DelMar Pharmaceuticals Announces Third Quarter Fiscal Year 2016 Financial Results

DelMar Pharmaceuticals (OTCQX:DMPI) announced its financial results for the quarter ending March 31, 2016, the third quarter of the 2016 fiscal year. The Company also highlighted recent corporate and clinical achievements and provided an overview of expected near-term milestones.
As quoted in the press release:

RECENT CORPORATE HIGHLIGHTS

• Raised $6.1 million in new capital through private placement of preferred shares and restructured certain investor warrants in order to help position the Company to qualify to list its common stock on a senior exchange;
• Confirmed that the Company plans to meet with the US Food and Drug Administration (FDA) to discuss a Phase III study design for refractory glioblastoma multiforme (GBM) during the first half of 2016;
• Presented new data demonstrating that VAL-083 appears to have a distinct mode of action from other chemotherapies widely used in the treatment of cancer;
• Entered into a collaboration agreement with the University of Texas MD Anderson Cancer Center (MD Anderson) to accelerate the clinical development of VAL-083 for the treatment of GBM.  As part of the collaboration, MD Anderson will initiate a new Phase II clinical study with VAL-083 in patients with GBM at first recurrence/progression, prior to Avastin® exposure;
• Obtained an orphan drug designation for VAL-083 in the United States for the treatment of ovarian cancer and medulloblastoma, in addition to previous orphan drug designations for VAL-083 in glioma in the USA and Europe; and
• Presented data at the American Association for Cancer Research (AACR) annual meeting that confirmed a well-tolerated VAL-083 dosing regimen of 40 mg/m²/daily every 3 days in a 21-day cycle has been selected for advancement into a Phase III study as a potential new therapy for the treatment of refractory GBM.

EXPECTED NEAR-TERM MILESTONES

• Apply to list our shares on a senior stock exchange;
• Engage the FDA regarding the design of a proposed registration-directed Phase II/III clinical trial for VAL-083 in refractory GBM;
• Initiate the Phase II clinical study at MD Anderson with VAL-083 in patients with GBM at first recurrence/progression;
• Initiate clinical studies in newly-diagnosed GBM patients as an alternative to temozolomide in patients with high expression of MGMT;
• Initiate new clinical trials with VAL-083 in refractory non-small cell lung cancer;
• Initiate registration-directed Phase II/III clinical trials for VAL-083 as a new treatment option for refractory GBM in 2016;
• Continue to pursue pre-clinical research with leading investigators to advance VAL-083 as a potential treatment for other chemo-resistant cancers including ovarian cancer and pediatric medulloblastoma;
• Maximize the value of the VAL-083 pipeline through potential partnering opportunities in high value oncology markets;
• Continue to build the Company’s intellectual property portfolio; and
• Continue to implement strategies to enable DelMar to meet qualifications to list its shares on a senior stock exchange.

DelMar Pharmaceuticals Chairman & CEO, Jeffrey Bacha, stated:

Our data continues to demonstrate VAL-083’s unique cytotoxic anti-cancer mechanism which may provide new treatment opportunities for patients whose cancer has failed or is unlikely to respond to currently available therapies.  In particular, the data we have presented in our refractory GBM clinical trial positions us to advance this program into registration-directed Phase III clinical trials and we look forward to discussing our proposed trial design with the FDA.
Importantly, new funds raised subsequent to quarter end enable us to fund current operations through 2017 and help position DelMar to qualify to list its common stock on a senior exchange.

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