Company will host a business update conference call and webcast on Tuesday, November 15, 2016 at 4:30 PM EST
The Company also highlights recent corporate and clinical achievements and provides an overview of expected near-term milestones.
VANCOUVER, British Columbia and MENLO PARK, Calif., Nov. 14, 2016 /PRNewswire/ — DelMar Pharmaceuticals, Inc. (NASDAQ: 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 quarter ending September 30, 2016, the first quarter of the Company’s 2017 fiscal year. DelMar executive management will host a business update conference call and live webcast for investors, analysts and other interested parties on Tuesday, November 15, 2016 at 4:30 pm EST.
“Looking back, 2016 has been a transformational year for our Company,” stated Jeffrey Bacha, DelMar’s Chairman and chief executive officer. Our goals this year included listing our company’s shares on a national exchange, successfully completing our initial Phase I/II clinical trial in refractory GBM, preparing for a pivotal Phase III clinical trial and expanding our research efforts with VAL-083 into new indications.”
RECENT CORPORATE HIGHLIGHTS
•DelMar raised gross proceeds of approximately $7.2 million in a private placement and our common stock began trading on the Nasdaq Capital Markets under the symbol “DMPI”;
•DelMar confirmed that the Institutional Review Board (“IRB”) at the University of Texas MD Anderson Cancer Center (“MD Anderson”) approved our planned Phase II clinical study with VAL-083 in patients with GBM at first recurrence/progression;
•DelMar reported promising data from our Phase I/II clinical trial of VAL-083 in refractory GBM at the American Society of Clinical Oncology (“ASCO”) annual meeting; supporting the potential for an improved survival benefit for bevacizumab-failed GBM patients treated with VAL-083 in comparison to current salvage chemotherapy;
•DelMar announced the successful completion of an ‘End of Phase II’ meeting with the FDA and confirmed plans to advance VAL-083 into a pivotal Phase III clinical trial for GBM patients whose tumors have progressed following treatment with bevacizumab;
•DelMar entered into a collaborative research agreement with Accurexa, Inc. to explore local delivery of VAL-083 as a potential combination therapy for the treatment of brain tumors;
•DelMar continued to report promising research results supporting the potential of VAL-083 in new indications: ◦Presented data supporting the effectiveness of VAL-083 against chemotherapy-resistant ovarian cancers, including data suggesting the potential for treatment synergy of VAL-083 combined with Astra Zeneca’s PARP inhibitor, Lynparza™ (olaparib), at the 11th Biennial Ovarian Cancer Research Symposium;
◦Presented new research results demonstrating that VAL-083 exhibits a distinct mode of action compared to other chemotherapies used in the treatment of newly diagnosed GBM patients at the European Association of Neuro-Oncology annual meeting;
◦Presented new non-clinical data supporting the differentiation of VAL-083 in the treatment of lung cancer in comparison to platinum and tyrosine kinase inhibitor treatments at the AACR New Horizons in Cancer Research meeting;
◦Presented data indicating that VAL-083 offers potential therapeutic alternatives in difficult-to-treat pediatric brain tumors at the AACR – Advances in Pediatric Research: From Mechanisms and Models to Treatment and Survivorship Conference.
•DelMar continued to strengthen its intellectual property portfolio. DelMar now holds six issued US patents and seven issued patents outside of the US representing thirteen patent families in various stages of prosecution, and over 100 patent filings in total.
“We were very pleased with the outcome of our End-of-Phase II meeting and the guidance provided by the FDA,” said Mr. Bacha. “The DelMar clinical team and our advisors have been developing a Phase III study protocol that would provide strong statistical power, enroll fewer than 200 patients, and is designed to reach its final endpoint in two years or less. We plan to submit the protocol to the FDA in the coming weeks, and subject to the FDA’s continued guidance and availability of funding, anticipate initiating a registration-directed Phase III study as soon as practicable.”
DelMar is also pleased to confirm the accomplishment of critical steps toward initiating new clinical trials designed to position VAL-083 as an alternative to temozolomide in newly diagnosed GBM for patients whose tumors exhibit a high expression of MGMT, the DNA repair enzyme linked to failure of standard front-line chemotherapy and poor patient outcomes:
•The MD Anderson IRB has approved the protocol of the Company’s planned Phase II Study of VAL-083 in patients with MGMT-unmethylated, bevacizumab-naive recurrent glioblastoma. DelMar anticipates completing study initiation activities and commencing the dosing of patients in the coming weeks.
•The Company is also completing the final remaining steps required for initiation of an international clinical trial in newly diagnosed GBM patients with high expression of MGMT.
“Importantly, these two new Phase II trials are largely supported through our collaborators, so their initiation will not materially impact our near-term cash expenditures,” stated Mr. Bacha. “Our current working capital will support DelMar’s operations for at least the next twelve months and, while our planned Phase III clinical trial will require additional financing, we have the opportunity to expand our clinical research efforts in GBM and to continue advancing our research into new indications without an immediate need to raise additional funds.”
EXPECTED NEAR-TERM MILESTONES
•Commence treating patients at MD Anderson with VAL-083 in a Phase II clinical study of GBM patients with high expression of MGMT at first recurrence/progression;
•Submit a Phase III protocol to the FDA proposing a pivotal, multi-center, randomized clinical trial of VAL-083 in GBM patients who have failed both standard chemo-radiation and bevacizumab;
•Initiate a Phase II clinical trial in China in newly-diagnosed GBM patients as an alternative to temozolomide in patients with high expression of MGMT;
•Expand DelMar’s clinical research with VAL-083 in new solid tumor indications, subject to financial resources;
•Present our research results at international peer-reviewed scientific meetings;
•Continue to pursue pre-clinical research that further differentiates VAL-083 from established chemotherapeutic regimens, and to identify opportunities for combination therapy;
•Maximize the value of the VAL-083 pipeline through collaborations with industry leaders in attractive oncology markets; and
•Continue to build our intellectual property portfolio.
CONFERENCE CALL DETAILS
DelMar plans to host a conference call to discuss quarterly results and provide a corporate update on Tuesday, November 15, 2016, at 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-in Number is 800‑895‑0198 (toll free) 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 FIRST QUARTER OF FISCAL YEAR 2017 ENDED SEPTEMBER 30, 2016
For the three months ended September 30, 2016 the Company reported a net loss of $2,290,339, or a net loss per share of $0.23, compared to a net loss of $1,621,388, or a net loss per share of $0.15 for the three months ended September 30, 2015.
The following represents selected financial information as of September 30, 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 here.