DelMar Pharmaceuticals Announces September 30, 2014 Results and Provides Corporate Update

VANCOUVER, British Columbia and MENLO PARK, Calif., Nov. 10, 2014 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (OTCQB: DMPI) ("DelMar" "the company") today announced the filing of September 30, 2014 quarterly financial statements. 

DelMar's financial statements as filed with the U.S. Securities Exchange Commission can be viewed on the company's website at: http://ir.delmarpharma.com/all-sec-filings. The company will host an investor update call to discuss recent highlights and plans for continued advancement of its business plan on Monday, November 10, 2014 at 2PM PST / 5PM EST. 

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A summary of recent corporate highlights include:

• We filed a protocol amendment with the U.S. Food and Drug Administration (FDA) for our ongoing clinical trial with VAL-083 as a potential new treatment for refractory glioblastoma multiforme (GBM). The amendment allows for enrollment of two additional doses of VAL-083: 50mg/m² and 60mg/m². We are now delivering substantially higher doses compared to previous clinical trials conducted by the National Cancer Institutes (NCI) in the United States. We believe that such higher doses may enhance the potential of VAL-083 to impact a patent's tumor and as well as to improve patient outcomes.
• We received a notice of allowance from the United States Patent and Trademark Office for our second U.S. patent covering VAL-083. We currently hold two U.S. patents and one international patent, and have filed a total of ten patent applications, which are being prosecuted in the United States and International jurisdictions.
• We presented new non-clinical research supporting the potential utility of VAL-083 in the treatment of non-small cell lung cancer at AACR's New Horizons in Cancer Research on October 9, 2014. This research is an important component of our strategy to broaden our product development pipeline beyond our first program in refractory GBM.
• We continued efforts to expand our visibility within the capital markets and Roth Capital Partners initiated research coverage on November 6, 2014.  A list of research analysts currently covering DelMar can be found on our website at:  http://www.delmarpharma.com/investors/contacts/
• We raised approximately $1.3 million in additional non-dilutive capital through warrant exercise during the quarter ended September 30, 2014 and subsequent to period end.

The following represents selected financial information as at September 30, 2014 and June 30, 2014. The company's financial information has been prepared in accordance with US GAAP and this selected information should be read in conjunction with DelMar's financial statements and Management's Discussion and Analysis (MD&A), as filed.

Selected Balance Sheet Data:

We have continued to work with our warrant holders to access non-dilutive capital and reduce the derivative liability. Subsequent to the quarter ended September 30, 2014 we raised an additional $738,626 to fund operations and reclassified a portion of our derivative liability to equity. Based on our current operations, we have working capital sufficient to fund the company's activities through at least the end of the first calendar quarter of 2016.

Cash received from the exercise of the warrants and the reclassification of a portion of the derivative liability resulted in an increase in net equity of approximately $1.9 million subsequent to September 30, 2014. The increase subsequent to the period end combined with the equity on our balance sheet at September 30, 2014, results in pro-forma net equity in excess of $2.0 million. This is an important milestone toward listing our shares on a more senior stock exchange and improving liquidity for our shareholders. Details of these transactions can be found on our website at: http://ir.delmarpharma.com/all-sec-filings

Selected Statement of Quarterly Operations (net of share-based payments):

The largest component of research and development expenses are attributable to clinical development costs as the Company continued with its Phase I/II clinical trial with VAL-083 in recurrent GBM, the most common and deadly form of brain cancer. VAL-083 is a small-molecule chemotherapy with a unique "first-in-class" chemical structure and cytotoxic mechanism.  In prior clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 exhibited clinical activity against a number of tumor-types in a number of cancers including lung, brain, cervical, ovarian and hematologic malignancies. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia and lung cancer and has received orphan drug designation in Europe and the United States for the treatment of gliomas. Our research demonstrates that VAL-083 may provide a new therapeutic option for GBM patients who fail or are unlikely to respond to current standard of care. 

The goal of our current clinical trial is to establish a modernized dosing regimen for advancement into registration directed trials in the United States as a potential new therapy for the treatment of refractory GBM. The current trial involves studying the safety and tolerability of VAL-083 in escalating doses to determine the maximum tolerated dose (MTD) in a modernized dosing regimen.  To date, no drug-related serious adverse events have been detected and MTD has not been reached at doses up to 40mg/m², and we are currently studying a dose of 50mg/m².  

"At this time, we have identified or enrolled sufficient patients to fill the 50mg/m² cohort; however, to date none have completed the required 35 day period following dosing to meet the primary endpoint for determination MTD," stated Jeffrey Bacha, president & CEO of DelMar Pharmaceuticals. 

"Our clinical protocol requires us to obtain safety data for 35 days following a patient's initial treatment with VAL-083. Normal instances in clinical development such as patient ineligibility at screening, failure to obtain patient consent or patient death prior to 35 days following dosing may require identification and recruitment of replacement patients.  Once we have 35-day safety data from three patients in the 50mg/m² cohort, we will either confirm MTD or advance to higher doses. We will work with our clinical advisors to obtain and analyze these data in the timeliest manner possible. Based on our current enrollment and timelines, we believe we remain on track to advance to registration directed trials with VAL-083 in the first half of 2015."

Detailed results will be presented at the Society for NeuroOncology Annual Meeting on Friday November 14, 2014 and available on DelMar's website at http://www.delmarpharma.com/products/publications/.

We also continued our efforts to expand our drug development efforts beyond our lead program.  Results presented at the AACR New Horizons in Cancer conference on October 9, 2014 suggest that VAL-083 is superior to cisplatin in both TKI-sensitive and resistant tumor models, has synergistic effect in combination with cisplatin, and suggest clinical potential in TKI-resistant NSCLC. Details of DelMar's presentation are posted under http://www.delmarpharma.com/products/publications/ 

"VAL-083 is approved for the treatment of lung cancer in China," stated Mr. Bacha. "These data provide support to influencing practice patterns and commercial positioning of VAL-083 under the current approval in China and provide direction to clinical research to support expanded global development. Next steps include clinical validation of these promising results in a clinical study. We plan to initiate this work in China in a post-approval setting in the first half of 2015. Our collaborator in China, Guangxi Wuzhou Pharmaceutical (Group) Co., Ltd., will fund these clinical studies in accordance with the terms of our collaboration agreement with their company." 

About DelMar Pharmaceuticals

DelMar Pharmaceuticals was founded in 2010 to develop and commercialize proven cancer therapies in new orphan drug indications where patients are failing modern targeted or biologic treatments. The Company's lead asset, VAL-083, is currently undergoing clinical trials in the United States as a potential treatment for recurrent glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. VAL-083 benefits from extensive clinical research sponsored by the U.S. National Cancer Institute (NCI) and is currently approved for the treatment of chronic myelogenous leukemia (CML) and lung cancer in China. Published pre-clinical and clinical data suggest that VAL-083 may be active against a range of tumor types via a novel mechanism of action. DelMar's scientific presentations can be viewed on the company's website at www.delmarpharma.com.

Safe Harbor Statement

Any statements contained in this press release 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 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.

For further information, please visit www.delmarpharma.com.

SOURCE DelMar Pharmaceuticals, Inc.