ASLAN Pharmaceuticals Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Corporate Update
22 März 2019 - 12:25PM
ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage
oncology-focused biopharmaceutical company developing novel
therapeutics for global markets, today reported financial results
for the quarter and full year ended 31 December 2018 and provided
an update on its clinical activities.
Dr Carl Firth, Chief Executive Officer, ASLAN
Pharmaceuticals, said: “Our accomplishments in 2018 have
positioned ASLAN for the achievement of key milestones in the
coming year. We completed recruitment for our pivotal study testing
varlitinib in biliary tract cancer ahead of schedule and have
recently seen activity in neoadjuvant breast cancer in an
investigator initiated study. We have started dosing the fourth
cohort in our phase 2 trial testing ASLAN003 in acute myeloid
leukaemia, and have seen further evidence of activity from the
third cohort since we last published data in December 2018. We
expect to dose our last patient in the single ascending dose study
of ASLAN004 before the end of March and move into a multiple
ascending dose study in atopic dermatitis patients in the second
half of 2019.”
Fourth quarter 2018 and recent business
highlights
Clinical development
Varlitinib
- Completed enrolment for the varlitinib global pivotal TreeTopp
(TREatmEnt OPPortunity) study ahead of schedule. The study
recruited 127 patients with biliary tract cancer (BTC) who have
failed first line therapy from 56 sites worldwide including the US,
Europe, Australia, Japan, Korea, and other Asia Pacific
countries.
- Presented positive varlitinib data in first-line biliary tract
cancer in combination with chemotherapy at 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.
- Presented new data on varlitinib showing promising results in
heavily pre-treated BTC and colorectal cancer patients, and a
poster on ASLAN003 at the 2018 European Society for Medical
Oncology (ESMO) Congress.
- Announced study results from phase 2 study of varlitinib in
first-line gastric cancer. In the study, varlitinib did not meet
the primary endpoint of significant reductions in tumour size after
12 weeks of treatment.
- In an investigator initiated trial testing varlitinib in
combination with paclitaxel and trastuzumab in neoadjuvant breast
cancer, 3 out of 5 patients (60%) have demonstrated pathological
complete response.
- New preclinical data on varlitinib’s activity in triple
negative breast cancer (TNBC) cell lines was published online in
Cancers, a peer-reviewed oncology journal.
ASLAN003
- Completed third cohort in phase 2 trial testing ASLAN003
monotherapy in acute myeloid leukemia (AML). One patient remains on
treatment and has been stable for over 4 months, with bone marrow
blasts continuing to fall from the peak of 38% to 22% from the last
biopsy.
- Presented new data at the American Society of Hematology Annual
Meeting for ASLAN003 that showed early signs of safety and efficacy
in relapsed and refractory AML patients.
- Submitted an Investigational New Drug (IND) application for
ASLAN003 in the potential treatment of AML to the United States
Food and Drug Administration (FDA) and the FDA concluded its 30-day
review.
ASLAN004
- Initiated a phase 1 single ascending dose (SAD) study
investigating ASLAN004 as a therapeutic antibody for atopic
dermatitis.
- Expecting to dose the final patient in the phase 1 SAD study
before the end of March 2019.
Corporate updates
- Appointed Robert E. Hoffman, an experienced pharmaceutical
industry leader, as an Independent Non-Executive Director.
- Announced a strategic corporate restructuring to focus
resources on the lead clinical programs: varlitinib in BTC,
ASLAN003 in AML and ASLAN004 in atopic dermatitis.
- Entered into agreements with BioGenetics Co Ltd that grant
exclusive commercialisation rights for varlitinib and ASLAN003 in
all indications in South Korea. For varlitinib, ASLAN received an
upfront payment of US$2 million, up to US$11 million in sales and
development milestones and tiered double-digit royalties up to the
mid-twenties. For ASLAN003, ASLAN received an upfront payment of
US$1 million, up to US$8 million in sales and development
milestones and tiered double-digit royalties up to the
mid-twenties.
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 first half of
2019.
- Completion of phase 1 study of ASLAN004 as a treatment for
atopic dermatitis in the first half of 2019.
Fourth quarter 2018 financial highlights
- Cash used in operations for the quarter ended 31 December 2018
was US$9.6 million compared to US$10.4 million in the same period
in 2017.
- Research and development expense was US$9.2 million and general
and administrative expense was US$1.9 million for the fourth
quarter of 2018, compared to US$11.7 million and US$2.7 million
respectively in the same period in 2017.
- Net loss for the fourth quarter of 2018 was US$11.2 million
compared to a net loss of US$14.5 million for the fourth quarter of
2017.
Full Year 2018 financial highlights
- Cash used in operations for year ended 31 December 2018 was
US$39.5 million compared to US$34.1 million in the same period in
2017.
- Research and development expense was US$31.8 million and
general and administrative expense was US$10.5 million for the full
year 2018, compared to US$30.4 million and US$8.8 million
respectively in the same period in 2017.
- Net loss for the full year 2018 was US$42.2 million compared to
a net loss of US$39.9 million for the full year 2017.
- Cash, cash equivalents and short-term investments totaled
US$28.9 million as of 31 December 2018 compared to US$50.6 million
as of 31 December 2017.
|
ASLAN Pharmaceuticals
LimitedConsolidated Balance
Sheet1(in US dollars, unaudited) |
|
|
|
|
|
|
|
December 31,2017 |
|
December 31,2018 |
ASSETS |
|
|
|
|
CURRENT ASSETS |
|
|
|
|
Cash and cash
equivalents |
|
$ |
50,573,211 |
|
|
$ |
28,908,901 |
|
Prepayments |
|
|
71,946 |
|
|
|
183,599 |
|
NON-CURRENT ASSETS |
|
|
|
|
|
|
|
|
Financial assets at
fair value through profit or loss |
|
|
- |
|
|
|
60,004 |
|
Financial
assets at fair value through other comprehensive income |
|
|
- |
|
|
|
187,244 |
|
Property,
plant and equipment |
|
|
443,566 |
|
|
|
288,418 |
|
Intangible assets |
|
|
84,052 |
|
|
|
23,080,592 |
|
Refundable deposits |
|
|
160,947 |
|
|
|
172,080 |
|
Total
non-current assets |
|
|
688,565 |
|
|
|
23,788,338 |
|
TOTAL ASSETS |
|
$ |
51,333,722 |
|
|
$ |
52,880,838 |
|
EQUITY AND
LIABILITIES |
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES |
|
|
|
|
|
|
|
|
Trade
payables |
|
$ |
3,898,291 |
|
|
$ |
5,315,737 |
|
Other
payables |
|
|
2,080,544 |
|
|
|
2,682,661 |
|
Total
current liabilities |
|
|
5,978,835 |
|
|
|
7,998,398 |
|
NON-CURRENT
LIABILITIES |
|
|
|
|
|
|
|
|
Long-term
borrowings |
|
|
9,679,451 |
|
|
|
13,974,794 |
|
Other
non-current liabilities |
|
|
162,000 |
|
|
|
289,613 |
|
Total
non-current liabilities |
|
|
9,841,451 |
|
|
|
14,264,407 |
|
Total
liabilities |
|
|
15,820,286 |
|
|
|
22,262,805 |
|
EQUITY |
|
|
|
|
|
|
|
|
Ordinary
shares |
|
|
41,514,016 |
|
|
|
51,627,219 |
|
Capital
surplus |
|
|
84,282,681 |
|
|
|
111,459,672 |
|
Accumulated deficits |
|
|
(90,283,261 |
) |
|
|
(132,468,858 |
) |
Total
equity |
|
|
35,513,436 |
|
|
|
30,618,033 |
|
TOTAL EQUITY AND
LIABILITIES |
|
$ |
51,333,722 |
|
|
$ |
52,880,838 |
|
|
|
|
|
|
|
|
|
|
|
ASLAN Pharmaceuticals
LimitedConsolidated Statements of Comprehensive
Income1(in US dollars, unaudited) |
|
|
|
|
|
|
|
For the Three Months Ended December
31 |
|
For the Twelve Months Ended December
31 |
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
OPERATING EXPENSES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General
and administrative |
|
$ |
(1,900,675 |
) |
|
$ |
(2,694,766 |
) |
|
$ |
(10,513,707 |
) |
|
$ |
(8,758,710 |
) |
Research
and development |
|
|
(9,203,972 |
) |
|
|
(11,744,291 |
) |
|
|
(31,834,364 |
) |
|
|
(30,381,016 |
) |
Total operating
expenses |
|
|
(11,104,647 |
) |
|
|
(14,439,057 |
) |
|
|
(42,348,071 |
) |
|
|
(39,139,726 |
) |
LOSS FROM
OPERATIONS |
|
|
(11,104,647 |
) |
|
|
(14,439,057 |
) |
|
|
(42,348,071 |
) |
|
|
(39,139,726 |
) |
NON-OPERATING INCOME
AND EXPENSES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
28,636 |
|
|
|
86,095 |
|
|
|
268,330 |
|
|
|
363,137 |
|
Other income |
|
|
- |
|
|
|
- |
|
|
|
187,244 |
|
|
|
- |
|
Other gains and
losses |
|
|
42,708 |
|
|
|
(70,996 |
) |
|
|
213,243 |
|
|
|
(698,691 |
) |
Finance
costs |
|
|
(158,537 |
) |
|
|
(106,369 |
) |
|
|
(491,904 |
) |
|
|
(416,698 |
) |
Total
non-operating income and expenses |
|
|
(87,193 |
) |
|
|
(91,270 |
) |
|
|
176,913 |
|
|
|
(752,252 |
) |
LOSS
BEFORE INCOME TAX |
|
|
(11,191,840 |
) |
|
|
(14,530,327 |
) |
|
|
(42,171,158 |
) |
|
|
(39,891,978 |
) |
INCOME
TAX EXPENSE |
|
|
- |
|
|
|
- |
|
|
|
(14,439 |
) |
|
|
- |
|
NET LOSS FOR THE
PERIOD |
|
|
(11,191,840 |
) |
|
|
(14,530,327 |
) |
|
|
(42,185,597 |
) |
|
|
(39,891,978 |
) |
TOTAL
COMPREHENSIVE LOSS FOR THE PERIOD |
|
$ |
(11,191,840 |
) |
|
$ |
(14,530,327 |
) |
|
$ |
(42,185,597 |
) |
|
$ |
(39,891,978 |
) |
LOSS PER SHARE |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.07 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.28 |
) |
|
$ |
(0.32 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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-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
States 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, if any,
contains 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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