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DelMar Pharmaceuticals Announces Third

Key Takeaway: DelMar Pharmaceuticals Announces Third Quarter Fiscal Year 2019 Financial Results - Company will host a business update May 23, 2019 at 4:30 PM Eastern Time VANCOUVER, British Columbia and MENLO PARK, California, May 15, 2019 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (Nas

Full Press Release Details

DelMar Pharmaceuticals Announces Third
Quarter Fiscal Year 2019 Financial Results
- Company will host a business update
May 23, 2019 at 4:30 PM Eastern Time
VANCOUVER, British Columbia and MENLO PARK,
California, May 15, 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 third
quarter ended March 31, 2019. DelMar executive management will host a business update conference call for investors, analysts
and other interested parties on May 23, 2019 at 4:30 p.m. Eastern Time.
"The third quarter proved to be an important period of
progress as we advanced VAL-083 in both of our Phase 2 clinical trials in GBM with encouraging early results, especially in our
first line GBM trial, while continuing the evaluation of this first-in-class, small molecule's potential to treat a range
of solid tumor cancers. I am also pleased by the establishment of our formal Scientific Advisory
Board led by world-renowned oncology experts," commented Saiid Zarrabian, President and Chief Executive Officer of DelMar
Pharmaceuticals. "In addition, we initiated execution of our planned rights offering to provide capital to continue the advancement
of our clinical trials through their estimated planned completion in mid-calendar 2020, and we executed the necessary recent reverse
stock split which potentially enables us to regain compliance with Nasdaq's listing requirements."
Key Highlights and Recent Developments
On February 20, 2019, DelMar announced that its Phase 2 study
evaluating VAL-083 in patients with newly diagnosed GBM achieved its halfway enrollment point. This trial, targeted to enroll up
to thirty patients, is a single-arm, open-label study testing VAL-083 in combination with standard radiotherapy in GBM patients
who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. An estimated 60% of GBM patients
possess an unmethylated MGMT gene, which confers a more limited response to current standard of care treatment as well as a lower
survival probability. This clinical trial was initiated in February 2017 and is being conducted at SYSUCC in Guangzhou, China
in collaboration with Guangxi Wuzhou Pharmaceutical Company. As of February 15, 2019, fifteen patients have been enrolled
The Company was pleased
to report that for the 15 patients enrolled as of February 15, 2019, 11 completed their prospectively planned Magnetic Resonance
Imaging (MRI) scans and have had their initial assessment for tumor progression. Tumor progression is based on the trial investigator's
clinical and radiologic assessment, according to the Response Assessment in NeuroOncology (RANO) criteria. Of these 11 patients,
five were assessed by the Principal Investigator as having a "Complete Response," three of whom were based on significant
tumor shrinkage, and two of whom were based on their tumors continuing to remain "below measurable level" from post-surgery
baseline MRI to post-cycle three MRI. Additionally, six patients were assessed as having "Stable Disease." Of the remaining
four patients, one died prior to their post-cycle three MRI and three have not been on study long enough to reach their planned
post-cycle three MRI. As of the February 15, 2019 data cutoff, 12 of the 15 enrolled patients were still alive. Similar to
prior experience, myelosuppression has been the most common adverse event observed. Two dose-limiting toxicities have been reported
(thrombocytopenia) - one at the 40 mg/m2/day dose and one at the 30 mg/m2/day
Throughout the quarter, DelMar continued to enroll patients
in VAL-083's Phase 2, open-label, second-line, Avastin-na ve, MGMT-unmethylated, recurrent GBM study being conducted
at the MDACC. On April 3, 2019, the Company announced that the MDACC's IRB approved a trial protocol amendment to expand
the study with the addition of up to 35 patients at a dose of 30 mg/m2. Also, the MDACC IRB approved the addition of
up to 24 patients in the pre-temozolomide (TMZ) maintenance setting. The biomarker driven trial, which was originally designed
as a single arm study evaluating VAL-083 in patients with MGMT-unmethylated bevacizumab (Avastin)-na ve recurrent GBM,
has been expanded to include an additional maintenance-stage (adjuvant therapy) treatment group. This protocol amendment,
in addition to the Company's ongoing Phase 2 trial in newly diagnosed patients with MGMT-unmethylated GBM being conducted at SYSUCC,
expands DelMar's evaluation range of VAL-083 as a potential treatment for unmethylated GBM patients to include newly-diagnosed,
maintenance-stage, and recurrent patients. Maintenance-stage GBM provides the greatest opportunity to control disease progression
after radiation therapy, and represents the largest addressable GBM market opportunity for VAL-083 given patients are typically
healthier and as such, are able to optimally benefit therapeutically from increased treatment cycles compared to the recurrent
treatment setting. Maintenance GBM patients may be able to receive 12+ cycles of VAL-083 versus five or six cycles for recurrent
At the American Association for Cancer Research's annual
meeting in April 2019, we reported that per investigator assessment at the end of cycle two for the MDACC study:
The Company has launched a rights offering made available to
stockholders of record as of Tuesday, May 21, 2019. If fully subscribed, this financing initiative will provide DelMar with sufficient
cash to fund planned operations into the middle of calendar 2020, and the estimated enrollment completion date for all three of
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 nine months ended March 31, 2019 filed
with the SEC on May 14, 2019:
CONFERENCE CALL DETAILS
DelMar will host a conference call to discuss its financial
results for quarter ended March 31, 2019 and provide a corporate update on May 23, 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 1-877-876-9173
(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 MARCH 31,
At March 31, 2019, the Company had cash
and cash equivalents on hand of approximately $2.2 million.
For the three months ended March 31, 2019,
the Company reported a net loss of $1,663,985, or $0.67 per share, compared to a net loss of $2,933,057, or $1.31 per share, for
the three months ended March 31, 2018.
For the nine months ended March 31, 2019,
the Company reported a net loss of $5,465,486, or $2.27 per share, compared to a net loss of $8,761,061, or $4.41 per share, for
the nine months ended March 31, 2018.
The following represents selected financial
information as of March 31, 2019. 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 condensed interim 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
March 31, 2019 $ June 30, 2018 $
Cash and cash equivalents 2,152,233 5,971,995
Working capital 1,244,563 5,407,929
Total assets 2,457,126 7,074,855
Total stockholders' equity 1,259,161 5,435,223
Selected Statement of Operations Data
For the three months ended:
March 31, March 31,
2019 2018
$ $
Research and development 735,844 1,779,609
General and administrative 935,530 1,155,038
Change in fair value of derivative liability 189 (2,160 )
Foreign exchange loss 5,819 6,420
Interest income (13,397 ) (5,850 )
Net and comprehensive loss for the period 1,663,985 2,933,057
Series B preferred stock dividend 23,202 46,626
Net and comprehensive loss available to common stockholders 1,687,187 2,979,683
Basic weighted average number of shares outstanding 2,518,452 2,283,245
Basic loss per share 0.67 1.31
Research and development expenses decreased to $735,844 during
the three months ended March 31, 2019 from $1,779,609 for the three months ended March 31, 2018. The decrease was largely attributable
to a decrease in clinical development costs, intellectual property, personnel, and preclinical research during the three months
ended March 31, 2019 compared to the three months ended March 31, 2018.
General and administrative expenses decreased during the three
months ended March 31, 2019 to $935,530 from $1,155,038 for the three months ended March 31, 2018, largely due to a decrease in
non-cash, share-based compensation expense, professional fees and travel, partially offset by higher personnel costs in the current
quarter compared to the prior quarter.
For the nine months ended:
March 31, March 31,
2019 2018
$ $
Research and development 2,702,213 5,856,197
General and administrative 2,796,884 2,911,538
Change in fair value of derivative liability (852 ) (57,839 )
Foreign exchange loss 16,754 57,406
Interest income (49,513 ) (6,241 )
Net and comprehensive loss for the period 5,465,486 8,761,061
Series B Preferred stock dividend 75,477 142,358
Net and comprehensive loss available to common stockholders 5,540,963 8,903,419
Basic weighted average number of shares outstanding 2,444,065 2,017,977
Basic loss per share 2.27 4.41
Research and development expenses decreased to $2,702,213 during
the nine months ended March 31, 2019 from $5,856,197 for the nine months ended March 31, 2018. The decrease was largely attributable
to a decrease in clinical development costs, personnel, preclinical research, intellectual property and travel costs during the
nine months ended March 31, 2019 compared to the nine months ended March 31, 2018.
Last updated: May 15, 2019