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Business Update Conference Call

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Presentation on theme: "Business Update Conference Call"— Presentation transcript:

1 Business Update Conference Call
May 19, 2016

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.

3 DelMar Pharmaceuticals, Inc
DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) 2016: A Transformational Year Recent Highlights FINRA approved 1:4 reverse stock split in preparation for senior exchange up-listing $6.1 million private placement Restructured 72% of outstanding investor warrants to reduce derivative liability Presented three abstracts at American Association for Cancer Research Annual Meeting US FDA expanded orphan designation for VAL-083 to include medulloblastoma and ovarian cancer MD Anderson Collaboration for first-recurrence of GBM

4 Selected Statement of Operations Data for the three months ended:
Current operating funds thru end of 2017 Quarterly Burn: ~$1 million Cash available from “in the money” warrants: $10 million Net Equity and operating funds sufficient to meet senior exchange requirements $000 March 31, 2016 March 31, 2015 (as restated) Research & Development $ $ General & Administrative 630 501 Change in fair value of derivative liability (269) 781 Loss on exchange of warrants -- 156 Foreign exchange (gain) loss (11) 7 Net loss from operations $ 1,140 $ 2,087 Basic loss per share $0.03 $0.05

5 DelMar Pharmaceuticals Financial Snapshot
Current operating funds thru end of 2017 Quarterly Burn: ~$1 million Cash available from “in the money” warrants: $10 million Net Equity and operating funds sufficient to meet senior exchange requirements 31-Mar/2016 Pro-Forma Cash $937K $6.4 m Derivative Liability $1.0 m $500K Net Shareholders Equity/(Deficit) $(687K) $5.3 m Common Shares Outstanding Pre-split Post-split DMPI Shares 40.2 m 10.0 m ExchangeCo 4.0 m 1.0 m Total Outstanding 44.2 m 11.0 m Other securities (as converted to common) Preferred Shares 7.6m 1.9 m Warrants 18.4 m 18.7m 4.7 m Options 3.5 m 3.4m 0.9 m Fully Diluted 66.1 m 73.9 m 18.5 m

6 Select Senior Exchange Listing Requirements
DelMar current net equity and operating funds sufficient to meet senior exchange requirements LISTING STANDARD NYSE-MKT NASDAQ Standard #2 Standard #3 Equity Standard Market Value Standard Stockholders Equity $4 million $ 4 million $ 5 million Market Cap n.a. $50 million Round Lot Holders 400 300 Minimum Bid Price $3 $2 $4

7 VAL-083: DelMar’s Initial Product Candidate
Historical data from NCI-sponsored research First-in-class small molecule chemotherapy >40 NCI-sponsored clinical trials demonstrate clinical activity against multiple tumor types CNS, Solid & Hematologic Tumors Readily crosses blood-brain-barrier Safety database: >1000 patients Safety & toxicity Pharmacokinetics C6H10O MW=146

8 SOLVE UNMET NEEDS IN CANCER TREATMENT TODAY
VAL-083: DelMar’s Initial Product Candidate Leveraging Historical Clinical Data with Modern Science Reduce Cost, Risk & Time in Drug Discovery & Development SOLVE UNMET NEEDS IN CANCER TREATMENT TODAY VAL-083 PRIOR CLINICAL VALIDATION > 40 NCI-sponsored clinical trials Ex-USA clinical research Modern Understanding of Biological Mechanism New I.P.

9 AACR 2016: VAL-083 Mechanism of Action
s-phase arrest

10 AACR 2016: VAL-083 Mechanism of Action
VAL-083 takes advantage of defects in cellular machinery that is common to cancer cells VAL-083 rapidly forms DNA cross links at N7-position of guanine Cancer cells are defective in DNA damage checkpoints Cross-link is durable and difficult for cancer cells to repair Cancer cells are defective in homologous repair mechanism Cell cycle arrest and cancer cell death in S-phase during DNA replication Active independent of common chemo-resistance mechanisms (e.g. MGMT, MMR, p53) Resistance to VAL-083 treatment is difficult for cancer cells to acquire

11 VAL-083 Targeting Unmet Medical Needs in Cancer
VAL-083 Mechanism: Differentiation from Standard-of-Care Chemotherapy = Commercial Opportunity in Solving Unmet Medical Needs Chemotherapy = standard of care VAL-083 historical clinical activity chemo resistance = unmet medical need

12 VAL-083 Targeting Unmet Medical Needs in Cancer
Data supports VAL-083 for multiple cancer indications 2014 ww Revenue Non-small cell lung cancer $6.8 B Glioma $1.0 B Ovarian cancer >$500 M Pediatric medulloblastoma orphan Source: Evaluate Pharma

13 VAL-083’s First Opportunity: A Paradigm Shift in the Treatment of GBM
VAL-083 Addresses MGMT-mediated resistance: A Major Unmet Need 2/3 of newly diagnosed GBM patients are resistant to Temodar® due to high-expression of MGMT VAL-083 is active independent of MGMT-resistance MGMT is a biomarker for patient selection Prior NCI-sponsored trials demonstrate clinical activity against GBM

14 VAL-083 Post Avastin Refractory GBM Ongoing Phase I/II Clinical Trial
AACR 2016 Ongoing Phase I/II Clinical Trial in Post-Avastin GBM Defined well-tolerated dosing regimen with good therapeutic window Treating “most difficult” GBM patients (high MGMT + IDH1wt ) Observed clinical activity (survival benefit) supported by pharmacokinetic data Next Steps: Meeting with USFDA to discuss planned Phase III Clinical Trial in Post-Avastin GBM Two New Phase II Clinical Trials in GBM Patients with High MGMT Newly Diagnosed First Recurrence Phase I/II: Safety Study of VAL-083 in Patients With Recurrent Malignant Glioma Patients have failed Temodar® (temozolomide) and Avastin® (bevacizumab) ClinicalTrials.gov Identifier: NCT

15 VAL-083 Post Avastin Refractory GBM Ongoing Phase I/II Clinical Trial
We have determined a dosing regimen suitable for advancement to registration-directed trials 40 mg/m2/daily every 3 days in a 21 day cycle has been selected for advancement Dose limiting toxicities (DLT) observed at doses above 40 mg/m2 DLT primarily thrombocytopenia, resolves rapidly and spontaneously following treatment No DLT observed below 40 mg/m2 One DLT due to prior drug exposure observed at 40 mg/m2 Addressed via enrollment criteria requiring higher platelets for patients with prior nitrosourea

16 VAL-083 Post Avastin Refractory GBM Ongoing Phase I/II Clinical Trial
Assess Patient Outcomes: Data suggests survival signal superior to historical literature in Avastin-failed GBM patients Pharmacokinetics support activity Reference Post Avastin Salvage Therapy Median Survival from Avastin Failure Rahman (2014) nitrosourea 4.3 months Mikkelson (2011) TMZ + irinotecan 4.5 months Lu (2011) dasatinib 2.6 months Reardon (2011) etoposide 4.7 months TMZ 2.9 months Iwomoto (2009) various 5.1 months VAL-083 interim Therapeutic Dose After Avastin Failure 6 months 9 months 12 months 52% 43% 22% Expected Median OS: 8 – 9 months 40 mg/m2/d Estimated Maximum Tumor Concentration in Brain (day 3) IC50 in GBM Cell Lines 3.86 μM 2 – 4 μM

17 VAL-083 Post Avastin Refractory GBM Ongoing Phase I/II Clinical Trial
Important factor Majority of GBM tumors tested for biomarkers in VAL-083 trial exhibited features associated with particularly poor outcomes High expression of MGMT: 84% IDH1wt : 91% Impact of MGMT and IDH1 on Survival (published studies) MGMT Expression mOS Low 23 months High 16 months Gilbert et al, JCO 2013 Isocitrate dehyrogenase (IDH1) mOS IDH mutant >60 months IDH1 wild-type ~18 months Combs et al., Rad Onc 2011 Time (months) 100- 80- 60- 40- 20- Overall Survival (%) 12 24 36 48 MGMT Promoter (expression) Methylated (low) Unmethylated (high) IDH1MUT IDH1WT 100- 80- 60- 40- 20- 11 Overall Survival (%) 10 20 30 40 50 60 80 90 Time (months)

18 VAL-083’s First Opportunity: GBM 2016 Clinical Plan … Implementing the Paradigm Shift
Current Treatment Paradigm New Paradigm Vision for VAL-083 Diagnosis Diagnosis Surgical “debulking” Surgical “debulking” Temodar® + Radiation MGMT Assessment 2/3 of patients fail HIGH MGMT (unmethylated) LOW MGMT (methylated) Avastin® 2/3 VAL-083 + Radiotherapy 1/3 Temodar® + Radiotherapy No impact on survival VAL-083 Phase II/III Clinical Trial Refractory GBM Planed H2-2016 Describe paradigm shift for 2/3 of patients China Clinical Trial to begin H1-2016 USA-MDACC Clinical Trial to begin H1-2016 Newly Diagnosed GBM VAL-083 + Radiotherapy First GBM Recurrence following temozolomide failure MDACC: MD Anderson Cancer Center

19 VAL-083’s First Opportunity: GBM
VAL-083’s distinct anti-cancer mechanism Would create a new survival paradigm for the first time in decades Unlocks potential to overcome chemo-resistance and surpass standard of care Lays the foundation for global development to address >$1 billion market opportunity as chemotherapy of choice in the treatment of GBM

20 Expanding DelMar’s VAL-083 Portfolio
VAL-083 Mechanism: Differentiation from Standard-of-Care Chemotherapy = Commercial Opportunity in Solving Unmet Medical Needs Glioblastoma Multiforme Non-small cell lung cancer Ovarian Cancer CNS metastases Combination chemotherapy Pediatric brain tumors Chemotherapy = standard of care VAL-083 historical clinical activity VAL-083 unique mechanism to overcome chemo- resistance

21 China – Partnered with Manufacturer
DelMar Pharma 2016: A Transformational Year PROFORMA: H NYSE/NASDAQ: DMPI VAL-083 Phase I Phase II Phase III NDA / COMMERCIAL STATUS: May 2016 GBM: Post-Avastin FDA End of Phase 2 meeting H1-2016 GBM: First-recurrence (MDACC) Two new GBM Trials: IRB/Ethics Committee Submissions Underway GBM: Newly Diagnosed MGMT+ Non-small cell lung cancer Protocol update based on mechanism Ovarian Pre-clinical research into combination therapies Pediatric CNS Tumors Pre-clinical research and discussions with KoLs regarding clinical protocol design Grant supported research Potential to expand pipeline in additional indications China – Partnered with Manufacturer Lung Cancer – CFDA Approved CML – CFDA Approved

22 Growing Patent Portfolio: Robust Intellectual Property Protection
Eight separate patent families with multiple patents Claims include use, manufacturing, analytical, mechanism and composition claims Five US patents and four international patents issued to date Patent protection into 2033 in USA 90 additional patents + 4 provisional applications pending VAL-083 granted orphan drug designation in US & EU Seven years market exclusivity after approval in US 10 years market exclusivity after approval in Europe

23 2016: Actionable Milestones
DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) 2016: A Transformational Year 2016: Actionable Milestones Clinical Research Refractory GBM Advancing to Phase III Front-line GBM New Phase II clinical trial planned First Recurrence in GBM New Phase II clinical trial planned (collaboration with MDACC) Non-small cell lung cancer Pre-clinical Research Ovarian Cancer Pre-clinical research to define clinical strategy Medulloblastoma Combination Therapies Pre-clinical research underway Regulatory FDA Guidance Meeting in preparation for Phase III clinical trials in refractory GBM Corporate National Exchange Listing (NYSE-MKT or NASDAQ)

24 DelMar Pharmaceuticals Investment Opportunity
VAL-083 “First‐in‐class" small molecule chemotherapy Unique anti-cancer mechanism overcomes chemo-resistance NCI demonstrated clinical activity across a range of cancers Promising interim outcomes data in refractory GBM clinical trial Advancing to “late-stage” clinical development in 2016 Pipeline expansion opportunities in high value oncology markets Robust IP protection from newly issued patents Orphan drug designation in USA and EU Experienced Team with History of Success Solid Financial Position Transformational Near-term Catalysts

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