ASLAN Pharmaceuticals, a clinical-stage oncology and immunology focused biopharma company, reported financial results for the quarter ended 30 September 2019 and provided an update on its clinical activities.
SINGAPORE, Oct. 31, 2019 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage oncology and immunology focused biopharma company, today reported financial results for the quarter ended 30 September 2019 and provided an update on its clinical activities.
Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: “ASLAN made strong progress during the third quarter including new data presented for varlitinib at ESMO and a late breaking oral presentation at CSCO. In October, we secured a US$3 million loan facility funded by the company’s chairman, members of the board and several major investors that will be used to provide additional working capital to support ongoing research and development programs and clinical studies. We also entered an agreement with Bukwang Pharmaceutical that established a joint venture company, JAGUAHR Therapeutics, that will focus on the development of AhR antagonists. We are preparing to announce topline data from our pivotal TreeTopp trial testing varlitinib as second line treatment for biliary tract cancer in mid-November and data from our study of ASLAN004 in atopic dermatitis early in 2020.”
Third quarter 2019 and recent business highlights
Clinical development
Varlitinib
- Presented late-breaking topline data from a phase 2 study conducted in China testing varlitinib and capecitabine in second line biliary tract cancer (BTC) at the Chinese Society of Clinical Oncology meeting. Patients achieved response rate of 11% including two complete responses, median progression free survival (PFS) of 2.7 months and overall survival (OS) of 5.8 months, which is still maturing. Patients on study appeared to present with more aggressive disease as only 10% of patients responded to first line gemcitabine-based treatment prior to enrolment. The combination treatment may provide a new therapeutic option for second line BTC patients.
- Presentation of new data from a phase 1b open-label, dose escalation study of varlitinib in combination with modified irinotecan and infusional 5-fluorouracil (mFOLFIRI) chemotherapy at the 2019 European Society for Medical Oncology Congress. This investigator initiated trial enrolled 16 patients with a median of three lines of prior chemotherapy to assess the safety, tolerability and maximum tolerated dose (MTD) in advanced solid tumours. The overall response rate was 13% and median PFS was 4.2 months.
ASLAN004
- In October, ASLAN enrolled the first patient in its multiple ascending dose (MAD) study testing the first-in-class therapeutic antibody ASLAN004 in patients with moderate to severe atopic dermatitis (AD). It is the second part of a phase 1 study of ASLAN004 and will be conducted in up to 50 AD patients. The MAD study will evaluate 3 doses of ASLAN004 delivered subcutaneously and will be followed by an expansion cohort at the most efficacious dose. Interim results are expected in early 2020.
Corporate updates
- Established a joint venture, JAGUAHR Therapeutics, with Bukwang Pharmaceutical, a leading R&D focused Korean pharmaceutical company. Under the terms of the agreement, ASLAN is transferring the global rights to all of its assets related to aryl hydrocarbon receptor (AhR) antagonists. JAGUAHR will focus on developing new immuno-oncology therapeutics for global markets targeting the AhR pathway and will be based in Singapore. Bukwang will invest US$5 million in JAGUAHR in two tranches to fund its development operations.
Anticipated upcoming milestones
- Topline global pivotal trial (TreeTopp) data on varlitinib as second line treatment for biliary tract cancer in mid-late November 2019. If positive, ASLAN intends to submit an NDA to the US FDA for accelerated approval in second-line biliary tract cancer.
- Interim safety and efficacy data from a multiple ascending dose trial for ASLAN004 in patients with moderate to severe atopic dermatitis in early 2020.
Third quarter 2019 financial results
- Cash used in operations for the quarter ended 30 September2019 was US$7.0 million compared to US$9.9 million in the same period in 2018.
- Research and development (R&D) expense was US$4.1 million and general and administrative (G&A) expense was US$1.1 million for the third quarter of 2019, compared to US$8.7 million and US$2.4 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.
- Net loss for the third quarter of 2019 was US$5.2 million compared to a net loss of US$11.2 million for the third quarter of 2018.
- Cash, cash equivalents and short-term investments totaled US$8.0 million as of 30 September 2019 compared to US$28.9 million as of 31 December 2018. Weighted average shares outstanding for the third quarter of 2019 was 160.2 million, remaining the same compared to the third quarter of 2018. One American Depositary Share is the equivalent of five ordinary shares.
ASLAN Pharmaceuticals Limited
Consolidated Balance Sheet1
(in US dollars, unaudited)
| September 30, 2019 | September 30, 2018 | ||||||||||||
| ASSETS | Amount | Amount | |||||||||||
| CURRENT ASSETS | |||||||||||||
| Cash and cash equivalents | $ | 7,993,458 | $ | 28,908,901 | |||||||||
| Prepayments | 143,120 | 183,599 | |||||||||||
| Total current assets | 8,136,578 | 29,092,500 | |||||||||||
| NON-CURRENT ASSETS | |||||||||||||
| Financial assets at fair value through profit or loss | 38,006 | 60,004 | |||||||||||
| Financial assets at fair value through other comprehensive income | 178,198 | 187,244 | |||||||||||
| Property, plant and equipment | 56,152 | 288,418 | |||||||||||
| Right-of-use assets | 794,403 | - | |||||||||||
| Intangible assets | 23,077,223 | 23,080,592 | |||||||||||
| Refundable deposits | 108,077 | 172,080 | |||||||||||
| Total non-current assets | 24,252,059 | 23,788,338 | |||||||||||
| TOTAL | $ | 32,388,637 | $ | 52,880,838 | |||||||||
| LIABILITIES AND EQUITY | |||||||||||||
| CURRENT LIABILITIES | |||||||||||||
| Trade payables | $ | 2,235,232 | $ | 5,315,737 | |||||||||
| Other payables | 1,892,733 | 2,682,661 | |||||||||||
| Lease liabilities – current | 194,437 | - | |||||||||||
| Total current liabilities | 4,322,402 | 7,998,398 | |||||||||||
| NON-CURRENT LIABILITIES | |||||||||||||
| Long-term borrowings | 14,161,243 | 13,974,794 | |||||||||||
| Lease liabilities - non-current | 625,156 | - | |||||||||||
| Other non-current liabilities | 88,497 | 289,613 | |||||||||||
| Total non-current liabilities | 14,874,896 | 14,264,407 | |||||||||||
| Total liabilities | 19,197,298 | 22,262,805 | |||||||||||
| EQUITY | |||||||||||||
| Ordinary shares | 51,627,219 | 51,627,219 | |||||||||||
| Capital surplus | 111,502,183 | 111,459,672 | |||||||||||
| Accumulated deficits | (149,929,017 | ) | (132,468,858 | ) | |||||||||
| Other equity | (9,046 | ) | - | ||||||||||
| Total equity | 13,191,339 | 30,618,033 | |||||||||||
| TOTAL | $ | 32,388,637 | $ | 52,880,838 | |||||||||
ASLAN Pharmaceuticals Limited
Consolidated statements of comprehensive income1
(US dollars, unaudited)
| Three Months Ended 30 September | Nine Months Ended 30 September | |||||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||||
| NET REVENUE | $ | - | $ | - | $ | 3,000,000 | $ | - | ||||||||||
| COST OF REVENUE | - | - | (425,000 | ) | - | |||||||||||||
| GROSS PROFIT | - | - | 2,575,000 | - | ||||||||||||||
| General and administrative | $ | (1,111,697 | ) | $ | (2,741,101 | ) | (5,253,502 | ) | (8,613,032 | ) | ||||||||
| Research and development | (4,145,827 | ) | (8,685,051 | ) | (13,883,992 | ) | (22,630,392 | ) | ||||||||||
| Total operating expenses | (5,257,524 | ) | (11,426,152 | ) | (19,137,494 | ) | (31,243,424 | ) | ||||||||||
| LOSS FROM OPERATIONS | (5,257,524 | ) | (11,426,152 | ) | (16,562,494 | ) | (31,243,424 | ) | ||||||||||
| NON-OPERATING INCOME AND EXPENSES | ||||||||||||||||||
| Interest income | 206 | 105,844 | 144,417 | 239,694 | ||||||||||||||
| Other income | - | 187,244 | - | 187,244 | ||||||||||||||
| Other gains and losses | 199,054 | 40,098 | (38,290 | ) | 170,535 | |||||||||||||
| Finance costs | (206,596 | ) | (108,906 | ) | (608,502 | ) | (333,367 | ) | ||||||||||
| TOTAL NON-OPERATING INCOME AND EXPENSES | (7,336 | ) | 224,280 | (502,375 | ) | 264,106 | ||||||||||||
| LOSS BEFORE INCOME TAX | (5,264,860 | ) | (11,201,872 | ) | (17,064,869 | ) | ( 30,979,318 | ) | ||||||||||
| INCOME TAX EXPENSE | 79,710 | (4,697 | ) | (395,290 | ) | (14,439 | ) | |||||||||||
| NET LOSS FOR THE PERIOD | (5,185,150 | ) | (11,206,569 | ) | (17,460,159 | ) | (30,993,757 | ) | ||||||||||
| 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 | (9,046 | ) | - | (9,046 | ) | - | ||||||||||||
| TOTAL COMPREHENSIVE LOSS FOR THE PERIOD | $ | (5,194,196 | ) | $ | (11,206,569 | ) | $ | (17,469,205 | ) | $ | (30,993,757 | ) | ||||||
| LOSS PER SHARE | ||||||||||||||||||
| Basic | $ | (0.03 | ) | $ | (0.07 | ) | $ | (0.11 | ) | $ | (0.21 | ) | ||||||
| Weighed- avg. Shares Outstanding (in thousand) | 160,249 | 160,202 | 160,249 | 146,198 | ||||||||||||||
1 Financial statements in US dollars are prepared by the company
Ends
Media and IR contacts
| Emma Thompson Spurwing Communications Tel: +65 6751 2021 Email: ASLAN@spurwingcomms.com |
Robert Uhl Westwicke ICR Tel: +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.
