MOLOGEN AG. Pioneering Immune Therapy. Q1 Results 2014 Conference Call. Dr. Matthias Schroff, CEO
|
|
- Marianna Meghan Alexander
- 5 years ago
- Views:
Transcription
1 Pioneering Immune Therapy Q1 Results 2014 Conference Call Dr. Matthias Schroff, CEO Berlin, 14 May 2014
2 V1-6 Disclaimer Certain statements in this presentation contain formulations or terms referring to the future or future developments, as well as negations of such formulations or terms, or similar terminology. These are described as forward-looking statements. In addition, all information in this presentation regarding planned or future results of business segments, financial classification numbers, developments of the financial situation, or other financial or statistical data contains such forward-looking statements. The company cautions prospective investors not to rely on such forwardlooking statements as certain prognoses of actual future events and developments. The company is neither responsible nor liable for these forward-looking statements. It is not responsible for updating such information, which only represents the state of affairs on the day of publication
3 Agenda Highlights Q Capital increase Product pipeline MGN1703 cancer immune therapy MGN1601 therapeutic vaccination against cancer Key financials Q Outlook
4 Highlights Q Capital increase Gross proceeds of around 16 million, predominantly to be used to finance the pivotal trial IMPALA Free float and international institutional investor base increased MGN1703 Application for IMPALA trial submitted (pivotal study in mcrc) IMPULSE trial started (randomized study in SCLC) Final data of phase I safety trial in the U.S. MGN1601 Final results of ASET trial (phase I/II in renal cancer) confirmed safety and tolerability
5 Capital increase enables start of pivotal study with MGN1703 Issuance of 1,541,244 new no-par-bearer shares at per new share 10% increase of share capital to 16,960,756 Gross proceeds of around 16 million Predominantly used to finance the IMPALA with MGN1703 in colorectal cancer Free float increased to ca. 53% Broader international institutional investor base
6 cancer immune therapy MGN
7 MGN1703 IMPALA trial: Pivotal randomized study in mcrc Application for trial submitted Use of findings from IMPACT trial, e.g. patient stratification based on biomarkers Primary endpoint: OS Standard first-line chemotherapy for mcrc Induction CT (14-28 weeks) PR/CR Responder Screening Randomization 1:1 Trial Treatment Period Maintenance MGN1703 Control Group P D P D Re-Induction MGN1703 with Induction CT Induction CT P D P D Start of 2 nd Line Open-label, randomized controlled two-arm, multinational phase III trial 540 patients in more than 100 sites in eight European countries, including Top 5 European pharma markets mcrc metastatic colorectal cancer CT chemotherapy PR partial response CR complete response PD progressive disease OS overall survival
8 MGN1703 IMPULSE trial in SCLC started Trial application approved in Belgium and start of recruitment Additional applications submitted to authorities in Germany, Austria, Spain Standard firstline chemotherapy for Extensive Disease SCLC Induction CT (4 cycles of platinumbased therapy) PR/CR Responder Screening Randomization 3:2 Trial Treatment Period Maintenance Experimental arm: 5th cycle of platinum based CT followed by MGN1703 mainten. Control group: 5th cycle of platinum based CT followed by local practice P D P D Start of 2 nd Line Primary endpoint: OS Randomized controlled two-arm, multinational trial with 100 patients Biomarkers are used as stratification factors: NSE levels and NKTs SCLC small cell lung cancer NSE neuron specific enolase - a tumor marker for lung cancer NKT Natural Killer T cells CT chemotherapy PR partial response CR complete response OS overall survival PD progressive disease
9 MGN1703 MGN1703: Successful safety trial in the U.S. Placebo-controlled, double-blind phase I study in healthy volunteers Evaluation of cardiac safety, pharmacokinetics and pharmacodynamics Favorable safety, tolerability and pharmacokinetic profile Consistent immune activation Investigational New Drug (IND) application approved by the U.S. Food and Drug Administration (FDA) for MGN1703 in solid tumors IND enables inclusion of the U.S. in the future MGN1703 development program
10 MGN1703 MGN1703 clinical development program Colorectal cancer IMPALA trial: Clinical trial applications submitted Expected timelines: First Patient In (FPI) Q3 2014; recruitment 24 months; primary analysis H2 2017; filing/approval possible in 2018 Target population for a marketing authorization includes patients with a response to any prior induction therapy (50-60% of patients treated in first line) Small cell lung cancer IMPULSE trial: Protocol approved in Belgium, study started and first patient included Austria, Spain and Germany will follow Expected timelines: recruitment 12 months; primary analysis in late
11 therapeutic vaccination against cancer MGN
12 MGN1601 ASET: Promising data from renal cancer trial with tumor vaccine MGN1601 Final data set presented in a poster at ASCO GU and CIMT: Favorable safety and tolerability profile Promising overall survival data in subgroup of patients Evaluation of T-cell responses in subgroup: cytotoxic antitumor immune response and improved cellular immune function Patients with advanced renal cell cancer No standard therapy available Trial inclusion Treatment per protocol (TPP) 8 applications of MGN1601 in 12 weeks i.d. Trial Treatment Period Disease Control Extension phase Max. 5 applications in week 24, 36, 48, 72, and 120 PD** PD** Primary endpoints met: safety and tolerability Open-label, proof-ofprinciple, multi-center phase I/II trial 19 patients with advanced renal cell carcinoma who failed prior systemic ** Treatment after PD at investigators discretion therapies PD progressive disease i.d. intradermal injection CIMT Association for Cancer Immunotherapy, Germany
13 KEY FINANCIALS Q
14 Key financials Q1 2014: Strong cash inflow from capital increase [in million] Q Dec Cash and cash equivalents % Balance sheet total % Balance sheet dominated by cash inflow from capital increase of around 16 million Equity ratio 95% 94% 1% [in million] Q Q R&D expenses (2.9) (1.4) 107% Profit/loss for the year (4.1) (2.2) 86% Cash flow from operating activities Cash flow from financing activities (3.2) (2.0) 60% Monthly cash burn % Preparation of IMPALA and start of IMPULSE studies main drivers of increased R&D costs Monthly cash burn increased accordingly CF from financing activities includes capital increase
15 OUTLOOK 2014 AND SUMMARY
16 FY 2014: Unchanged outlook and forecast Development of product pipeline well on track Intensify clinical development of MGN1703: pivotal study in colorectal cancer and randomized study in small cell lung cancer MGN1601: plan and prepare continuative study in renal cancer Partnering discussions ongoing Loss expected at a higher level compared to 2013 Clinical trials progress will lead to increased R&D expenses
17 Corporate calendar August 13, 2014 Half-Year Report as of June 30, 2014 November 13, 2014 Quarterly Report as of September 30, 2014 November 24-26, 2014 German Equity Forum 2014 Analyst and Investor Conference, Frankfurt/Main, Germany Fabeckstraße 30 D Berlin Germany Phone: Fax: MOLOGEN, MIDGE and dslim are registered trademarks of the 16
18 APPENDIX
19 Advanced product pipeline with strong focus on cancer immune therapies Research Pre-clinic Phase I Phase II Phase III Approval Oncology MGN MGN MGN colorectal cancer small cell lung cancer other solid tumors Pivotal randomized trial being prepared Randomized controlled trial, study started MGN1601 renal cancer Phase I/II completed MGN malignant melanoma First patient enrolled Infectious Diseases MGN1331 MGN1333 leishmaniasis hepatitis B 1 IND filed in U.S.; safety trial in U.S.: final analysis completed 2 in collaboration with Max-Delbrueck-Center for Molecular Medicine and Charité Universitaetsmedizin, Berlin IND Investigational New Drug (IND) application
20 MGN1703 IMPACT: Successful phase II colorectal cancer trial The primary endpoint was progression-free survival (PFS) from randomization 59 patients were enrolled Trial Treatment Period Induction CT months Maintenance Metastatic colorectal cancer patients treated first-line with FOLFOX/XELOX or FOLFIRI +/- Bevacizumab* * at investigators discretion At least SD Screening Randomization 2:1 Experimental arm: 60mg MGN1703 twice weekly s.c. No maintenance Placebo twice weekly s.c. PD** PD** CT chemotherapy SD stable disease PD progressive disease s.c. subcutaneous injection ** Treatment after PD at investigators discretion
21 MGN1703 IMPACT trial provides proof of efficacy Final analysis was presented at ESMO 15th World Congress on Gastrointestinal Cancer in July 2013* (database lock end of March 2013) Hazard Ratio of 0.55 (p=0.04) on primary progression-free survival (PFS) on maintenance therapy endpoint 10% long-term responders (>15-30 months) in the MGN1703 arm, follow-up ongoing, updated data will be presented at an upcoming cancer conference Promising trend in overall survival Hazard ratio of 0.63 (p=0.29) median overall survival of 22.6 months (MGN1703) vs.15.1 months (placebo) (after a median follow-up in excess of 17 months approx. 65% of patients in the MGN1703 arm and 50% of patients in the placebo arm were still alive ) *recognised by ESMO as one of the most important contributions of the conference (
22 MGN1703 Excellent safety and tolerability Treatment with MGN1703 does not add any burden to cancer patients quality of life Superior safety and tolerability compared to most other cancer immune therapies, antibody therapies, and chemotherapies: Very good tolerability Mild and transient fever as typical signs of an immune response Long term treatment over many months is safe and well tolerated
23 MGN1703 IMPACT study: Predictive biomarkers identified Exploratory subgroup analyses identified potential predictive biomarkers for an increased treatment effect with MGN1703: normal CEA levels reduction of tumor by induction therapy activated Natural Killer T (NKT) cells These findings are in line with the biological mode-of-action of an immunemodulating drug CEA carcinoembryonic antigen - a tumor marker for colorectal cancer
MOLOGEN 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 information9M RESULTS 2014 CONFERENCE CALL DR. MATTHIAS SCHROFF, CEO
9M RESULTS 2014 CONFERENCE CALL DR. MATTHIAS SCHROFF, CEO BERLIN, 13 NOVEMBER, 2014 Disclaimer Certain statements in this presentation contain formulations or terms referring to the future or future developments,
More informationMOLOGEN AG Jefferies 2014 London Healthcare Conference
Jefferies 2014 London Healthcare Conference Dr. Matthias Schroff Chief Executive Officer London 20 November 2014 V1-6 Disclaimer Certain statements in this presentation contain formulations or terms referring
More informationMOLOGEN AG. Our research for you. Annual Results Analysts Call March 21, 2013
Our research for you. Annual Results 2012 Analysts Call March 21, 2013 Disclaimer Certain statements in this communication contain formulations or terms referring to the future or future developments,
More informationMOLOGEN AG. Company Presentation October 2015
Company Presentation October 2015 Agenda Business Overview Market MGN1703 Cancer Immunotherapy MGN1601 Therapeutic Vaccination against Cancer EnanDIM New Generation of Immunomodulators Key Financials and
More informationMOLOGEN AG. Our research for you. German Equity Forum November 2012
Our research for you. German Equity Forum 12-14 November 2012 Disclaimer Certain statements in this communication contain formulations or terms referring to the future or future developments, as well as
More informationMOLOGEN AG. Company Presentation February 2016
Company Presentation February 2016 Agenda Business Overview Market Lefitolimod (MGN1703) Cancer Immunotherapy MGN1601 Therapeutic Vaccination against Cancer EnanDIM New Generation of Immunomodulators Key
More informationMOLOGEN AG. Company Presentation April 2016
Company Presentation April 2016 Agenda Business Overview Market Lefitolimod (MGN1703) MGN1601 Therapeutic Vaccination against Cancer EnanDIM New Generation of Immunomodulators Key Financials and Outlook
More informationOur research for you. German Equity Forum November 2011
Our research for you. German Equity Forum 21-23 November 2011 Disclaimer Certain statements in this communication contain formulations or terms referring to the future or future developments, as well as
More informationGERMAN EQUITY FORUM 2017
GERMAN EQUITY FORUM 2017 DR. MARIOLA SÖHNGEN- CHIEF EXECUTIVE OFFICER FRANKFURT, 28 NOVEMBER 2017 www.mologen.com Disclaimer This presentation does not constitute an offer to buy shares or other securities
More informationRODMAN & RENSHAW 18 TH ANNUAL GLOBAL INVESTMENT CONFERENCE DR. MARIOLA SÖHNGEN - CEO NEW YORK, 13 SEPTEMBER
RODMAN & RENSHAW 18 TH ANNUAL GLOBAL INVESTMENT CONFERENCE DR. MARIOLA SÖHNGEN - CEO NEW YORK, 13 SEPTEMBER 2016 www.mologen.com Disclaimer Certain statements in this presentation contain formulations
More informationH RESULTS DR IGNACIO FAUS CEO WALTER MILLER CFO BERLIN, 9 AUGUST 2018
H1 2018 RESULTS DR IGNACIO FAUS CEO WALTER MILLER CFO BERLIN, 9 AUGUST 2018 1 DISCLAIMER This presentation does not constitute an offer to buy shares or other securities of MOLOGEN AG and does not replace
More informationCOMPANY PRESENTATION MAY/JUNE
COMPANY PRESENTATION MAY/JUNE 2017 www.mologen.com Disclaimer Certain statements in this presentation contain formulations or terms referring to the future or future developments, as well as negations
More informationBERENBERG AND GOLDMAN SACHS 7 TH GERMAN CORPORATE CONFERENCE
BERENBERG AND GOLDMAN SACHS 7 TH GERMAN CORPORATE CONFERENCE DR IGNACIO FAUS MUNICH, 25 SEPTEMBER 2018 1 DISCLAIMER This presentation does not constitute an offer to buy shares or other securities of MOLOGEN
More informationTOP-LINE DATA FROM THE RANDOMIZED PHASE 2 IMPULSE STUDY IN SMALL-CELL LUNG CANCER (SCLC): IMMUNOTHERAPEUTIC MAINTENANCE TREATMENT WITH LEFITOLIMOD
Abstract #1527O TOP-LINE DATA FROM THE RANDOMIZED PHASE 2 IMPULSE STUDY IN SMALL-CELL LUNG CANCER (SCLC): IMMUNOTHERAPEUTIC MAINTENANCE TREATMENT WITH LEFITOLIMOD M. Thomas, S. Ponce-Aix, A. Navarro Mendivil,
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 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 informationFor personal use only
ASX/Media Release (Code: PRR) 14 September 2011 CVac TM Phase III CANVAS Ovarian Cancer Clinical Update Highlights Upcoming CVac Phase III trial to be named CANVAS CANcer VAccine Study Successful progress
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 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 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 informationDawson 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 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 informationPCI Biotech press release 24 th August Attachment
PCI Biotech press release 24 th August 2018 Attachment 1 BILE DUCT CANCER CLINICAL PHASE I STUDY Cohort IV is selected dose for pivotal study limited but promising data (per Aug 2018) Parameters 1) Average
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 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 informationJune IMMUNE DESIGN The in vivo generation of cytotoxic CD8 T cells (CTLs)
June 2015 IMMUNE DESIGN The in vivo generation of cytotoxic CD8 T cells (CTLs) 1 Forward-looking Statements This presentation contains forward-looking statements with respect to, among other things, our
More informationINTERIM RESULTS AS OF JUNE 30, 2014 CSE/OMX:BAVA, OTC:BVNRY
INTERIM RESULTS AS OF JUNE 30, 2014 Q2 AUGUST 28, 2014 CSE/OMX:BAVA, OTC:BVNRY FINANCIAL HIGHLIGHTS 2.6 million doses IMVAMUNE delivered to the SNS during H1 (0.9 million in Q2) Increased contribution
More informationArgos Therapeutics Reports Fourth Quarter and Year-End 2013 Financial Results
March 27, 2014 Argos Therapeutics Reports Fourth Quarter and Year-End 2013 Financial Results - AGS-003 Phase 3 ADAPT Trial on Track to Complete Enrollment This Year - - AGS-004-Induced Immune Responses
More informationCorporate Presentation October 2018 Nasdaq: ADXS
Innovations in Immuno-Oncology Corporate Presentation October 2018 Nasdaq: ADXS Forward-Looking Statements This presentation contains forward-looking statements, including, but not limited to, statements
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 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 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 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 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 informationARQ 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 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 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 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 information3Q 2016 presentation
Arming the patient s immune system to fight cancer 3Q 2016 presentation 17 November 2016 Important notice and disclaimer This report contains certain forward-looking statements based on uncertainty, since
More informationAnalyst/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 informationData will be submitted to health authorities globally, including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA)
Investor Update Basel, 20 November 2017 Phase III IMpower150 study showed Roche s TECENTRIQ (atezolizumab) and Avastin (bevacizumab) plus chemotherapy significantly reduced the risk of disease worsening
More informationCorporate Presentation
Corporate Presentation Leerink Global Healthcare Conference February 14 th -15 th, 2018 C O N F I D E N T I A L a n d P R O P R I E T A R Y Forward Looking Statements / Safe Harbor This presentation contains
More informationNewLink Genetics Corporation
Cantor Fitzgerald Global Healthcare Conference NewLink Genetics Corporation NASDAQ: NLNK September 25, 2017 Forward-Looking Disclaimer This presentation contains forward-looking statements of NewLink that
More informationCorporate Presentation May Transforming Immuno-Oncology Using Next-Generation Immune Cell Engagers
Corporate Presentation May 2016 Transforming Immuno-Oncology Using Next-Generation Immune Cell Engagers Forward-looking statements / safe harbor This presentation and the accompanying oral commentary contain
More informationREFERENCE CODE GDHC471DFR PUBLICAT ION DATE NOVEM BER 2014 VECTIBIX (COLORECTAL CANCER) FORECAST AND MARKET ANALYSIS TO 2023
REFERENCE CODE GDHC471DFR PUBLICAT ION DATE NOVEM BER 2014 VECTIBIX (COLORECTAL CANCER) Executive Summary Table below presents the key metrics for Vectibix for colorectal cancer (CRC) in the eight major
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 informationOncoSec Provides 2018 Business Outlook
January 3, 2018 OncoSec Provides 2018 Business Outlook Complete stage 1 enrollment of PISCES/KEYNOTE-695 clinical trial of ImmunoPulse IL-12 in combination with KEYTRUDA (pembrolizumab) Present preliminary
More informationJEFFERIES 2018 LONDON HEALTHCARE CONFERENCE NOVEMBER 15, 2018
1 JEFFERIES 2018 LONDON HEALTHCARE CONFERENCE NOVEMBER 15, 2018 FORWARD-LOOKING STATEMENTS This presentation includes forward-looking statements that involve risks, uncertainties and other factors, many
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 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 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 informationVeriStrat 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 informationMedia Release. Basel, 26 March 2018
Media Release Basel, 26 March 2018 Phase III IMpower150 study showed Roche s TECENTRIQ (atezolizumab) and Avastin (bevacizumab) plus carboplatin and paclitaxel helped people with advanced lung cancer live
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 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 informationTivantinib Overview April 2016
Tivantinib Overview April 2016 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
More informationREFERENCE CODE GDHC476DFR PUBLICAT ION DATE NOVEMBER 2014 CYRAMZA (COLORECTAL CANCER) FORECAST AND MARKET ANALYSIS TO 2023
REFERENCE CODE GDHC476DFR PUBLICAT ION DATE NOVEMBER 2014 CYRAMZA (COLORECTAL CANCER) Executive Summary Table below presents the key metrics of Cyramza for colorectal cancer (CRC) in the eight major pharmaceutical
More informationCompany overview. Highlights for the 1 st quarter 2018 (January-March)
Company overview Vaccibody is a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies. The company is a leader in the rapidly developing field of
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 informationNATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Technology Appraisals. Patient Access Scheme Submission Template
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Technology Appraisals Patient Access Scheme Submission Template Bevacizumab in combination with fluoropyrimidine-based chemotherapy for the first-line
More informationAVEO 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 information8 of 21 (38.1%) Achieved RECIST v1.1 Durable Complete Response (CR) in Predicted Anti-PD-1 Non-Responder Melanoma Patients at 24 Weeks
October 19, 2017 OncoSec Presents Positive Phase 2 Data for ImmunoPulse IL-12 in Combination with Pembrolizumab Demonstrating a Best Overall Response Rate (BORR) of 50% in Predicted Anti-PD-1 Non- Responder
More informationCorporate Presentation September Nasdaq: ADXS
Corporate Presentation September 2018 Nasdaq: ADXS Forward-Looking Statements This presentation contains forward-looking statements, including, but not limited to, statements regarding the ability and
More informationINTERIM RESULTS AS OF MARCH 31, 2018
INTERIM RESULTS AS OF MARCH 31, 2018 1 FORWARD-LOOKING STATEMENTS This presentation includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of
More informationPTAC meeting held on 5 & 6 May (minutes for web publishing)
PTAC meeting held on 5 & 6 May 2016 (minutes for web publishing) PTAC minutes are published in accordance with the Terms of Reference for the Pharmacology and Therapeutics Advisory Committee (PTAC) and
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 informationQ Financial Update November 6, 2018 NASDAQ:FPRX
Q3 2018 Financial Update November 6, 2018 NASDAQ:FPRX 2 Forward-Looking Statements Disclaimer Forward-looking statements contained in this presentation include statements regarding (i) the timing of initiation,
More informationINTERIM RESULTS AS OF MARCH 31, 2014 CSE/OMX:BAVA, OTC:BVNRY
INTERIM RESULTS AS OF MARCH 31, 2014 Q1 MAY 14, 2014 CSE/OMX:BAVA, OTC:BVNRY FINANCIAL HIGHLIGHTS 1.7 million doses delivered to the SNS during Q1 Full year financial expectations maintained DKK million
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 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 informationClinical: Ipilimumab (MDX-010) Update and Next Steps
Clinical: Ipilimumab (MDX-010) Update and Next Steps Geoffrey M. Nichol, M.D., M.B.A. Senior Vice President, Product Development Medarex, Inc. R&D Day December 9, 2005 Ipilimumab: New Class of Cancer Therapy
More informationMEETING SUMMARY ESMO 2018, Munich, Germany. Dr. Jenny Seligmann University of Leeds, UK HIGHLIGHTS ON COLORECTAL CANCER
MEETING SUMMARY ESMO 2018, Munich, Germany Dr. Jenny Seligmann University of Leeds, UK HIGHLIGHTS ON COLORECTAL CANCER DISCLAIMER Please note: The views expressed within this presentation are the personal
More informationCorporate Presentation
Corporate Presentation October 2017 Forward-looking Statements Except for historical information, this presentation contains forward-looking statements, which reflect Immunovaccine s current expectations
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 informationNewLink Genetics Corporation Provides Operational Update and Reports Second Quarter 2015 Financial Results
July 31, 2015 NewLink Genetics Corporation Provides Operational Update and Reports Second Quarter 2015 Financial Results -Management to Host Conference Call Today at 8:30 a.m. ET- AMES, Iowa, July 31,
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 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 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 informationArming the patient s immune system to fight cancer
Arming the patient s immune system to fight cancer Redeye - Fight Cancer Seminar 10 th March 2017 Øystein Soug, CEO Important notice and disclaimer This report contains certain forward-looking statements
More informationRevolutionizing the Treatment of Cancer
Revolutionizing the Treatment of Cancer September 2013 Safe Harbor Statement The statements that follow (including projections and business trends) are forward looking statements. Rexahn's actual results
More informationFrédéric Triebel MD, PhD World Immunotherapy Congress Basel, October 30, 2018
Two ACTive immunotherapies in melanoma (TACTI-mel): results of a phase I trial combining a soluble LAG-3 receptor (Eftilagimod Alpha) with Pembrolizumab Frédéric Triebel MD, PhD World Immunotherapy Congress
More informationNewLink 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 informationThis clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.
abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical
More informationSAVARA CORPORATE PRESENTATION (NASDAQ: SVRA) NOVEMBER 2018
SAVARA CORPORATE PRESENTATION (NASDAQ: SVRA) NOVEMBER 2018 SAFE HARBOR STATEMENT Savara Inc. ( Savara or the Company ) cautions you that statements in this presentation that are not a description of historical
More informationNexavar in Combination with Chemotherapy Demonstrates 74 Percent Improvement in Progression-Free Survival
Investor News Bayer AG Investor Relations 51368 Leverkusen Germany www.investor.bayer.com Phase II Study in Advanced Breast Cancer: Nexavar in Combination with Chemotherapy Demonstrates 74 Percent Improvement
More informationPrimary Endpoint The primary endpoint is overall survival, measured as the time in weeks from randomization to date of death due to any cause.
CASE STUDY Randomized, Double-Blind, Phase III Trial of NES-822 plus AMO-1002 vs. AMO-1002 alone as first-line therapy in patients with advanced pancreatic cancer This is a multicenter, randomized Phase
More informationAviragen Therapeutics, Inc. and Vaxart Inc. Joint Conference Call UNLOCKING THE FULL POTENTIAL OF ORAL VACCINES
Aviragen Therapeutics, Inc. and Vaxart Inc. Joint Conference Call UNLOCKING THE FULL POTENTIAL OF ORAL VACCINES October 30, 2017 Safe Harbor This presentation contains forward-looking statements about
More informationINTERIM MANAGEMENT STATEMENT Q3 2017
INTERIM MANAGEMENT STATEMENT Q3 2017 Significant progress across all clinical programs New pre-clinical immunooncology data to be presented during R&D Day in New York Research & Development highlights:
More informationAXL inhibition to prolong life
AXL inhibition to prolong life First-in-class medicines to treat aggressive cancers Third Quarter 2017 presentation 17th November 2017 1 Disclaimer Certain statements contained in this presentation constitute
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 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 informationSUMMARY OF THE SIRFLOX RESULTS
SUMMARY OF THE SIRFLOX RESULTS The SIRFLOX study results on the combination of SIR-Spheres Y-90 resin microspheres with first-line chemotherapy were published in Journal of Oncology in early 2016. 1 There
More informationDISCLOSURE SLIDE. ARGOS: research funding, scientific advisory board
INTERIM ANALYSIS OF THE PHASE 3 ADAPT TRIAL EVALUATING ROCAPULDENCEL-T (AGS-003), AN INDIVIDUALIZED IMMUNOTHERAPY FOR THE TREATMENT OF NEWLY-DIAGNOSED PATIENTS WITH METASTATIC RENAL CELL CARCINOMA (MRCC)
More informationIncyte Reports 2014 Second Quarter Financial Results and Updates Shareholders on Key Clinical Programs
Print Page Close Window Press Release Incyte Reports 2014 Second Quarter Financial Results and Updates Shareholders on Key Clinical Programs $84.0 million of 2014 second quarter net product revenues from
More informationINTERIM RESULTS AS OF JUNE 30, 2016 CSE/OMX:BAVA, OTC:BVNRY
INTERIM RESULTS AS OF JUNE 30, 2016 Q2 CSE/OMX:BAVA, OTC:BVNRY FORWARD-LOOKING STATEMENTS This presentation includes forward-looking statements that involve risks, uncertainties and other factors, many
More informationQ PRESENTATION November 13, 2018 Per Walday, CEO Ronny Skuggedal, CFO
Q3 2018 PRESENTATION November 13, 2018 Per Walday, CEO Ronny Skuggedal, CFO 1 PCI BIOTECH Important notice and disclaimer This presentation may contain certain forward-looking statements and forecasts
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 informationAACR 2018 Investor Meeting
AACR 218 Investor Meeting April 16, 218 1 Forward-Looking Information This presentation contains statements about the Company s future plans and prospects that constitute forward-looking statements for
More informationRecurrent Ovarian Cancer Phase 1b Results
Recurrent Ovarian Cancer Phase 1b Results December 5 th, 2017 Forward-looking Statements Except for historical information, this presentation contains forward-looking statements, which reflect Immunovaccine
More information