DelMar Pharmaceuticals, Inc. ($DMPI), with a fiscal year ending September 30, 2015, announced its 2016 first quarter financial results, along with a recap of recent positive corporate highlights and an overview of near-term milestones. On Monday, November 23rd at 4:30 p.m. ET, the company will host a conference call and live webcast in order to provide an update on their business.
Over the last three months, DelMar completed a $2.6 million public offering of its shares and, based on management's current projections, the company has enough capital to fund its operations through third quarter of 2016. In Q1 2016, the company reported a net loss of $1,621,388. In connection with the preparation of DelMar’s financial statements for Q1 2016, it was determined that certain common stock purchase warrants issued for placement agents' services on March 6, 2013 should have originally been accounted for as a derivative liability in theirr audited financial statements.
"We strive to maintain the utmost integrity in all aspects of our business. Importantly, the reclassification of the Placement Agent Warrants does not affect our working capital or our operations as we seek to build shareholder value by implementing DelMar's business plan," said Jeffrey Bacha, president and CEO of DelMar Pharmaceuticals.
A biopharmaceutical company focused on the development and commercialization of new cancer therapies, DelMar’s has made a number of significant strides with its anti-cancer drug, VAL-083. VAL-083, the company’s first-in-class, small-molecule chemotherapeutic, is used to treat chronic myelogenous leukemia lung cancer in China, and is currently undergoing clinical trials in the US.
"We have made tremendous progress in executing our clinical development strategy with VAL-083 in refractory glioblastoma multiforme (GBM) and identifying additional value drivers through non-clinical research that position us to expand our clinical development efforts into non-small cell lung cancer ("NSCLC") and other solid tumors,” saidBacha.“We have completed full enrollment of the Phase II expansion cohort in our refractory GBM clinical trial. The results of this study will be the basis for advancing VAL-083 into the planned registration-directed Phase II/III trial in refractory GBM."
Reported company highlights are as follows:
● DelMar completed enrollment of the 14-patient expansion cohort of our Phase II clinical study of VAL-083 in patients with refractory GBM. In addition, the company confirmed 40mg/m2 as the maximum tolerated dose (MTD) for advancement into registration-directed clinical trials.
● The company reported additional non-clinical data supporting the favorable differentiation of VAL-083 versus standard of care in the treatment of GBM, non-small cell lung cancer and other solid tumors. They believe the data support the potential of VAL-083 to address the modern unmet medical needs in the treatment of a range of cancers, especially where other therapies have failed or are predicted to give sub-optimal outcomes.
● The Mayo Clinic Cancer Center in Rochester, Minnesota and the Sarah Cannon Cancer Research Center at HealthOne, Denver, Colorado have had been added as new clinical trial sites in DelMar’s ongoing, multicenter Phase I/II clinical trial study of VAL-083 in patients with refractory GBM. The company now has five clinical sites involved in their study.
● At the American Association for Cancer Research (AACR) - Advances in Pediatric Research: From Mechanisms and Models to Treatment and Survivorship, the company presented data indicating that VAL-083 offers potential therapeutic alternatives in difficult-to-treat pediatric brain tumors.
● At AACR's Advances in Ovarian Cancer Research: Exploiting Vulnerabilities Conference, the company presented data supporting the effectiveness of VAL-083 against cisplatin-resistant ovarian cancers and raised the potential for VAL-083 as a treatment for ovarian cancer as a single-agent against platinum-resistant tumors or in combination with platinum-based chemotherapeutic regimens.
● The company assessed additional capital to support our drug development and research programs through a registered stock offering for gross proceeds of $2.6 million.
"I am extremely pleased with our significant achievements in recent months,” said Bacha.DelMar is well positioned for major developments as VAL-083 advances toward registration-directed studies for refractory GBM and into clinical trials for new indications. We anticipate that the VAL-083 program will continue to produce key data during the remainder of 2015 and throughout 2016."
Reported expected near-term milestones are as follows:
● Present updated safety and efficacy data from the Phase II clinical trial in patients with refractory GBM at the Society for Neuro-Oncology Annual Meeting;
● Initiate registration-directed Phase II/III clinical trials for VAL-083 as a new treatment option for refractory GBM in 2016;
● Initiate new clinical trials, including front-line GBM and NSCLC;
● Continue to pursue non-clinical research with VAL-083 as a potential treatment option for chemo-resistant cancers;
● Establish collaboration discussions with leading investigators to advance VAL-083 into clinical studies as a potential treatment for children suffering from recurrent medulloblastoma or high grade gliomas;
● Maximize the value of the VAL083 pipeline through potential partnering opportunities;
● Continue to actively communicate DelMar's progress to the investment and medical communities through presentations at peer-reviewed scientific meetings;
● Continue to build DelMar’s intellectual property portfolio; and
● Continue to implement strategies to enable DelMar to meet qualifications to list its shares on a national stock exchange.
DelMar, through their focus on the development and commercialization of new cancer therapies, is looking to be starting 2016 with promising progress and secured capital through Q3. The company’s exciting developments bring the field of medicine closer to providing effective treatments for a variety of cancers.
"The fundamentals of our business, including developing our portfolio of clinical and non-clinical data supporting the potential of VAL-083 to address modern unmet medical needs in the treatment of cancer and the solid experience base of our development team, remain strong."
Equities.com had the opportunity to interview Jeffrey Bacha, President and CEO of DelMar Pharmaceuticals. The interview can be watchedhere. For more information about DelMar Pharmaceuticals, visit www.delmarpharma.com.
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