VANCOUVER, British Columbia and MENLO PARK, Calif., May 18, 2017 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced its financial results for the quarter ending March 31, 2017, the third quarter of the Company's 2017 fiscal year. DelMar's executive management will host a business update conference call and live webcast for investors, analysts and other interested parties on Wednesday May 24th, 2017 at 4:30 p.m. Eastern Standard Time.
RECENT CORPORATE HIGHLIGHTS
Completed public offering of common stock and warrants for gross proceeds of $9.0 million
Continued to advance the development of VAL-083 as a potential new treatment for Glioblastoma Multiforme ("GBM")
Expanded research collaborations with leading academic institutions
Presented promising research results supporting the potential of VAL-083 in the treatment of other cancers at leading scientific conferences
"Our recent financing enables us to remain on-track to initiate the pivotal Phase 3 clinical trial of VAL-083 in refractory GBM. This milestone, combined with VAL-083's recent scientific advancements form the foundation for this molecule to serve as a platform asset addressing unmet medical needs in a broad range of tumor types including GBM, non-small cell lung cancer, ovarian cancer and other solid tumors both as a single agent and as a key component of combination therapy regimens," stated Jeffrey Bacha DelMar's chairman & CEO.
In April, the Company announced the closing of a $9 million offering of common stock and warrants which was led by leading healthcare dedicated institutional investors.
During the quarter, the Company made key advancements for VAL-03 as a treatment for GBM patients whose tumors express features, such as high expression of the enzyme MGMT, that make their cancer resistant to, or unlikely to, respond to currently available therapy. Accomplishments achieved included submitting a protocol to the FDA for a pivotal, controlled Phase 3 Study in Temozolomide-Avastin Recurrent GBM ("STAR-3") to evaluate overall survival versus salvage chemotherapy for GBM patients who have previously failed both temozolomide (Temodar™) and bevacizumab (Avastin™). The Company also announced a collaboration with PRA Health Sciences ("PRA") as the contract research organization to oversee and manage the Company's pivotal VAL-083 STAR-3 GBM clinical trial. PRA Health Sciences is one of the world's leading global contract research organizations, providing outsourced clinical development services to the biotechnology and pharmaceutical industries. PRA's global clinical development platform includes more than 70 offices across North America, Europe, Asia, Latin America, South Africa, Australia and the Middle East, and approximately 13,000 employees worldwide.
During the period, the Company also continued enrolling its Phase 2 clinical study of VAL-083 in patients with MGMT-unmethylated GBM at first recurrence/progression prior to bevacizumab (Avastin®) exposure in collaboration with the University of Texas MD Anderson Cancer Center ("MD Anderson"). Additionally, DelMar received ethics committee approval, retained a contract research organization, and submitted an application to the China Office of Human Genetic Resources Authority ("OHGRA") to allow for initiation of the Company's planned Phase 2 clinical trial in newly diagnosed patients with MGMT-unmethylated GBM at Sun Yat Sen University in Guangzhou, China. DelMar also entered into a sponsored research agreement with Duke University to evaluate VAL-083 as a front-line treatment for newly diagnosed patients with GBM.
DelMar also continued to present promising research results supporting the potential of VAL-083 in the treatment of a range of cancers, including GBM, at leading scientific conferences. The Company presented data supporting the effectiveness of VAL-083 against chemotherapy-resistant ovarian cancers at the 11th Biennial Ovarian Cancer Research Symposium. Additionally, data was presented indicating that VAL-083 offers potential therapeutic alternatives in difficult-to-treat pediatric brain tumors – Advances in Pediatric Research: From Mechanisms and Models to Treatment and Survivorship. In April, new non-clinical data supporting the differentiation of VAL-083 in the treatment of lung cancer was presented at the American Association for Cancer Research's ("AACR") annual meeting. And in May, the Company presented new research at the 5th Quadrennial Meeting of the World Federation of Neuro-Oncology Societies demonstrating that VAL-083 circumvents both of the primary mechanisms correlated to chemoresistance to temozolomide, the current standard of care in the treatment of GBM.
"GBM represents one of the few cancers that has been largely left behind in the tremendous medical advancements of modern cancer care. Success in our GBM clinical trials will provide VAL-083 as a new treatment for patients who currently have no viable therapeutic option," said Mr. Bacha. "Our research with VAL-083 also seeks to expand this opportunity beyond GBM to a wide range of solid tumor patients whose cancer is resistant or unlikely to respond to currently available treatments. Unlocking the value of VAL-083 for our patients and our shareholders is our primary goal."
CONFERENCE CALL DETAILS
DelMar plans to host a conference call to discuss quarterly results and provide a corporate update on Wednesday, May 24th, 2017, at 4:30 p.m. Eastern Standard Time. For both "listen-only" participants and those who wish to take part in the question and answer portion of the call, the telephone Dial-in Number is 800‑894‑5910 (toll free) with Conference ID DELMAR.
SUMMARY OF FINANCIAL RESULTS FOR THE QUARTER ENDED MARCH 31, 2017; THIRD QUARTER OF FISCAL YEAR 2017
For the three months ended March 31, 2017 the Company reported a net loss of $1,868,460 or $0.18 per share, compared to a net loss of $1,140,401, or $0.10 per share for the three months ended March 31, 2016.
For the nine months ended March 31, 2017 the Company reported a net loss of $5,480,772 or $0.54 per share, compared to a net loss of $5,408,479, or $0.50 per share for the nine months ended March 31, 2016.
Our quarterly expenditures during the current fiscal year to date have been consistent and reflect increased activities being undertaken in preparation for initiation of our planned pivotal Phase 3 clinical trial.
The following represents selected financial information as of March 31, 2017. The Company's financial information has been prepared in accordance with U.S. GAAP and this selected information should be read in conjunction with DelMar's consolidated financial statements and management's discussion and analysis ("MD&A"), as filed.
Change in fair value of stock option and derivative liabilities
Change in fair value of derivative liability due to change in warrant terms
Foreign exchange loss (gain)
Net and comprehensive loss for the period
Series B preferred stock dividend
Net and comprehensive loss available to common stockholders
Basic weighted average number of shares outstanding
Basic and fully diluted loss per share
Excluding the impact of non-cash expense, research and development expenses increased to $968,332 during the three months ended March 31, 2017 from $660,857 for the three months ended March 31, 2016. The difference was largely attributable to an increase in clinical research and intellectual property costs. Clinical research costs have increased due to protocol development and manufacturing activities conducted in preparation for our pending pivotal Phase 3 clinical trial in refractory GBM, our two Phase 2 clinical trials in MGMT-unmethylated GBM as well as an expansion of our preclinical and other research activities compared to the prior period.
Excluding the impact of non-cash expenses, general and administrative expenses increased in the three months ended March 31, 2017 to $635,769 from $517,030 for the three months ended March 31, 2016. The increase was largely attributable to activities undertaken in preparation for our recent financing.
We estimate that our current working capital, including proceeds from our recent financing is sufficient to support our planned operations for the next 18-24 months.
VAL-083 is a "first-in-class," small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments.
VAL-083 has received an orphan drug designation in Europe for the treatment of malignant gliomas and the U.S. FDA Office of Orphan Products has granted an orphan designation to VAL-083 for the treatment of glioma, medulloblastoma and ovarian cancer.
About DelMar Pharmaceuticals, Inc.
DelMar Pharmaceuticals, Inc. was founded to develop and commercialize new cancer therapies in indications where patients are failing or have become intolerable to modern targeted or biologic treatments. The Company's lead drug in development, VAL-083, is currently undergoing clinical trials in the U.S. as a potential treatment for refractory glioblastoma multiforme. VAL-083 has been extensively studied by U.S. National Cancer Institute, and is currently approved for the treatment of chronic myelogenous leukemia 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 that could provide improved treatment options for patients.
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.