DelMar Pharmaceuticals Announces Second Quarter Fiscal Year 2017 Financial Results

VANCOUVER, British Columbia and MENLO PARK, Calif., Feb.13, 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 December 31, 2016, the second 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, February 15, 2017 at 4:30 p.m. Eastern Standard Time.

"During the past several months, we have increased activities related to our upcoming pivotal Phase 3 clinical trial with our lead VAL-083 program in refractory GBM," said Jeffrey Bacha, chairman and chief executive officer of DelMar Pharmaceuticals, Inc.  We also undertook key steps toward advancing VAL-083 as an alternative to temozolomide in MGMT-unmethylated GBM and into other solid tumor indications for patients whose tumors exhibit features that make them resistant or unlikely to respond to currently available chemotherapies."

RECENT CORPORATE HIGHLIGHTS

• DelMar initiated a new 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").
• DelMar continued the advancement of its VAL-083 lead product development program in refractory GBM toward a pivotal Phase 3 clinical trial.  DelMar has developed a proposed study design based on feedback from an End of Phase 2 meeting with the United States Food and Drug Administration ("FDA") and input from its clinical advisors. 
  The proposed trial will enroll approximately 180 patients with histologically confirmed recurrent GBM who have failed both standard chemo-radiation and bevacizumab with a primary endpoint of overall survival.  Patients will be randomized in a 2:1 fashion to receive either VAL-083 or a commonly used salvage chemotherapy at approximately 25 centers.  The proposed study is powered at 90% and will include an interim analysis at 50% of events for futility, superiority and sample size readjustment.  DelMar estimates that the proposed study will take less than two years from initiation to completion. 
• DelMar accessed additional funds to support our research programs through additional non-dilutive funding support from the Government of Canada and the exercise of warrants for cash. The Company estimates that current working capital is sufficient to fund our current operations through the end of calendar 2017.  
• We continued to obtain promising research results supporting the potential of VAL-083 in a range of treatment-resistant cancer indications:
  • DelMar presented additional data demonstrating that VAL-083 exhibits a mechanism of action distinct from other chemotherapies used in the treatment of GBM at the annual meetings of the European Association of Neuro-Oncology ("EANO") and the Society for NeuroOncology ("SNO");
  • DelMar presented data demonstrating that VAL-083 overcomes cisplatin-resistance in ovarian cancer cell lines with known p53 mutations and displays synergy with both cisplatin and AstraZeneca's PARP inhibitor Olaparib™ against ovarian cancer in vitro at the 11^th Biennial Ovarian Cancer Research Symposium;
  • DelMar presented new non-clinical data supporting the differentiation of VAL-083 in the treatment of lung cancer at the American Association for Cancer Research's ("AACR") annual meeting and at the IASLC 17^th World Congress on Lung Cancer; and
  • DelMar presented data indicating that VAL-083 offers potential therapeutic alternatives in difficult-to-treat pediatric brain tumors at the AACR – Advances in Pediatric Research: From Mechanisms and Models to Treatment and Survivorship Conference.
• DelMar continued to strengthen its intellectual property portfolio around VAL-083. The Company now holds seven issued US patents and eight issued patents outside of the US. DelMar's patent filings encompass thirteen patent families in various stages of prosecution and over 100 patent filings globally.

"Our excitement about VAL-083 and its potential to extend survival for bevacizumab-failed GBM patients continues to grow as we take steps toward initiating our planned pivotal Phase 3 trial," said Mr. Bacha.

"The recent initiation of a new Phase 2 clinical trial in collaboration with MD Anderson for bevacizumab-naïve MGMT-unmethylated GBM patients, along with a planned trial in newly diagnosed MGMT-unmethylated GBM patients, represent significant steps toward positioning VAL-083 as the chemotherapy of choice for the approximately two-thirds of newly diagnosed GBM patients whose tumors express high levels of MGMT. MGMT is a DNA repair enzyme linked with resistance to currently available chemotherapies including temozolomide and nitrosoureas."

Mr. Bacha continued, "We are also very pleased with our escalating progress to establish VAL-083's potential to address chemo-resistance across a range of cancer indications for patients whose tumors exhibit features that make their cancer resistant or unlikely to respond to currently available therapy.  Our research demonstrates the potential of VAL-083 to address unmet medical needs in a range of tumor types including GBM, non-small cell lung cancer, ovarian cancer and other solid tumors."

CONFERENCE CALL DETAILS

DelMar plans to host a conference call to discuss quarterly results and provide a corporate update on Wednesday, February 15, 2016, 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 800‑895‑1549 (toll free) or 785‑424‑1057 with Conference ID DELMAR.

Listeners can also attend the call via webcast.  A link to the webcast and slides will be available on the IR Calendar of the Investors section of the Company's website at www.delmarpharma.com and will be archived for 30 days.

SUMMARY OF FINANCIAL RESULTS FOR THE QUARTER ENDED DECEMBER 31, 2016; SECOND QUARTER OF FISCAL YEAR 2017

For the three months ended December 31, 2016 the Company reported a net loss of $1,321,973 or $0.13 per share, compared to a net loss of $2,646,690, or $0.24 per share for the three months ended December 31, 2015.

For the six months ended December 31, 2016 the Company reported a net loss of $3,612,312 or $0.36 per share, compared to a net loss of $4,268,078, or $0.40 per share for the six months ended December 31, 2015.

The following represents selected financial information as of December 31, 2016. 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.

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.

 

 

Excluding the impact of non-cash expense, research and development expenses increased to $1,186,637 during the three months ended December 31, 2016 from $747,001 for the three months ended December 31, 2015.  The difference was largely attributable to increased intellectual property-related expenditures, initiation of clinical manufacturing and other activities conducted in preparation of our planned 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 decreased in the three months ended December 31, 2016 to $580,761 from $602,579 for the three months ended December 31, 2015. 

We estimate that our current working capital, including non-dilutive funding support and cash from warrant exercises subsequent to December 31, 2016, is sufficient to fund our current operations through the end of calendar 2017.  

About VAL-083

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.

For further information, please visit http://delmarpharma.com/; or contact DelMar Pharmaceuticals Investor Relations: ir@delmarpharma.com / (604) 629-5989. Connect with the Company on Twitter, LinkedIn, Facebook, and Google+.

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.

 

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SOURCE DelMar Pharmaceuticals, Inc.