Download - DelMar Pharma reviews glioblastoma clinical trials and new therapeutic development (CEOLIVE.tv presentation)

©2013 -‐ DELMAR PHARMACEUTICALS 7Oct2010

OUR MISSION To benefit pa?ents and create shareholder value by rapidly developing and commercializing well-‐validated an?-‐cancer therapies in high-‐impact orphan cancer indica?ons where pa?ents have failed modern therapy. OTCQB: DMPI


Glioblastoma Mul?forme (GBM) VAL-‐083 Showing Promising Results in Phase 1/2 Clinical Trial

•  Most common and aggressive form of brain cancer

•  Affects ~15,000 adults / year in US

•  Approximately 50% of pa>ents tumors fail all other treatments

•  VAL-‐083 has dis?nct mechanism from other treatments that suggests will be ac?ve where other drugs are failing


VAL-‐083: DelMar’s First Product Opportunity

•  VAL-‐083 is a novel, first-‐in-‐class small-‐molecule chemotherapy with ac?vity in a wide-‐range of cancers

•  Well studied in >40 previous human clinical studies at Na?onal Cancer Ins?tute (NCI)

•  Approved cancer chemotherapy in China to treat lung cancer & leukemia

•  Favorable safety and dosing profile; fewer side effects; dis?nct mechanism of ac?on

•  Commercial scale manufacturing in place

•  Solid intellectual property posi?on

©2013 -‐ DELMAR PHARMACEUTICALS

DelMar Is Rapidly Advancing VAL-‐083 to Treat Aggressive Cancers; Key Time in Development

•  Ini>ated U.S. clinical trial in refractory glioblastoma (GBM) 4Q11

•  FDA grants orphan drug status in GBM 1Q12

•  Interim Phase 1/2 clinical trial data presented at ASCO13 2Q13

•  Expanded clinical trial to UCSF (3rd site) •  FDA allows accelerated dosing •  USPTO grants key patent for VAL-‐083

3Q13

•  Presen?ng at Society of NeuroOncology (SNO) 4Q13


Building Value: Advancing Clinical Development in USA

•  2013: Complete dose-‐escala?on & define registra?on trial design in refractory GBM

•  Society for NeuroOncology Mee>ng (SNO) •  November 21-‐24

•  2014: Ini?ate registra?on-‐directed trials in refractory GBM

•  An>cipated design: 80-‐100 pa>ents; open label; PFS6 & radiographic response as primary endpoints

•  Key Conferences: AACR / ASCO / SNO

All refractory GBM clinical trials are expected to be open label design enabling presenta?on of interim data at key conferences throughout development.

December 2011

May 2013

By February 2012, 50% reduc>on in tumor mass observed on MRI. Reduc>on maintained as of August 2013.


VAL-‐083: Product Development Strategy

New IP

Clinical Valida?on

: >40 NCI

Sponsored Clinical Trials

-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐ Approved

Drug in China

Addi?onal Indica?ons

China (approved)

Orphan Drug Approval(s)

Clinical Data Creates New Revenue & Partnering Opportuni?es

GBM (Phase II – USA)

Solid Tumors

Orphan Drug Approval

Big-‐Pharma Collabora?on


Glioblastoma Mul?forme (GBM) VAL-‐083 Showing Promising Results in Phase 1/2 Clinical Trial

•  Large market opportunity •  2nd + 3rd line therapy: = $200M -‐ $500M annual sales •  Front line therapy: > $1B annual sales

•  DelMar’s clinical and non-‐clinical data supports VAL-‐083 ac?vity where other treatments fail •  American Associa>on of Cancer Research (AACR): 2012 & 2013 •  Society for NeuroOncology (SNO): 2012


VAL-‐083 Is Approved in China for Lung Cancer and Chronic Myelogenous Leukemia

Commercial and development partnership with Guangxi Wuzhou Pharmaceu?cal Group Co. Ltd. •  Provides DelMar with global rights to VAL-‐083

•  Near-‐term revenue opportunity for DelMar in high-‐growth interna>onal markets

•  Guangxi Wuzhou Pharma will fund any clinical ac>vi>es in China

•  DelMar plans to partner China marke>ng rights to access an established sales force and generate royalty revenue


•  Lung cancer = 1,000,000 new cases annually by 2025

•  Challenge: current sales of VAL-‐083 in China are minimal

•  Drug is not well posi>oned vis-‐à-‐vis standard of care in approved indica>ons

•  Solu>on: re-‐posi>oning and re-‐launch

•  Support sales growth with Specific Data

•  Support sales growth with Appropriate Promo>ons

•  Guangxi Wuzhou Pharma will fund any clinical ac>vi>es in China

Expanding VAL-‐083 Market Opportunity in China for Near Term Revenue Opportuni?es


2013 Corporate Goals: Building Value

1. Advance VAL-‐083 Clinical Development in USA Ø  Complete dose-‐escala>on por>on of Phase I/II GBM clinical

trial and posi>on to begin registra>on studies

2. Realize Commercial Opportunity of VAL-‐083 in China

Ø  Enter into marke>ng partnership & develop new data to support commercial reposi>oning and re-‐launch

Ø  2014: Begin developing new clinical data to support sales growth


Stay in Touch with DelMar Pharma

Ø  View the presenta>on for the next 90 days at:

www.RetailInvestorConferences.com

Ø  Download slides, view webcasts and sign up for e-‐updates

www.delmarpharma.com

Ø  Follow us on Twiker

@delmarpharma


Strong Product Opportunity: Value for Pa?ents and Shareholders

•  VAL-‐083 is well-‐validated: Safety profile & efficacy established

•  Management has a history of successful exits: Matrix, ChemGenex

•  Team successfully developed Synribo®: FDA approved by TEVA in 2012

•  Hold VAL-‐083 China commercial rights: Near-‐term revenue opportunity

•  Streamlined clinical and global commercializa?on plan: Near-‐term value

•  Strong financial posi?on: Funding thru Q1’2015

•  OTCQB: DMPI

Download - DelMar Pharma reviews glioblastoma clinical trials and new therapeutic development (CEOLIVE.tv presentation)

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