3 Results Presented for a PD-1 Immune Checkpoint Inhibitor

First Phase 3 Results Presented for a PD-1 Immune Checkpoint Inhibitor September 30, 2014 Positive Phase 3 Data for Opdivo (nivolumab) in Advanced Melanoma Patients Previously Treated with Yervoy @ (ipilimumab) Presented at the ESMO 2014 Congress First Phase 3 Results Presented

More information

VAL-083: Validated DNA-targeting Agent for Underserved Cancer Patients. September 2018

VAL-083: Validated DNA-targeting Agent for Underserved Cancer Patients. September 2018 VAL-083: Validated DNA-targeting Agent for Underserved Cancer Patients September 2018 Forward-Looking Statements Any statements contained in this presentation that do not describe historical facts may

More information

PLENARY SESSION 1: CLINICAL TRIAL DESIGN IN AN ERA OF HORIZONTAL DRUG DEVELOPMENT Industry Perspective

PLENARY SESSION 1: CLINICAL TRIAL DESIGN IN AN ERA OF HORIZONTAL DRUG DEVELOPMENT Industry Perspective PLENARY SESSION 1: CLINICAL TRIAL DESIGN IN AN ERA OF HORIZONTAL DRUG DEVELOPMENT Industry Perspective Davy Chiodin, VP - Regulatory Science, QA and Compliance, Acerta Pharma (A Member of the AstraZeneca

More information

Delcath Investor Presentation (OTCQB: DCTH)

Delcath Investor Presentation (OTCQB: DCTH) Delcath Investor Presentation (OTCQB: DCTH) December 2018 1 DELCATH SYSTEMS, INC Forward-looking Statements This presentation contains forward-looking statements, within the meaning of the federal securities

More information

XP23829 PHASE 2 PSORIASIS TRIAL PRELIMINARY TOPLINE DATA PRESENTATION SEPTEMBER 15, 2015 COPYRIGHT 2015 XENOPORT, INC. ALL RIGHTS RESERVED.

XP23829 PHASE 2 PSORIASIS TRIAL PRELIMINARY TOPLINE DATA PRESENTATION SEPTEMBER 15, 2015 COPYRIGHT 2015 XENOPORT, INC. ALL RIGHTS RESERVED. XP23829 PHASE 2 PSORIASIS TRIAL PRELIMINARY TOPLINE DATA PRESENTATION SEPTEMBER 15, 2015 COPYRIGHT 2015 XENOPORT, INC. ALL RIGHTS RESERVED. SAFE HARBOR DISCLAIMER These slides and the accompanying oral

More information

Building Shareholder Value

Building Shareholder Value Building Shareholder Value June 4, 2014 Jefferies Healthcare Conference Tim Clackson, Ph.D. Hans Loland P r e s i d e n t o f R & D, C h i e f S c i e n t i f i c O f f i c e r with wife Cynthia A R I

More information

Idera Pharmaceuticals

Idera Pharmaceuticals Idera Pharmaceuticals ILLUMINATE-204 Clinical Data Update December 2018 Forward Looking Statements and Other Important Cautions This presentation contains forward-looking statements within the meaning

More information

Determined to realize a future in which people with cancer live longer and better than ever before

Determined to realize a future in which people with cancer live longer and better than ever before Determined to realize a future in which people with cancer live longer and better than ever before 3Q 2018 EARNINGS PRESENTATION NOVEMBER 2018 1 Forward-looking statements disclosure This presentation

More information

Revolutionizing the Treatment of Cancer

Revolutionizing the Treatment of Cancer Revolutionizing the Treatment of Cancer January 2014 Safe Harbor Statement The statements that follow (including projections and business trends) are forward looking statements. Rexahn's actual results

More information

CORPORATE PRESENTATION

CORPORATE PRESENTATION CORPORATE PRESENTATION June 2017 FORWARD LOOKING SAFE HARBOR STATEMENT This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

More information

EGFR Mutation-Positive Acquired Resistance: Dominance of T790M

EGFR Mutation-Positive Acquired Resistance: Dominance of T790M Treatment of EGFR Mutation-Positive Acquired Resistance: T790M+ or T790M- H. Jack West, MD Swedish Cancer Institute, Seattle, WA EGFR Mutation-Positive Acquired Resistance: Dominance of T790M Yu, Clin

More information

Jefferies 2016 Healthcare Conference. Reid Huber, PhD Chief Scientific Officer

Jefferies 2016 Healthcare Conference. Reid Huber, PhD Chief Scientific Officer Jefferies 2016 Healthcare Conference Reid Huber, PhD Chief Scientific Officer June 8, 2016 Forward-looking Statements Except for the historical information set forth herein, the matters set forth in this

More information

HALOZYME REPORTS SECOND QUARTER 2018 RESULTS

HALOZYME REPORTS SECOND QUARTER 2018 RESULTS Contacts: Robert H. Uhl Managing Director Westwicke Partners, LLC 858-356-5932 robert.uhl@westwicke.com Laurie Stelzer 858-704-8222 ir@halozyme.com FOR IMMEDIATE RELEASE HALOZYME REPORTS SECOND QUARTER

More information

Building a Premier Oncology Biotech

Building a Premier Oncology Biotech Building a Premier Oncology Biotech August 208 Forward-Looking Statements All of the statements in this presentation that are not statements of historical facts constitute forward-looking statements within

More information

Announce Expected Initiation of an Investigator-Initiated, Randomized, Phase 2, Multicenter Trial of Ficlatuzumab and Cetuximab in HNSCC in 2H 2017

Announce Expected Initiation of an Investigator-Initiated, Randomized, Phase 2, Multicenter Trial of Ficlatuzumab and Cetuximab in HNSCC in 2H 2017 AVEO Oncology and Biodesix Announce Results from Two Investigator-Sponsored Phase 1 Studies of HGF Targeted Antibody Ficlatuzumab at the 2017 ASCO Annual Meeting Announce Expected Initiation of an Investigator-Initiated,

More information

G1 Corporate Overview March 11, 2019

G1 Corporate Overview March 11, 2019 G1 Corporate Overview March 11, 2019 www.g1therapeutics.com NASDAQ: GTHX 1 Forward-looking statements This presentation and the accompanying oral commentary contain forward-looking statements within the

More information

Corporate Overview. May 2017 NASDAQ: CYTR

Corporate Overview. May 2017 NASDAQ: CYTR Corporate Overview May 2017 NASDAQ: CYTR CytRx Safe Harbor Statement THIS PRESENTATION CONTAINS FORWARD-LOOKING STATEMENTS THAT INVOLVE CERTAIN RISKS AND UNCERTAINTIES. ACTUAL RESULTS COULD DIFFER MATERIALLY

More information

IMMUNOMEDICS, INC. Advanced Antibody-Based Therapeutics. Jefferies 2014 Global Healthcare Conference Cynthia L. Sullivan, President and CEO

IMMUNOMEDICS, INC. Advanced Antibody-Based Therapeutics. Jefferies 2014 Global Healthcare Conference Cynthia L. Sullivan, President and CEO IMMUNOMEDICS, INC. Advanced Antibody-Based Therapeutics Oncology Autoimmune Diseases Jefferies 2014 Global Healthcare Conference Cynthia L. Sullivan, President and CEO Forward-Looking Statements This presentation,

More information

Targeted Therapies for Advanced NSCLC

Targeted Therapies for Advanced NSCLC Targeted Therapies for Advanced NSCLC Current Clinical Developments Friday, June 3, 2016 Supported by an independent educational grant from AstraZeneca Not an official event of the 2016 ASCO Annual Meeting

More information

Emerging Algorithm for Optimal Sequencing of EGFR TKIs in EGFR Mutation Positive NSCLC

Emerging Algorithm for Optimal Sequencing of EGFR TKIs in EGFR Mutation Positive NSCLC Emerging Algorithm for Optimal Sequencing of EGFR TKIs in EGFR Mutation Positive NSCLC Keunchil Park, MD, PhD Samsung Medical Center, Sungkyunkwan University School of Medicine Faculty Disclosure Consulting

More information

Bank of America Merrill Lynch 2016 Health Care Conference

Bank of America Merrill Lynch 2016 Health Care Conference Bank of America Merrill Lynch 2016 Health Care Conference Dr. Steven Stein Chief Medical Officer David Gryska Chief Financial Officer May 11, 2016 Forward Looking Statements Except for the historical information

More information

NewLink Genetics Corporation

NewLink Genetics Corporation Cantor Fitzgerald 2018 Global Healthcare Conference NewLink Genetics Corporation NASDAQ: NLNK October 3, 2018 Cautionary Note Regarding Forward-Looking Statements This presentation contains forward-looking

More information

Targeted therapy in NSCLC: do we progress? Prof. Dr. V. Surmont. Masterclass 27 september 2018

Targeted therapy in NSCLC: do we progress? Prof. Dr. V. Surmont. Masterclass 27 september 2018 Targeted therapy in NSCLC: do we progress? Prof. Dr. V. Surmont Masterclass 27 september 2018 Outline Introduction EGFR TKI ALK TKI TKI for uncommon driver mutations Take home messages The promise of

More information

Molecular Targets in Lung Cancer

Molecular Targets in Lung Cancer Molecular Targets in Lung Cancer Robert Ramirez, DO, FACP Thoracic and Neuroendocrine Oncology November 18 th, 2016 Disclosures Consulting and speaker fees for Ipsen Pharmaceuticals, AstraZeneca and Merck

More information

Positioned for Growth

Positioned for Growth Positioned for Growth Annual Shareholders Meeting July 21, 2016 Paris Panayiotopoulos President and Chief Executive Officer David Sachs Non small cell lung cancer ARIAD clinical trial patient This presentation

More information

Revolutionizing the Treatment of Cancer

Revolutionizing the Treatment of Cancer Revolutionizing the Treatment of Cancer March 2014 Safe Harbor Statement The statements that follow (including projections and business trends) are forward-looking statements. Rexahn's actual results may

More information

Treatment of EGFR mutant advanced NSCLC

Treatment of EGFR mutant advanced NSCLC Treatment of EGFR mutant advanced NSCLC Raffaele Califano Department of Medical Oncology The Christie and University Hospital of South Manchester, Manchester, UK Outline Data on first-line Overcoming T790M

More information

TARCEVA NEARLY DOUBLED THE TIME PEOPLE WITH A GENETICALLY DISTINCT TYPE OF LUNG CANCER LIVED WITHOUT THEIR DISEASE GETTING WORSE

TARCEVA NEARLY DOUBLED THE TIME PEOPLE WITH A GENETICALLY DISTINCT TYPE OF LUNG CANCER LIVED WITHOUT THEIR DISEASE GETTING WORSE NEWS RELEASE Genentech Contacts: Media Contact: Charlotte Arnold (650) 467-6800 Advocacy Contact: Jen Mills (650) 467-6722 Investor Contacts: Thomas Kudsk Larsen (650) 467-2016 Karl Mahler 011 41 61 687

More information

Revolutionizing the Treatment of Cancer

Revolutionizing the Treatment of Cancer Revolutionizing the Treatment of Cancer June 2014 Safe Harbor Statement The statements that follow (including projections and business trends) are forward looking statements. Rexahn's actual results may

More information

D Ross Camidge, MD, PhD

D Ross Camidge, MD, PhD i n t e r v i e w D Ross Camidge, MD, PhD Dr Camidge is Director of the Thoracic Oncology Clinical Program and Associate Director for Clinical Research at the University of Colorado Cancer Center in Aurora,

More information

Dawson James Conference

Dawson James Conference Dawson James Conference October 2018 Forward-looking Statements Except for historical information, this presentation contains forward-looking statements, which reflect IMV s current expectations regarding

More information

Next Generation EGFR Inhibitors

Next Generation EGFR Inhibitors Next Generation EGFR Inhibitors Tony Mok MD Li Shu Fan Medical Foundation Professor of Clinical Oncology Dept. of Clinical Oncology The Chinese University of Hong Kong EGFR TKIs First Generation -Gefitinib

More information

MERCK ONCOLOGY OVERVIEW ASCO 2018 JUNE 4, 2018

MERCK ONCOLOGY OVERVIEW ASCO 2018 JUNE 4, 2018 MERCK ONCOLOGY OVERVIEW ASCO 218 JUNE 4, 218 Forward-Looking Statement of Merck & Co., Inc., Kenilworth, NJ, USA This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the company ) includes forward

More information

REWRITING CANCER TREATMENT THROUGH EPIGENETIC MEDICINES

REWRITING CANCER TREATMENT THROUGH EPIGENETIC MEDICINES REWRITING CANCER TREATMENT THROUGH EPIGENETIC MEDICINES May 18, 2017 Molecularly Defined Solid Tumor Program Update FORWARD-LOOKING STATEMENTS Any statements in this press release about future expectations,

More information

Circulating Tumor DNA in GIST and its Implications on Treatment

Circulating Tumor DNA in GIST and its Implications on Treatment Circulating Tumor DNA in GIST and its Implications on Treatment October 2 nd 2017 Dr. Ciara Kelly Assistant Attending Physician Sarcoma Medical Oncology Service Objectives Background Liquid biopsy & ctdna

More information

Genta Incorporated. A Multiproduct Late-Stage Oncology Company

Genta Incorporated. A Multiproduct Late-Stage Oncology Company Genta Incorporated A Multiproduct Late-Stage Oncology Company This presentation may contain forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking

More information

LONDON CANCER NEW DRUGS GROUP RAPID REVIEW. Erlotinib for the third or fourth-line treatment of NSCLC January 2012

LONDON CANCER NEW DRUGS GROUP RAPID REVIEW. Erlotinib for the third or fourth-line treatment of NSCLC January 2012 Disease background LONDON CANCER NEW DRUGS GROUP RAPID REVIEW Erlotinib for the third or fourth-line treatment of NSCLC January 2012 Lung cancer is the second most common cancer in the UK (after breast),

More information

37 th ANNUAL JP MORGAN HEALTHCARE CONFERENCE

37 th ANNUAL JP MORGAN HEALTHCARE CONFERENCE 37 th ANNUAL JP MORGAN HEALTHCARE CONFERENCE January 2019 Safe Harbor Statement This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as

More information

Cowen Annual Healthcare Conference. March 2018

Cowen Annual Healthcare Conference. March 2018 Cowen Annual Healthcare Conference March 2018 Forward Looking Statements Certain of the statements made in this presentation are forward looking, such as those, among others, relating to future spending,

More information

DS-8201 Strategic Collaboration

DS-8201 Strategic Collaboration DS-8201 Strategic Collaboration DAIICHI SANKYO CO., LTD George Nakayama Chairman and CEO March 29, 2019 Forward-Looking Statements Management strategies and plans, financial forecasts, future projections

More information

Merck Announces FDA Approval of KEYTRUDA. Provided to Investors as a Reference

Merck Announces FDA Approval of KEYTRUDA. Provided to Investors as a Reference Merck Announces FDA Approval of KEYTRUDA Provided to Investors as a Reference Forward-Looking Statement This presentation includes forward-looking statements within the meaning of the safe harbor provisions

More information

Cabozantinib (Cometriq )

Cabozantinib (Cometriq ) Cabozantinib (Cometriq ) Workshop dose escalation EMA 4/5 Dec 2014 Frans Opdam, internist-clinical pharmacologist Clinical assessor, Dutch Medicines Agency Phase 3 Study XL184-301 (EXAM): Design Cabozantinib

More information

Media Contact: Ron Rogers Investor Contact: Scott Gleason (801) (801)

Media Contact: Ron Rogers Investor Contact: Scott Gleason (801) (801) News Release Media Contact: Ron Rogers Investor Contact: Scott Gleason (801) 584-3065 (801) 584-1143 rrogers@myriad.com sgleason@myriad.com Myriad Receives FDA Approval of BRACAnalysis CDx as Companion

More information

Use of Single-Arm Cohorts/Trials to Demonstrate Clinical Benefit for Breakthrough Therapies. Eric H. Rubin, MD Merck Research Laboratories

Use of Single-Arm Cohorts/Trials to Demonstrate Clinical Benefit for Breakthrough Therapies. Eric H. Rubin, MD Merck Research Laboratories Use of Single-Arm Cohorts/Trials to Demonstrate Clinical Benefit for Breakthrough Therapies Eric H. Rubin, MD Merck Research Laboratories Outline Pembrolizumab P001 study - example of multiple expansion

More information

Phase III ARISER trial data ASCO 2013 RENCAREX - Unique targeted antibody therapy for adjuvant treatment of non-metastatic clear cell renal cell

Phase III ARISER trial data ASCO 2013 RENCAREX - Unique targeted antibody therapy for adjuvant treatment of non-metastatic clear cell renal cell Phase III ARISER trial data ASCO 2013 RENCAREX - Unique targeted antibody therapy for adjuvant treatment of non-metastatic clear cell renal cell carcinoma patients June 2013 Carbonic Anhydrase IX (CAIX):

More information

Treatment of EGFR mutant advanced NSCLC

Treatment of EGFR mutant advanced NSCLC Treatment of EGFR mutant advanced NSCLC Raffaele Califano Department of Medical Oncology The Christie and Manchester University Hospital Manchester, UK Outline Data on first-line Overcoming T790M mutation

More information

Corporate Overview. February 2018 NASDAQ: CYTR

Corporate Overview. February 2018 NASDAQ: CYTR Corporate Overview February 2018 NASDAQ: CYTR CytRx Safe Harbor Statement THIS PRESENTATION CONTAINS FORWARD-LOOKING STATEMENTS THAT INVOLVE CERTAIN RISKS AND UNCERTAINTIES. ACTUAL RESULTS COULD DIFFER

More information

HALOZYME THERAPEUTICS, INC. (Exact name of registrant as specified in its charter)

HALOZYME THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of Earliest Event

More information

Idenix Pharmaceuticals Building a Leading Antiviral Franchise. Cowen & Company 27 th Annual Healthcare Conference March 13, 2007 Boston

Idenix Pharmaceuticals Building a Leading Antiviral Franchise. Cowen & Company 27 th Annual Healthcare Conference March 13, 2007 Boston Idenix Pharmaceuticals Building a Leading Antiviral Franchise Cowen & Company 27 th Annual Healthcare Conference March 13, 2007 Boston Safe Harbor This presentation includes forward-looking statements

More information

Wells Fargo Healthcare Conference September 6, 2018

Wells Fargo Healthcare Conference September 6, 2018 Wells Fargo Healthcare Conference September 6, 2018 Safe Harbor Statement To the extent that statements contained in this presentation are not descriptions of historical facts regarding TESARO, they are

More information

NY-ESO SPEAR T-cells in Synovial Sarcoma

NY-ESO SPEAR T-cells in Synovial Sarcoma NY-ESO SPEAR T-cells in Synovial Sarcoma ASCO Update June 6, 2017 Disclaimer This presentation contains forward-looking statements, as that term is defined under the Private Securities Litigation Reform

More information

Background Comparative effectiveness of nivolumab

Background Comparative effectiveness of nivolumab NCPE report on the cost effectiveness of nivolumab (Opdivo ) for the treatment of locally advanced or metastatic squamous non-small cell lung cancer after prior chemotherapy in adults. The NCPE has issued

More information

Full Year 2017 Financial Results. February 14, 2018

Full Year 2017 Financial Results. February 14, 2018 Full Year 2017 Financial Results February 14, 2018 Agios Conference Call Participants Prepared Remarks Introduction KENDRA ADAMS, Sr. Director, Investor Relations 2018 Vision & Key Milestones DAVID SCHENKEIN,

More information

UCB announces first presentation of primary data from latest Phase 3 study evaluating brivaracetam

UCB announces first presentation of primary data from latest Phase 3 study evaluating brivaracetam UCB announces first presentation of primary data from latest Phase 3 study evaluating brivaracetam as adjunctive treatment of partial-onset seizures in epilepsy Primary efficacy and safety data from the

More information

IRESSA (Gefitinib) The Journey. Anne De Bock Portfolio Leader, Oncology/Infection European Regulatory Affairs AstraZeneca

IRESSA (Gefitinib) The Journey. Anne De Bock Portfolio Leader, Oncology/Infection European Regulatory Affairs AstraZeneca IRESSA (Gefitinib) The Journey Anne De Bock Portfolio Leader, Oncology/Infection European Regulatory Affairs AstraZeneca Overview The Drug The Biomarker and Clinical Trials Sampling Lessons Learned The

More information

Leerink Immuno-Oncology Roundtable Conference

Leerink Immuno-Oncology Roundtable Conference Leerink Immuno-Oncology Roundtable Conference September 28, 2017 NASDAQ:FPRX Forward-Looking Statements Disclaimer This presentation contains forward-looking statements within the meaning of the Private

More information

AM-125 : Intranasal Betahistine

AM-125 : Intranasal Betahistine AM-125 : Intranasal Betahistine February 3, 2017 NASDAQ: EARS Forward-looking Statements This presentation and the accompanying oral commentary contain forward-looking statements that involve substantial

More information

Lonnie Moulder, CEO Leerink Global Healthcare Conference February 12, 2015

Lonnie Moulder, CEO Leerink Global Healthcare Conference February 12, 2015 Lonnie Moulder, CEO Leerink Global Healthcare Conference February 12, 2015 Safe Harbor Statement Statements made in this presentation about TESARO, Inc. that are not descriptions of historical facts are

More information

Investor Presentation

Investor Presentation Investor Presentation February 2018 2 FORWARD-LOOKING INFORMATION The following presentation contains statements that are considered forward-looking information ( FLI ) within the meaning of securities

More information

Leading the Next Wave of Biotech Breakthroughs

Leading the Next Wave of Biotech Breakthroughs Leading the Next Wave of Biotech Breakthroughs Corporate Extensive corporate assets Platforms Pipeline Partnerships Building a sustainable global business Platform licenses represent a source of non-dilutive

More information

NSCLC: immunotherapy as a first-line treatment. Paolo Bironzo Oncologia Polmonare AOU S. Luigi Gonzaga Orbassano (To)

NSCLC: immunotherapy as a first-line treatment. Paolo Bironzo Oncologia Polmonare AOU S. Luigi Gonzaga Orbassano (To) NSCLC: immunotherapy as a first-line treatment Paolo Bironzo Oncologia Polmonare AOU S. Luigi Gonzaga Orbassano (To) The 800-pound gorilla Platinum-based chemotherapy is the SOC for 1st-line therapy in

More information

Osimertinib (AZD9291) a science-driven, collaborative approach

Osimertinib (AZD9291) a science-driven, collaborative approach Annals of Oncology Advance Access published March 8, 2016 1 Osimertinib (AZD9291) a science-driven, collaborative approach to rapid drug design and development A. Yver Global Medicines Development, AstraZeneca,

More information

Zogenix Announces Positive Top-line Results from Pivotal Phase 3 Clinical Trial of ZX008 in Dravet Syndrome

Zogenix Announces Positive Top-line Results from Pivotal Phase 3 Clinical Trial of ZX008 in Dravet Syndrome Zogenix Announces Positive Top-line Results from Pivotal Phase 3 Clinical Trial of ZX008 in Dravet Syndrome Primary Endpoint Achieved - Statistically Significant Convulsive Seizure Reduction for ZX008

More information

Calliditas Therapeutics Q2 Report Webcast August 16, 2018, 10:00 Presenters: Renée Aguiar-Lucander, CEO Fredrik Johansson, CFO

Calliditas Therapeutics Q2 Report Webcast August 16, 2018, 10:00 Presenters: Renée Aguiar-Lucander, CEO Fredrik Johansson, CFO Calliditas Therapeutics Q2 Report 2018 Webcast August 16, 2018, 10:00 Presenters: Renée Aguiar-Lucander, CEO Fredrik Johansson, CFO Disclaimer Important information This presentation may contain certain

More information

Lung Cancer Case. Since the patient was symptomatic, a targeted panel was sent. ALK FISH returned in 2 days and was positive.

Lung Cancer Case. Since the patient was symptomatic, a targeted panel was sent. ALK FISH returned in 2 days and was positive. Lung Cancer Case Jonathan Riess, M.D. M.S. Assistant Professor of Medicine University of California Davis School of Medicine UC Davis Comprehensive Cancer Center 63 year-old woman, never smoker, presents

More information