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.
Singapore, 22 March 2019 – 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 Limited
Consolidated Balance Sheet1
(in US dollars, unaudited)
December 31, 2017 | December 31, 2018 | |||||||||||||||
ASSETS |
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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 ) |