Genta Incorporated. A Multiproduct Late-Stage Oncology Company
|
|
- Silvester Harris
- 6 years ago
- Views:
Transcription
1 Genta Incorporated A Multiproduct Late-Stage Oncology Company
2 This presentation may contain forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Forward-looking statements include, without limitation, statements about: the Company s ability to obtain necessary regulatory approval for its products from the U.S. Food and Drug Administration ( FDA ) or other regulatory authorities; the safety and efficacy of the company s products or product candidates; the Company s assessment of its clinical trials; timing of the commencement and completion of clinical trials; the Company s ability to develop, manufacture, license and sell its products or product candidates; the Company s ability to enter into and successfully execute license and collaborative agreements, if any; the adequacy of the Company s capital resources and cash flow projections, and the Company s ability to obtain sufficient financing to maintain the Company s planned operations; the adequacy of the Company s patents and proprietary rights; and the other risks described under Certain Risks and Uncertainties Related to the Company s Business, as contained in the Company s Annual Report on Form 10-K and Quarterly Report on Form 10-Q. The Company does not undertake to update any forwardlooking statements. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company's most recent Annual Report on Form 10-K and its most recent quarterly report on Form 10-Q.
3 Genta Incorporated Oncology focus on novel small molecules De-risked pipeline: oral analogs of highly active agents Objective: direct marketer in U.S. Experienced senior management Berkeley Heights, NJ USA
4 Oncology Focused Pipeline Small Molecules PIPELINE Preclinical Phase 1 Phase 2 Phase 3 Market Tesetaxel PLANNED Ganite (gallium nitrate injection) Oral Gallium
5 Tesetaxel Phase 3 Oncology Opportunity New Chemical Entity (NCE) Indications: Gastric, Breast, Prostate First-to-Market Oral Taxane
6 Tesetaxel A leading anti-tubulin agent Taxanes: established market O Tubulin: highly validated target Current products: marked limitations O N N H F H O O O O O N Tesetaxel features: H O O H O O Convenient oral dosing O O No infusion reactions or premeds Reduced nerve damage Active in taxane-resistant disease Established Phase 2 activity Projected launch: 2015
7 Tesetaxel: Phase 1 Studies Summary of 5 completed/ongoing trials Dose range: mg/m 2 Every 3 week schedule: Maximally tolerated dose (MTD): 27 mg/m 2 Dose-limiting: neutropenia Weekly schedule: Weekly x 3 weeks, one week off MTD: defined Dose-limiting: constitutional symptoms (fatigue, anorexia) Two dose-ranging studies with capecitabine (Xeloda ): Full doses of each drug can be co-administered DLTs: neutropenia vs. thrombocytopenia/hand-foot (capecitabine)
8 Clinical Development Program Broad Phase 2; pending Phase 3 Confidential Tesetaxel Preclinical Phase 1 Phase 2 Phase 3 Market Gastric Cancer (2 nd Line) Open (Confirmatory) (Pending) Gastric Cancer (1 st Line) Open Breast Cancer (1 st Line) Open (Confirmatory) Prostate Cancer (1 st Line) Open Bladder Cancer (2 nd Line) Open
9 Confidential Gastric Cancer Program Completed Phase 2 2 nd line Ongoing Confirmatory Phase 2 2 nd -line Ongoing Initial Phase 2 1 st line combination Planned Phase 3 Trial -- 2 nd -line
10 Phase 2a Trial (completed) 2 nd Line gastric cancer efficacy* Response n Percent Partial 7 20% Stable 13 37% Progression/non-evaluable 15 40% * Efficacy population: n = 35
11 Ongoing Phase 2b Trial (confirmatory) 2 nd Line gastric cancer Trial design Phase 2, open-label, multi-center Progression on 1 chemotherapy regimen: 5-FU or platinum, or both Taxane-naive Three cohorts: Cohort A 40 mg flat dose (complete; n=13) Cohort B 50 mg flat dose (complete; n=13) Cohort C 27 mg/m 2 BSA (ongoing; n=15+)* Dose/schedule: once every 3 weeks Primary endpoint: Overall response rate (RECIST) *November 2011
12 Ongoing Phase 2b Trial (confirmatory) 2 nd Line gastric cancer overall response rate Response Cohort A (40 mg) n=13 Cohort B (50 mg) n=13 Cohort C (27 mg/m 2 ) n=15* Partial 1 (8%) 2 (15%) 3 (20%)* Stable Progression Not evaluable Too early *Pending update ASCO GI, January 2012
13 Gastric Cancer -- Single-Agent Comparative 2 nd -line therapies Event Tesetaxel Docetaxel 1-4 Everolimus 5.6 Response rate 20% 5% 14% 18% 19% 0% Time-toprogression (median, mos) n/a (95% CI: 50-91d) Neutropenia Gr 3-4: 37% Gr 3-4: 10-60% N/A Plts: 21% 1 Graziano F et al.: Ann Oncol. 11:1263, 2000; 2 Jo J-L et al.: Jpn J Clin Oncol 37:936, 2007; 3 Vanhoefer U, et al.: Proc ASCO 18:303a, 1999; 4 Lee J-L et al.: Cancer Res Treat. 37:201, 2005; 5 Doi et al., J Clin Oncol. 28:1904, 2010; 6 Currently in multinational Phase 3 trials as 2 nd -line therapy.
14 Proportion Surviving Ongoing Phase 2b Trial (confirmatory) 2 nd Line gastric cancer overall survival* 100 Confidential Cohort A Cohort B Cohort C 80 Median (mos) Events (N) / /13 1/13 Percent (92%) (77%) Overall Survival (Months) *K-M estimate, November 2011 N = 39 patients accrued Pending update: ASCO GI, January 2012
15 Gastric Cancer Proposed pivotal study Phase 3, randomized, double-blind trial Stratification/ Randomization Active + Tesetaxel Active + Placebo Population: 2 nd -line; progression on 1 st -line platinum/fp regimen Multinational: U.S., Western Europe, East Asia; 580 patients Primary endpoint: OS; target HR: 0.75; 90% power: a =0.05 Secondary Endpoints: TTP; ORR; DCR; PE analyses; safety Stratifications: Geography (Asia/Other); Liver mets (Y/N); Gastrectomy (Y/N); progression on 1 st line 4 mos
16 Confidential Breast Cancer Program Completed Phase 2 Confirmatory Phase 2 (ongoing)
17 Phase 2 Trial (completed) 2 nd Line breast cancer efficacy (n = 32) Response N Percent Partial 13 38% Stable 10 29% Progression 9 28% Not Evaluable 2
18 Ongoing Phase 2 Trial (confirmatory) 1 st Line breast cancer design Phase 2 open label, single arm, multicenter study N = 45+ (New cohort planned for weekly schedule) Chemotherapy naive; adjuvant taxane permitted if 12 months prior to study No limitation on prior hormonal regimens HER2+ excluded Dose/schedule: 27 mg/m 2 every 3 weeks 15 mg/m 2 weekly x 3 (amendment pending) Primary endpoint: Overall response rate (RECIST)
19 Percent Change From Baseline Ongoing Phase 2 Trial (confirmatory) 1 st Line breast cancer efficacy in 24 evaluable pts* = CR/PR = SD = PD SABCS 12/9/11 Major response rate: 50% (12/24) Disease control rate: 79% (19/24)
20 Hematological Toxicity -- Phase 2 Comparative safety with other taxanes Confidential Event Tesetaxel 1 N = 159 Paclitaxel 2 N = 812 Docetaxel 3 N = 2045 Neutropenia (Grade 4) Febrile Neutropenia 23% 52% 75% 3% 2-15% 11% Anemia (Gr 3-4) 11% 16% 9% 1 Aggregated results of tesetaxel Phase 2 studies for patients who initiated treatment at 27 mg/m 2 (MTD); 2 Taxol 2000 package insert; 3 Taxotere 2006 package insert
21 Non-Hematological Toxicity -- Phase 2 Comparative safety with other taxanes Confidential Event Tesetaxel 1 N = 159 Paclitaxel 2 N = 812 Docetaxel 3 N = 2045 Diarrhea 4% 2%-4% 5% Nausea 4% 10%-29% 3%-10% Vomiting 3% 10%-29% 2%-8% Neurosensory 2% 30-45% 4 -- Hypersensitivity 0% > 50% > 50% 1 Aggregated results of tesetaxel Phase 2 studies for patients who initiated treatment at 27 mg/m 2 (MTD); 2 Taxol 2000 package insert; 3 Taxotere 2006 package insert 4 Conlin et al., J Clin Oncol (Suppl.) 2009 (data for nab-paclitaxel [Abraxane ] in 200 patients)
22 Regulatory Status Global activity reflects broad program interest Activities Status* Orphan Drug designations: Gastric cancer (US and EU) Fast Track designation (U.S.: Gastric) EMA Scientific Advice (Phase 3 Gastric) FDA End-of-Phase 2 (Phase 3 Gastric) Japan PMDA submissions/mtg: trial open Korea KFDA submissions: 2 trials open Taiwan Phase 3 Gastric China IMPD/SFDA Granted Granted Completed Completed Completed Completed Approved Submitted *Q1 2012
23 Tesetaxel: Market Opportunity Large population -- validated markets Treatable Patients US EU JAPAN CHINA Large global population in multiple tumor types Gastric Cancer Breast Cancer Prostate Cancer Market Opportunity Product 2010 Sales VALIDATED CLASS Microtubule Inhibitors VALIDATED STRATEGY Oral Alternatives Taxotere $2.440M Taxol $ 460M Abraxane $ 350M Ixempra $ 419M Total Projected $3.669M Xeloda $1.005M S-1 $ 357M Total Projected $1.362M Sources: Oncology Inc/Synovate; Foster IIBD; Datamonitor Cytotoxic Therapy Cancer Brands ; ACS/ IARC databases.
24 Tesetaxel Value proposition First-to-market oral taxane Large well-validated markets Abraxane : validated taxane market for reduced side-effects No oral taxane competitor in clinical trials Phase 3 opportunities in gastric and breast cancer Established clinical activity No hypersensitivity; no pre-medications; reduced neuropathy Lack of taxane cross-resistance increases market potential Potential approval(s) within 3 years; clear paths to registration Convenience enables novel combinations All oral combinations with new targeted therapies Strong pharmaco-economic arguments
25 Financials Cash/short-term investments $5.9 MM* Completed (conditional) financing $8.5 MM Projected cash burn/month ~ $1.0 MM *EOQ September 2011
26 Genta Milestones Multiple products drive value: 2012 Milestones Tesetaxel: Phase 2b gastric: updated response/survival Q1 11 Phase 2a gastric: initial data -- 1 st -line Q2 11 Phase 2b breast: updated response/pfs Q2 11 Phase 2a prostate: initial data 1 st -line Q2 11 Weekly dosing schedule: final data Q2 11 Phase 3 gastric cancer: initiation Co-development /commercial partnership(s) TBD TBD All events /dates are forward-looking estimates and subject to FDA approval, funding, and other factors
27
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 informationCorporate 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 informationNovel Chemotherapy Agents for Metastatic Breast Cancer. Joanne L. Blum, MD, PhD Baylor-Sammons Cancer Center Dallas, TX
Novel Chemotherapy Agents for Metastatic Breast Cancer Joanne L. Blum, MD, PhD Baylor-Sammons Cancer Center Dallas, TX New Chemotherapy Agents in Breast Cancer New classes of drugs Epothilones Halichondrin
More informationGASTRIC & PANCREATIC CANCER
GASTRIC & PANCREATIC CANCER ASCO HIGHLIGHTS 2005 Fadi Sami Farhat, MD Head of Hematology Oncology Division Hammoud Hospital University Medical Center Saida Lebanon Tel: +961 3 753 155 E-Mail: drfadi@drfadi.org
More informationThird 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 informationTarge:ng HER2 in Metasta:c Breast Cancer in 2014
Targe:ng HER2 in Metasta:c Breast Cancer in 2014 Kimberly L. Blackwell MD Professor Department of Medicine and Radia:on Oncology Duke University Medical Center Director, Breast Cancer Program Duke Cancer
More informationContemporary Chemotherapy-Based Strategies for First-Line Metastatic Breast Cancer
Contemporary Chemotherapy-Based Strategies for First-Line Metastatic Breast Cancer Hope S. Rugo, MD Professor of Medicine Director, Breast Oncology and Clinical Trials Education University of California
More information33 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 informationSimultaneous filing in US/EU/JPN
Simultaneous filing in US/EU/JPN Japan/Asia Clinical Research Product Creation Unit Oncology Group, Clinical development Tomio Nakamura Eisai Oncology : Clinical Development EU USA Japan Eisai Oncology;
More informationMerrimack Pharmaceuticals: A Refocused R&D Company January 2017
Merrimack Pharmaceuticals: A Refocused R&D Company January 2017 Forward Looking Statements This presentation contains forward-looking statements of the Company that involve substantial risks and uncertainties.
More informationR&D Conference Call. CHUGAI PHARMACEUTICAL CO., LTD. Department Manager of Oncology Lifecycle Management Dept. Megumi Uzu.
R&D Conference Call CHUGAI PHARMACEUTICAL CO., LTD. Department Manager of Oncology Lifecycle Management Dept. Megumi Uzu July 4, 2016 Forward-Looking Statements This presentation may include forward-looking
More informationIMMUNOMEDICS, 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 informationInvestor 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 informationNew chemotherapy drugs in metastatic breast cancer. Guy Jerusalem, MD, PhD
New chemotherapy drugs in metastatic breast cancer Guy Jerusalem, MD, PhD MBC Patients survival over time Median survival increases over time, but is still measured in months This is not yet a chronic
More informationAugust 7, Q Financial Results
August 7, 2018 Q2 2018 Financial Results 1 Agenda Today s Speakers Paul Cox, Senior Director, Investor Relations Jeff Jonas, M.D., Chief Executive Officer Steve Kanes, M.D., Ph.D., Chief Medical Officer
More informationTargeting and Treating Cancer
Targeting and Treating Cancer Mark R. Baker, Chief Executive Officer Jefferies Healthcare Conference June 2015 Disclosure Notice This presentation may contain projections and other forward-looking statements
More informationSTUDY FINDINGS PRESENTED ON TAXOTERE REGIMENS IN HEAD AND NECK, LUNG AND BREAST CANCER
Contact: Anne Bancillon + 33 (0)6 70 93 75 28 STUDY FINDINGS PRESENTED ON TAXOTERE REGIMENS IN HEAD AND NECK, LUNG AND BREAST CANCER Key results of 42 nd annual meeting of the American Society of Clinical
More informationA Fully Integrated Cancer Company.
A Fully Integrated Cancer Company. Jefferies 2015 Healthcare Conference June 2, 2015 Robert Mulroy, President & CEO Forward Looking Statements To the extent that statements contained in this presentation
More informationThe next wave of successful drug therapy strategies in HER2-positive breast cancer. Hans Wildiers University Hospitals Leuven Belgium
The next wave of successful drug therapy strategies in HER2-positive breast cancer Hans Wildiers University Hospitals Leuven Belgium Trastuzumab in 1st Line significantly improved the prognosis of HER2-positive
More informationChemotherapy for Advanced Gastric Cancer
Chemotherapy for Advanced Gastric Cancer Andrés Cervantes Professor of Medicine DISCLOSURE OF INTEREST Employment: None Consultant or Advisory Role: Merck Serono, Roche, Beigene, Bayer, Servier, Lilly,
More informationIMMUNOMEDICS, 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 informationMerck ASCO 2015 Investor Briefing
Merck ASCO 2015 Investor Briefing Forward-Looking Statement This presentation includes forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation
More informationFirst 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 informationOncology 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 informationCombining HS-110 and anti-pd-1 in NSCLC. September 1, 2015
Combining HS-110 and anti-pd-1 in NSCLC September 1, 2015 Forward Looking Statements This presentation includes statements that are, or may be deemed, forward-looking statements. In some cases, these forward-looking
More informationRevolutionizing 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 informationNY-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 informationJuly, 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 informationVAL-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 informationRevolutionizing 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 informationDelcath 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 informationIMMUNOMEDICS, INC. Advanced Antibody-Based Therapeutics. Jefferies 2015 Global Healthcare Conference Peter P. Pfreundschuh, VP Finance and CFO
IMMUNOMEDICS, INC. Advanced Antibody-Based Therapeutics Oncology Autoimmune Diseases Jefferies 2015 Global Healthcare Conference Peter P. Pfreundschuh, VP Finance and CFO Forward-Looking Statements This
More informationRevolutionizing 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 informationNational Horizon Scanning Centre. Bevacizumab (Avastin) in combination with non-taxanes for metastatic breast cancer - first line therapy
Bevacizumab (Avastin) in combination with non-taxanes for metastatic breast cancer - first line therapy December 2007 This technology summary is based on information available at the time of research and
More informationPatient-Centric Science-Based Performance-Driven
Patient-Centric Science-Based Performance-Driven Cowen & Co. 38 th Annual Health Care Conference Michael Pehl, President and Chief Executive Officer March 12, 2018 Forward-Looking Statements This presentation,
More informationLION. Corporate Presentation June 2016 BIOTECHNOLOGIES. Leadership & Innovation in Oncology
LION BIOTECHNOLOGIES Leadership & Innovation in Oncology Corporate Presentation June 2016 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private
More informationVan Cutsem E et al. Proc ASCO 2009;Abstract LBA4509.
Efficacy Results from the ToGA Trial: A Phase III Study of Trastuzumab Added to Standard Chemotherapy in First-Line HER2- Positive Advanced Gastric Cancer Van Cutsem E et al. Proc ASCO 2009;Abstract LBA4509.
More informationADAPTIMMUNE INVESTOR PRESENTATION. August 2016
ADAPTIMMUNE INVESTOR PRESENTATION August 2016 DISCLAIMER This presentation contains forward-looking statements, as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA),
More informationCorporate Overview. July 2016 NASDAQ: CYTR
Corporate Overview July 2016 NASDAQ: CYTR CytRx Safe Harbor Statement THIS PRESENTATION CONTAINS FORWARD-LOOKING STATEMENTS THAT INVOLVE CERTAIN RISKS AND UNCERTAINTIES ASSOCIATED WITH A DEVELOPMENT-STAGE
More informationA Fully Integrated Cancer Company.
A Fully Integrated Cancer Company. Jefferies Global Healthcare Conference June 3, 2014 Robert Mulroy, President and CEO Forward Looking Statements To the extent that statements contained in this presentation
More informationRecent advances in the management of metastatic breast cancer in older adults
Recent advances in the management of metastatic breast cancer in older adults Laura Biganzoli Medical Oncology Dept New Hospital of Prato Istituto Toscano Tumori Italy Important recent advances in the
More informationScience-Based Innovation-Focused ADC Company. Corporate Overview June 2018
Science-Based Innovation-Focused ADC Company Corporate Overview June 2018 Forward-Looking Statements This presentation, in addition to historical information, contains certain forwardlooking statements
More informationDeveloping & Commercializing Targeted Small Molecule Drugs in Cancer
Developing & Commercializing Targeted Small Molecule Drugs in Cancer SAFE HARBOR STATEMENT 2 Forward-looking statements made in the course of this presentation are made pursuant to the safe harbor provisions
More informationUnder the terms of the agreement, AVEO will receive an initial cash payment of $125 million, composed of a $75 million license fee and $50 million in
Astellas Pharma Inc. AVEO Pharmaceuticals Corporate Communications Investor Contact: Astellas Pharma Inc. Monique Allaire AVEO Pharmaceuticals +81(3)-3244-3201 (617) 299-5810 Media Contact: Dan Budwick
More informationEvolving Paradigms in HER2+ MBC: Strategies for Individualizing Therapy with Available Agents
Evolving Paradigms in HER2+ MBC: Strategies for Individualizing Therapy with Available Agents Kimberly L. Blackwell MD Professor Department of Medicine and Radiation Oncology Duke University Medical Center
More informationArQule 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 informationArQule 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 informationDetermined to realize a future in which people with cancer live longer and better than ever before Q Conference Call
Reimagining Cancer Treatment Determined to realize a future in which people with cancer live longer and better than ever before Q1 2016 Conference Call 1 Forward-Looking Statements Disclosure This presentation
More informationPfizer Presents Final Phase 2 Data on Investigational PARP Inhibitor Talazoparib in Patients with Germline BRCA-Positive Advanced Breast Cancer
For immediate release June 3, 2017 Media Contact: Sally Beatty (212) 733-6566 Investor Contact: Ryan Crowe (212) 733-8160 Pfizer Presents Final Phase 2 Data on Investigational PARP Inhibitor Talazoparib
More informationREWRITING 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 informationImmunoconjugates in Both the Adjuvant and Metastatic Setting
Immunoconjugates in Both the Adjuvant and Metastatic Setting Mark Pegram, M.D. Director, Stanford Breast Oncology Program Co-Director, Molecular Therapeutics Program Trastuzumab Treatment of Breast Tumor
More informationDynavax Corporate Presentation
Dynavax Corporate Presentation Forward-Looking Statements This presentation contains forward-looking statements, including statements regarding our HEPLISAV-B TM regulatory submissions, product profile,
More informationEdith A. Perez, Ahmad Awada, Joyce O Shaughnessy, Hope Rugo, Chris Twelves, Seock-Ah Im, Carol Zhao, Ute Hoch, Alison L. Hannah, Javier Cortes
BEACON: A Phase 3 Open-label, Randomized, Multicenter Study of Etirinotecan Pegol (EP) versus Treatment of Physician s Choice (TPC) in Patients With Locally Recurrent or Metastatic Breast Cancer Previously
More informationCommitted to Transforming the Treatment Paradigm for Migraine Prevention
Committed to Transforming the Treatment Paradigm for Migraine Prevention 36th Annual J.P. Morgan Healthcare Conference January 8, 2018 Forward-Looking Statements This presentation and the accompanying
More informationEribulin for locally advanced or metastatic breast cancer third line; monotherapy
Eribulin for locally advanced or metastatic breast cancer third line; monotherapy April 2009 This technology summary is based on information available at the time of research and a limited literature search.
More informationARIAD 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 informationRexahn Pharmaceuticals Overview
Rexahn Pharmaceuticals Overview May 2018 Safe Harbor Statement The statements that follow (including projections and business trends) are forward-looking statements. Rexahn s actual results may differ
More informationPhase 3 Top-Line Results Show IBRANCE in Combination with Fulvestrant Meets Progression-Free Survival (PFS) Primary Endpoint
For immediate release: April 15, 2015 Media Contact: Sally Beatty (212) 733-6566 Investor Contact: Ryan Crowe (212) 733-8160 Pfizer Announces PALOMA-3 Trial for IBRANCE (Palbociclib) Stopped Early Due
More informationAVEO 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 informationBuilding a Leading Oncology Franchise
ASDAQ: MEIP Building a Leading Oncology Franchise 17th Annual eedham Healthcare Conference March 27, 2018 Forward-Looking Statements This presentation contains, and our officers and representatives may
More informationClovis Oncology Announces First Quarter 2017 Operating Results. May 3, :06 PM ET
Clovis Oncology Announces First Quarter 2017 Operating Results May 3, 2017 4:06 PM ET Strong Q1 launch quarter for Rubraca (rucaparib) in U.S. with $7M reported in net sales Clovis notified that ARIEL3
More informationDetermined 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 4Q 2016 EARNINGS PRESENTATION MARCH 2017 1 Forward-looking statements disclosure This presentation contains
More informationMETRIC Study Key Eligibility Criteria
The METRIC Study METRIC Study Key Eligibility Criteria The pivotal METRIC Study is evaluating glembatumumab vedotin in patients with gpnmb overexpressing metastatic triple-negative breast cancer (TNBC).
More informationCompany presentation. September NASDAQ: ASLN TPEx: 6497
Company presentation September 2018 NASDAQ: ASLN TPEx: 6497 Disclaimer This presentation and the accompanying oral presentation contain forward-looking statements. These statements are based on the current
More informationKarcinom dojke. PANEL: Semir Bešlija, Zdenka Gojković, Robert Šeparović, Tajana Silovski
Karcinom dojke PANEL: Semir Bešlija, Zdenka Gojković, Robert Šeparović, Tajana Silovski MBC: HER2 PHEREXA: Study Design Multicenter, randomized, open-label phase III trial Stratified by prior CNS disease,
More informationLonnie 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 informationBusiness 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 informationLead team presentation Eribulin for treating locally advanced or metastatic breast cancer after two or more prior chemotherapy regimens STA
For projector and public [noacic] Lead team presentation Eribulin for treating locally advanced or metastatic breast cancer after two or more prior chemotherapy regimens STA 1 st Appraisal Committee meeting
More informationNektar Investor & Analyst Call. Nektar & z Bristol-Myers Squibb Collaboration. February 14, 2018
Nektar Investor & Analyst Call Nektar & z Bristol-Myers Squibb Collaboration February 14, 2018 This presentation includes forward-looking statements regarding Nektar s proprietary drug candidates, the
More informationDelcath Investor Presentation (OTCQB: DCTH)
Delcath Investor Presentation (OTCQB: DCTH) June 2018 1 DELCATH SYSTEMS, INC Forward-looking Statements This presentation contains forward-looking statements, within the meaning of the federal securities
More informationMERCK ONCOLOGY OVERVIEW AACR 2018 APRIL 16, 2018
MERCK ONCOLOGY OVERVIEW AACR 2018 APRIL 16, 2018 Forward-Looking Statement of Merck & Co., Inc., Kenilworth, NJ, USA This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the company ) includes
More informationXARACOLL Phase 3 Results Webcast. MATRIX 1 and MATRIX 2 Clinical Trials May 25, 2016
XARACOLL Phase 3 Results Webcast MATRIX 1 and MATRIX 2 Clinical Trials May 25, 2016 Forward Looking Statements This presentation contains forward-looking statements about our ongoing development of XARACOLL
More informationAVEO 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 informationDetermined 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 informationSpectrum Pharmaceuticals
Spectrum Pharmaceuticals Joe Turgeon President and CEO June 2018 Investor Presentation 1 Safe Harbor Statement This presentation contains forward looking statements regarding future events and the future
More informationCase 1 Metastatic Pancreatic Adenocarcinoma: What Therapy Should I Select First?
Case 1 Metastatic Pancreatic Adenocarcinoma: What Therapy Should I Select First? Marc Peeters, MD, PhD Head of the Oncology Department Antwerp University Hospital Antwerp, Belgium marc.peeters@uza.be 71-year-old
More informationIpilimumab ASCO Data Review and Discussion Webcast. Monday, June 2, 2008
Ipilimumab ASCO Data Review and Discussion Webcast Monday, June 2, 2008 Slide 2 Forward Looking Statements Except for historical information, the matters contained in this slide presentation may constitute
More informationCommitted to Transforming the Treatment Paradigm for Migraine Prevention
June 14, 2018 Committed to Transforming the Treatment Paradigm for Migraine Prevention September 6, 2018 Forward-Looking Statements This presentation and the accompanying commentary contains certain forward-looking
More informationCabozantinib (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 informationBuilding a Fully Integrated Biopharmaceutical Company. June 2014
Building a Fully Integrated Biopharmaceutical Company June 2014 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of The Private Securities Litigation
More informationFOURTH 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 informationClovis 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 informationMetronomic chemotherapy for breast cancer
Metronomic chemotherapy for breast cancer M. Colleoni International Breast Cancer Study Group (IBCSG), Division of Medical Senology, European Institute of Oncology Metronomic Scheduling and Inhibition
More informationHALOZYME 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 informationJefferies 2014 Global Healthcare Conference. June 5, 2014
Jefferies 2014 Global Healthcare Conference June 5, 2014 ArQule, Inc. Safe Harbor This presentation and other statements by ArQule may contain forwardlooking statements within the meaning of the Private
More informationAttached from the following page is the press release made by BMS for your information.
June 2, 2015 Opdivo (nivolumab) Demonstrates Superior Survival Compared to Standard of Care (docetaxel) for Previously-Treated Squamous Non-Small Cell Lung Cancer in Phase III Trial (PRINCETON, NJ, May
More informationIRONWOOD AND FOREST ANNOUNCE POSITIVE LINACLOTIDE RESULTS FROM PHASE 3 TRIAL IN PATIENTS WITH IRRITABLE BOWEL SYNDROME WITH CONSTIPATION
FOR IMMEDIATE RELEASE Ironwood Contact: Forest Contact: Susan Brady Frank J. Murdolo Corporate Communications Vice President, Investor Relations 617.621.8304 212.224.6714 sbrady@ironwoodpharma.com frank.murdolo@frx.com
More informationScottish Medicines Consortium
P Oral) Scottish Medicines Consortium vinorelbine 20 and 30mg capsules (NavelbineP Pierre Fabre Ltd No. (179/05) 06 May 2005 The Scottish Medicines Consortium (SMC) has completed its assessment of the
More informationBAVARIAN NORDIC BIO DEUTSCHLAND PRESENTATION OCTOBER 2014 CSE/OMX:BAVA, OTC:BVNRY
BAVARIAN NORDIC BIO DEUTSCHLAND PRESENTATION OCTOBER 2014 CSE/OMX:BAVA, OTC:BVNRY This presentation includes "forward-looking statements" that involve risks, uncertainties and other factors, many of which
More informationDS-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 informationBuilding a Premier Oncology Biotech
Corporate Presentation Building a Premier Oncology Biotech Dr. Helen Torley, President and CEO February 2019 Forward-Looking Statements All of the statements in this presentation that are not statements
More informationThird 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 informationMOLOGEN AG. Pioneering Immune Therapy. Q1 Results 2014 Conference Call. Dr. Matthias Schroff, CEO
Pioneering Immune Therapy Q1 Results 2014 Conference Call Dr. Matthias Schroff, CEO Berlin, 14 May 2014 V1-6 Disclaimer Certain statements in this presentation contain formulations or terms referring to
More informationPhase 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 informationMOLOGEN AG. Pioneering Immune Therapy. Annual Results Analysts Call March 25, 2014
Pioneering Immune Therapy Annual Results 2013 Analysts Call March 25, 2014 Disclaimer Certain statements in this presentation contain formulations or terms referring to the future or future developments,
More informationESTABLISH 2 Top Line Data Release
The Future of Anti-Infectives ESTABLISH 2 Top Line Data Release March 25, 2013 1 Forward Looking Statements Statements contained in this data release regarding matters that are not historical facts are
More informationDelcath Investor Presentation (OTCQB: DCTH)
Delcath Investor Presentation (OTCQB: DCTH) March 2018 1 DELCATH SYSTEMS, INC Forward-looking Statements This presentation contains forward-looking statements, within the meaning of the federal securities
More informationClinical Research on PARP Inhibitors and Triple-Negative Breast Cancer (TNBC)
Clinical Research on PARP Inhibitors and Triple-Negative Breast Cancer (TNBC) Eric P Winer, MD Disclosures for Eric P Winer, MD No real or apparent conflicts of interest to disclose Key Topics: PARP and
More informationNational Bank 8th Annual Quebec Conference TSX: IMV. May 30, IMV Inc. All rights reserved.
National Bank 8th Annual Quebec Conference TSX: IMV May 30, 2018 Forward-looking Statements Except for historical information, this presentation contains forward-looking statements, which reflect IMV Inc.
More informationDetermined to realize a future in which people with cancer live longer and better than ever before CORPORATE PRESENTATION SEPTEMBER 2017
Determined to realize a future in which people with cancer live longer and better than ever before CORPORATE PRESENTATION SEPTEMBER 2017 1 Forward-looking statements disclosure This presentation contains
More information