DelMar Pharmaceuticals (NASDAQ:DMPI), 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
“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.
| Selected Balance Sheet Data | ||||||||
| December 31, 2016 $ |
June 30,
2016 $ |
|||||||
| Cash and cash equivalents | 3,417,377 | 6,157,264 | ||||||
| Working capital | 2,845,141 | 5,692,336 | ||||||
| Total assets | 3,594,456 | 6,355,799 | ||||||
| Derivative liability | 171,211 | 693,700 | ||||||
| Total stockholders’ equity | 2,702,231 | 4,858,778 | ||||||
| Selected Statement of Operations Data | ||||||||
| For the Three Months Ended: | ||||||||
| December 31, |
December 31, |
|||||||
| 2016 | 2015 | |||||||
| $ | $ | |||||||
| Research and development | 1,120,910 | 789,187 | ||||||
| General and administrative | 571,286 | 890,672 | ||||||
| Change in fair value of stock option and derivative liabilities | (361,668) | 680,188 | ||||||
| Change in fair value of derivative liability due to change in warrant terms | – | 242,400 | ||||||
| Foreign exchange (gain) loss | (8,495) | 44,253 | ||||||
| Interest income | (60) | (10) | ||||||
| Net and comprehensive loss for the period | 1,321,973 | 2,646,690 | ||||||
| Series B preferred stock dividend | 159,756 | – | ||||||
| Net and comprehensive loss available to common stockholders | 1,481,729 | 2,646,690 | ||||||
| Basic weighted average number of shares outstanding | 11,424,845 | 10,994,879 | ||||||
| Basic loss per share | 0.13 | 0.24 | ||||||
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: [email protected] / (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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