On March 19, 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 quarter and full year ended 31 December 2019 and provided an update on its clinical activities (Press release, ASLAN Pharmaceuticals, MAR 19, 2020, View Source [SID1234555690]).

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Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: "2019 marked a year of change for ASLAN as we focused our development efforts on the highly promising ASLAN004, a fully human monoclonal antibody that binds to the IL-13 receptor α1 subunit (IL-13Rα1), for the treatment of atopic dermatitis (AD) and asthma. The data we announced last December from our ongoing multiple ascending dose (MAD) study in AD was very encouraging, showing early signs of efficacy and a favourable side effect profile, and we believe that ASLAN004 has the potential to be a best-in-disease treatment for AD. The second dose cohort is recruiting well and we plan to wait until the end of cohort 3 to announce additional data, when the full dataset can be unblinded rather than releasing additional blinded data at the end of cohort 2. Our recent fundraising has positioned us well to complete the study and, at the same time, prepare to initiate a Phase 2b study in early 2021 as the next step in our development plan."

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 of US$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 the US FDA in the middle of 2020

Initiation of Phase 2b study of ASLAN004 for AD in 1H 2021.

Fourth quarter 2019 financial results

Cash used in operations for the quarter ended 31 December 2019 was US$5.1 million compared to US$9.6 million in the same period in 2018.

Research and development expenses were US$2.7 million, general and administrative expenses were US$3.3 million for the fourth quarter of 2019, compared to US$9.2 million and US$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 of US$11.2 million for the fourth quarter of 2018. This reflects a one-off impairment charge of US$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 was US$6.5 million compared to a net loss of US$11.2 million for the fourth quarter of 2018.

Full Year 2019 financial highlights

Cash used in operations for year ended 31 December 2019 was US$25.8 million compared to US$39.5 million in the same period in 2018.

Research and development expenses were US$16.6 million, general and administrative expenses were US$8.5 million for the full year 2019, compared to US$31.8 million and US$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 of US$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 was US$23.9 million compared to a net loss of US$42.2 million for the full year 2018.

Cash, cash equivalents and short-term investments totaled US$22.2 million as of 31 December 2019 compared to US$28.9 million as of 31 December 2018.