On November 13, 2017 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, reported its financial results for the first quarter ended September 30, 2017 (Press release, DelMar Pharmaceuticals, NOV 13, 2017, View Source [SID1234522002]). DelMar executive management will host a business update conference call and live webcast for investors, analysts and other interested parties on Tuesday, November 14, 2017 at 4:30 p.m. Eastern Standard Time.
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KEY DEVELOPMENTS
Initiated the STAR-3 pivotal Phase 3 clinical trial of VAL-083 in refractory GBM and enrolled its first patient.
Initiated patient recruitment for an open label Phase 2 clinical trial of VAL-083 in newly diagnosed patients with MGMT-unmethylated GBM.
Received a notice of allowance from the FDA to commence with a Phase 1/2 VAL-083 REPROVe clinical trial in platinum-resistant ovarian cancer.
Presented new data and promising research results at peer-reviewed scientific meetings supporting the potential of VAL-083 in the glioblastoma and ovarian cancer treatment landscape.
Granted a new patent from the U.S. Patent and Trademark Office covering improved analytical methods related to the manufacturing of VAL-083.
Completed offerings of common stock and warrants for aggregate gross proceeds of approximately $19.0 million.
"I am extremely pleased with the progress achieved this past quarter across clinical and corporate development fronts. As we transition to a late stage development company with a balanced pipeline of oncology indications, including a pivotal Phase 3 study, I am looking forward to playing an integral role in guiding the company to its next phase of growth," commented Saiid Zarrabian, Interim Chief Executive Officer.
The first quarter of 2018 proved to be an important period for the clinical development of the VAL-083 pipeline of therapeutic candidates. In July, the Company initiated its pivotal Phase 3 Study in Temozolomide-Avastin Recurrent GBM ("STAR-3") and during the quarter enrolled our first patient. The STAR-3 GBM trial is an adaptive design, randomized, controlled, pivotal Phase 3 clinical trial to assess the efficacy and safety of VAL-083 versus salvage therapy in patients with late-stage glioblastoma multiforme (GBM) whose disease has progressed following prior treatment with temozolomide and Avastin, for whom there is currently no standard-of-care therapy. A total of up to 180 eligible patients will be randomized at approximately 25 centers in the United States to receive VAL-083 or "investigator’s choice salvage therapy" in a 2:1 fashion. The primary endpoint of the trial is overall survival of VAL-083 versus a control arm consisting of physician’s choice of temozolomide, lomustine or carboplatin chemotherapy. The statistical design between the two arms of the study is 90% power, and includes an interim analysis at 50% of events.
In September, DelMar initiated patient recruitment for an open label Phase 2 clinical trial of VAL-083 in newly diagnosed patients with MGMT-unmethylated GBM. The study will enroll 20-30 newly diagnosed GBM patients whose tumors exhibit high-expression of the DNA-repair enzyme O6-methylguanine methyltransferase (MGMT) and will be treated with VAL-083 in combination with radiotherapy to examine the safety and efficacy of VAL-083 in this population. The primary efficacy endpoint of this trial is progression free survival (PFS). Results will be used to guide the design of global randomized studies, which if successful, will position VAL-083 as a potential replacement for the current standard-of-care (chemoradiation with temozolomide) in newly diagnosed GBM patients, particularly for the approximately 2/3 of patients whose tumors feature MGMT-unmethylated GBM. Patients with an unmethylated-MGMT promoter express high levels of MGMT, which inhibits the anti-tumor activity of temozolomide, the current standard-of-care chemotherapy used in the treatment of GBM, resulting in treatment resistance and poor patient outcomes.
Also in September, the Company received a notice of allowance from the FDA to commence with a multi-center Phase 1/2 Study of VAL-083 in patients with Recurrent Platinum Resistant Ovarian Cancer ("VAL-083 REPROVe Trial"). Ovarian cancer remains the leading cause of death among women with gynecological cancers and the fifth most frequent cause of cancer deaths in women overall. The American Cancer Society estimates that in 2017, approximately 22,440 women in the US will be diagnosed with ovarian cancer and approximately 14,080 will die from their disease. The majority of these deaths were patients whose tumors had become resistant to platinum-based chemotherapy regimens. Currently, there are no high-efficacy therapeutic options for platinum-resistant ovarian cancer, leaving these cancer patients with very poor prognosis. DelMar plans to initiate the REPROVe trial as soon as practicable.
Throughout the period, DelMar presented new data and promising research results supporting the therapeutic potential of VAL-083 at peer-reviewed scientific conferences. Highlights included, presenting data supporting the effectiveness of VAL-083 in the treatment of GBM at the annual meetings of the American Society for Clinical Oncology ("ASCO"), the American Association of Cancer Research ("AACR"), the World Federation of NeuroOncology Societies ("WFNOS"), the European Association for NeuroOncology and the recent AACR (Free AACR Whitepaper) Special Conference on Ovarian Cancer.
On the corporate development front, DelMar continued to enhance its operational capabilities and overall positioning. In September, the U.S. Patent and Trademark Office granted DelMar a new patent covering improved analytical methods related to manufacturing of VAL-083. The patent strengthens the Company’s control over VAL-083’s manufacturing process. VAL-083 is currently protected by eight US patents and eight patents outside of the US, with issued claims providing patent protection into 2033 in the United States.
In April and September, DelMar completed offerings of common stock and warrants for aggregate gross proceeds of approximately $19.0 million. The Company intends to use the net proceeds of these offerings for clinical trials and general corporate purposes, which may include working capital, capital expenditures, research and development and other business initiatives
SUMMARY OF FINANCIAL RESULTS FOR THE QUARTER ENDED SEPTEMBER 30, 2017
At September 30, 2017, the Company had cash and clinical trial deposits on hand of approximately $14.1 million (unaudited).
For the quarter ended September 30, 2017, the Company reported a net loss of $2,666,406 or $(0.18) per share, compared to a net loss of $2,290,339, or $(0.23) per share, for the quarter ended September 30, 2016.
The following represents selected financial information as of September 30, 2017. 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: View Source
Excluding the impact of non-cash expense, research and development expenses increased to $1,939,617 during the current quarter compared to $676,892 for the same period in the prior year. The increase was largely attributable to VAL-083 clinical development and manufacturing costs related to the Company’s pivotal STAR-3 refractory-GBM clinical trial and two Phase 2 clinical trials in MGMT-unmethylated GBM, all of which were initiated during the past 9 months.
Excluding the impact of non-cash expenses, general and administrative expenses decreased in the quarter ended September 30, 2017 to $676,258 compared to $726,414 for the quarter ended September 30, 2016.
Based on current estimates, the Company believes that it will be able to fund operations beyond the next 12 months.
CONFERENCE CALL DETAILS
DelMar plans to host a conference call to discuss its financial results for the quarter ended September 30, 2017 and provide a corporate update on Tuesday, November 14, 2017, 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 1 866 831 8713 (toll free) with Conference ID DELMAR.
A replay of the conference call 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.