ASLAN Pharmaceuticals Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Corporate Update
Dr
Fourth quarter 2019 and recent business highlights
Clinical development
ASLAN004
- Initiated a randomised, double-blind, placebo-controlled MAD study in October to evaluate 3 doses of ASLAN004 (between 200mg and 600mg) in moderate to severe AD patients following the successful completion of the Single Ascending Dose clinical trial in healthy volunteers.
- In December, preliminary results from the first patients treated with ASLAN004 showed early signs of efficacy in the low dose cohort. In a review of unclean blinded data, the Eczema Area and Severity Index (EASI) scores of the 3 patients who had completed at least one month of dosing were reduced by 85%, 70% and 59% from baseline and the
EASI score continued to fall at 4 weeks with maximal efficacy expected at 6 to 8 weeks. - Following a meeting of the Data Monitoring Committee in late December, the second dose cohort began recruiting patients in
Singapore . Recruitment currently appears unaffected by the COVID-19 pandemic and the trial is on track to complete in 2H 2020. Rather than announcing additional blinded data at the end of cohort 2, ASLAN plans to wait until the end of cohort 3, when data from all 3 dose cohorts can be unblinded. ASLAN expects to announce this unblinded, interim data in 3Q 2020, and will then open the expansion cohort at the selected dose.
ASLAN003
- Published preclinical data in
Haematologica Journal that showed ASLAN003’s potential as a potent human dihydroorotate dehydrogenase (DHODH) inhibitor and novel target for differentiation therapy with a favourable toxicity profile.
AhR antagonist
- In September, ASLAN transferred the global rights to all of the assets related to aryl hydrocarbon receptor (AhR) antagonists, originally discovered and developed by ASLAN and its collaborators, to JAGUAHR Therapeutics, a joint venture with Bukwang Pharmaceutical.
- JAGUAHR will identify a lead development compound to develop as a new immuno-oncology therapeutic targeting the AhR pathway and file an Investigational New Drug (IND) application. Bukwang will invest
US$5 million in JAGUAHR in two tranches to fund the development of the assets.
Additional Pipeline Programs
- Announced topline data from the TreeTopp study of varlitinib in second line biliary tract cancer in October.
Corporate updates
- Elected existing board member
Andrew Howden as non-executive Chairman of the board and separated the roles of Chairman and Chief Executive Officer to maintain high standards of corporate governance. - Secured a
US$3 million loan facility provided by the company’s Chairman, members of the board, and several major investors in October. - Successfully closed
US$15 million public offering of 5,893,206 American Depositary Shares at a public offering price ofUS$2.50 per ADS in December supported by new investors, including the exercise in full of the underwriter’s option to purchase additional ADSs.
Anticipated upcoming milestones for ASLAN004
- Interim, unblinded data from the 3 dose cohorts (up to 24 patients) expected in 3Q 2020, and initiation of the expansion cohort (an additional 18 patients)
- Completion of MAD clinical trial in moderate-to-severe AD patients in 4Q 2020
- Opening of clinical trial sites in
Australia and filing of IND application with theUS FDA in the middle of 2020 - Initiation of Phase 2b study of ASLAN004 for AD in 1H 2021
Fourth quarter 2019 financial highlights
- Cash used in operations for the quarter ended
31 December 2019 wasUS$5.1 million compared toUS$9.6 million in the same period in 2018. - Research and development expenses were
US$2.7 million , general and administrative expenses wereUS$3.3 million for the fourth quarter of 2019, compared toUS$9.2 million andUS$1.9 million respectively in the same period in 2018. - Net loss for the fourth quarter of 2019 was
US$29.6 million compared to a net loss ofUS$11.2 million for the fourth quarter of 2018. This reflects a one-off impairment charge ofUS$23 million related to the write-down of varlitinib in the fourth quarter of 2019. Excluding the non-cash impairment charge, net loss for the fourth quarter of 2019 wasUS$6.5 million compared to a net loss ofUS$11.2 million for the fourth quarter of 2018.
Full Year 2019 financial highlights
- Cash used in operations for year ended
31 December 2019 wasUS$25.8 million compared toUS$39.5 million in the same period in 2018. - Research and development expenses were
US$16.6 million , general and administrative expenses wereUS$8.5 million for the full year 2019, compared toUS$31.8 million andUS$10.5 million respectively in the same period in 2018. - Net loss for the full year 2019 was
US$47.0 million including a one-off impairment charge ofUS$23 million related to the write-down of varlitinib in the fourth quarter of 2019. Excluding the non-cash impairment charge, net loss for the full year 2019 wasUS$23.9 million compared to a net loss ofUS$42.2 million for the full year 2018. - Cash, cash equivalents and short-term investments totaled
US$22.2 million as of31 December 2019 compared toUS$28.9 million as of31 December 2018 .
CONSOLIDATED BALANCE SHEETS1
(In
ASSETS | 2018 | 2019 | ||||||
CURRENT ASSETS | ||||||||
Cash and cash equivalents | $ | 28,908,901 | $ | 22,203,031 | ||||
Prepayments | 183,599 | 68,923 | ||||||
Total current assets | 29,092,500 | 22,271,954 | ||||||
NON-CURRENT ASSETS | ||||||||
Financial assets at fair value through profit or loss | 60,004 | 68,256 | ||||||
Financial assets at fair value through other comprehensive income | 187,244 | 132,160 | ||||||
Property, plant and equipment | 288,418 | 38,333 | ||||||
Right-of-use assets | - | 727,866 | ||||||
Intangible assets | 23,080,592 | 2,845 | ||||||
Refundable deposits | 172,080 | 108,076 | ||||||
Total non-current assets | 23,788,338 | 1,077,536 | ||||||
TOTAL ASSETS | $ | 52,880,838 | $ | 23,349,490 | ||||
LIABILITIES AND EQUITY | ||||||||
CURRENT LIABILITIES | ||||||||
Trade payables | $ | 5,315,737 | $ | 1,871,843 | ||||
Other payables | 2,682,661 | 3,246,842 | ||||||
Lease Liabilities - current | - | 264,543 | ||||||
Total current liabilities | 7,998,398 | 5,383,228 | ||||||
NON-CURRENT LIABILITIES | ||||||||
Financial liabilities at fair value through profit or loss | - | 262,350 | ||||||
Long-term borrowings | 13,974,794 | 17,065,305 | ||||||
Long-term borrowing from related parties | - | 566,176 | ||||||
Lease Liabilities - non-current | - | 490,835 | ||||||
Other non-current liabilities | 289,613 | 184,870 | ||||||
Total non-current liabilities | 14,264,407 | 18,569,536 | ||||||
Total liabilities | 22,262,805 | 23,952,764 | ||||||
EQUITY ATTRIBUTABLE TO STOCKHOLDERS OF THE COMPANY | ||||||||
Ordinary shares | 51,627,219 | 61,366,844 | ||||||
Capital surplus | 111,459,672 | 116,495,710 | ||||||
Accumulated deficits | (132,468,858 | ) | (179,484,825 | ) | ||||
Other reserves | - | (55,084 | ) | |||||
Total equity attributable to stockholders of the Company | 30,618,033 | (1,677,355 | ) | |||||
NON-CONTROLLING INTERESTS | - | 1,074,081 | ||||||
Total equity | 30,618,033 | (603,274 | ) | |||||
TOTAL LIABILITIES AND EQUITY | $ | 52,880,838 | $ | 23,349,490 |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME(LOSS)1 | |||||||||||||
(In |
|||||||||||||
Three Months Ended |
Twelve Months Ended |
||||||||||||
2018 | 2019 | 2018 | 2019 | ||||||||||
NET REVENUE | $ | - | $ | - | $ | - | $ | 3,000,000 | |||||
COST OF REVENUE | - | (17,741 | ) | - | (407,259 | ) | |||||||
GROSS PROFIT | - | (17,741 | ) | - | 2,592,741 | ||||||||
OPERATING EXPENSES | |||||||||||||
General and administrative expenses | (1,900,675 | ) | (3,258,197 | ) | (10,513,707 | ) | (8,511,699 | ) | |||||
Research and development expenses | (9,203,972 | ) | (2,702,625 | ) | (31,834,364 | ) | (16,586,617 | ) | |||||
Total operating expenses | (11,104,647 | ) | (5,960,822 | ) | (42,348,071 | ) | (25,098,316 | ) | |||||
OTHER OPERATING INCOME AND EXPENSES | - | (23,073,400 | ) | - | (23,073,400 | ) | |||||||
LOSS FROM OPERATIONS | (11,104,647 | ) | (29,016,481 | ) | (42,348,071 | ) | (45,578,975 | ) | |||||
NON-OPERATING INCOME AND EXPENSES | |||||||||||||
Interest income | 28,636 | 6,193 | 268,330 | 150,610 | |||||||||
Other income | - | - | 187,244 | - | |||||||||
Other gains and losses | 42,708 | (289,268 | ) | 213,243 | (327,558 | ) | |||||||
Finance costs | (158,537 | ) | (293,110 | ) | (491,904 | ) | (901,612 | ) | |||||
Total non-operating income and expenses | (87,193 | ) | (576,185 | ) | 176,913 | (1,078,560 | ) | ||||||
LOSS BEFORE INCOME TAX | (11,191,840 | ) | (29,592,666 | ) | (42,171,158 | ) | (46,657,535 | ) | |||||
INCOME TAX EXPENSE | - | (12,712 | ) | (14,439 | ) | (408,002 | ) | ||||||
NET LOSS FOR THE YEAR | (11,191,840 | ) | (29,605,378 | ) | (42,185,597 | ) | (47,065,537 | ) | |||||
OTHER COMPREHENSIVE LOSS | |||||||||||||
Items that will not be reclassified subsequently to profit or loss: | |||||||||||||
Unrealized loss on investments in equity instruments at fair value through other comprehensive income | - | (46,038 | ) | - | (55,084 | ) | |||||||
TOTAL COMPREHENSIVE LOSS FOR THE YEAR | $ | (11,191,840 | ) | $ | (29,651,416 | ) | $ | (42,185,597 | ) | $ | (47,120,621 | ) | |
NET LOSS ATTRIBUTABLE TO: | |||||||||||||
Stockholders of the Company | (11,191,840 | ) | $ | (29,555,808 | ) | $ | (42,185,597 | ) | $ | (47,015,967 | ) | ||
Non-controlling interests | - | (49,570 | ) | - | (49,570 | ) | |||||||
$ | (11,191,840 | ) | $ | (29,605,378 | ) | $ | (42,185,597 | ) | $ | (47,065,537 | ) | ||
TOTAL COMPREHENSIVE LOSS ATTRIBUTABLE TO: | |||||||||||||
Stockholders of the Company | $ | (11,191,840 | ) | $ | (29,601,846 | ) | $ | (42,185,597 | ) | $ | (47,071,051 | ) | |
Non-controlling interests | - | (49,570 | ) | - | (49,570 | ) | |||||||
$ | (11,191,840 | ) | $ | (29,651,416 | ) | $ | (42,185,597 | ) | $ | (47,120,621 | ) | ||
LOSS PER SHARE | |||||||||||||
Basic and diluted | $ | (0.07 | ) | $ | (0.18 | ) | $ | (0.28 | ) | $ | (0.29 | ) | |
Weighed- avg. Outstanding Shares (in thousand) | 160,249 | 168,754 | 149,739 | 162,392 |
1 Financial statements in US dollars are prepared by the company and are audited by certified public accountant as of
Ends
Media and IR contacts
Tel: +65 6751 2021 Email: ASLAN@spurwingcomms.com |
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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
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.
Source: ASLAN PHARMACEUTICALS LIMITED