VANCOUVER, British Columbia and
MENLO PARK, Calif., Feb.
12, 2019 /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 second quarter
ended December 31, 2018. DelMar
executive management will host a business update conference call
for investors, analysts and other interested parties on
February 19, 2019 at 4:30 p.m. Eastern Time.
"During the second quarter, we continued enrollment in our Phase
2 clinical trials for MGMT-unmethylated GBM patients at the MD
Anderson Cancer Center in Houston,
Texas, and at Sun Yat-sen University Cancer Center in
Guangzhou, China," commented
Saiid Zarrabian, President and Chief
Executive Officer of DelMar Pharmaceuticals. "We are now nearing
full enrollment at MD Anderson and halfway enrollment in
China. We are eagerly anticipating
data from each of these studies."
RECENT HIGHLIGHTS
- Continued enrolling patients in Phase 2, open-label,
second-line, Avastin-naïve, MGMT-unmethylated, recurrent
glioblastoma multiforme ("GBM") study being conducted at the MD
Anderson Cancer Center (the "MDACC study").
-
- As of January 31, 2019, forty-six
patients have been enrolled in the MDACC study
- The dosing levels used in the MDACC study have continued to
demonstrate a safety profile well within the existing safety
monitoring guidelines described in the present study protocol
- Similar to prior clinical experience, myelosuppression has been
the most common adverse event observed
- Continued enrolling patients in Phase 2, open-label, first-line
temozolomide-naïve, MGMT-unmethylated GBM study at Sun Yat-sen
University Cancer Center.
-
- As of January 31, 2019, fourteen
patients have been enrolled in this study
- Observed increased enrollment rates in the recent quarter
- On February 4, 2019, the Company
received a written notice that The Nasdaq Capital Market LLC
(Nasdaq) had granted the Company an extension until June 25, 2019 to regain compliance with the
Minimum Bid Price requirement. During the extension, the Company
must remain in compliance with all other listing requirements of
Nasdaq.
- Based on overall clinical and corporate development progress
achieved to date, DelMar expects to have cash available to fund
planned operations into the middle of calendar 2019.
For further details on the Company's operating and financial
results, as well as more detail about its updated strategy, refer
to DelMar's Form 10-K filed with the SEC on September 24, 2018, as well as the Company's
Quarterly Report on Form 10-Q for the three and six months ended
December 31, 2018 filed with the SEC
on February 11, 2019:
http://ir.delmarpharma.com/all-sec-filings.
CONFERENCE CALL DETAILS
DelMar will host a conference call to discuss its financial
results for quarter ended December 31,
2018 and provide a corporate update on February 19, 2019, 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 1-877‑876‑9174 (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.
SUMMARY OF FINANCIAL RESULTS FOR PERIODS ENDED DECEMBER 31, 2018
At December 31, 2018, the Company
had cash and cash equivalents on hand of approximately $3.7 million.
For the three months ended December 31,
2018, the Company reported a net loss of $1,809,697, or $0.08 per share, compared to a net loss of
$3,161,598, or $0.14 per share, for the three months ended
December 31, 2017.
For the six months ended December 31,
2018, the Company reported a net loss of $3,801,501, or $0.16 per share, compared to a net loss of
$5,828,004, or $0.31 per share, for the six months ended
December 31, 2017.
The following represents selected financial information as of
December 31, 2018. 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, 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
|
|
|
|
December
31,
2018
$
|
|
June
30,
2018
$
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
3,702,902
|
|
|
5,971,995
|
Working
capital
|
|
|
2,751,675
|
|
|
5,407,929
|
Total
assets
|
|
|
4,037,552
|
|
|
7,074,855
|
Total stockholders'
equity
|
|
|
2,769,264
|
|
|
5,435,223
|
Selected Statement
of Operations Data
|
|
For the three
months ended:
|
|
|
December
31,
|
|
December
31,
|
|
|
2018
|
|
2017
|
|
|
$
|
|
$
|
|
|
|
|
|
Research and
development
|
|
|
947,249
|
|
|
2,141,945
|
General and
administrative
|
|
|
874,884
|
|
|
1,011,879
|
Change in fair value
of derivative liability
|
|
|
(1,261)
|
|
|
889
|
Foreign exchange
loss
|
|
|
5,097
|
|
|
7,120
|
Interest
income
|
|
|
(16,272)
|
|
|
(235)
|
Net and comprehensive
loss for the period
|
|
|
1,809,697
|
|
|
3,161,598
|
Series B preferred
stock dividend
|
|
|
16,190
|
|
|
54,066
|
Net and comprehensive
loss available to common stockholders
|
|
|
1,825,887
|
|
|
3,215,664
|
Basic weighted
average number of shares outstanding
|
|
|
24,242,223
|
|
|
22,559,234
|
Basic loss per
share
|
|
|
0.08
|
|
|
0.14
|
Research and development expenses decreased to $947,249 during the three months ended
December 31, 2018 from $2,141,945 for the three months ended
December 31, 2017. The decrease was
largely attributable to a decrease in clinical development costs,
personnel, preclinical research, and non-cash, share-based
compensation expense during the three months ended December 31, 2018 compared to the three months
ended December 31, 2017.
General and administrative expenses decreased during the three
months ended December 31, 2018 to
$874,884 from $1,011,879 for the three months ended
December 31, 2017, largely due to a
decrease in professional fees and personnel, partially offset by
higher non-cash, share-based compensation expense in the current
quarter compared to the prior quarter.
For the six months
ended:
|
|
|
|
December
31,
|
|
December
31,
|
|
|
2018
|
|
2017
|
|
|
$
|
|
$
|
|
|
|
|
|
Research and
development
|
|
1,966,369
|
|
4,076,588
|
General and
administrative
|
|
1,861,354
|
|
1,756,500
|
Change in fair value
of derivative liability
|
|
(1,041)
|
|
(55,679)
|
Foreign exchange
loss
|
|
10,935
|
|
50,986
|
Interest
income
|
|
(36,116)
|
|
(391)
|
Net and comprehensive
loss for the period
|
|
3,801,501
|
|
5,828,004
|
Series B Preferred
stock dividend
|
|
52,275
|
|
95,732
|
Net and comprehensive
loss available to common stockholders
|
|
3,853,776
|
|
5,923,736
|
Basic weighted
average number of shares outstanding
|
|
23,605,657
|
|
18,882,259
|
Basic loss per
share
|
|
0.16
|
|
0.31
|
Research and development expenses decreased to $1,966,369 during the six months ended
December 31, 2018 from $4,076,588 for the six months ended December 31, 2017. The decrease was largely
attributable to a decrease in clinical development costs,
personnel, preclinical research, intellectual property and travel
costs during the current period compared to the prior period.
General and administrative expenses were $1,861,354 for the six months ended December 31, 2018 compared to $1,756,500 for the six months ended December 31, 2017. A significant portion of
the increase was due to an increase in non-cash, share-based
compensation expense and personnel costs in the current period
compared to the prior period. Partially offsetting the impact
of these two items were lower professional fees and travel costs
during the six months ended December 31,
2018 compared to the six months ended December 31, 2017.
About DelMar Pharmaceuticals, Inc.
DelMar 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 are unable to tolerate, standard-of-care
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 National Cancer Institute
(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 to solve significant unmet medical
needs.
VAL-083 is 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. In addition,
DelMar has 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 additional 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 the Company's filings with the SEC,
including, the Company's Annual Report on Form 10-K for the year
ended June 30, 2018, the Company's
Quarterly Reports on Form 10-Q and the Company's Current Reports on
Form 8-K.
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SOURCE DelMar Pharmaceuticals, Inc.