ASLAN Pharmaceuticals Reports Second Quarter 2019 Financial Results and Provides Corporate Update
13 August 2019 - 10:03AM
ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage
oncology and immunology focused biopharma company, today reported
financial results for the quarter ended 30 June 2019 and provided
an update on its clinical activities.
Dr Carl Firth, Chief Executive Officer, ASLAN
Pharmaceuticals, said: “ASLAN made significant progress
through the second quarter of this year, highlighted by our
agreement with K-MASTER investigating varlitinib in metastatic
gastric cancer patients, updated results from the ongoing clinical
program studying ASLAN003 in AML, as well as results from our
ASLAN004 single ascending dose study supporting differentiation
versus other IL4/IL13 receptor inhibitors. Based on this exciting
new data, we amended the agreement with CSL Limited to include full
global rights to develop, manufacture, and commercialise this first
in class therapeutic antibody for atopic dermatitis and other
indications. Looking forward to the remainder of the year, we await
topline data from our pivotal TreeTopp trial as second line
treatment for biliary tract cancer, in the fourth quarter.”
Second quarter 2019 and recent business
highlights
Clinical development
Varlitinib
- Signed an agreement with the Korean Cancer Diagnosis &
Treatment Enterprise (K-MASTER) to investigate varlitinib in a
phase 1b/2 multi-centre umbrella study to evaluate the safety and
efficacy of varlitinib in combination with weekly paclitaxel as a
second-line treatment in HER1/HER2 co-expressing advanced or
metastatic gastric cancer patients. The open label, multi-centre
study will recruit approximately 400 patients, divided between four
experimental arms and a common control arm based on biomarker
profiling.
ASLAN003
- The first part of a phase 2 clinical trial with ASLAN003 in
patients with advanced relapsed/refractory acute myeloid leukaemia
(AML) was fully recruited and four doses of ASLAN003 (100mg QD,
200mg QD, 100mg BID and 200mg BID) have been tested as monotherapy.
Significant reductions in peripheral blood blast cells of up to 98%
and fast onset of blast cell reduction were observed in a number of
patients. ASLAN003 has been well-tolerated in AML patients with
only one patient out of 24 experiencing febrile neutropenia and
tumor lysis syndrome, which were classified as drug-related serious
adverse events. ASLAN is now evaluating next steps in the
development of ASLAN003.
ASLAN004
- Completed a single ascending dose (SAD) study testing ASLAN004
in healthy volunteers and announced the updated data from the
second part of the study that tested a subcutaneous formulation of
ASLAN004. The results from the single ascending dose study
confirmed ASLAN004’s favourable tolerability profile, complete
inhibition of downstream mediators and potential for monthly
dosing.
- Amended license agreement with CSL Limited (CSL) so that ASLAN
has full global rights to develop, manufacture and commercialise
ASLAN004 in all indications. The amended agreement replaces the
licensing agreement ASLAN and CSL signed in May 2014. Under the
terms of the amended agreement, ASLAN will make a first payment of
US$30 million to CSL upon commencement of a phase 3 study of
ASLAN004. CSL is also eligible to receive up to US$95 million of
regulatory milestones, US$655 million of sales milestones and
tiered royalties on net sales between mid-single digits and
10%.
Corporate updates
- Elected Andrew Howden as non-executive Chairman of the Board.
Dr Carl Firth, who has held the positions of Chairman and CEO since
founding the company in 2010, will continue to serve as CEO and as
a Director. This planned separation of the Chairman and CEO roles
was conducted to align to best corporate governance practices.
Anticipated upcoming milestones
- Presentation of new phase 1 data for varlitinib in combination
with mFOLFIRI chemotherapy in advanced solid tumours at the
European Society for Medical Oncology (ESMO) Congress 2019 in late
September.
- Initiation of a multiple ascending dose trial for ASLAN004 in
patients with moderate to severe atopic dermatitis in the second
half of 2019.
- Topline global pivotal trial (TreeTopp) data on varlitinib as
second line treatment for biliary tract cancer in the fourth
quarter of 2019.
Second quarter 2019 financial results
- Cash used in operations for the quarter ended 30 June 2019 was
US$6.5 million compared to US$10.0 million in the same period in
2018.
- Research and development (R&D) expense was US$5.3 million
and general and administrative (G&A) expense was US$1.9 million
for the second quarter of 2019, compared to US$8.3 million and
US$3.1 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 in the period resulted from the restructuring implemented
in January 2019.
- Net loss for the second quarter of 2019 was US$7.9 million
compared to a net loss of US$11.0 million for the second quarter of
2018.
- Cash, cash equivalents and short-term investments totaled
US$15.1 million as of 30 June 2019 compared to US$28.9 million as
of 31 December 2018. Weighted average shares outstanding for the
second quarter of 2019 was 160.2 million compared to 147.9 million
for the second quarter of 2018. One American Depositary Share is
the equivalent of five ordinary shares.
ASLAN Pharmaceuticals
LimitedConsolidated Balance
Sheet1(in US dollars, unaudited)
|
|
June 30, 2019 |
|
June 30, 2018 |
|
|
ASSETS |
|
Amount |
|
Amount |
|
|
CURRENT ASSETS |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
15,050,131 |
|
|
$ |
44,952,396 |
|
|
|
Prepayments |
|
|
144,606 |
|
|
|
198,043 |
|
|
|
Total current assets |
|
|
15,194,737 |
|
|
|
45,150,439 |
|
|
|
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 |
|
|
99,119 |
|
|
|
396,906 |
|
|
|
Right-of-use assets |
|
|
862,009 |
|
|
|
- |
|
|
|
Intangible assets |
|
|
23,078,202 |
|
|
|
23,083, 850 |
|
|
|
Refundable deposits |
|
|
143,790 |
|
|
|
191,739 |
|
|
|
Total non-current assets |
|
|
24,430,368 |
|
|
|
23,645,495 |
|
|
|
TOTAL |
|
$ |
39,625,105 |
|
|
$ |
68,795,934 |
|
|
|
LIABILITIES AND
EQUITY |
|
|
|
|
|
|
CURRENT LIABILITIES |
|
|
|
|
|
|
Trade payables |
|
$ |
3,573,561 |
|
|
$ |
3,354,095 |
|
|
|
Other payables |
|
|
2,163,399 |
|
|
|
2,388,089 |
|
|
|
Lease liabilities –
current |
|
|
239,362 |
|
|
|
- |
|
|
|
Total current liabilities |
|
|
5,976,322 |
|
|
|
5,742,184 |
|
|
|
NON-CURRENT LIABILITIES |
|
|
|
|
|
|
Long-term borrowings |
|
|
14,275,109 |
|
|
|
9,715,329 |
|
|
|
Lease liabilities -
non-current |
|
|
626,225 |
|
|
|
- |
|
|
|
Other non-current
liabilities |
|
|
327,777 |
|
|
|
486,000 |
|
|
|
Total non-current liabilities |
|
|
15,229,111 |
|
|
|
10,201,329 |
|
|
|
Total liabilities |
|
|
21,205,433 |
|
|
|
15,943,513 |
|
|
|
|
|
|
|
|
|
|
EQUITY |
|
|
|
|
|
|
Ordinary shares |
|
|
51,627,219 |
|
|
|
51,587,993 |
|
|
|
Capital surplus |
|
|
111,536,320 |
|
|
|
111,334,877 |
|
|
|
Accumulated deficits |
|
|
(144,743,867 |
) |
|
|
(110,070,449 |
) |
|
|
Total equity |
|
|
18,419,672 |
|
|
|
52,852,421 |
|
|
|
TOTAL |
|
$ |
39,625,105 |
|
|
$ |
68,795,934 |
|
|
|
|
|
|
|
|
|
|
ASLAN Pharmaceuticals Limited
Consolidated statements of comprehensive income1
(US dollars, unaudited)
|
|
Three Months Ended 30 June |
|
|
Six Months Ended 30 June |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
SALES |
$ |
- |
|
$ |
- |
|
$ |
3,000,000 |
|
$ |
- |
|
OPERATING
EXPENSES |
|
- |
|
|
- |
|
|
(425,000 |
) |
|
- |
|
GROSS PROFIT |
|
- |
|
|
- |
|
|
2,575,000 |
|
|
- |
|
General and administrative |
$ |
(1,885,444 |
) |
$ |
(3,064,060 |
) |
|
(4,141,805 |
) |
$ |
(5,871,931 |
) |
Research and development |
|
(5,288,633 |
) |
|
(8,322,539 |
) |
|
(9,738,165 |
) |
|
(13,945,341 |
) |
Total operating expenses |
|
(7,174,077 |
) |
|
(11,386,599 |
) |
|
(13,879,970 |
) |
|
(19,817,272 |
) |
LOSS FROM
OPERATIONS |
|
(7,174,077 |
) |
|
(11,386,599 |
) |
|
(11,304,970 |
) |
|
(19,817,272 |
) |
NON-OPERATING
INCOME AND EXPENSES |
|
|
|
|
Interest income |
|
75,187 |
|
|
72,303 |
|
|
144,211 |
|
|
133,850 |
|
Other gains and losses |
|
(157,789 |
) |
|
392,863 |
|
|
(237,344 |
) |
|
130,437 |
|
Finance costs |
|
(202,206 |
) |
|
(112,186 |
) |
|
(401,906 |
) |
|
(224,461 |
) |
TOTAL
NON-OPERATING INCOME AND EXPENSES |
|
(284,808 |
) |
|
352,980 |
|
|
(495,039 |
) |
|
39,826 |
|
LOSS BEFORE INCOME
TAX |
|
(7,458,885 |
) |
|
(11,033,619 |
) |
|
(11,800,009 |
) |
|
(19,777,446 |
) |
INCOME TAX
EXPENSE |
|
(472,082 |
) |
|
(9,742 |
) |
|
(475,000 |
) |
|
(9,742 |
) |
NET LOSS FOR THE
PERIOD |
|
(7,930,967 |
) |
|
(11,043,361 |
) |
|
(12,275,009 |
) |
|
(19,787,188 |
) |
Items that will
not be reclassified subsequently to profit or loss: |
|
|
|
|
Exchange
differences arising on translation to the presentation
currency |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
TOTAL
COMPREHENSIVE LOSS FOR THE PERIOD |
$ |
(7,930,967 |
) |
$ |
(11,043,361 |
) |
$ |
(12,275,009 |
) |
$ |
(19,787,188 |
) |
LOSS PER
SHARE |
|
|
|
|
Basic |
$ |
(0.05 |
) |
$ |
(0.07 |
) |
$ |
(0.8 |
) |
$ |
(0.14 |
) |
Avg. Shares Outstanding (in thousand) |
|
160,249 |
|
|
147,931 |
|
|
160,249 |
|
|
139,079 |
|
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 biopharma company targeting
cancers 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
clinical 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 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.
ASLAN Pharmaceuticals (NASDAQ:ASLN)
Historical Stock Chart
Von Jun 2024 bis Jul 2024
ASLAN Pharmaceuticals (NASDAQ:ASLN)
Historical Stock Chart
Von Jul 2023 bis Jul 2024