SAN DIEGO, May 13, 2020 /PRNewswire/ -- DelMar
Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the
"Company"), a biopharmaceutical company focused on the development
of new solid tumor cancer therapies, announced its financial
results for the three and nine months ended March 31, 2020 and provided a corporate
update.
"We continue to be pleased with the rapid enrollment pace in
both of our Phase 2 GBM trials," stated Saiid Zarrabian, CEO of DelMar Pharmaceuticals.
"While we cannot predict the future impact of COVID-19 on our
studies at MD Anderson Cancer Center in Houston and Sun
Yat-sen University Cancer Center in China, we have been encouraged that COVID-19
has not negatively impacted trial enrollment and dosing to
date. As previously stated, we have completed full enrollment
of our first line study in China,
and based on historical enrollment rates, we are optimistic that we
will complete full enrollment of the remaining two patient cohorts
by the end of calendar year 2020. In the meantime, we look
forward to sharing updated clinical data at the American Society of
Clinical Oncology ASCO20 Virtual Scientific Program being held
May 29-31 and the American
Association for Cancer Research Virtual Annual Meeting II being
held June 22-24."
RECENT CORPORATE UPDATES
- May 2020 - Announced enrollment
of our 22nd patient (study over 90% enrolled) in the adjuvant arm
of our ongoing Phase 2 clinical study investigating adjuvant
treatment (pre-temozolomide -- or TMZ – maintenance therapy) of
MGMT-unmethylated glioblastoma multiforme (GBM) with VAL-083. The
adjuvant arm of the Phase 2 study of VAL-083 is being conducted at
the MD Anderson Cancer Center (MDACC) and is designed to enroll up
to 24 newly-diagnosed patients who have undergone surgery and
chemoradiation with TMZ but will now receive VAL-083 in place of
standard of care TMZ for adjuvant therapy.
- May 2020 - Provided an enrollment
update for the recurrent arm of the study, which is also being
conducted at MDACC, where 72 patients out of a planned 83 patients
have been enrolled.
- February 2020 - Announced we had
enrolled the final patient in our ongoing Phase 2 clinical study
investigating the first-line treatment of VAL-083 with radiation
therapy in newly-diagnosed, MGMT-unmethylated GBM being conducted
at Sun Yat-sen University Cancer Center in China.
SUMMARY OF FINANCIAL RESULTS FOR THE QUARTER ENDED
MARCH 31, 2020
For the three months ended March 31,
2020, the Company reported a net loss of approximately
$1.96 million, or $0.17 per share, compared to a net loss of
approximately $1.7 million, or
$0.67 per share, for the same period
of 2019.
For the nine months ended March 31,
2020, the Company reported a net loss of approximately
$5.3 million, or $0.52 per share, compared to a net loss of
approximately $5.5 million, or
$2.27 per share, for the same period
of 2019.
Selected Balance
Sheet data
|
|
|
|
March
31,
2020
|
|
June 30,
2019
|
|
|
|
$
|
|
$
|
|
Cash and cash
equivalents
|
|
|
4,973,378
|
|
|
3,718,758
|
|
Working
capital
|
|
|
3,716,827
|
|
|
1,955,468
|
|
Total
assets
|
|
|
5,102,241
|
|
|
4,037,255
|
|
Total stockholders'
equity
|
|
|
3,720,486
|
|
|
1,967,530
|
|
|
|
Selected Statement
of operations data
|
|
For the three
months ended
|
|
|
|
March
31,
|
|
March
31,
|
|
|
|
|
|
2020
|
|
2019
|
|
|
|
|
|
$
|
|
$
|
|
|
|
Research and
development
|
|
|
898,720
|
|
735,844
|
|
|
|
General and
administrative
|
|
|
1,077,642
|
|
935,530
|
|
|
|
Other
income
|
|
|
(19,380)
|
|
(7,389)
|
|
|
|
Net loss for the
period
|
|
|
1,956,982
|
|
1,663,985
|
|
|
|
Series B Preferred
stock dividend
|
|
|
1,473
|
|
23,202
|
|
|
|
Net loss attributable
to common stockholders
|
|
|
1,958,455
|
|
1,687,187
|
|
|
|
Basic and fully
diluted number of shares
|
|
|
11,417,456
|
|
2,518,452
|
|
|
|
Basic and fully
diluted loss per share
|
|
|
0.17
|
|
0.67
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the nine
months ended
|
|
|
|
March
31,
|
|
March
31,
|
|
|
|
|
|
2020
|
|
2019
|
|
|
|
|
|
$
|
|
$
|
|
|
|
Research and
development
|
|
|
2,332,388
|
|
2,702,213
|
|
|
|
General and
administrative
|
|
|
3,045,017
|
|
2,796,884
|
|
|
|
Other
income
|
|
|
(74,501)
|
|
(33,611)
|
|
|
|
Net loss for the
period
|
|
|
5,302,904
|
|
5,465,486
|
|
|
|
Series B Preferred
stock dividend
|
|
|
6,071
|
|
75,477
|
|
|
|
Net loss attributable
to common stockholders
|
|
|
5,308,975
|
|
5,540,963
|
|
|
|
Basic and fully
diluted number of shares
|
|
|
10,116,541
|
|
2,444,065
|
|
|
|
Basic and fully
diluted loss per share
|
|
|
0.52
|
|
2.27
|
|
|
|
|
|
|
|
|
|
|
|
|
At March 31, 2020, the Company had
cash and cash equivalents of approximately $5.0 million. In August 2019, the Company completed an
underwritten public offering for net proceeds of approximately
$6.6 million. The cash and cash
equivalents at March 31, 2020 are
expected to be sufficient to fund the Company's planned operations
into the fourth quarter of calendar year 2020.
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.
ABOUT DELMAR PHARMACEUTICALS, INC.
Located in San Diego,
California, 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.
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, including statements regarding the status of the
Company's clinical trials, the reporting of the results and the
impact of the COVID-19 pandemic. 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 impact of the COVID-19 pandemic
on the Company's operations and clinical trials, 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, 2019, the Company's
Quarterly Reports on Form 10-Q, and the Company's Current Reports
on Form 8-K.
CONTACTS:
Investors:
CORE IR
516-222-2560
ir@coreir.com
Media:
Jules
Abraham
Director of Public
Relations
CORE
IR
917-885-7378
julesa@coreir.com
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SOURCE DelMar Pharmaceuticals, Inc.