Full Press Release Details
Pharmaceuticals Announces Third Quarter Fiscal Year 2015 Financial Results and Provides Corporate Update
Lead product candidate, VAL-083 for the treatment of glioblastoma multiforme (GBM), positioned to enter registration-directed
Phase II/III clinical trials in 2H 2015 -
British Columbia and MENLO PARK, Calif., May 18, 2015 /PRNewswire/ -- DelMar Pharmaceuticals, Inc.
(OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on developing and commercializing
proven cancer therapies in new orphan drug indications, today announced its financial results for the three and nine months ending
March 31, 2015 and provided an overview of recent Company highlights and expected near-term milestones.
(dianhydrogalactitol), for the treatment of glioblastoma multiforme (GBM)
for the treatment of non-small cell lung cancer (NSCLC)
third quarter of fiscal 2015 was marked by several key data milestones related to our 'first-in-class' small molecule chemotherapeutic,
VAL-083, and its potential to address a significant unmet need as a new therapy for GBM patients who fail, or are unlikely to
respond to, current standard of care. Based on recently reported pre-clinical data, we believe VAL-083 has the potential to replace
temozolomide (TMZ) as the chemotherapy of choice in chemo-radiation treatment in a majority of newly diagnosed GBM patients whose
tumors express features correlated with resistance to standard chemotherapy," stated Jeffrey Bacha, president & CEO
of DelMar Pharmaceuticals.
are also very pleased with the progress and potential for VAL-083 in NSCLC and believe it will be a very important therapy, especially
in drug-resistant NSCLC where there are many shortcomings in the current treatments available. Our goal is to initiate new human
clinical trials with VAL-083 as a potential new therapy for NSCLC this year."
NEAR-TERM MILESTONES
OF FINANCIAL RESULTS FOR THE THREE AND NINE MONTHS ENDED MARCH 31, 2015
the nine months ended March 31, 2015, the Company reported a net loss of approximately $4,050,000, or a net loss per share of
$0.11, compared to a net income of approximately $2,730,000, or a net income per share, of $0.09 for the nine months ended March
31, 2014. The income from 2014 was due to the revaluation of our derivative liability. During the nine months ended March 31,
2015 the Company has reduced its derivative liability from approximately $3,300,000 at June 30, 2014 to approximately $1,500,000
at March 31, 2015 through warrant exercises and exchanges.
Company ended the third fiscal quarter with approximately $3,000,000 of cash.
Company will present its next clinical data at the 2015 American Association of Clinical Oncology (ASCO) Annual Meeting on Monday
June 1, 2015. DelMar plans to hold an investor call to discuss its latest data and financial results following the ASCO meeting.
following represents selected financial information as of March 31, 2015. 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.
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.
| March 31, 2015 $ | June 30, 2014 $ | |||||||
| Cash and cash equivalents | 3,006,598 | 4,759,711 | ||||||
| Working capital | 2,883,603 | 4,704,044 | ||||||
| Total Assets | 3,413,281 | 5,003,910 | ||||||
| Derivative liability | 1,487,137 | 3,329,367 | ||||||
| Total stockholders' equity | 1,217,021 | 880,479 |
Statement of Quarterly Operations:
| For the three months ended: | ||||||||
| March 31, 2015 $ | March 31, 2014 $ | |||||||
| Research and development | 641,839 | 618,869 | ||||||
| General and administrative | 500,753 | 966,923 | ||||||
| Change in fair value of derivative liability | 343,569 | 1,599,349 | ||||||
| Loss on exchange of warrants | 156,219 | - | ||||||
| Foreign exchange loss | 6,826 | 11,947 | ||||||
| Interest expense | - | 2,015 | ||||||
| Interest income | (70 | ) | (496 | ) | ||||
| Net and comprehensive loss | 1,649,136 | 3,198,607 | ||||||
| Weighted average number of shares outstanding | 38,976,827 | 31,659,791 | ||||||
| Loss per share | 0.04 | 0.10 |
is a "first-in-class", small-molecule chemotherapeutic. In more than 40 Phase 1 and 2 clinical studies sponsored by
the U.S. National Cancer Institutes, VAL-083 demonstrated safety and efficacy in treating a number of cancers including lung,
brain, cervical, ovarian tumors and blood cancers. 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.
a potential treatment for glioblastoma, VAL-083's mechanism of action appears to be unaffected by the expression of MGMT, a DNA
repair enzyme that causes chemotherapy resistance to front-line treatment with Temodar (temozolomide).
is currently studying multi-center VAL-083 in a Phase I/II clinical trial for patients with refractory glioblastoma multiforme
in accordance with the protocol that has been filed with the U.S. Food and Drug Administration (FDA). Eligible GBM patients must
have failed both Avastin (bevacizumab) and Temodar (temozolomide) unless either of these therapies
was contraindicated. (ClinicalTrials.gov Identifier NCT01478178).
DelMar Pharmaceuticals, Inc.
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.
further information, please visit http://delmarpharma.com/; or contact DelMar Pharmaceuticals Investor Relations: ir@delmarpharma.com
Safe Harbor Statement
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.