Targeting and Treating Cancer
|
|
- Marilynn Hopkins
- 6 years ago
- Views:
Transcription
1 Targeting and Treating Cancer Mark R. Baker CEO Jefferies Healthcare Conference June 8, 2017
2 DISCLOSURE NOTICE This presentation may contain projections and other forward-looking statements regarding future events. Such statements are predictions only, and are subject to risks and uncertainties that could cause actual events or results to differ materially. These risks and uncertainties include, among others, the cost, timing and results of clinical trials and other development activities; the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; the performance of our partners; market acceptance for approved products; generic and other competition; the possible impairment of, inability to obtain and costs of obtaining intellectual property rights; and possible safety or efficacy concerns, general business, financial and accounting matters, litigation and other risks. More information concerning Progenics and such risks and uncertainties is available on its website, and in its press releases and reports it files with the U.S. Securities and Exchange Commission. Progenics is providing the information in this presentation as of its date and does not undertake any obligation to update or revise it, whether as a result of new information, future events or circumstances or otherwise. Additional information concerning Progenics and its business may be available in press releases or other public announcements and public filings made after the date of this presentation. This presentation may not be copied, reproduced, altered or disseminated in any manner or medium without written consent of Progenics. 2
3 PROGENICS: TARGETING AND TREATING CANCER AZEDRA Near-term commercial opportunity in ultra-orphan indication Company to submit NDA by mid-2017 Prostate Cancer Theranostics Robust portfolio of imaging agents and therapeutics designed to improve detection, monitoring and treatment of prostate cancer RELISTOR Strong financial foundation driven by RELISTOR franchise 3
4 PIPELINE Preclinical Phase 1 Phase 2 Pivotal/ Phase 3 Approved ULTRA-ORPHAN THERANOSTIC AZEDRA Theranostic Pheochromocytoma REGISTRATIONAL PHASE 2 UNDER SPA PROSTATE CANCER THERANOSTICS Automated Bone Scan Index (absi) Bone Scan Index Software 1404 PSMA-targeted SPECT Imaging Agent PyL PSMA-targeted PET Imaging Agent 1095 Small Molecule Therapeutic PSMA Antibody Conjugated with Alpha Emitter Licensed to Bayer OIC Treatment RELISTOR SC Opioid-induced Constipation 4 RELISTOR Tablets Opioid-induced Constipation
5 PHEOCHROMOCYTOMA AND PARAGANGLIOMA Adrenal Glands No currently approved therapies in the U.S. Rare tumors found primarily in the adrenal glands Results in the release of excess hormones that control heart rate, metabolism and blood pressure Left untreated, tumors most often lead to death due to high blood pressure, heart failure, stroke or metastatic disease 25-30% of cases are genetic 5
6 AZEDRA: POSITIVE DATA FROM REGISTRATIONAL TRIAL Design Achieved Primary Endpoint Favorable Tumor Response Data Multi-center study under SPA agreement with FDA Patients receive 2 therapy doses, 3 months apart 68 evaluable patients 17 patients reported 50% reduction in antihypertensive medications for at least 6 months 95% confidence interval: 16.15% % 12 responders required to achieve endpoint 92.2% of patients showed partial response or stable disease based on RECIST Safety Generally well tolerated Most common TEAEs were nausea, thrombocytopenia, anemia, fatigue, leukopenia, and neutropenia, consistent with prior studies 6
7 TRIAL ACHIEVED PRIMARY ENDPOINT Met the primary endpoint evaluating the proportion of patients who achieved a 50% reduction of all antihypertensive medication for at least six months. Under the study protocol, the primary endpoint is achieved if the lower limit of the two-sided 95% confidence interval is >10% 12 patients required to achieve endpoint Responders (%) Lower bound of Confidence Interval Upper bound of Confidence Interval Overall (n=68) 17 (25.00%) 16.15% 36.52% By Number of Doses: Two Doses (n=50) 16 (32.00%) 20.70% 45.87% One Dose (n=18) 1 (5.56%) 0.0% 27.65% 7
8 FAVORABLE TUMOR RESPONSE RATES Key secondary endpoint: the proportion of patients with overall tumor response as measured by RECIST 92.2% of evaluable patients (59/64) who received at least one AZEDRA therapeutic dose achieved partial response or stable disease Overall Tumor Response Assessment per RECIST Criteria Best confirmed response after first therapeutic dose (target and non-target lesions) Complete Response Partial Response Stable Disease Progressive Disease Unable to Evaluate Overall (n=64*) 0% 23.4% 68.8% 4.7% 3.1% 2 doses (n=50) 0% 30.0% 68.0% 2.0% 0% 1 dose (n=14 ) 0% 0% 71.4% 14.3% 14.3% * Four patients did not have follow-up scans 8
9 AZEDRA US Filing Strategy Multiple FDA Designations Rolling NDA Submission Expect Expedited Review Breakthrough Therapy Designation Fast Track Status Orphan Drug Status Non-clinical sections already submitted Expect to complete submission by mid-2017 Expect the NDA will support full approval 9
10 AZEDRA Plan to Commercialize Independently Targeted Market U.S. market reachable with a small specialty salesforce targeting major centers where these rare tumors are treated Established Relationships Majority of patients are treated at centers in U.S., many of which are sites that are participating in our registrational trial Building the Commercial Infrastructure Hired a head of commercial to develop the launch strategy; identified a U.S. based commercial manufacturer 10
11 ADDRESSING PROSTATE CANCER WITH A NOVEL PORTFOLIO OF PSMA TARGETED DIAGNOSTICS AND THERAPEUTICS 1 in 7 men will be diagnosed with prostate cancer during his lifetime 2.9M American men living with prostate cancer 1404 PyL TM PSMA Antibody 1095 Conjugated with Bone Scan BSI Alpha Emitter More sensitive in detecting cancer vs. MRI in Phase 2; currently enrolling Phase 3 study Potential to detect minimal levels of cancer, sites of relapse; currently enrolling Phase 2/3 study Potent activity in advanced cancer, First patient dosed in Phase 1 at MSK Licensed to Bayer Quantifies tumor burden of the skeleton and calculates the Bone Scan Index *Zerocancer.org
12 PSMA HAS LONG BEEN CONSIDERED AMONG THE BEST ONCOLOGY TARGETS PSMA is an attractive molecular target for radionuclide imaging and therapy of prostate cancer: Prostate cancer: Cell-surface expression of PSMA Mainly expressed in the prostate Highly expressed at all stages of the disease Upregulated in androgen-insensitive or metastatic disease Expressed on the cell surface as an integral membrane protein, and not released into the circulation Internalized after compound binding by receptormediated endocytosis Normal 12
13 1404 (SPECT/CT) PyL (PET/CT) MULTIPLE POTENTIAL USES FOR PSMA-TARGETED IMAGING AGENTS Stage in Rx Path Initial Diagnosis After Elevated PSA Rationale for Imaging Agent Localize lesions for targeting biopsy; avoid over/under diagnosis associated with biopsy Active Surveillance Initial diagnosis low risk cancer Lower morbidity than biopsy and higher specificity than PSA Primary Staging Treatment Monitoring and Planning Detecting Metastatic Disease PSMA identifies lymph node and visceral lesions in addition to bone metastases Improve accuracy of surgery and radical radiotherapy; open curative window for treatment of metastases Images lesions that are not detected by current technologies 13
14 1404 PSMA-TARGETED IMAGING AGENT SPECT radiopharmaceutical product candidate targeting PSMA In Phase 3 with interim results completed 4Q 2016 Positive Phase 2 data: higher detection rate vs. MRI Detected prostate cancer in the prostate gland with a high degree of sensitivity (94%) 1404 readers detected more prostate cancer in the prostate gland (94%) than MRI (86%) Potential to transform clinical practice with improved detection & monitoring Initial application: enabling Active Surveillance SPECT/CT SPECT/CT scan scan showing showing primary primary prostate prostate cancer cancer 14
15 Half of all men with newly diagnosed cancer have low risk tumors 40-50% of eligible men are now choosing Active Surveillance 1404 has the potential to enable Active Surveillance 15
16 LIMITATIONS OF ACTIVE SURVEILLANCE USING CURRENT APPROACHES Biopsy: Has high false negative rate Positive biopsies may miss higher grade disease thereby under-diagnosing Risk of infections and related complication Repeat biopsy generally required for active surveillance today: PSA kinetics and other measures may not be reliable in determining progression of disease Increased risk of impotence due to repeated biopsies Although more men are now participating in active surveillance, more than half still avoid active surveillance and seek treatment because of anxiety regarding the possible progression or metastasizing of their disease AUA Prostate Cancer Guidelines, NCCN Prostate Cancer Guidelines, Klotz et al. J Clin Oncol, EUA Prostate Cancer Guudelines, 2014.
17 DETECTING PROSTATE CANCER IN THE GLAND - MRI Gleason 4+5 Lesion Prostate 17
18 DETECTING PROSTATE CANCER IN THE GLAND 1404 SPECT/CT Histopathology 18
19 1404: PHASE 2 RESULTS T:B quantitative and semi-quantitative methods of assessing gland/lobe uptake show highly significant correlation with Gleason score (p<0.0001) Uptake of 1404 in the prostate gland is significantly lower in treated patients (p<0.0001) 19
20 1404 PHASE 3 STUDY DESIGN Patient Population N Primary Endpoint Secondary Endpoint Biopsy confirmed low-grade prostate cancer who are candidates for active surveillance ~450 evaluable patients Trial proceeding following interim analysis conducted in December In addition to patients electing to undergo radical prostatectomy, protocol amendment permits patients with low to very low grade prostate cancer to participate without having to undergo a radical prostatectomy. Specificity of 1404 to identify patients without clinically significant prostate cancer Sensitivity of 1404 to identify patients with clinically significant prostate cancer Safety and tolerability; Location of disease 1404 Study Overview: Biopsy Confirmed Gleason Score Dosing SPECT/ CT Imaging Prostatectomy or biopsy Histopathology 20
21 PyL: PET/CT IMAGING AGENT In-licensed from Johns Hopkins University PSMA Targeting Enables visualization of both bone and soft tissue metastases Highly specific to prostate cancer cells, not confounded by degenerative or inflammatory conditions Very high standardized uptake values (SUV) even in small lesions Identified more lesions than conventional imaging Could detect lesions as small as 3mm PyL Research Access Program underway >200 patients scanned to date 21
22 PyL PHASE 2/3 STUDY UNDERWAY Patient Population Subjects with recurrent and/or metastatic prostate cancer N Approximately 300, with ~10 sites in the U.S. and Canada Primary Endpoint Secondary Endpoint To assess diagnostic performance of PyL PET/CT imaging to detect prostate cancer in patients with recurrent and/or metastatic disease. Safety and tolerability; detection rate; pharmacokinetics parameters PyL Study Overview: High risk local and/or metastatic prostate cancer 18 F-PyL Dosing PET/ CT Imaging Prostatectomy and/or lymph nodes/ metastatic lesions dissection Histopathology of prostate and/or lymph nodes/ metastatic lesions 22
23 % CHANGE IN PSA 1095: PSMA TARGETED SMALL MOLECULE THERANOSTIC FOR PROSTATE Targeted small molecule radiotherapeutic that selectively binds to PSMA 100 * Best PSA Response in 25 patients Markedly reduced PSA levels in a heavily pretreated group of 25 evaluable patients, and reduced bone pain in German compassionate use setting in advanced prostate cancer 0 Primary study site for Phase 1: Memorial Sloan Kettering, the Coordinating Center for the Prostate Cancer Clinical Trials Consortium (PCCTC) First patient dosed March PATIENT NUMBER Zechmann et al. Eur J Nucl Med Mol Imaging,
24 LEVERAGING OUR PSMA ANTIBODY TECHNOLOGY April 2016 Granted Bayer worldwide rights to develop and commercialize products combining our PSMA Antibody Technology exclusively with Bayer s alpha-emitting radionuclides Upfront payment of $4M million Up to an additional $49M in potential clinical and regulatory development milestones Program moving forward; 2 pre-clinical milestones met in 2016 Potential net sales milestone payments up to an aggregate total of $130M Single digit royalties on net sales 24
25 EXINI Located in Lund, Sweden Capabilities Sophisticated software that assists physicians and patients in visualizing, understanding, targeting and treating cancer Successful development and commercialization of software products based on medical image analysis and machine learning Relationships with key European partners, clinicians, and researchers to support late-stage pipeline EXINI Bone BSI Quantifies tumor burden of the skeleton and calculates the Bone Scan Index BSI outcome not affected by human reader variability Reduced turnaround time Observer-independent FDA 510(k) clearance and CE-marked 25
26 $50 Million RELISTOR Non-Dilutive Royalty-Backed Financing PAMORA for treatment of Opioid- Induced Constipation (OIC) Marketed by Valeant RELISTOR Tablets launched in the U.S. on September 6, 2016 SC formulation approved in U.S. and Europe Royalty-backed agreement with Healthcare Royalty Partners $50M of non-recourse loan proceeds received November 2016 Progenics retains long-term upside potential, including rights to the to sales milestones totaling up to $200M, including $10M on first $100M in sales 26
27 2017: ADVANCING TOWARD KEY CATALYSTS AZEDRA Complete NDA submission mid-2017 Prepare for potential U.S. commercialization 1404 Complete enrollment in Phase 3 trial PyL Advance Phase 2/3 trial 1095 Advance Phase 1 trial Strong financial position to advance portfolio and launch AZEDRA Ended 1Q2017 with $126.3M in cash 27
28 Targeting and Treating Cancer Mark R. Baker CEO Jefferies Healthcare Conference June 8, 2017
Targeting and Treating Cancer
Targeting and Treating Cancer Mark R. Baker, Chief Executive Officer Jefferies 2016 DISCLOSURE NOTICE This presentation may contain projections and other forward-looking statements regarding future events.
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 informationLeading Development of Radiopharmaceuticals to Detect and Treat Cancer
Leading Development of Radiopharmaceuticals to Detect and Treat Cancer October 2018 All trademarks, registered or otherwise, are the property of their respective owner. 2018 Progenics Pharmaceuticals,
More informationPSMA-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 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 informationProstate 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 informationCowen 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 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 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 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 informationCorporate Overview June 2014 Jefferies Healthcare Conference NASDAQ: GLYC
Corporate Overview June 2014 Jefferies Healthcare Conference NASDAQ: GLYC Forward-Looking Statements To the extent that statements contained in this presentation are not descriptions of historical facts
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 informationSunesis Pharmaceuticals Reports Second Quarter 2011 Financial Results
Investor and Media Inquiries: David Pitts Argot Partners 212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc. 650-266-3717 Sunesis Pharmaceuticals Reports Second Quarter 2011 Financial Results SOUTH
More informationIpsen Acquisition of Clementia Pharmaceuticals. February 25, 2019
Ipsen Acquisition of Clementia Pharmaceuticals February 25, 2019 Disclaimer & Safe Harbor This presentation includes only summary information and does not purport to be comprehensive. Forward-looking statements,
More informationDicerna Pharmaceuticals Overview. Delivering RNAi-Based Breakthrough Therapies
Pharmaceuticals Overview Delivering RNAi-Based Breakthrough Therapies Forward-Looking Statements This information may contain projections and other forward looking statements regarding future events, including
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 informationCorporate 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 informationBuilding 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 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 informationGenomic Health. Kim Popovits, Chairman, CEO and President
Genomic Health Kim Popovits, Chairman, CEO and President Safe Harbor Statement Various remarks that we make in this presentation that are not historical, including those about our future financial and
More informationIMMUNOMEDICS, 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 informationAVENUE THERAPEUTICS, INC. NASDAQ: ATXI JANUARY 2018
AVENUE THERAPEUTICS, INC. NASDAQ: ATXI JANUARY 2018 Forward Looking Statements Statements in this presentation that are not descriptions of historical facts are forward-looking statements within the meaning
More informationRevolutionizing how advanced heart disease is treated
LEERINK Partners 5th Annual Healthcare Conference Revolutionizing how advanced heart disease is treated NASDAQ: NCVN, TSX: NVC Alexei Marko, CEO February 2016 Forward-Looking Statements Statements contained
More informationBayer and Loxo Oncology to develop and commercialize two novel oncology therapies selectively targeting genetic drivers of cancer
Investor News Not intended for U.S. and UK Media Bayer AG Investor Relations 51368 Leverkusen Germany www.investor.bayer.com Bayer and Loxo Oncology to develop and commercialize two novel oncology therapies
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 informationLauren Silvernail, CFO & VP Corporate Development to present at 2005 Thomas Weisel Partners Healthcare Conference on September 7, 2005 at 3:50 pm EST
Lauren Silvernail, CFO & VP Corporate Development to present at 2005 Thomas Weisel Partners Healthcare Conference on September 7, 2005 at 3:50 pm EST Forward Looking Statements Certain statements contained
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 informationMemory Pharmaceuticals Establishes Plans for Clinical Program for MEM 3454 in Schizophrenia. -Broadens Roche Nicotinic Alpha-7 Alliance-
Memory Pharmaceuticals Establishes Plans for Clinical Program for MEM 3454 in Schizophrenia -Broadens Roche Nicotinic Alpha-7 Alliance- -Secures Additional $5M Debt Financing to Support Phase 2a Trial-
More informationBuilding 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 informationLiquid 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 informationLehman Brothers Eighth Annual Global Healthcare Conference March 30, 2005 Bruce A. Peacock President and Chief Executive Officer
Lehman Brothers Eighth Annual Global Healthcare Conference March 30, 2005 Bruce A. Peacock President and Chief Executive Officer 2005 Adolor Corporation. All rights reserved. Safe Harbor Statement This
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 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 informationInvestor Presentation March 2015
Investor Presentation March 2015 1 Safe Harbor Statement This presentation and other matters discussed today or answers that may be given to questions asked include forward-looking statements within the
More information2018 OPTIONS FOR INDIVIDUAL MEASURES: REGISTRY ONLY. MEASURE TYPE: Process
Quality ID #102 (NQF 0389): Prostate Cancer: Avoidance of Overuse of Bone Scan for Staging Low Risk Prostate Cancer Patients National Quality Strategy Domain: Efficiency and Cost Reduction 2018 OPTIONS
More informationGenta 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 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 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 informationInovio Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter)
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 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 informationUBS Global Healthcare Conference May 19, 2014
UBS Global Healthcare Conference May 19, 2014 Safe Harbor Statement This presentation may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section
More informationIntercell and Novartis form world leading strategic partnership to drive vaccines innovation
Intercell and Novartis form world leading strategic partnership to drive vaccines innovation Alliance creates opportunity for two strong innovators to combine development efforts in attractive areas Intercell
More informationN A S D A Q : E V F M
N A S D A Q : E V F M Jefferies Global Healthcare Conference June 7, 2018 Disclaimer This presentation contains forward looking statements within the meaning of The Private Securities Litigation Reform
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 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 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 informationBuilding 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 informationCompany Presentation. September 2018
Company Presentation September 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
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 informationNASDAQ: ZGNX. Company Presentation. October 2017
NASDAQ: ZGNX Company Presentation October 2017 2 Forward Looking Statement Zogenix cautions you that statements included in this presentation that are not a description of historical facts are 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 information2016 PQRS OPTIONS FOR INDIVIDUAL MEASURES: REGISTRY ONLY
Measure #104 (NQF 0390): Prostate Cancer: Adjuvant Hormonal Therapy for High Risk or Very High Risk Prostate Cancer National Quality Strategy Domain: Effective Clinical Care 2016 PQRS OPTIONS FOR INDIVIDUAL
More informationPhase 2b/3 Topline Trial Results
Phase 2b/3 Topline Trial Results RP-G28 For the Treatment of Lactose Intolerance March 2017 Forward - Looking Statement To the extent that statements contained in this presentation are not descriptions
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 informationPhotocure ASA Executing the Strategy
Photocure ASA Executing the Strategy NOVEMBER 2012 ERIK DAHL, CFO KATHLEEN DEARDORFF, COO Disclaimer The information included in this Presentation contains certain forward-looking statements that address
More informationLEERINK GLOBAL HEALTHCARE CONFERENCE. Marino Garcia EVP, Chief Strategy Officer February 15, 2017
LEERINK GLOBAL HEALTHCARE CONFERENCE Marino Garcia EVP, Chief Strategy Officer February 15, 2017 SAFE HARBOR STATEMENT This presentation and any statements made for and during any presentation or meeting
More informationPositioned 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 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 informationAnti-IL-33 (ANB020) Program
Anti-IL-33 (ANB020) Program Phase 2a Peanut Allergy Clinical Trial Interim Data Update March 26 th 2018 NASDAQ: ANAB Safe Harbor Statement This presentation and the accompanying oral presentation contain
More informationFebruary 23, Q4 and Year-End 2016 Financial Results
February 23, 2017 Q4 and Year-End 2016 Financial Results 2 RETHINKING CNS Agenda Today s Speakers Paul Cox, Senior Director, Investor Relations Jeff Jonas, M.D., Chief Executive Officer Jim Doherty, Ph.D.,
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 informationSAKURA 3 Open-Label Phase 3 Safety Study with DaxibotulinumtoxinA for Injection (RT002) for the Treatment of Moderate to Severe Glabellar Lines
SAKURA 3 Open-Label Phase 3 Safety Study with DaxibotulinumtoxinA for Injection (RT002) for the Treatment of Moderate to Severe Glabellar Lines Presented by Dan Browne, Co-Founder, President & CEO, and
More informationREATA PHARMACEUTICALS, INC. ANNOUNCES SECOND QUARTER 2018 FINANCIAL RESULTS AND AN UPDATE ON DEVELOPMENT PROGRAMS
REATA PHARMACEUTICALS, INC. ANNOUNCES SECOND QUARTER 2018 FINANCIAL RESULTS AND AN UPDATE ON DEVELOPMENT PROGRAMS IRVING, Texas August 8, 2018 Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a clinical-stage
More informationMANIFEST Phase 2 Enhancement / Expansion
MANIFEST Phase 2 Enhancement / Expansion Investor Conference Call Stellar Science, Breakthrough Medicine October 11, 2018 Forward-Looking Statements This presentation contains forward-looking statements
More informationTamsulosin Hydrochloride 0.4 mg Capsule
Tamsulosin Hydrochloride 0.4 mg Capsule, Tamsulosin Hydrochloride 0.4 mg Capsule India, Tamsulosin Hydrochloride 0.4 mg Capsule manufacturers India, side effects Tamsulosin Hydrochloride 0.4 mg Capsule
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 informationNASDAQ: CYTR FIGHTING CANCER WITH CUTTING EDGE SCIENCE. Corporate Overview. July 2018
NASDAQ: CYTR Corporate Overview July 2018 CytRx Safe Harbor Statement THIS PRESENTATION CONTAINS FORWARD-LOOKING STATEMENTS THAT INVOLVE CERTAIN RISKS AND UNCERTAINTIES. ACTUAL RESULTS COULD DIFFER MATERIALLY
More informationPRO 140. First self-administered antibody therapy for HIV in late-stage clinical development. March
PRO 140 First self-administered antibody therapy for HIV in late-stage clinical development March 2018 Forward-Looking Statements This presentation includes forward-looking statements and forward-looking
More informationValneva Reports Strong 2017 Revenues Driven by Double Digit Product Sales Growth
Valneva Reports Strong 2017 Revenues Driven by Double Digit Product Sales Growth Strong sales performance in 2017 (unaudited) Total revenues of 109.8 million in 2017 (2016-97.9 million) representing year-on-year
More informationPROFOUND MEDICAL CORP.
PROFOUND MEDICAL CORP. Pioneering a new standard of care in the treatment of prostate cancer Forward-Looking Statements This presentation and oral statements made during this meeting regarding Profound
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 informationInvestor 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 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 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 informationBuilding a Stroke Portfolio. June 28, 2018
Building a Stroke Portfolio June 28, 2018 1 Forward-Looking Statements This presentation contains forward-looking statements, including statements relating to: the potential benefits, safety and efficacy
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 informationCorporate Overview H.C. Wainwright & Co. Global Life Sciences Conference April 10, 2018 Douglas M. Fambrough, CEO Jack Green, CFO
NASDAQ: DRNA Corporate Overview H.C. Wainwright & Co. Global Life Sciences Conference April 10, 2018 Douglas M. Fambrough, CEO Jack Green, CFO Forward looking statements This information may contain projections
More informationPierre Legault CEO June 2, 2014
April 2012 Pierre Legault CEO June 2, 2014 Forward Looking Statements This presentation includes statements that are, or may be deemed, forward-looking statements. In some cases, these forward-looking
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 informationVolitionRx Announces First Quarter 2016 Financial Results and Business Update
May 13, 2016 VolitionRx Announces First Quarter 2016 Financial Results and Business Update NAMUR, Belgium, May 13, 2016 /PRNewswire/ -- VolitionRx Limited (NYSE MKT: VNRX), a life sciences company focused
More informationBank 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 informationIdenix 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 informationDisrupting the Cell Cycle to Treat AML and MDS Rodman & Renshaw Conference
CYC 682 Disrupting the Cell Cycle to Treat AML and MDS Rodman & Renshaw Conference September 2014 Disclaimer This presentation contains forward-looking statements within the meaning of the safe harbor
More informationManaging Prostate Cancer After Initital Treatment Fails: Are There Good Next Steps?
Managing Prostate Cancer After Initital Treatment Fails: Are There Good Next Steps? Michael J Zelefsky, M.D. Professor of Radiation Oncology Chief Brachytherapy Service Department of Radiation Oncology
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 informationINVESTOR PRESENTATION
INVESTOR PRESENTATION May 2018 2 FORWARD-LOOKING INFORMATION The following presentation contains statements that are considered forward-looking information ( FLI ) within the meaning of securities regulation.
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 informationEgalet Corporate Presentation
Egalet Corporate Presentation Specialty Pharmaceutical Company Focused on Pain 1 NASDAQ: EGLT Forward-Looking Statements Statements included in this presentation that are not historical in nature are "forward-looking
More informationJefferies Healthcare Conference. June 6, 2018
Jefferies Healthcare Conference June 6, 2018 Forward-Looking Statements and Non-GAAP Financial Information Some statements in this presentation may be forward-looking statements for purposes of the Private
More informationAmicus Establishes Gene Therapy Pipeline for Lysosomal Storage Disorders (LSDs) Conference Call and Webcast September 20, 2018
Amicus Establishes Gene Therapy Pipeline for Lysosomal Storage Disorders (LSDs) Conference Call and Webcast September 20, 2018 Introduction 2 Safe Harbor This presentation contains "forward-looking statements"
More information35 th Annual J.P. Morgan Healthcare Conference
35 th Annual J.P. Morgan Healthcare Conference Forward Looking Statement This presentation includes forward-looking statements. All statements, other than statements of historical facts, regarding management's
More information- Amendment accelerates anticipated PROSPER top-line results by two years -
Pfizer Contacts: For Media Dean Mastrojohn (212) 733-6944 dean.mastrojohn@pfizer.com For Investors Ryan Crowe (212) 733-8160 ryan.crowe@pfizer.com Astellas Contact: For Media Tyler Marciniak (847) 736-7145
More informationTwo-stage study designed to evaluate tolerability and efficacy of pracinostat combined with azacitidine in patients with high and very high risk MDS
Helsinn Group and MEI Pharma Announce First Patient Dosed in Phase 2 Dose-Optimization Study of Pracinostat and Azacitidine in Myelodysplastic Syndrome Two-stage study designed to evaluate tolerability
More informationUsing PET/CT in Prostate Cancer
Using PET/CT in Prostate Cancer Legal Disclaimer These materials were prepared in good faith by MITA as a service to the profession and are believed to be reliable based on current scientific literature.
More informationSpecial Meeting in Lieu of Annual Meeting of Shareholders
Special Meeting in Lieu of Annual Meeting of Shareholders Thursday, June 19, 2008 James A. Bianco, M.D. President and CEO Agenda Call meeting to order Introduction of the inspector of elections, secretary,
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 informationAVEO 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 informationPLEO-CMT Top-line Results. Presentation October 16, 2018
PLEO-CMT Top-line Results Presentation October 16, 2018 Disclaimer References herein to this presentation (the Presentation ) shall mean and include this document, any oral presentation accompanying this
More informationSanthera to Acquire Option from Idorsia for Exclusive Sub-License to First-in-class Dissociative Steroid Vamorolone. Webcast, 21 November 2018
Santhera to Acquire Option from Idorsia for Exclusive Sub-License to First-in-class Dissociative Steroid Vamorolone Webcast, 21 November 2018 Disclaimer This presentation is not and under no circumstances
More informationDARA Reports Year-End 2012 Financial Results
April 1, 2013 DARA Reports Year-End 2012 Financial Results Company Provides a Commercial Portfolio and Development Pipeline Business Update RALEIGH, NC -- (MARKETWIRE) -- 04/01/13 -- DARA BioSciences,
More information