DelMar Pharmaceuticals Announces First Quarter Fiscal Year 2018 Financial Results
VANCOUVER, British Columbia and MENLO PARK, Calif., Nov. 13, 2017 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, announced its financial results for the first quarter ended September 30, 2017. 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.
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 O(6)-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 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: http://ir.delmarpharma.com/all-sec-filings.
Selected Balance Sheet Data
---------------------------
September 30, June 30,
2017 2017
$ $
--- ---
Cash and cash equivalents 13,156,485 6,586,014
Working capital 12,888,140 6,566,371
Total assets 14,448,163 7,911,021
Derivative liability 4,660 61,228
Total stockholders' equity 12,918,754 6,578,524
Selected Statement of Operations Data
-------------------------------------
For the three months ended:
September 30, September 30,
2017 2016
$ $
--- ---
Research and
development 1,934,643 732,729
General and
administrative 744,621 1,316,639
Change in fair value
of stock option and
derivative
liabilities (56,568) 225,688
Foreign exchange loss 43,866 15,324
Interest income (156) (41)
---- ---
Net and comprehensive
loss for the period 2,666,406 2,290,339
Series B Preferred
stock dividend 41,666 307,298
------ -------
Net and comprehensive
loss available to
common stockholders 2,708,072 2,597,637
Basic weighted average
number of shares
outstanding 15,292,781 11,301,989
Basic and fully
diluted loss per
share 0.18 0.23
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.
About DelMar Pharmaceuticals, Inc.
DelMar Pharmaceuticals is focused on the development and commercialization of new therapies for cancer patients who have limited or no treatment options. By focusing on understanding tumor biology and mechanisms of treatment resistance, the Company identifies biomarkers to personalize new therapies in indications where patients are failing, or have become intolerable to modern targeted or biologic treatments.
The Company's current pipeline is based around VAL-083, a "first-in-class," small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers including central nervous system, ovarian and other solid tumors (e.g. NSCLC, bladder cancer, head & neck) in U.S. clinical trials sponsored by the NCI. Based on DelMar's internal research programs and these prior NCI-sponsored clinical studies, the Company is conducting clinical trials to support the development and commercialization of VAL-083 across multiple oncology indications to solve significant unmet medical needs.
VAL-083 is also being studied in two collaborator-supported, biomarker driven, Phase 2 clinical trials for MGMT-unmethylated GBM. Overcoming MGMT-mediated resistance represents a significant unmet medical need in the treatment of GBM. DelMar also recently announced the allowance of a separate IND for VAL-083 as a potential treatment for platinum-resistant ovarian cancer.
Further information on DelMar's clinical trials can be found on clinicaltrials.gov: https://www.clinicaltrials.gov/ct2/results?cond=&term=val-083&cntry1=&state1=&recrs
For further information, please visit http://delmarpharma.com/; or contact DelMar Pharmaceuticals Investor Relations: ir@delmarpharma.com / (604) 629-5989.
Connect with the Company on Twitter, LinkedIn, Facebook, and Google+.
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.
DelMar Pharmaceuticals, Inc.
Consolidated Balance Sheet
(in US dollars unless otherwise noted)
Note June 30, June 30,
2017 2016
$ $
--- ---
Assets
Current assets
Cash 6,586,014 6,157,264
Prepaid expenses and deposits 8 1,208,122 144,131
Taxes and other receivables 76,595 18,387
------ ------
7,870,731 6,319,782
Intangible assets - net 40,290 36,017
------ ------
7,911,021 6,355,799
========= =========
Liabilities
Current liabilities
Accounts payable and accrued
liabilities 1,182,312 584,002
Related party payables 6 88,957 43,444
Current portion of derivative
liability 4 33,091 -
------ ---
1,304,360 627,446
Stock option liability 5 - 175,875
Derivative liability 4 28,137 693,700
------ -------
1,332,497 1,497,021
--------- ---------
Stockholders' accumulated equity
Preferred stock
Authorized
5,000,000 shares, $0.001 par
value
Issued and outstanding
278,530 Series A shares at June
30, 2017 (June 30, 2016 -
278,530) 3,5 278,530 278,530
881,113 Series B shares at June
30, 2017 (June 30, 2016 -
902,238) 5 6,146,880 6,294,255
1 special voting share at June
30, 2017 (June 30, 2016 - 1) - -
Common stock
Authorized
50,000,000 shares, $0.001 par
value
14,509,633 issued at June 30,
2017 (June 30, 2016 -
11,187,023) 5 14,510 11,187
Additional paid-in capital 5 36,665,285 28,833,105
Warrants 5 4,570,574 1,658,382
Accumulated deficit (41,118,433) (32,237,859)
Accumulated other comprehensive
income 21,178 21,178
------ ------
6,578,524 4,858,778
--------- ---------
7,911,021 6,355,799
========= =========
DelMar Pharmaceuticals, Inc.
Consolidated Statement of Operations and Comprehensive Loss
(in US dollars unless otherwise noted)
Note Year Year
ended ended
June 30, June 30,
2017 2016
$ $
--- ---
Expenses
Research and development 6 5,003,640 3,360,878
General and administrative 6 3,317,189 2,853,140
--------- ---------
8,320,829 6,214,018
--------- ---------
Other loss (income)
Change in fair value of stock
option and derivative liabilities 4,5 (245,963) 2,341,660
Change in fair value of derivative
liability due to change in
warrant terms 4,5 - 295,456
Foreign exchange loss 7,355 13,838
Interest income (457) (108)
---- ----
(239,065) 2,650,846
-------- ---------
Net and comprehensive loss for the
year 8,081,764 8,864,864
========= =========
Computation of basic loss per
share
Net and comprehensive loss for the
year 8,081,764 8,864,864
Series B Preferred stock dividend 5 790,454 238,326
------- -------
8,872,218 9,103,190
========= =========
Basic and fully diluted loss per
share 0.74 0.83
==== ====
Basic weighted average number of
shares 12,047,079 10,948,481
========== ==========
The accompanying notes are an
integral part of these consolidated
financial statements.
DelMar Pharmaceuticals, Inc.
Consolidated Statement of Cash Flows
(in US dollars unless otherwise noted)
Years ended June 30,
--------------------
2017 2016
Note $ $
---- --- ---
Cash flows from
operating
activities
Loss for the
period (8,081,764) (8,864,864)
Items not
affecting cash
Amortization of
intangible
assets 16,683 10,288
Change in fair
value of stock
option and
derivative
liabilities 4,5 (245,963) 2,341,660
Change in fair
value of
derivative
liability due
change in
warrant terms 4,5 - 295,456
Shares issued
for services 5 564,000 146,900
Warrants issued
for services 5 81,602 647,902
Stock option
expense 5 124,747 394,132
Changes in non-
cash working
capital
Prepaid expenses
and deposits 8 (1,063,991) 100,907
Taxes and other
receivables (58,208) 7,444
Accounts payable
and accrued
liabilities 598,310 (178,263)
Related party
payables 6 45,513 (47,376)
------ -------
(8,019,071) (5,145,814)
---------- ----------
Cash flows from
investing
activities
Intangible
assets -
website
development
costs (20,956) (16,762)
------- -------
(20,956) (16,762)
------- -------
Cash flows from
financing
activities
Net proceeds
from the
issuance of
shares and
warrants 5 7,932,107 2,453,633
Net proceeds
from the
issuance of
Series B
Preferred Stock 5 - 6,540,821
Proceeds from
the exercise of
warrants 5 545,026 579,309
Series A
preferred stock
dividend 5 (8,356) (8,356)
------ ------
8,468,777 9,565,407
--------- ---------
Increase in cash
and cash
equivalents 428,750 4,402,831
Cash - beginning
of year 6,157,264 1,754,433
--------- ---------
Cash - end of
year 6,586,014 6,157,264
========= =========
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SOURCE DelMar Pharmaceuticals, Inc.
