On September 4, 2015 DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported its financial results for the fiscal year ending June 30, 2015 and provided an overview of recent Company highlights and expected near-term milestones (Press release, DelMar Pharmaceuticals, SEP 4, 2015, View Source [SID:1234507397]).
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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/m2 had a median survival of nine (9) months vs. five (5) months at doses up to 5mg/m2.
Initiated a Phase II expansion cohort for the GBM study at a dose of 40mg/m2. 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/m2 dose.
To further explore the therapeutic window, three (3) patients have also initiated treatment at an interim dose of 45mg/m2. 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.