ASLAN Pharmaceuticals Reports First Quarter 2019 Financial Results and Provides Corporate Update
29 April 2019 - 11:02AM
ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical stage
oncology and immunology focused biopharmaceutical company
developing novel therapeutics for global markets, today reported
financial results for the quarter ended 31 March 2019 and provided
an update on its clinical activities.
Dr Carl Firth, Chief Executive Officer, ASLAN
Pharmaceuticals, said: “I am pleased with the pace of our
accomplishments so far in 2019 and anticipate the achievement of
additional key milestones later in the year. As reported, we
completed recruitment for our pivotal study testing varlitinib in
biliary tract cancer ahead of schedule and remain on track to
report topline results in the second half of this year. Dosing of
the fourth cohort in our phase 2 trial testing ASLAN003 in acute
myeloid leukemia is continuing. In addition, we have completed
dosing in the single ascending dose study of ASLAN004 and are on
track to move into a multiple ascending dose study in patients with
atopic dermatitis with this differentiated product candidate in the
second half of 2019.”
First quarter 2019 and recent business
highlights
Clinical development
Varlitinib
- The varlitinib global pivotal TreeTopp (TREatmEnT OPPortunity)
study completed patient enrolment ahead of schedule with the
recruitment of 127 patients with biliary tract cancer (BTC) who
failed first line therapy from 56 sites worldwide including the US,
Europe, Australia, Japan, Korea, and other Asia Pacific countries.
The trial is ongoing and proceeding according to plan.
- In January, positive varlitinib data was presented in
first-line biliary tract cancer in combination with chemotherapy at
the American Society of Clinical Oncology Gastrointestinal Cancers
Symposium (ASCO GI). The data demonstrated a response rate of 44%
across all evaluable patients and a 60% response rate in the
highest dose cohort, compared to historical rates of 26% with
current standard of care treatment.
ASLAN003
- Completed the third cohort (100mg BID) in
phase 2a trial testing ASLAN003 in acute myeloid
leukemia (AML). Six patients recruited into the fourth cohort
(200mg BID). All patients are currently ongoing.
ASLAN004
- Completed the first part of the phase 1 single ascending dose
(SAD) study testing the intravenous formulation of the
first-in-class therapeutic antibody ASLAN004 in healthy volunteers.
ASLAN004 is a fully human monoclonal antibody that binds to the
IL-13 receptor α1 subunit (IL-13Rα1), blocking signalling of two
pro-inflammatory cytokines, IL-4 and IL-13, which are central to
triggering symptoms of atopic dermatitis, such as redness and
itching of the skin. Analysis of downstream mediators demonstrated
complete inhibition within one hour of dosing, which was then
maintained for more than 29 days, suggesting monthly dosing may be
achievable.
- Last patient dosed in the second part of the ongoing SAD trial
on 27 March. ASLAN is testing a subcutaneous formulation and
expects to report data from this part of the study in May.
Initiation of a multiple ascending dose study in patients with
moderate to severe atopic dermatitis is planned for the second half
of 2019.
Corporate updates
- In February, ASLAN entered into an agreement with BioGenetics
Co Ltd that granted exclusive commercialisation rights for
varlitinib in all indications in South Korea. ASLAN received an
upfront payment of US$2 million and can receive up to US$11 million
in sales and development milestones. ASLAN is also eligible to
receive tiered royalties on net sales from the high-teens to the
mid-twenties range.
- In March, ASLAN entered into a second agreement with
BioGenetics Co Ltd that granted exclusive commercialisation rights
for ASLAN003 in all indications in South Korea. Under terms of the
agreement, ASLAN received an upfront payment of US$1 million and is
eligible to receive up to US$8 million in sales and development
milestones. ASLAN is also eligible to receive tiered royalties on
net sales from the high-teens to the mid-twenties range.
Anticipated upcoming milestones
- Topline global pivotal trial (TreeTopp) data on varlitinib as
second line treatment for biliary tract cancer in the second half
of 2019.
- Part 1 readout of ASLAN003 phase 2 trial in the second quarter
of 2019.
- Completion of single ascending dose trial for ASLAN004 in
atopic dermatitis in the second quarter of 2019.
- Initiation of a multiple ascending dose trial for ASLAN004 in
patients with moderate to severe atopic dermatitis in the second
half of 2019.
First quarter 2019 financial results
- Cash used in operations for the quarter ended 31 March 2019 was
US$7.2 million compared to US$10.0 million in the same period in
2018.
- Research and development (R&D) expense was US$4.4 million
and general and administrative (G&A) expense was US$2.3 million
for the first quarter of 2019, compared to US$5.6 million and
US$2.8 million, respectively, in the same period in 2018. The
decrease in R&D expense was due to the completion of clinical
studies and lower manufacturing expenses. The decrease in G&A
expense was the result of the restructuring implemented in January
2019.
- Net loss for the first quarter of 2019 was US$4.3 million
compared to a net loss of US$8.7 million for the first quarter of
2018. The narrower loss in the first quarter of 2019 was due
primarily to recognition of the US$3 million upfront payment from
the licensing agreements with BioGenetics Co Ltd and lower
operational costs.
- Cash, cash equivalents and short-term investments totaled
US$21.6 million as of 31 March 2019 compared to US$28.9 million as
of 31 December 2018. Weighted average shares outstanding for the
first quarter of 2019 was 160.2 million compared to 130.2 million
for the first quarter of 2018. One American Depositary Share is the
equivalent of five ordinary shares.
ASLAN Pharmaceuticals
LimitedConsolidated Balance
Sheet1(in US dollars, unaudited)
|
|
March 31, 2019
(Reviewed) |
|
|
December 31, 2018
(Audited) |
|
|
|
|
|
|
|
ASSETS |
|
Amount |
|
Amount |
|
CURRENT ASSETS |
|
|
|
|
|
Cash and cash
equivalents |
|
$ |
21,620,307 |
|
|
$ |
28,908,901 |
|
|
Accounts
receivable |
|
|
1,000,000 |
|
|
|
- |
|
|
Prepayments |
|
|
248,300 |
|
|
|
183,599 |
|
|
Total
current assets |
|
|
22,868,607 |
|
|
|
29,092,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NON-CURRENT ASSETS |
|
|
|
|
|
|
|
|
|
|
|
Financial assets at
fair value through profit or loss |
|
|
60,004 |
|
|
|
60,004 |
|
|
Financial assets at
fair value through other comprehensive income |
|
|
187,244 |
|
|
|
187,244 |
|
|
Property, plant and
equipment |
|
|
226,149 |
|
|
|
288,418 |
|
|
Right-of-use
assets |
|
|
267,111 |
|
|
|
- |
|
|
Intangible assets |
|
|
23,079,180 |
|
|
|
23,080,592 |
|
|
Refundable
deposits |
|
|
174,206 |
|
|
|
172,080 |
|
|
Total
non-current assets |
|
|
23,993,894 |
|
|
|
23,788,338 |
|
|
TOTAL |
|
$ |
46,862,501 |
|
|
$ |
52,880,838 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
EQUITY |
|
|
|
|
|
CURRENT
LIABILITIES |
|
|
|
|
|
Trade payables |
|
$ |
3,706,431 |
|
|
$ |
5,315,737 |
|
|
Other payables |
|
|
2,094,057 |
|
|
|
2,682,661 |
|
|
Lease liabilities -
current |
|
|
223,833 |
|
|
|
- |
|
|
Total
current liabilities |
|
|
6,024,321 |
|
|
|
7,998,398 |
|
|
|
|
|
|
|
|
NON-CURRENT
LIABILITIES |
|
|
|
|
|
Long-term
borrowings |
|
|
14,139,819 |
|
|
|
13,974,794 |
|
|
Lease liabilities -
non-current |
|
|
42,238 |
|
|
|
- |
|
|
Other non-current
liabilities |
|
|
365,230 |
|
|
|
289,613 |
|
|
Total
non-current liabilities |
|
|
14,547,287 |
|
|
|
14,264,407 |
|
|
Total
liabilities |
|
|
20,571,608 |
|
|
|
22,262,805 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EQUITY |
|
|
|
|
|
Ordinary shares |
|
|
51,627,219 |
|
|
|
51,627,219 |
|
|
Capital surplus |
|
|
111,476,574 |
|
|
|
111,459,672 |
|
|
Accumulated
deficits |
|
|
(136,812,900 |
) |
|
|
(132,468,858 |
) |
|
Total
equity |
|
|
26,290,893 |
|
|
|
30,618,033 |
|
|
TOTAL |
|
$ |
46,862,501 |
|
|
$ |
52,880,838 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ASLAN Pharmaceuticals
LimitedConsolidated Statements of Comprehensive
Income1(in US dollars, unaudited)
|
|
For the Three Months Ended March
31 |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
Amount |
|
|
|
Amount |
|
|
|
|
|
|
|
|
|
|
SALES |
|
$ |
3,000,000 |
|
|
|
$ |
- |
|
|
|
OPERATING COSTS |
|
|
100,000 |
|
|
|
|
- |
|
|
|
GROSS PROFIT |
|
|
2,900,000 |
|
|
|
|
- |
|
|
|
OPERATING EXPENSES |
|
|
|
|
|
|
|
General
and administrative |
|
|
(2,256,361 |
) |
|
|
|
(2,807,871 |
) |
|
|
Research
and development |
|
|
(4,449,532 |
) |
|
|
|
(5,622,802 |
) |
|
|
Total
operating expenses |
|
|
(6,705,893 |
) |
|
|
|
(8,430,673 |
) |
|
|
LOSS FROM
OPERATIONS |
|
|
(3,805,893 |
) |
|
|
|
(8,430,673 |
) |
|
|
NON-OPERATING INCOME
AND EXPENSES |
|
|
|
|
|
|
|
Interest
income |
|
|
69,024 |
|
|
|
|
61,546 |
|
|
|
Other
gains and losses |
|
|
(404,555 |
) |
|
|
|
(262,426 |
) |
|
|
Finance
costs |
|
|
(199,700 |
) |
|
|
|
(112,275 |
) |
|
|
Total
non-operating income and expenses |
|
|
(535,231 |
) |
|
|
|
(313,155 |
) |
|
|
LOSS BEFORE INCOME
TAX |
|
|
(4,341,124 |
) |
|
|
|
(8,743,828 |
) |
|
|
INCOME TAX EXPENSE |
|
|
(2,918 |
) |
|
|
|
- |
|
|
|
NET LOSS FOR THE
PERIOD |
|
|
(4,344,042 |
) |
|
|
|
(8,743,828 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL COMPREHENSIVE
LOSS FOR THE PERIOD |
|
$ |
(4,344,042 |
) |
|
|
$ |
(8,743,828 |
) |
|
|
|
|
|
|
|
|
|
|
LOSS PER SHARE |
|
|
|
|
|
|
|
Basic |
|
$ |
(0.03 |
) |
|
|
$ |
(0.07 |
) |
|
|
Avg.
Shares Outstanding |
|
|
160,248,940 |
|
|
|
|
130,128,940 |
|
|
|
1 Financial statements in US dollars are prepared by the
Company
Media and IR contacts
Emma
ThompsonSpurwing CommunicationsTel: +65 6751 2021Email:
ASLAN@spurwingcomms.com |
Robert
UhlWestwicke PartnersTel: +1 858 356 5932 Email:
robert.uhl@westwicke.com |
About ASLAN Pharmaceuticals ASLAN
Pharmaceuticals (Nasdaq:ASLN, TPEx:6497) is a clinical-stage
oncology and immunology focused biopharmaceutical company
developing novel therapeutics for global markets. ASLAN targets
diseases that are both highly prevalent in Asia and orphan
indications in the United Stated and Europe. Led by a senior
management team with extensive experience in global and regional
development and commercialisation, ASLAN is headquartered in
Singapore and has offices in Taiwan and China. ASLAN’s portfolio is
comprised of three product candidates which target validated growth
pathways applied to new patient segments, novel immune checkpoints
and novel cancer metabolic pathways. ASLAN’s partners include Array
BioPharma, Bristol-Myers Squibb, Almirall and CSL. For additional
information please visit www.aslanpharma.com.
Forward looking statements
This release and the accompanying financial information, contain
forward-looking statements. These statements are based on the
current beliefs and expectations of the management of ASLAN
Pharmaceuticals Limited and/or its affiliates (the "Company").
These forward-looking statements may include, but are not limited
to, statements regarding the Company’s business strategy, the
Company’s plans to develop and commercialise its product
candidates, the safety and efficacy of the Company’s product
candidates, the Company’s plans and expected timing with respect to
regulatory filings and approvals, and the size and growth potential
of the markets for the Company’s product candidates. The Company’s
estimates, projections and other forward-looking statements are
based on management's current assumptions and expectations of
future events and trends, which affect or may affect the Company’s
business, strategy, operations or financial performance, and
inherently involve significant known and unknown risks and
uncertainties. Actual results and the timing of events could
differ materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, which
include, without limitation the risk factors described in the
Company’s US Securities and Exchange Commission filings
and reports (Commission File No. 001-38475), including the
Company’s prospectus dated May 8, 2018 filed with
the US Securities and Exchange Commission on such
date.
All statements other than statements of historical fact are
forward-looking statements. The words “believe,” “may,” “might,”
“could,” “will,” “aim,” “estimate,” “continue,” “anticipate,”
“intend,” “expect,” “plan,” or the negative of those terms, and
similar expressions that convey uncertainty of future events or
outcomes are intended to identify estimates, projections and other
forward-looking statements. Estimates, projections and other
forward-looking statements speak only as of the date they were
made, and, except to the extent required by law, the Company
undertakes no obligation to update or review any estimate,
projection or forward-looking statement.
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