VANCOUVER, British Columbia and MENLO PARK, Calif. , Sept. 4, 2015 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (OTCQX: 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 fiscal year ending June 30, 2015 and provided an overview of recent Company highlights and expected near-term milestones.
DelMar's management team will host a business update conference call and live webcast for investors, analysts and other interested parties today at 11:00 a.m. EDT / 8:00 a.m. PDT .
RECENT HIGHLIGHTS
VAL-083 (dianhydrogalactitol), for the treatment of refractory glioblastoma multiforme (GBM)
Completed Phase I dose-escalation in the clinical trial in refractory GBM and presented data supporting a dose response trend . Patients receiving a dose >/= 30mg/m 2 had a median survival of nine (9) months vs. five (5) months at doses up to 5mg/m 2 . Initiated a Phase II expansion cohort for the GBM study at a dose of 40mg/m 2 . We anticipate enrolling approximately 14 patients in the Phase II expansion cohort. To date, 19 patients have been screened and six (6) patients have initiated treatment with VAL-083 at the 40mg/m 2 dose. To further explore the therapeutic window, three (3) patients have also initiated treatment at an interim dose of 45mg/m 2 . The Phase II expansion cohort may be continued at this higher dose if warranted by safety data. Continued preparation for advancement into registration-directed Phase II/III clinical trials . Presented additional data on the activity of VAL-083 against temozolomide-resistant GBM and its potential as a therapeutic option for patients who fail or are unlikely to respond to current front-line therapy. Added the fourth and fifth Phase I/II clinical trial sites at Mayo Clinic Cancer Center in Rochester, MN and Sarah Cannon Cancer Research Center at HealthOne in Denver, CO . Expanding our drug development pipeline: Lung and Ovarian Cancer
Non-small cell lung cancer (NSCLC) Presented preclinical data in lung cancer models supporting differentiation of VAL-083 versus platinum-based chemotherapy in treatment of drug-resistant NSCLC. Announced plans to initiate clinical research in NSCLC in collaboration with Guangxi Wuzhou Pharmaceutical Group (Co) Ltd. Ovarian Cancer Announced the upcoming presentation of new non-clinical data supporting the activity of VAL-083 in treatment-resistant ovarian cancer. Corporate
Raised $2.6 million gross proceeds in a registered direct offering . Announced an additional non-dilutive funding increase of up to CDN$287,000 from the National Research Council of Canada Industrial Research Assistance Program for continued support of our non-clinical research programs. Continued to take steps toward listing our common shares on a national stock exchange including reducing the derivative liability component of our balance sheet, appointing new independent directors and establishing required corporate governance structures and policies. "We have made tremendous progress during this fiscal year in executing our clinical development strategy and driving value into our lead product candidate VAL-083. The promising results of the Phase I dose-escalation study were instrumental in advancing the program in GBM. We anticipate reporting additional data from the Phase II expansion cohort at upcoming peer reviewed scientific meetings and are implementing our plan to advance VAL-083 into a Phase II/III registration-directed clinical program in refractory GBM," stated Jeffrey Bacha , president & CEO of DelMar Pharmaceuticals.
"Based on promising results of grant-funded research, we are also preparing to expand the VAL-083 clinical research portfolio into non-small cell lung cancer (NSCLC), which will be funded through our collaboration with Guangxi Wuzhou Pharmaceutical (Group) Co., Ltd.," added Mr. Bacha. "We believe our VAL-083 program in NSCLC has significant future potential for partnering opportunities."
Mr. Bacha concluded, "We believe that the unique mechanism of action of VAL-083 provides a basis to address unmet medical needs in a range of cancers."
FY2016 MILESTONES
Complete enrollment of the Phase II expansion study in refractory GBM; Advance VAL-083 into registration-directed Phase II/III clinical trials; Expand our clinical development activities through new trials supported by our collaboration with Guangxi Wuzhou Pharmaceutical (Group) Co. Ltd.; Continue to actively communicate our progress to the investment and medical communities through presentations at peer-reviewed scientific meetings; Continue to build our intellectual property portfolio; and Implement strategies to enable DelMar to meet qualifications to list its shares on a national stock exchange. CONFERENCE CALL DETAILS
The DelMar business update conference call and live webcast is scheduled to begin today at 11:00 a.m. Eastern Time / 8:00 a.m. Pacific 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 (866) 394-9399 (toll-free) with Conference ID 22042321. 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 FISCAL YEAR ENDED JUNE 30, 2015
For the twelve months ended June 30, 2015 the Company reported a net loss of $4,796,030 , or a net loss per share of $0.13 , compared to a net income of $3,129,348 , or a net income per share of $0.10 for the twelve months ended June 30, 2014 . The income from 2014 was due to the revaluation of our derivative liability. During the twelve months ended June 30, 2015 the Company has reduced its derivative liability from approximately $3.3 million at June 30, 2014 to approximately $1.0 million at June 30, 2015 through warrant exercises and exchanges.
The Company ended the 2015 fiscal year with approximately $1.75 million of cash and cash equivalents. Subsequent to the 2015 fiscal year end, the company announced the closing of a registered direct placement with $2.6 million in gross proceeds received from the offering.
Based on management's current projections, the Company has enough capital to fund its operations into the third quarter of 2016.
FINANCIAL SUMMARY
The following represents selected financial information as of June 30, 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 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:
June 30,
June 30,
2015
2014
$
$
Cash and cash equivalents
1,754,433
4,759,711
Working capital
1,722,336
4,704,044
Total assets
2,575,421
5,003,910
Derivative liability
1,031,004
3,329,367
Total stockholders' equity
511,887
880,479
Selected Statement of Operations Data:
June 30,
June 30,
2015
2014
$
$
Research and development
2,555,754
2,119,217
General and administrative
2,168,899
3,134,409
Change in fair value of derivative liability
(179,170)
(8,300,438)
Change in fair value of derivative liability due to change in warrant terms
(23,658)
(111,179)
Loss on exchange of warrants
249,062
-
Foreign exchange loss
23,415
22,581
Interest expense
2,091
8,140
Interest income
(363)
(2,078)
Net and comprehensive loss (income)
4,796,030
(3,129,348)
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 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 (CML) and lung cancer and has received orphan drug designation in Europe and the U.S. for the treatment of gliomas.
DelMar is currently studying VAL-083 in a multi-center Phase I/II clinical trial for patients with refractory GBM in accordance with the protocol that has been filed with the U.S. Food and Drug Administration (FDA) at five clinical centers in the United States: Mayo Clinic ( Rochester, MN ); UCSF ( San Francisco, CA ) and three centers associated with the Sarah Cannon Cancer Research Institute ( Nashville, TN , Sarasota, FL and Denver, CO ). As 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 is implicated in chemotherapy resistance and poor outcomes following front-line treatment with Temodar ® (temozolomide).
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 http://delmarpharma.com/ ; or contact DelMar Pharmaceuticals Investor Relations: [email protected] / (604) 629-5989. Follow us on Twitter @DelMarPharma or Facebook.com/delmarpharma . Investor Relations Counsel: Amato & Partners LLC.
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.