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

Size: px
Start display at page:

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

Transcription

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

2 Forward-Looking Statements Any statements contained in this presentation that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. Any forward-looking statements contained herein or made in the course of the presentation are based on current expectations, but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company's products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in our filings with the SEC and the British Columbia Securities Commission, including our current reports on Form 8- K s, Form 10-Q s and most recent Form 10-K. We do not undertake to update these forward-looking statements made by us. 2

3 Corporate Overview & Recent Developments VAL-083: DNA-targeting agent with well-established mechanism of action (MOA) for multiple solid tumor indications Leveraging estimated $90M+ of prior investment by NCI: ~40 PH 1 and PH 2 clinical trials and preclinical studies in multiple indications >1,000 patient safety database Lead indication: Recurrent glioblastoma multiforme (rgbm) leverages biomarker for an underserved patient population Benefitting from accelerated enrollment in both our two PH 2 clinical studies potential to allow for earlier trial completion Strengthened our Board of Directors with world class scientific pedigree through the addition of Dr. Napoleone Ferrara Oppenheimer & Co. Inc. appointed as strategic advisor December 2017 FDA Fast Track Designation for VAL-083 in rgbm Orphan drug designations for glioma, medulloblastoma and ovarian cancer in U.S. and glioma in E.U. 3

4 Development Strategy for Optimizing VAL-083's Potential Focus on oncology indications for patients with limited alternatives Unique mechanism of action, and biomarker driven studies reduce development risk, cost, and timelines Updated September 2017 NCCN guidelines: Great opportunity for VAL-083 in MGMT-unmethylated GBM Validated standard-of-care biomarker (MGMT promoter methylation) for treatment of GBM Phase 2 second-line GBM study ongoing at MD Anderson Phase 2 front-line GBM international study ongoing at Sun Yat-sen University 505(b)2 strategy allows DelMar to use previous NCI data to support FDA filings Future pipeline opportunities in ovarian and other solid tumor cancers 4

5 Expanding Pipeline Preclinical IND Phase I Phase II Phase III 2nd Line MGMT-unmethylated GBM VAL st Line MGMT-unmethylated GBM Platinum-Resistant Ovarian Cancer Other Solid Tumors Efficient use of shareholder capital to date $34.3M spent to establish clinical programs in multiple indications (as of June 30, 2018) 5

6 VAL-083: A Validated Precision DNA-targeting Agent 6

7 Only DNA-Targeting Agents Have Demonstrated Survival Benefit in GBM Interventions with proven therapeutic benefit in GBM - Surgery - Radiotherapy - DNA-targeting agents (temozolomide (TMZ); nitrosoureas) VAL-083 is a structurally-unique, brain-penetrating, DNAtargeting agent - Established clinical activity in GBM (NCI studies) - Differentiated mechanism from TMZ and nitrosoureasovercomes tumor-resistance of those agents 7

8 DNA-Targeting Agents Are Well-Established Anti-Cancer Class of Drugs ANTI-CANCER DRUG temozolomide BCNU/CCNU Peak Annual Sales $1.1 B (2013) ~$100 m (1980s) Platinum-based chemotherapies bendamustine >$1 billion (2000s) $800 m (2014) VAL-083 DNA Target O6-guanine O6-guanine N7-guanine N7-guanine N7-guanine MGMT Dependent Dependent Independent Independent Independent Cross blood-brain barrier? yes yes no no yes p53 Dependent Dependent Dependent Dependent Less dependent Primary indications CNS tumors CNS tumors Solid tumors Hematologic malignancies CNS & Solid Tumors TBD VAL-083 is a first-in-class DNA-targeting agent with the potential to overcome drug-resistance >60% of GBM patients are MGMT-unmethylated, not responsive to TMZ VAL-083 targeting of N7 of guanine on DNA to overcome MGMT-mediated TMZ resistance (O6 monofunctional DNA alkylation) Established activity in platinum-resistant cancer cell lines (ovarian and NSCLC) 8

9 GBM Patients Have Very Limited Treatment Options Across All Disease Stages GBM Treatment Paradigm MGMT methylation is a wellestablished, validated biomarker for gauging TMZ efficacy mos < 15mo <40% pts MGMT-methylated mos = 21.7mo >60% pts MGMTunmethylated mos ~ 12.7mo No impact on survival 19.6% ORR, DOR 3.9mo MGMT-unmethylated represents >60% of patients who do not benefit from TMZ treatment resulting in: Treatment-related side effects Increased cost of treatment Source: : Hegi et al. 2005, N Eng J Med 9

10 MGMT Methylation Status Correlates With GBM Patient Survival Outcomes <40% GBM pts >60% GBM pts Hegi et al NEJM, 2005 MGMT methylation status is correlated with GBM patient survival outcomes TMZ + radiotherapy provides no survival benefit to MGMT-unmethylated GBM compared to radiotherapy alone - Evidenced by September 2017 NCCN guidelines update Source: : Hegi et al. 2005, N Eng J Med 10

11 Biomarker Testing For MGMT Promoters and Recent NCCN Guidelines Evaluating MGMT promotor methylation: - Has increasingly become standard-of-care in GBM diagnosis - Impacts treatment practice and outcomes September 2017 NCCN guidelines KPS 60: Clinical benefit from temozolomide is likely to be lower in patients whose tumors lack MGMT promoter methylation KPS<60: temozolomide monotherapy is only recommended if tumor is MGMT promoter methylated MGMT testing is a validated and commercially available diagnostic 11

12 GBM: Initial Opportunity Focusing on MGMT Status Most common and aggressive adult brain tumor with annual incidence estimated at 3-5 per 100,000 adults = ~29,000 new cases in US and EU each year Percentage of newly diagnosed GBM patients (est.) MGMT-Methylated MGMT-Unmethylated 40% 60% > $1 billion annually Treatable patient population (est.) U.S. E.U. Percentage of recurrent GBM patients (est.) 5,104 6,400 7,656 9,600 25% 75% $ million Treatable patient population (est.) U.S. E.U. Market Size 1,914 2,400 5,742 7,200 Source: CBTRUS report 2017; Hegi et al. 2005, N Eng J Med; Brandes et al. 2009, J Clin Onc. 12

13 VAL-083 is Equipotent Independent of MGMT Promoter Methylation Status U251 MGMT-Methylated GBM Cell line T98G MGMT-Unmethylated GBM Cell line GBM Cell Line U251 (MGMT-methylated) T98G (MGMT-unmethylated) MGMT Expression LOW High TMZ* IC 50 = 22.7μM >>100μM TMZ resistant VAL-083 IC 50 = 2.5μM 2.5μM VAL-083 sensitive *The IC50 values for TMZ are created based on inadequate dose-response curves, as the tested cell lines were moderately or fully resistant to TMZ. Source: Hu et al, AACR

14 Opportunity for VAL-083 in MGMT-Unmethylated Patients In 2 nd Line and Newly Diagnosed GBM Currently Enrolling: Two Phase 2 clinical trials designed to capitalize on robust VAL-083 scientific and clinical data and recently revised NCCN guidelines Recurrent GBM - MD Anderson: Study of VAL-083 in Patients With MGMT-Unmethylated, Avastin-naive Recurrent Glioblastoma (NCT ) Newly Diagnosed GBM - International trial: VAL-083 and Radiotherapy in Patients With Newly Diagnosed GBM Having Unmethylated MGMT Expression (NCT ) 14

15 Phase 2 Trial: Avastin-Naïve Second-Line GBM Patients With MGMT-Unmethylated Tumors : Study enrollment ongoing Validate VAL-083 in 2nd-line Avastin-naïve GBM patients post temozolomide failure (N=48) Single arm, MGMT methylation biomarker-driven open label study Primary Endpoint: Overall Survival - The lomustine arm of EORTC26101 trial is the reference control (mos= 7.1 mo) 15

16 VAL-083 Phase 2 trial In Avastin-Naïve Second-Line GBM Patients With MGMT-Unmethylated Tumors As of September 21, of a planned 48 patients enrolled Enrollment is ahead of original projections Assuming recent enrollment rates continue, we forecast full enrollment by end of 2018 Per protocol design, we anticipate median overall survival to be reached approximately three months after final patient is enrolled 16

17 Expanded Opportunity For VAL-083 In MGMT- Unmethylated Newly Diagnosed (Front-Line) GBM Updated NCCN guidelines highlight opportunity for VAL VAL-083 equipotent independent of MGMT methylation NCI studies demonstrate survival benefit of VAL radiotherapy vs. radiotherapy alone MGMT-unmethylated GBM: >60% of all newly diagnosed patients = ~17,000 patients annually in US and EU VAL-083 Phase 2 study in 30 newly diagnosed MGMTunmethylated GBM - Sun Yat-sen University Cancer Center (Guangzhou, China) - Open label trial for temozolomide-naïve GBM patients 17

18 VAL-083 Phase 2 Trial in MGMT-Unmethylated For Newly Diagnosed (Front-Line) GBM Precedent-setting Biomarker Aided Patient Selection Validate activity of VAL-083 plus radiation in newly diagnosed MGMTunmethylated GBM patients compared to historical control (N=30) Primary Endpoint: Progression free survival (PFS) Compare with MGMT-unmethylated in historical control PFS=5.3m Secondary Endpoint: Overall survival (OS) Source: Hegi et al. 2005, N Eng J Med 18

19 VAL-083 Phase 2 trial In Newly Diagnosed GBM Patients With MGMT-Unmethylated Tumors As of September 21, 2018 Study Update 9 patients enrolled at Dose-escalation stage 3 patients started dosing at 40mg/m 2 19

20 VAL-083 Reduces GBM tumor Progression in vivo, after Bevacizumab induced Hypoxia Study conducted by Luxemburg Institute of Health 20

21 VAL-083: Opportunity in Platinum-Resistant Ovarian Cancer Ranked 5th in female cancer death worldwide Incidence: Est per 100,000 women= ~66,000 new cases in US and EU annually Median survival Pt-resistant ovarian cancer with currently available therapies <12 months Newly diagnosed ovarian cancer patients (est.) Patient PopulationUS Patient PopulationEU 22,400 44,149 Recurrence rate Platinum-Resistant ovarian cancer patients (est.) Est. over $3 billion in % 13,888 Market Size 27,367 Source: EUCAN, NCI-SEER, Birrer 2014, Am Soc Clin Oncol Educ Book, Ethier 2017, Gyne. Can. Evaluate Pharma 21

22 Advisory Committee for Ovarian Cancer Established a highly capable ovarian cancer advisory board Dr. Bradley Monk Dr. Maurie Markman Dr. Thomas Herzog Arizona Oncology (US Oncology Network) Cancer Treatment Centers of America University of Cincinnati Cancer Institute Seek to combine with PARP inhibitors for platinum-resistant ovarian cancer, a highly unmet medical need Initiate Phase 1/2 trial when a suitable design, and sufficient capital to complete the trial is secured 22

23 Financial Position Condensed Balance Sheet Data As of June 30, 2018 Cash $6.0 million Total liabilities $1.6 million Total stockholders equity $5.4 million Condensed Statement of Cash Flow Data Cash used in operating activities Fully Diluted, As-Converted Shares Year Ended June 30, 2018 $9.9 million 43.3 million 23

24 Upcoming CY 2018 Milestones Clinical Data Update for both PH 2 ongoing trials: Targeted for Peer-reviewed Scientific Conference SNO (November 2018) Open label studies allows for intermediate publication of results Financials First Quarter FY 2019 (November 2018) 24

25 Investment Summary VAL-083: Structurally unique and differentiated activity DNA-targeting agent Unique potential to circumvent MGMT-related temozolomide-resistance in the treatment of GBM Leverages MGMT biomarker per September 2017 NCCN guidelines Represents >60% of GBM patients Multiple opportunities validated by numerous late stage clinical studies VAL-083 s Orphan Drug Designation in GBM and ovarian cancer Ovarian cancer is no longer eligible for orphan drug designation given its prevalence of >200,000 in the U.S. Prudent management focused on efficient use of shareholder capital Strengthened Board of Directors and management team 25

26

DelMar Pharmaceuticals Inc. (OTCQX: DMPI, Target Price: $5.75)

DelMar Pharmaceuticals Inc. (OTCQX: DMPI, Target Price: $5.75) Equity Healthcare / Biotechnology Update (December 3, 2015) DelMar Pharmaceuticals Inc. (OTCQX: DMPI, Target Price: $5.75) DelMar Pharmaceuticals, Inc. ( DelMar, OTCQX: DMPI) is a clinical stage biotechnology

More information

Small-Cap Research. Delmar Pharma (DMPI-NASDAQ) DMPI: Zacks Company Report OUTLOOK

Small-Cap Research. Delmar Pharma (DMPI-NASDAQ) DMPI: Zacks Company Report OUTLOOK Small-Cap Research May 25, 2017 Grant Zeng, CFA 312-265-9466 gzeng@zacks.com scr.zacks.com 10 S. Riverside Plaza, Chicago, IL 60606 Delmar Pharma (DMPI-NASDAQ) DMPI: Zacks Company Report DMPI: A New Phase

More information

A company developing innovative, high-impact drugs for cancer

A company developing innovative, high-impact drugs for cancer A company developing innovative, high-impact drugs for cancer Investor Briefing March 2019 ASX: KZA NASDAQ : KZIA Twitter: @KaziaTx Forward-Looking Statements This presentation contains forward-looking

More information

CORPORATE PRESENTATION

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

More information

Oncology Therapeutics without Compromise APRIL 2011

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

More information

Small-Cap Research. Delmar Pharma (DMPI-OTCQB)

Small-Cap Research. Delmar Pharma (DMPI-OTCQB) Small-Cap Research February 24, 2015 Grant Zeng, CFA 312-265-9466 gzeng@zacks.com scr.zacks.com 10 S. Riverside Plaza, Chicago, IL 60606 Delmar Pharma (DMPI-OTCQB) DMPI: Ready to advance VAL-083 to pivotal

More information

Investor Call. May 19, Nasdaq: IMGN

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

More information

A Biopharmaceutical Company Focused on Controlled Immunotherapies and Point-of-Care Solutions

A Biopharmaceutical Company Focused on Controlled Immunotherapies and Point-of-Care Solutions A Biopharmaceutical Company Focused on Controlled Immunotherapies and Point-of-Care Solutions Second Quarter 2017 Company Update and Financial Results July 31, 2017 2 Forward-Looking Statements This presentation

More information

NewLink Genetics Corporation

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

More information

Pioneering vaccines that transform lives.

Pioneering vaccines that transform lives. Pioneering vaccines that transform lives. Immunomic Therapeutics, Inc. LAMP-Vax for Glioblastoma: CMV-LAMP-Vax Executive Summary Executive Summary pp65-lamp-vax First Line Therapy for Glioblastoma Multiforme

More information

IMMUNOMEDICS, INC. Advanced Antibody-Based Therapeutics

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

More information

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

Determined 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 information

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

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

More information

Business Update & Financial Results for Q1 2018

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

More information

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

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

More information

Merrimack Pharmaceuticals: A Refocused R&D Company January 2017

Merrimack 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 information

TARGET A BETTER NOW FORWARD-LOOKING STATEMENTS NASDAQ: IMGN. Current as of January 2018

TARGET A BETTER NOW FORWARD-LOOKING STATEMENTS NASDAQ: IMGN. Current as of January 2018 NASDAQ: IMGN TARGET A BETTER NOW Current as of January 2018 FORWARD-LOOKING STATEMENTS This presentation includes forward looking statements based on management's current expectations. These statements

More information

The Next Generation of Immunotherapy Platforms. 36 th Annual J.P. Morgan Healthcare Conference January 2018

The Next Generation of Immunotherapy Platforms. 36 th Annual J.P. Morgan Healthcare Conference January 2018 The Next Generation of Immunotherapy Platforms 36 th Annual J.P. Morgan Healthcare Conference January 2018 Forward-Looking Statements This presentation contains certain forward-looking information about

More information

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

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

More information

Corporate Overview. July 2016 NASDAQ: CYTR

Corporate 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 information

Wells Fargo Healthcare Conference September 6, 2018

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

More information

Third Quarter 2018 Financial Results. November 1, 2018

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

More information

Inducing Tumor-Specific Ischemic Necrosis to Enhance the Efficacy of Checkpoint Inhibitors and Chemotherapy

Inducing Tumor-Specific Ischemic Necrosis to Enhance the Efficacy of Checkpoint Inhibitors and Chemotherapy Inducing Tumor-Specific Ischemic Necrosis to Enhance the Efficacy of Checkpoint Inhibitors and Chemotherapy Company Overview, September 2018 Safe Harbor Statement This presentation contains forward-looking

More information

ArQule Jefferies Global Healthcare Conference June 2015

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

More information

Media Release. Basel, 17 November 2012

Media Release. Basel, 17 November 2012 Media Release Basel, 17 November 2012 Roche study showed that Avastin helped people with newly diagnosed glioblastoma live longer without their disease worsening when added to radiation and chemotherapy

More information

Path to Value and Profitability

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

More information

Amicus 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 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 information

Clovis Oncology Announces First Quarter 2017 Operating Results. May 3, :06 PM ET

Clovis 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 information

Disrupting the Cell Cycle to Treat AML and MDS Rodman & Renshaw Conference

Disrupting 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 information

Novogen Limited. An emerging oncology drug developer with two clinical-stage programs NRT NVGN. April 2017

Novogen Limited. An emerging oncology drug developer with two clinical-stage programs NRT NVGN. April 2017 Novogen Limited An emerging oncology drug developer with two clinical-stage programs NRT April 2017 NVGN Forward-Looking Statements This presentation contains forward-looking statements within the meaning

More information

Dawson James Conference

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

More information

Genta Incorporated. A Multiproduct Late-Stage Oncology Company

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

More information

ADAPTIMMUNE INVESTOR PRESENTATION. August 2016

ADAPTIMMUNE 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 information

Third Quarter 2015 Earnings Call. November 9, 2015

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

More information

LION. Corporate Presentation June 2016 BIOTECHNOLOGIES. Leadership & Innovation in Oncology

LION. 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 information

Roche announces final phase III study results of Avastin plus radiotherapy and chemotherapy in people with an aggressive form of brain cancer

Roche announces final phase III study results of Avastin plus radiotherapy and chemotherapy in people with an aggressive form of brain cancer Media Release Basel, 1 June 2013 Roche announces final phase III study results of Avastin plus radiotherapy and chemotherapy in people with an aggressive form of brain cancer Roche (SIX: RO, ROG; OTCQX:

More information

Leerink Immuno-Oncology Roundtable Conference

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

More information

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

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

More information

Bank of America Merrill Lynch 2016 Health Care Conference

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

More information

FORWARD II PROGRAM UPDATE

FORWARD II PROGRAM UPDATE FORWARD II PROGRAM UPDATE NASDAQ: IMGN May 17, 2018 FORWARD-LOOKING STATEMENTS This presentation includes forward-looking statements based on management's current expectations. These statements include,

More information

Liquid Biopsies. Next Generation Cancer Molecular Diagnostics

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

More information

ARQ 087 Overview. FGFR Inhibitor. March 2017

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

More information

Karyopharm Reports Second Quarter 2015 Financial Results and Highlights Recent Progress

Karyopharm Reports Second Quarter 2015 Financial Results and Highlights Recent Progress August 10, 2015 Karyopharm Reports Second Quarter 2015 Financial Results and Highlights Recent Progress - Positive Selinexor Clinical Data Presented across Several Difficult to Treat Cancers - - Provides

More information

NY-ESO SPEAR T-cells in Synovial Sarcoma

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

More information

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

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

More information

Full Year 2017 Financial Results. February 14, 2018

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

More information

ObsEva Reports Third Quarter 2017 Financial Results and Provides Business Update

ObsEva Reports Third Quarter 2017 Financial Results and Provides Business Update ObsEva Reports Third Quarter 2017 Financial Results and Provides Business Update - All Three Development Compounds Progressing with Key Clinical Milestones Over the Next 12 Months - Geneva, Switzerland

More information

Marizomib (MRZ): Brain Penetrant Irreversible Pan-Proteasome Inhibitor

Marizomib (MRZ): Brain Penetrant Irreversible Pan-Proteasome Inhibitor MARIZOMIB (MRZ) WITH BEVACIZUMAB (BEV) IN WHO GRADE IV MALIGNANT GLIOMA (G4 MG): FULL ENROLLMENT RESULTS FROM THE PHASE 1, MULTICENTER, OPEN-LABEL STUDY Daniela Bota, MD, PhD 1, Annick Desjardins, MD,

More information

Spectrum Pharmaceuticals

Spectrum 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 information

Five Prime Therapeutics, Inc. Corporate Overview

Five Prime Therapeutics, Inc. Corporate Overview Five Prime Therapeutics, Inc. Corporate Overview June 2015 NASDAQ:FPRX Forward-Looking Statements Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities

More information

Corporate Presentation. October 2017

Corporate Presentation. October 2017 AEPP Breakthrough technology for women s cancers Corporate Presentation October 2017 Oncolix 2017 1 Safe Harbor Certain of the statements and the projections set forth in this presentation constitute forward-looking

More information

Oppenheimer 28 th Annual Healthcare Conference March 20, 2018

Oppenheimer 28 th Annual Healthcare Conference March 20, 2018 Oppenheimer 28 th Annual Healthcare Conference March 20, 2018 Safe Harbor Statement This presentation and any statements made for and during any presentation or meeting contain forward-looking statements

More information

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

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

More information

Genomic Health. Kim Popovits, Chairman, CEO and President

Genomic 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 information

Building a Premier Oncology Biotech

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

More information

Building a Fully Integrated Biopharmaceutical Company. June 2014

Building 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 information

NewLink Genetics Corporation

NewLink Genetics Corporation Stifel Healthcare Conference Presentation NewLink Genetics Corporation NASDAQ: NLNK November 13, 2018 Cautionary Note Regarding Forward-Looking Statements This presentation contains forward-looking statements

More information

Copyright. Tocagen Inc. Lead Product Candidate: Toca 511 & Toca FC Preclinical Overview

Copyright. Tocagen Inc. Lead Product Candidate: Toca 511 & Toca FC Preclinical Overview Lead Product Candidate: Toca 511 & Toca FC Preclinical Overview Toca 511, delivers CD prodrug activator gene selectively to cancer cells Regulatory genes Structural RRV genes CD gene Regulatory genes Toca

More information

Corporate Overview. May 2017 NASDAQ: CYTR

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

More information

Novocure. 37 th annual J.P. Morgan Healthcare Conference January 9, Bill Doyle Executive Chairman

Novocure. 37 th annual J.P. Morgan Healthcare Conference January 9, Bill Doyle Executive Chairman Novocure 37 th annual J.P. Morgan Healthcare Conference January 9, 2019 Bill Doyle Executive Chairman forward-looking statements This presentation contains certain forward-looking statements with respect

More information

Special Meeting in Lieu of Annual Meeting of Shareholders

Special 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 information

Analyst/Investor Call

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

More information

REWRITING CANCER TREATMENT THROUGH EPIGENETIC MEDICINES

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

More information

ST. JUDE MEDICAL / THORATEC TRANSACTION HIGHLIGHTS July 22, 2015

ST. JUDE MEDICAL / THORATEC TRANSACTION HIGHLIGHTS July 22, 2015 ST. JUDE MEDICAL / THORATEC TRANSACTION HIGHLIGHTS July 22, 2015 1 FORWARD LOOKING STATEMENT This presentation contains forward-looking statements within the meaning of the Private Securities Litigation

More information

Revolutionizing the Treatment of Cancer

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

More information

Durable Response Rate in High Grade Glioma: an Emerging Endpoint for Immunotherapeutics. Timothy Cloughesy, MD University of California, Los Angeles

Durable Response Rate in High Grade Glioma: an Emerging Endpoint for Immunotherapeutics. Timothy Cloughesy, MD University of California, Los Angeles Durable Response Rate in High Grade Glioma: an Emerging Endpoint for Immunotherapeutics Timothy Cloughesy, MD University of California, Los Angeles Disclosure 2 FDA Endpoints for the Approval of Cancer

More information

Building a Leading Oncology Franchise

Building 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 information

Revolutionizing the Treatment of Cancer

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

More information

IMMUNOMEDICS, INC. Advanced Antibody-Based Therapeutics. Jefferies 2015 Global Healthcare Conference Peter P. Pfreundschuh, VP Finance and CFO

IMMUNOMEDICS, 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 information

Scottish Medicines Consortium

Scottish Medicines Consortium Scottish Medicines Consortium temozolomide 5, 20, 100 and 250mg capsules (Temodal ) Schering Plough UK Ltd No. (244/06) New indication: for the treatment of newly diagnosed glioblastoma multiforme concomitantly

More information

DS-8201 Strategic Collaboration

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

More information

Myriad Genetics Corporate Presentation 6/4/13

Myriad Genetics Corporate Presentation 6/4/13 Myriad Genetics Corporate Presentation 6/4/13 Forward Looking Statement Some of the information presented here today may contain projections or other forward-looking statements regarding future events

More information

June IMMUNE DESIGN The in vivo generation of cytotoxic CD8 T cells (CTLs)

June 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 information

A Fully Integrated Cancer Company.

A 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 information

Corporate Overview June 2014 Jefferies Healthcare Conference NASDAQ: GLYC

Corporate 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 information

Developing & Commercializing Targeted Small Molecule Drugs in Cancer

Developing & 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 information

Inarigivir ACHIEVE Trial Results and HBV Clinical Program Update. August 2, 2018

Inarigivir ACHIEVE Trial Results and HBV Clinical Program Update. August 2, 2018 Inarigivir ACHIEVE Trial Results and HBV Clinical Program Update August 2, 2018 FORWARD LOOKING STATEMENT This presentation includes forward-looking statements within the meaning of the Private Securities

More information

Concomitant (without adjuvant) temozolomide and radiation to treat glioblastoma: A retrospective study

Concomitant (without adjuvant) temozolomide and radiation to treat glioblastoma: A retrospective study Concomitant (without adjuvant) temozolomide and radiation to treat glioblastoma: A retrospective study T Sridhar 1, A Gore 1, I Boiangiu 1, D Machin 2, R P Symonds 3 1. Department of Oncology, Leicester

More information

Evofem Biosciences Reports Second Quarter 2018 Financial Results and Provides Corporate Update

Evofem Biosciences Reports Second Quarter 2018 Financial Results and Provides Corporate Update Evofem Biosciences Reports Second Quarter 2018 Financial Results and Provides Corporate Update Phase 3 Trial of Amphora for Hormone-free Contraception Continues to Move Ahead of Schedule; Top Line Data

More information

ARIAD Pharmaceuticals, Inc.

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

More information

Combining HS-110 and anti-pd-1 in NSCLC. September 1, 2015

Combining 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 information

Corporate Medical Policy

Corporate Medical Policy Corporate Medical Policy File Name: Origination: Last CAP Review: Next CAP Review: Last Review: tumor_treatment_fields_therapy 9/2013 11/2017 11/2018 6/2018 Description of Procedure or Service Tumor-treatment

More information

Small-Cap Research. Delmar Pharma (DMPI-OTCQB)

Small-Cap Research. Delmar Pharma (DMPI-OTCQB) Small-Cap Research July 2, 2013 Grant Zeng, CFA 312-265-9466 gzeng@zacks.com scr.zacks.com 111 North Canal Street, Chicago, IL 60606 Delmar Pharma (DMPI-OTCQB) DMPI: Clinical/commercial stage biopharmaceutical

More information

Investor Presentation

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

More information

Corporate Presentation

Corporate 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 information

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

Determined to realize a future in which people with cancer live longer and better than ever before Determined to realize a future in which people with cancer live longer and better than ever before 4Q 2016 EARNINGS PRESENTATION MARCH 2017 1 Forward-looking statements disclosure This presentation contains

More information

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

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

More information

Infinity Highlights Promising Preclinical Hedgehog Data and Announces First Quarter Financial Results

Infinity Highlights Promising Preclinical Hedgehog Data and Announces First Quarter Financial Results Infinity Highlights Promising Preclinical Hedgehog Data and Announces First Quarter Financial Results Heat Shock Protein 90 Program Continues to Advance Toward Potential Registration Trial CAMBRIDGE, Mass.,

More information

July, ArQule, Inc.

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

More information

TSX Venture: RVV OTCQB: RVVTF

TSX Venture: RVV OTCQB: RVVTF TSX Venture: RVV OTCQB: RVVTF The image part with relationship ID rid3 was not found in the file. 2017 Annual General and Special Meeting of Shareholders December 19, 2017 Revive Therapeutics Ltd. Office:

More information

Building a Premier Oncology Biotech

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

More information

Pioneering vaccines that transform lives.

Pioneering vaccines that transform lives. Pioneering vaccines that transform lives. Immunomic Therapeutics, Inc. LAMP-Vax for General Oncology Presentation Outline 1. Immunomic Therapeutics: corporate overview 2. Unmet need in cancer immunotherapy

More information

Needham Healthcare Conference. April 4, 2017

Needham Healthcare Conference. April 4, 2017 Needham Healthcare Conference April 4, 2017 Forward Looking Statements This presentation and various remarks we make during this presentation contain forward-looking statements within the meaning of The

More information

Corporate Medical Policy

Corporate Medical Policy Corporate Medical Policy Analysis of MGMT Promoter Methylation in Malignant Gliomas File Name: Origination: Last CAP Review: Next CAP Review: Last Review: analysis_of_mgmt_promoter_methylation_in_malignant_gliomas

More information

Revolutionizing the Treatment of Cancer

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

More information

Corporate Presentation May Transforming Immuno-Oncology Using Next-Generation Immune Cell Engagers

Corporate 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 information

Cilengitide (Impetreve) for glioblastoma multiforme. February 2012

Cilengitide (Impetreve) for glioblastoma multiforme. February 2012 Cilengitide (Impetreve) for glioblastoma multiforme February 2012 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to

More information

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

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

More information

TELECONFERENCE FY February 2015

TELECONFERENCE FY February 2015 TELECONFERENCE FY 2014 5 February 2015 Company disclaimer This presentation contains forward-looking statements that provide our expectations or forecasts of future events such as new product introductions,

More information

Positioned for Growth

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

More information