SAN DIEGO, Sept. 10, 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
year ended June 30, 2019.
"This has been a productive quarter and year for DelMar as we
have achieved multiple data milestones for both of our Phase 2 GBM
trials for VAL-083," commented Saiid
Zarrabian, DelMar's President and Chief Executive Officer.
"Most importantly, based on recent budget refinements, we now
believe we have sufficient capital to achieve release of topline
data for two of our three currently enrolling MGMT-unmethylated GBM
patient groups. These topline results include the recurrent setting
GBM trial being conducted at the MD Anderson Cancer Center and the
first line GBM trial being conducted at Sun Yat-sen University
Cancer Center in China. We anticipate results from both of
these trials to be announced during the fourth quarter of calendar
year 2020 and will be supported by the Company's recent financings
completed in June and August 2019.
Additionally, we have also relocated our headquarters to
San Diego to position ourselves
for better access to required expertise as we advance our
trials."
RECENT CORPORATE UPDATES
- September 2019 - Moved corporate
headquarters to San Diego,
California
- August 2019 – Closed an
underwritten public offering with net proceeds of approximately
$6.7 million
- August 2019 – Provided update on
Phase 2 clinical study on first line therapy in newly diagnosed
MGMT-unmethylated GBM patients being conducted at Sun Yat-sen
University Cancer Center. At the time of the update, nine
patients were assessed as having achieved complete response, seven
were assessed with stable disease, and one was assessed with
disease progression
- July 2019 – Enrolled first
patient in adjuvant (pre-temozolomide maintenance) arm of Phase 2
open label study of VAL-083 being conducted at MD Anderson Cancer
Center (MDACC)
- July 2019 – Provided enrollment
update of Phase 2 open label study of VAL-083 in recurrent GBM
patients with MGMT-unmethylated status. As of this
announcement, 56 of the planned 83 patients had been enrolled in
the study being conducted at MDACC
- June 2019 – Closed on registered
direct financing with net proceeds of approximately $3.2 million
- May 2019 – Expanded Scientific
Advisory Board to include leading neuro-oncologists, Dr.
David Reardon from Dana-Farber
Cancer Center, Dr. Timothy Cloughsey
from David Geffen School of
Medicine, and Dr. Nicholas Butowski
from UCSF and the Brain Tumor Center
- April 2019 – Announced formation
of Scientific Advisory Board, which includes current members of the
Company's board of directors, Dr. Napoleone
Ferrara and Dr. John de Groot
from the MD Anderson Cancer Center
SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR ENDED
JUNE 30, 2019
At June 30, 2019, the Company had
cash and cash equivalents on hand of approximately $3.7 million. In August 2019, the Company completed an
underwritten public offering for net proceeds of approximately
$6.7 million. The proceeds from the
August 2019 financing combined with
cash and cash equivalents on hand at June
30, 2019 are expected to be sufficient to fund the Company's
planned operations into the fourth quarter of calendar year
2020.
For the year ended June 30, 2019,
the Company reported a net loss of approximately $8.0 million, or $3.16 per share, compared to a net loss of
approximately $11.1 million, or
$5.42 per share, for the year ended
June 30, 2018.
At June 30,
2019
|
|
Selected Balance
Sheet data
|
|
|
June
30,
2019
|
|
June
30,
2018
|
|
$
|
|
$
|
Cash and cash
equivalents
|
|
3,718,758
|
|
|
5,971,995
|
Working
capital
|
|
1,955,468
|
|
|
5,407,929
|
Total
assets
|
|
4,037,255
|
|
|
7,074,855
|
Total stockholders'
equity
|
|
1,967,530
|
|
|
5,435,223
|
|
|
|
|
Selected Statement
of operations data
|
|
For the years
ended
|
|
|
|
|
|
June
30,
|
|
June
30,
|
|
2019
|
|
2018
|
|
$
|
|
$
|
Research and
development
|
|
3,662,056
|
|
|
7,132,952
|
General and
administrative
|
|
4,736,440
|
|
|
4,041,711
|
Other
income
|
|
(350,275)
|
|
|
(36,351)
|
Net and comprehensive
loss for the year
|
|
8,048,221
|
|
|
11,138,312
|
Series B Preferred
stock dividend
|
|
80,431
|
|
|
176,236
|
Net and comprehensive
loss available to common stockholders
|
|
8,128,652
|
|
|
11,314,548
|
Basic weighted
average number of shares
|
|
2,574,692
|
|
|
2,086,142
|
Basic and fully
diluted loss per share
|
|
3.16
|
|
|
5.42
|
|
|
|
|
|
|
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 and the reporting of the
results. 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, 2019, the Company's
Quarterly Reports on Form 10-Q, and the Company's Current Reports
on Form 8-K.
CONTACTS:
Investors:
John
Marco
Managing Director
CORE IR
516-222-2560
johnm@coreir.com
Media:
Jules
Abraham
Director of Public Relations
CORE IR
917-885-7378
julesa@coreir.com
View original content to download
multimedia:http://www.prnewswire.com/news-releases/delmar-pharmaceuticals-announces-fiscal-year-2019-financial-results-and-recent-corporate-updates-300915016.html
SOURCE DelMar Pharmaceuticals, Inc.