On July 13, 2020 ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage immunology and oncology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, reported financial results for the second quarter ended 30 June 2020 and provided an update on its clinical activities (Press release, ASLAN Pharmaceuticals, JUL 13, 2020, View Source [SID1234561827]).
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Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: "As COVID-19 restrictions gradually lift in Singapore we expect to resume recruitment into our multiple ascending dose (MAD) study of ASLAN004 in early August. With the continuing impact of COVID-19 causing some delays in patient recruitment, we plan to share further data from the trial during the fourth quarter of 2020. We have been proactive in preparing to open new study sites in Australia and the US to ensure we can accelerate recruitment, as well as support our planned global Phase 2b study in atopic dermatitis in 2021."
Second quarter 2020 and recent business highlights
Clinical development ASLAN004
Recruitment paused into randomised, double-blind, placebo-controlled MAD study of ASLAN004 in moderate to severe atopic dermatitis (AD) in April 2020 in response to government restrictions in Singapore to contain the spread of COVID-19.
To accelerate recruitment, ASLAN has identified several clinical sites in Australia and the US that could join the ongoing MAD study in the third quarter.
Clinical trial application submitted and regulatory process underway in Australia to initiate recruitment of patients into the ongoing MAD study.
Preparations underway to file Investigational New Drug application to the US Food and Drug Administration later this month.
Varlitinib
Two abstracts on varlitinib presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) virtual congress.
Anticipated upcoming milestones for ASLAN004
Interim, unblinded data from the 3 dose cohorts (up to 24 patients) expected in 4Q 2020, and initiation of the expansion cohort (an additional 18 patients).
Completion of MAD clinical trial in moderate-to-severe AD patients in 1H 2021.
Initiation of Phase 2b study of ASLAN004 for AD in 2021.
Second quarter 2020 financial highlights
Cash used in operations for the second quarter of 2020 was US$3.0 million compared to US$6.5 million in the same period in 2019.
Research and development expenses were US$1.9 million in the second quarter of 2020 compared to US$5.3 million in the second quarter of 2019. The decrease was driven by the completion of clinical studies related to varlitinib and lower manufacturing expenses.
General and administrative expenses were US$1.8 million in the second quarter of 2020 compared to US$1.9 million in the second quarter of 2019. The decrease was primarily due to lower headcount and staffing costs.
Net loss for the second quarter of 2020 was US$4.0 million compared to a net loss of US$7.9 million for the second quarter of 2019.
Cash, cash equivalents and short-term investments totaled US$13.8 million as of 30 June 2020 compared to US$22.2 million as of 31 December 2019. Weighted average shares outstanding for the second quarter of 2020 was 190.0 million compared to 160.2 million for the second quarter of 2019. One American Depositary Share is the equivalent of five ordinary shares.