Dear Shareholders and Friends of DelMar Pharmaceuticals:
I am pleased to provide you with an update as of the quarter ended September 30, 2013 and a summary of progress toward our goals for the year.
Our Financials Are on Budget
As of September 30, 2013 we have cash and equivalents of approximately $5.2 million. Our working capital balance is in line with our expectations. Based on our operating budget, we estimate that these funds will provide us with sufficient capital to support our ongoing research and development activities for the next 18 months. We continue to explore options for funding to finance further research beyond that date.
Details of our quarterly financials can be found via the SEC Filings section of our website at: http://www.delmarpharma.com/investors/sec_filings/.
We Are Making Continued Progress with VAL-083 Clinical Trials in Brain Cancer
VAL-083 was studied in more than 40 historical human clinical trials sponsored by the National Cancer Institutes (NCI) in the United States and is approved as a cancer chemotherapy in China for the treatment of both chronic myelogenous leukemia (CML) and lung cancer. Historical data suggests that VAL-083 has activity against a broad range of tumor types, including glioblastoma multiforme (GBM) the most common and aggressive form of brain cancer, for which there are currently limited treatment options.
Our business model focuses on identifying well-validated clinical and commercial-stage compounds and establishing a scientific rationale for development in modern orphan cancer indications. To this aim, we are currently conducting a Phase I/II dose-escalation trial designed to assess the safety and preliminary efficacy of our lead product candidate, VAL-083, for the treatment of GBM.
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. More than half of patients fail the currently approved treatments.
The goal of our current clinical trial is to establish the optimal VAL-083 dosing regimen for both safety and efficacy in a U.S.-based GBM patient population. This dose would then be advanced into a Phase III GBM registration study, which we expect to commence in mid-2014 . During the past quarter, the U.S. Food and Drug Administration (FDA) undertook a detailed safety review of the Phase I/II trial and allowed us to accelerate our dose escalation program. While this modification is unlikely to shorten the trial due to the length of our discussions with the FDA throughout this review, we should realize significant cost savings as fewer patients will be exposed to sub-optimal doses within the escalation study. We will present additional data from the ongoing Phase I/II trial during the Society for NeuroOncology (SNO) Annual Meeting on Friday November 22, 2013.
We Are Strengthening Our Intellectual Property Portfolio
We have filed a broad portfolio of new patent applications to protect our intellectual property. Our patent applications claim compositions and methods related to the use of VAL-083 and related compounds as well as methods of synthesis and quality controls for the manufacturing process of VAL-083. In addition to our patent portfolio, VAL-083 has been granted Orphan Drug protection for the treatment of glioma, including GBM, in both the U.S. and Europe. The orphan drug designation provides VAL-083 with market exclusivity following approval for seven years in the United States and ten years in Europe.
Earlier this year, we announced that a new patent covering methods for synthesizing VAL-083 had been granted to us by the United States Patent & Trademark Office. We continue to prosecute this as well as our other patent applications on a worldwide basis and we anticipate that additional patents will be granted in the future.
We Are Developing a Commercial Opportunity for VAL-083 in China
In 2006, VAL-083 received national approval in China as a treatment for both chronic myelogenous leukemia (CML) and lung cancer. However, the drug has never been actively marketed for the treatment of these diseases. In 2012, we established a collaboration and exclusive global supply agreement with Guangxi Wuzhou Pharmaceuticals, the only company licensed by the Chinese Food and Drug Administration to manufacture VAL-083 for the China market. We are working closely with our partner to support their cGMP qualification as an exclusive supplier for our global development of VAL-083.
Our research suggests that VAL-083 may have a valuable place in the modern treatment of CML and lung cancer, both in China and worldwide. During the past quarter, we established a clinical advisory board with leading cancer physicians in China. Our intention is to work with these clinicians and our partner, Guangxi Wuzhou Pharmaceuticals, to develop new post-market clinical data to support the utility of VAL-083 in the context of modern care under its existing approval in China. We believe these new clinical data, if favorable, would allow for the repositioning of VAL-083 in the China market as well as expanding its prospects for worldwide development. Guangxi Wuzhou Pharmaceuticals will provide funding for clinical trials conducted in China and will be the exclusive supplier of VAL-083, and DelMar will be responsible for undertaking clinical development and commercialization activities.
We are continuing our efforts to secure a sales and marketing partner for VAL-083 in China. We are in discussions with potential partners who have who have significant experience marketing oncology products in the China marketplace and who could be valuable in helping to position VAL-083 within this market. Our goal is to establish a sales and marketing relationship that will provide DelMar with ongoing royalty payments from sales in the China market.
We Are Attempting to Create Important New Medicines for Patients and Increased 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,
Jeffrey A. Bacha
President and CEO
DelMar Pharmaceuticals
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