VANCOUVER, BC and MENLO PARK, CA--(Marketwired - Aug 13, 2013) - DelMar Pharmaceuticals, Inc. (
Dear Shareholders and Friends of DelMar Pharmaceuticals:
I am pleased to provide you with an update on the first half of 2013 and a summary of progress toward our goals for the year.
Funding Research Plans On Track
As of June 30, 2013 we have cash and equivalents of $6.3 million. Based on our current operating budget, we estimate that these funds will provide us with working capital to support our drug development and corporate activities through at least March 31, 2015. Certain increases in expenditures during the six-month period ended June 30, 2013 were related to non-cash expenses such as one-time share-based payments. After considering the impact of share-based payments, our expenditures on research & development increased significantly compared to the same period last year in accordance with our research plan. Our general and administrative expenditures have also increased largely related to increased costs of managing a public company, and one-time costs associated with our reverse take over transaction (RTO) and public listing in the first quarter.
Details of our quarterly financials can be found via the SEC Filings section of our website at: http://www.delmarpharma.com/investors/sec_filings/.
VAL-083 Clinical Trial Shows Positive Interim Results
We are currently conducting a Phase I/II dose-escalation clinical trial designed to assess the safety and efficacy of our lead product candidate, VAL-083, as a potential treatment for brain cancer patients suffering from glioblastoma multiforme (GBM) and secondary brain tumors who have failed standard therapies and have no viable treatment options. During the past quarter, we continued to advance this clinical trial.
In June, we presented additional interim data from our VAL-083 clinical trial at the American Society of Clinical Oncology (ASCO) 2013 Annual Meeting. At ASCO, we also announced our intention to divide the trial into two separate arms: one focused on refractory GBM and the other focused on secondary brain tumors resulting from other cancers which have spread to the brain. We believe the strategy of splitting the trial into two separate studies will enable us to focus on accelerating the development of VAL-083 as a potential new treatment for glioblastoma while appropriately exploring the potential of the drug to treat patients with solid tumor brain metastases.
In general, the results reported to date have shown promising drug activity and we believe that VAL-083 represents a potential new treatment option for brain tumor patients who have failed or are unlikely to benefit from today's standard of care.
We remain focused on completing the dose escalation portion of the clinical trial with the goal of positioning VAL-083 for advancement into registration directed clinical trials. We anticipate presenting additional data at upcoming scientific and business meetings during 2013.
Developing VAL-083 Commercial Opportunities in China and Beyond
We are also continuing to work toward leveraging potential near-term commercial opportunities with VAL-083, which is currently approved in China for the treatment of chronic myelogenous leukemia (CML) and lung cancer. DelMar has established a collaboration and exclusive supply agreement with Guangxi Wuzhou Pharmaceuticals, the only company licensed by the Chinese Food and Drug Administration to manufacture VAL-083 as a cancer therapy. We are working in collaboration with Guangxi Wuzhou Pharmaceuticals to ensure the product specifications meet global standards in order to accelerate international development and regulatory approval for VAL-083 on a worldwide basis.
We are also working toward developing new clinical and non-clinical data in collaboration with leading cancer researchers in China to demonstrate the utility of VAL-083 in the treatment of CML and lung cancer in the context of the current standard of care. We believe these new data, if favorable, will allow the repositioning of VAL-083 in the China market, and eventually global markets, for the treatment of hematologic cancers and solid tumors. We are seeking a marketing partner for VAL-083 in China and we envisage signing a deal that generates royalty revenue from that market in the near-term.
As part of this effort, Guangxi Wuzhou Pharmaceuticals will provide funding for clinical trials conducted in China and will be the exclusive supplier of DAG for injection, and DelMar will be responsible for development and commercialization. DelMar is currently seeking to establish a separate collaboration for the distribution, sales and marketing of VAL-083 in China.
We plan on participating in industry and financial conferences to widen investor awareness of our company and provide continual communications with shareholders and potential investors during the coming months.
Creating Valuable Medicines for Patients and Value for Shareholders
On behalf of the entire DelMar Pharma team, I thank you for your continued support of our mission to develop and commercialize proven medicines for patients who have failed currently available therapy. As always, our goal remains to serve patients who have unmet clinical needs and to build value for our shareholders in the timeliest manner possible.
With warm personal regards,
/s/ Jeffrey A. Bacha
Jeffrey A. Bacha
President and CEO
Safe Harbor Statement
Any statements contained in this update 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.