otcqb: dmpi - DelMar Pharmaceuticals

OTCQB: DMPI
CORPORATE OVERVIEW
SEPTEMBER 2014
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- DELMAR PHARMACEUTICALS
Safe Harbor
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. 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, including, our current reports on Form 8-K. We do not undertake
to update these forward-looking statements made by us.
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OUR MISSION
To benefit patients and create shareholder value by
rapidly developing and commercializing wellvalidated anti-cancer therapies in high-impact
orphan cancer indications where patients have failed
modern therapy.
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Value Proposition: Accomplishing Our Mission
 Well-validated lead drug candidate: Safety profile & efficacy established in
published literature
 Management has a history of successful exits: Matrix, ChemGenex
 DelMar clinical team successfully developed Synribo®: FDA approved by
TEVA 26-Oct/2012
 Hold commercial rights to lead product in China: Near-term revenue
opportunity
 Streamlined clinical and global commercialization plan
 Strong financial position: Funding thru Q4’2015
 Public listing: DMPI (OTCQB)
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7Oct2010
2014 Corporate Goals:
Near Term Value Drivers
CLINICAL:
 Advance refractory glioblastoma clinical trial toward
registration-directed studies
 Expand pipeline opportunity beyond refractory GBM
FINANCIAL:
 Apply for an initial listing on the NYSEMKT or NASDAQ at the
earliest available opportunity
COMMERCIAL:
 Enable royalty-based cash flow from VAL-083 sales in China
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VAL-083: Product Development Strategy
(Phase II – USA)
Orphan Drug
Approval
Additional
Indications
Orphan Drug
Approval(s)
GBM
Clinical
Validation:
>40 NCI
Sponsored
Clinical Trials
---------Approved Drug
in China
New IP
China
(approved)
Solid Tumors
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Clinical Data Creates
New Revenue &
Partnering Opportunities
Big-Pharma
Collaboration
7Oct2010
Glioblastoma Multiforme
DelMar’s First Target Market for VAL-083
 Glioblastoma Multiforme (GBM): The most common and aggressive
form of brain cancer
 Large market opportunity:
 Second and third-line therapy: $200 m - $500 m annual sales
 Front line therapy: >$1 billion annual sales
 Affects approx. 15,000 adults each year in USA
 Median survival without treatment = 4 ½ months
 Approximately half of patients tumors fail all other treatments
 DelMar’s clinical and non-clinical data supports VAL-083 activity where
other treatments fail
 American Association of Cancer Research (AACR): 2012 & 2013
 Society for NeuroOncology (SNO): 2012
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VAL-083
Evidence of Clinical Efficacy in GBM
VAL-083 historical clinical data demonstrates comparable
incremental survival benefit and overall survival comparable to
today’s standard of care
Treatment of
GBM
Median Overall Survival
temozolomide
VAL-083
(Phase III
Stupp 2005)
( Phase II
Eagan 1979)
58 weeks
67 weeks
2.5 months
8.4 months
(p<0.01)
(p=0.02)
573
1:1
42
1:1
RT + Chemo
OS Benefit of adding Chemo:
RT & Chemo vs. XRT Only
Sample (n=)
Randomization
VAL-083 (NCI - 1979)
% surviving
Probability of Survival
temozolomide (Stupp, NEJM 2005)
100
80
60
RT + VAL-083
40
20
RT
10
8.3 mos
16.7 mos
30
90
60
Time from randomization
(weeks)
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VAL-083
Efficacy: GBM – comparison to historical agents
Chemotherapy
Comparative Therapy Survival
Radiation +
Radiation
Chemotherapy
Median Survival Benefit
vs. XRT
Temodar™
12.1 months
58 weeks
(14.6 months)
2.5 months
VAL-083
8.3 months
67 weeks
(16.7 months)
8.0 months
Reported Radiation + Chemo Survival w/ other chemotherapeutic agents in GBM
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Carmustine™ (BCNU)
40-50 weeks
Lormustine™ (CCNU)
52 weeks
Nimustine™ (ACNU)
35 weeks
Avastin™
No reported benefit to survival
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VAL-083
Active Independent of MGMT Resistance Mechanism
 VAL-083 is active independent of MGMT chemo-resistance
mechanism in vitro (Dunn, AACR 2012)
 Measurement of MGMT provides a validated biomarker for patient
selection in future clinical trials
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Toxicity Comparison
Temodar
BCNU
Hematologic*,
nausea, vomiting,
fatigue, asthenia,
neuropathy
Hematologic*,
Hematologic*
pulmonary, nausea,
vomiting,
encephalopathy, renal
NADR
21-28 days
21-35 days
18-21 days
Recovery
Within 14 days
42-56 days
Within 7-8 days
Severe toxicity
reported (>2%)
VAL-083
*DLT
As reported by BC Cancer Agency monograph (2010)
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literature (1970s) & China
commercial experience
7Oct2010
VAL-083 Clinical Trial Overview
 Interventional Phase I/II, open-label, single-arm study in patients with
recurrent malignant glioma
http://clinicaltrials.gov/ct2/show/NCT01478178?term=val-083&rank=1
 Seek to achieve doses higher than NCI regimen based on improved
management of toxicity:
“Hit the Tumor Harder, More Often”
 Primary endpoint: Determine MTD of VAL-083 in patients with recurrent GBM
 Post Temodar™ and Avastin™
 Secondary endpoint: Evaluate tumor response and pharmacokinetics
 Three Clinical Sites:
 UC San Francisco: California
 Sarah Cannon Cancer Research: Tennessee; Florida
 Most recent data: ASCO 2014
 Upcoming milestones:
 Achieve MTD
 Advance to registration-directed clinical trials
 Society for Neuro-Oncology (SNO) Annual Meeting (Nov.)
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VAL-083 Clinical Trial: Progress to Date
Dose Escalation
Scheme (mg/m2)
Cumulative dose in 33-day cycle
Patients
Treated
Status
(comparison to NCI historical regimen
of 125mg/m2 per cycle)
Original
Revised*
1.5
1.5
3
Completed – No DLT
9 mg/m2
3.0
3.0
4**
Completed – No DLT
18 mg/m2
5.0
5.0
10**
Completed – No DLT
30 mg/m2
10.0
10.0
3
Completed – No DLT
60 mg/m2
20.0
3
Completed – No DLT
120 mg/m2
30.0
3
Completed – No DLT
180 mg/m2
40.0
3
Completed – No DLT
240 mg/m2
Enrolling
300 mg/m2
To be enrolled subject to no DLT
in 50mg/m2 cohort
360 mg/m2
15.0
20.0
25.0
30.0
n.a.
50.0
60.0
3
(planned)
3
(planned)
*Revised based on discussions with FDA
**Cohorts 2 and 3 were expanded to allow for patient demand and to gather additional data on CNS
metastases patients.
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Illustrative Comparison of Dosing Regimen
“Hit the tumor harder; more often”
DelMar Pharma “modernized” dosing regimen
VAL-083 CSF Concentration
NCI regimen from published efficacy studies
time
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VAL-083 Clinical Trial: Results to Date
ASCO 2014
 VAL-083 is safe and well tolerated at doses tested to date (up to
40mg/m2
 Observations of Clinical Response:
 A portion of patients tumors were observed to shrink or stop growing following
initiation of VAL-083 treatment

One of two GBM patients in each of cohort 6 (30 mg/m2) and in cohort 7 (40mg/m2) exhibited
stable disease after 1 cycle of treatment (measured by RANO).

In earlier cohorts, DelMar reported that two patients exhibited a response (stable disease or
partial response) with a maximum response of 28 cycles (84 weeks) and improved clinical signs
prior to discontinuing due to adverse events unrelated to study.
 Delivering more drug to the tumor more often in comparison to
historical NCI dosing regimen
 Plasma exposure observed to date in line with historical expectations
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VAL-083 Clinical Trial: Results to Date
ASCO 2014
 MRI scans of patient before
(March 4, on the left), and
after (May 7, on the right)
two cycles of VAL-083
treatment. Thick confluent
regions of abnormal
enhancement have
diminished, now appearing
more heterogeneous.
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VAL-083: Clinical Development in GBM
 Current Phase 1/2 clinical trial in USA will lead to two
development programs, unlocking billions in potential value
Registration Trial: Refractory GBM
(USA)
Current Phaes I/II
Clinical Trial
MTD
Phase II / III Front-line GBM (global)
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VAL-083 Clinical Trial:
Refractory GBM - Anticipated Timelines
2014
KEY MILESTIONES
Q3
2015
Q4
H1
2016
2017
H2
Achieve MTD*
MTD Dose Expansion (14 pts)*
FDA Advisory Meeting**
Registration Directed Activities
Registration Trial Enrollment
~12 months from initiation
Data collection
~6 months from final patient enrollment
NDA Preparation
~6 months from final data “lock”
NDA Filing
Late 2016 / Early 2017
Commercial Launch
2017
*Timeline dependent on observation of DLT at 50mg/m2 or 60mg/m2 cohort (each cohort = 6 – 8 weeks)
**FDA guidance meeting to be requested during MTD Dose Expansion Cohort (to be scheduled w/in 75 days of request)
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VAL-083 Clinical Trial:
Refractory GBM - Anticipated Registration Trial Design
 Design: Phase II/III Open Label Registration-Directed Trial
 Enrollment: 80 – 100 patients
 Primary Endpoints
 Overall Survival
 Radiographic Response
 Secondary Endpoints
 Quality of Life
 Safety and Tolerability
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Expanding Our Pipeline:
Front-line GBM
Ultimate Goal: Alternative Front-line
therapy >$1 billion market potential
DelMar’s Initial Focus
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Expanding Our Pipeline:
Front-line GBM
 VAL-083 may be a viable alternative front line therapy in
GBM
 VAL-083 is active independent of Temodar® resistance mechanisms
 Phase II/III clinical trial in newly diagnosed patients with
unmethylated MGMT promoter
 MGMT methylation correlates with response to Temodar®
 60 – 75% of newly diagnosed patients are unmethylated
 Modernized dosing regiment from current Phase I/II study
can be advanced for newly diagnosed patients
 Potential Market Opportunity: >$1 billion
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Building our pipeline
Non-small cell lung cancer
 Lung cancer remains a leading cause of death world-wide
 Most common cause of cancer-related death in men and women
 >80% of lung cancer is non-small cell lung cancer
 Large market opportunity: >$1 billion in annual sales
 Overall 5 year NSCLC survival rate: 15%
 40% of NSCLC is Stage IV at diagnosis with median survival <1 year & 5 year survival <2%
 CNS metastases are a leading cause of NSCLC mortality
 Standard of care: Surgery, radiation, platinum-based chemotherapy
 Tyroskine kinase inhibitors (TKIs) for EGFR mutated adenocarcinoma
 Existing and new data support potential utility of VAL-083 in NSCLC
 Historical data from NCI-sponsored research demonstrates evidence of activity
 VAL-083 is already approved in China for the treatment of lung cancer
 New DelMar data presented at AACR 2014
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Building our pipeline
Non-small cell lung cancer
DelMar Data from AACR 2014
VAL-083 outperforms standard platinum-based therapy
in a an accepted lung cancer model in vivo
A549 NSCLC
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Treatment
MTV* at
day 68
P value**
Untreated Control
637.8883
n/a
Cisplatin 5 mg/kg
460.305
0.059
VAL-083 1.5 mg/kg
440.1114
0.069
VAL-083 3 mg/kg
302.6333
0.001
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Building our Pipeline & Building Value:
Realizing Commercial Opportunity in China through
Specific Data and Appropriate Promotions
 NSCLC 2014 Goal
 Begin developing new clinical data to
support sales growth
 Achieve royalty revenue through sales
partnership
 Position VAL-083 for global
development in lung cancer
DelMar clinical research in China will be supported by our
manufacturing partner Guangxi Wuzhou Pharmaceuticals
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Implementing and Financing our Business Plan
Establishing New Global Intellectual Property
 Ten new patent applications filed claiming:
 Novel uses & label claims
 New methods & manufacturing improvements
 Analytical methods required for cGMP
 Chemical composition of API & Drug Product
 Biological profile / mechanism of action
 Two new US patents and one international patent issued to date
 Patent protection into 2031 in USA
 World-wide protection being sought through patent cooperation treaty (PCT)
in international jurisdictions for all DelMar patent filings
 Additional IP protection granted in USA & Europe under Orphan
Drug Act
 Seven years market exclusivity after approval in USA
 10 years market exclusivity after approval in Europe
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Leadership & Experience
Jeffrey Bacha, BSc MBA: CEO & President




20 years of experience in biotech and pharmaceuticals
Founding CEO, Inimex Pharmaceuticals
Senior Manager & Director, KPMG Health Ventures
MBA Emory Univ., BSc UC San Diego, BioPhysics/PreMed
Dennis Brown, PhD: Chief Scientific Officer





30 years cancer drug discovery and development
Founder: Matrix Pharmaceuticals (acquired by Chiron)
Founder: Chemgenex Pharmaceuticals (acquired by Cephalon)
Academic Appointments: Harvard & Stanford Medical Schools
NYU, PhD Radiation and Cancer Biology
A. Scott Praill, CA & CPA: Chief Financial Officer




Development
Team
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CFO, Strata Oil & Gas
Director Finance, Inflazyme Pharmaceuticals
Accountant articling: PricewaterhouseCoopers
Finance Degree BC Institute of Technology; BSc Simon Frasier
University
Responsible for successful development & commercialization
of >20 oncology products.
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Directors & Advisors
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Bill Garner, MD
Director, Co-founder DelMar; Founder of Update Pharma, Inc.
John K. Bell, CA
Director, President of Onbelay Capital
Robert J. Toth
Director, Former Wall Street Analyst
Victor Levin, MD
Prof. Emeritus MD Anderson Cancer Center (Neuro-Oncology)
Susan Chang, MD
Chair, NeuroOncology Department UCSF
James Perry, MD
Chair, Canadian Brain Tumor Consortium
Howard Burris, MD
Director, Sarah Cannon Cancer Research Institute
Bill Bodell, PhD
Prof. Emeritus UC Berkley (DNA Damage & Repair)
Dan Zhang, MD
SFDA Oncology Advisory Panel (China FDA)
Christine Charette
Former Biotech Analyst, BMO Nesbitt Burns
Sol Barer, PhD
Founder, Celgene
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CAPITALIZATION
&
CAPITAL MARKETS STRATEGY
“NATIONAL EXCHANGE LISTING ASAP”
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Implementing and Financing our Business Plan
CAPITALIZATION – PRO FORMA AT 31-/2014 (UNAUDITED)
Ticker (OTCQB): DMPI
Auditor: PriceWaterhouseCoopers LLP
Cash: $5.0 million (Working Capital thru Dec. 2015)
Shares Outstanding
DMPI Shares
ExchangeCo
Total outstanding
Warrants*
Options
30.5 million
7.0 million
37.5 million
17.2 million
3.2 million
Fully Diluted
57.9 million
*8.3 million investor warrants can be called at $0.80/share if stock is >$1.60/share for 20 consecutive trading
days
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Implementing and Financing our Business Plan
Opportunity for “up-listing”
 DMPI’s required OTC “seasoning period” has been completed
 Achieving a National Exchange Listing
 Expands Universe of Potential Shareholders
 Improved liquidity
 Improved access to capital
 Discussions initiated with NASDAQ and NYSE-MKT
 Net Equity Requirements
 NYSE-MKT: $4 million
 NASDAQ: $5 million
 Derivative liability associated with certain warrants reduces net
equity below qualification threshold
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Derivative Liability vs. Up-listing Requirements
 Derivative liability is a non-cash accounting liability, which
does not affect working capital
 Raised $10.5 million in Q1’2013 … but, had negative net equity
 Amount of liability INCREASES with stock-price
 Warrant exercise
 Source of non-dilutive capital to fund continued advancement of VAL-083 into
registration-directed clinical trials
 Reduces derivative liability and provides capital requirements for up-listing
 Summer 2014 Tender Offer started to “clean up” balance sheet
 4.4 million warrants exercised for gross proceeds of $2.9 million
 Non-dilutive cash to fund operations + reduce warrant liability = “double”
impact on net equity value
 DMPI net equity is now positive
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Near-term Capital Markets Goals
1.
Lead program funded to commercialization:
Total Cash Required = ~$8.5 million

2.
~5.0 million working capital on balance sheet @ 31-Aug
National Exchange Listing:
NASDAQ = $5m net equity
Two Options to Achieve Our Goals
 Non-Dilutive: Achieve goals through warrant exercise
 ~65% of remaining investor warrants exercised
 $3.5 - $4.0 million cash + reduction in derivative liability
 Dilutive: Achieve goals through new capital
 $7.5 million new capital (no reduction in derivative liability)
 Excess cash needed to overcome derivative liability to meet NASDAQ net
equity requirements
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2014 Corporate Goals:
Near Term Value Drivers
CLINICAL:
 Advance refractory glioblastoma clinical trial toward
registration-directed studies
 Expand pipeline opportunity beyond refractory GBM
FINANCIAL:
 Apply for an initial listing on the NYSEMKT or NASDAQ at the
earliest available opportunity
COMMERCIAL:
 Enable royalty-based cash flow from VAL-083 sales in China
©2014
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DelMar Pharma Investment Thesis
DelMar Pharmaceuticals, Inc.
 Clinical-stage oncology company
www.delmarpharma.com
 Proven drug candidate
Jeffrey Bacha, BSc, MBA – President & CEO
 Streamlined commercialization plan
 Commercial opportunity in China

[email protected]
 +1 650 269 1984
Scott Praill, CFA – Chief Financial Officer
 Near-term milestones

[email protected]
 +1 604 202 1384
 Highly experienced team
Mean
Median
Early Stage Cancer Companies
$315m
$153m
Early Stage OTCBB Biotech Companies
$88m
$57m
$40m
©2014
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[email protected]
 +1 604 317 7022
Dennis Brown, PhD – Chief Scientific Officer
 Attractive valuation
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