DelMar Pharmaceuticals Announces December 31, 2014 Financial Results and Provides Corporate Update

VANCOUVER, British Columbia and MENLO PARK, Calif., Feb. 12, 2015 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company") today announced the filing of its financial statements for the six months ended December 31, 2014 and provided an overview of recent Company highlights and expected near-term milestones. Management will host an investor update conference call and live webcast to discuss recent highlights and the Company's plans for the continued advancement of its business plan on Tuesday, February 17, 2015, at 1:30 p.m. PST / 4:30 p.m. EST.

RECENT HIGHLIGHTS

VAL-083 (dianhydrogalactitol) for the treatment of refractory glioblastoma multiforme

• Reported first observation of a dose limiting toxicity in the ongoing Phase 1/2 clinical trial with VAL-083, which signals the near-term completion of dose-escalation and identification of a maximum tolerated dose that will be advanced into Phase 2/3 registration-directed clinical trials as a potential new therapy for the treatment of refractory glioblastoma multiforme (GBM), the most common and deadly form of human brain cancer.
• Presented an update on the ongoing Phase 1/2 clinical trial with VAL-083 as a potential new therapy for GBM at the Society for NeuroOncology Annual Meeting and shared new preclinical data supporting the favorable differentiation of VAL-083 versus the standard-of-care temozolomide treatment of GBM.

VAL-083 for the treatment of non-small cell lung cancer (NSCLC)

• Presented promising new data supporting the activity at the AACR's New Horizons in Cancer Research: Harnessing Breakthroughs – Targeting Cures. The data showed that VAL-083 is superior to cisplatin in both tumor models that are sensitive and resistant to tyrosine kinase inhibitors and has synergistic effect in combination with cisplatin. The data suggests important clinical and market potential of VAL-083 in NSCLC.

Corporate

• Continued the Company's strategic efforts to fulfill the requirements to up-list its common stock to a national exchange, such as NASDAQ or NYSE-MKT, with the appointment of Lynda Cranston, BScN, MScN, ICD.D, to its Board of Directors as an independent director. Ms. Cranston will serve as Chair of the Company's newly formed Governance and Compensation Committee.
• Completed a Warrant Exchange Tender Offer and the exercise of Investor Warrants to reduce the associated non-cash derivative liability and provide additional non-dilutive capital to the Company.
• Received a notice of allowance for a third United States patent covering VAL-083. DelMar currently holds three U.S. patents and one international patent, having filed a total of ten patent applications, which are being prosecuted in the United States and in international jurisdictions.
• Received approval for the up-listing of the Company's common stock from OTCQB to OTCQX and began trading on the OTCQX under ticker symbol DMPI in December of 2014.

"The recent months were marked by transformational events on both the clinical and operational fronts. Most importantly, we witnessed the first observation of dose limiting toxicity with our lead product candidate VAL-083 in the Phase 1/2 GBM study. This now brings us closer to advancing the program into late-stage clinical studies which we are expecting will commence this year," stated Jeffrey Bacha, president & CEO of DelMar Pharmaceuticals.

"I am also very pleased with the progress we have made on the operational side of the business. We are making great strides preparing to up-list to a national exchange, and the recent completion of the warrant tender offer and the appointment of a highly-experienced board member to Chair our newly appointment Governance and Compensation Committee represent meaningful steps towards achieving that goal," said Mr. Bacha.

Anticipated Near-Term Milestones

• Complete the dose-escalation portion of the Phase 1/2 clinical trial in the first half of calendar 2015 and advance VAL-083 into Phase 2/3 registration-directed clinical trials;
• Present interim data at peer-reviewed scientific meetings;
• Initiate clinical trials with VAL-083 in NSCLC and seek strategic opportunities to expand the Company's asset base;
• Pursue a national exchange listing to maximize shareholder value; and
• Continue to build a robust intellectual property portfolio.

"Moving forward, we will continue to advance VAL-083 into late-stage registration studies as rapidly as possible as well as identify ways in which we can expand our pipeline in additional indications such as non-small cell lung cancer, given our recent compelling results," Mr. Bacha continued. "We expect significant strategic momentum throughout 2015 due to several anticipated key milestones. Our team is committed to unlocking and maximizing shareholder value over both the short and long-term through solid execution of our business plan. We look forward to welcoming new investors in the coming months and years as we continue to ensure the Company's strong fundamentals and focus on bringing new, potentially game-changing treatments to patients where there is a true unmet need."

Summary of Financial Results for the Three and Six Months Ended December 31, 2014

For the three months ended December 31, 2014, the Company reported a net loss of approximately $1,077,000, or a net loss per share of $0.03, compared to a net loss of approximately $866,000, or a net loss per share, of $0.03 for the three months ended December 31, 2013.

For the six months ended December 31, 2014, the Company reported a net loss of approximately $2,399,000, or a net loss per share of $0.06, compared to a net income of approximately $5,928,000, or a net income per share, of $0.19 for the six months ended December 31, 2013.  The Company's income during the six months ended December 31, 2013 was, in part, due to revaluation of the derivative liability during that period.

The Company ended the calendar year with approximately $3,958,000 of cash and cash equivalents.  DelMar expects its current cash on hand to be sufficient to meet its operating and capital requirements until at least the end March 2016.

Conference Call Details

DelMar management will host a conference call and live webcast for investors and analysts on Tuesday, February 17, 2015, beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern 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 number is (866) 394-9399 (toll free) with Conference ID: 86244645.  A link to the webcast slides will be available on the Company's website at www.delmarpharma.com.

Financial Summary

The following represents selected financial information as of December 31, 2014 and June 30, 2014. 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 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.

Selected Balance Sheet Data:

Selected Statement of Quarterly Operations:

About VAL-083

VAL-083 is a first-in-class, small-molecule chemotherapeutic with a unique mechanism of action. In more than 40 Phase 1 and 2 clinical studies sponsored by the National Cancer Institute, VAL-083 has shown safety and efficacy in treating a number of cancers including lung, brain, cervical, ovarian tumors and leukemia. 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 U.S. for the treatment of gliomas. As a potential treatment for glioblastoma, VAL-083's mechanism of action is unaffected by the expression of MGMT, a DNA repair enzyme that causes chemotherapy resistance to front-line treatment with Temodar^® (temozolomide). DelMar is currently studying VAL-083 in a Phase 1/2 clinical trial for patients with refractory glioblastoma multiforme.

About DelMar Pharmaceuticals, Inc.

DelMar Pharmaceuticals, Inc. was founded to develop and commercialize proven cancer therapies in new orphan drug 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 (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 that could provide improved treatment options for patients.

For further information, please visit www.delmarpharma.com; or contact Jeffrey A. Bacha, President & CEO  (604) 629-5989 or Amato & Partners LLC, Investor Relations admin@amatoandpartners.com 
follow us on Twitter @delmarpharma or Facebook.com/delmarpharma.

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.