ASLAN Pharmaceuticals Provides Update on Financial Results and Clinical Programs for First Quarter 2024

Positive interim data from 22 patients in the TREK-DX study of eblasakimab showed unprecedented efficacy compared to prior atopic dermatitis (AD) studies with biologics: 60.0% of dupilumab-experienced AD patients treated with 400mg eblasakimab weekly achieved EASI-90 (at least a 90% reduction in their Eczema Area Severity Index (EASI) score) and 66.7% achieved a vIGA score of 0 or 1 (clear or almost clear skin) after 16 weeks, versus 14.3% of patients on placebo. On track to report topline data from two Phase 2 studies in the second half of 2024: topline interim data from FAST-AA, the Phase 2a, proof-of-concept study of farudodstat in alopecia areata expected in Q3 2024, and topline data from the full TREK-DX dataset expected by the end of 2024. SAN MATEO, Calif. and SINGAPORE, May 09, 2024 — ASLAN Pharmaceuticals (Nasdaq: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced financial results for the first quarter ended March 31, 2024, and provided an update on recent corporate activities. “The unprecedented positive efficacy data we announced from the interim analysis of the TREK-DX study of eblasakimab in dupilumab-experienced AD patients in April was a fantastic achievement for ASLAN. Most of the 22 patients on eblasakimab achieved EASI-90 and vIGA of 0 or 1 after just 16 weeks of treatment – numbers that have not been seen in other biologics AD studies. These data give us strong confidence in eblasakimab’s potential to be a best-in-class treatment for AD patients even after they have had an inadequate response to dupilumab, a significant and underserved patient population with limited safe and long-term treatment options,” said Dr Carl Firth, Chief Executive Officer of ASLAN Pharmaceuticals. “Discussions with potential partners on eblasakimab are progressing well and we look forward to the upcoming topline clinical readouts from FAST-AA, the Phase 2a, proof-of-concept study of farudodstat in alopecia areata, and TREK-DX in the second half of 2024.” First quarter 2024 and recent clinical developments In February 2024, received a favorable opinion from the European Patent Office (EPO) on a composition of matter patent application for farudodstat. The EPO is acting as the International Examiner on a polymorph patent application for farudodstat, which, if granted in the national stages, will extend effective patent protection for farudodstat until at least 2043.In March 2024, announced positive translational data from a head-to-head study of eblasakimab versus dupilumab in a human tissue model of COPD. In the study, eblasakimab performed better than dupilumab in improving airway function and enhancing bronchodilation at the same concentrations, providing further support for the potential of eblasakimab as a biologic therapy for COPD.In April 2024, announced positive interim results from the Phase 2 study of eblasakimab in moderate-to-severe atopic dermatitis (AD) adult patients previously treated with dupilumab, TREK-DX. Interim readout of 22 patients showed unprecedented efficacy data compared to prior AD studies with biologics. The primary endpoint, which is the percent change in Eczema Area Severity Index (EASI) score from baseline to Week 16, was statistically significant when compared to placebo (p=0.0059), even though the interim analysis was not powered for statistical significance due to the sample size. 73.3% (11/15) of eblasakimab-treated patients achieved a reduction in EASI score of at least 75% from baseline (EASI-75) compared to 14.3% (1/7) on placebo (p=0.0431). Of the six patients treated with eblasakimab that previously had an inadequate response to dupilumab, 66.7% achieved EASI-90 and a vIGA score of 0 or 1 after 16 weeks. Eblasakimab produced rapid and clinically meaningful itch relief versus placebo.In April, an abstract on positive translational data on eblasakimab in COPD was accepted for a late breaking poster that will be presented on May 20, 2024 at the American Thoracic Society (ATS) International Conference. Additional details from the late-breaker abstract will be shared after presentation at the conference.In May 2024, ASLAN announced the expansion of its collaboration with Zenyaku to explore the biology underlying differential effects of eblasakimab on AD patients, compared to other biologics, dupilumab and lebrikizumab. The findings may provide further insight to the recent clinical data that show some AD patients may respond to eblasakimab even after they have had an inadequate response to dupilumab. The first part of the collaboration will focus on receptor biology and kinetics to investigate the cellular and molecular basis of eblasakimab’s potential for differentiation and the work will be funded by Zenyaku.In May 2024, ASLAN hosted a virtual Key Opinion Leader (KOL) event, “Treatment Options for Atopic Dermatitis Patients with an Inadequate Response to Dupilumab: Exploring the Potential of Eblasakimab in this Sizable New Market.” The event featured a discussion with Lisa Beck, MD from University of Rochester, Peter Lio, MD from Northwestern University, and Raj Chovatiya, MD, PhD from Rosalind Franklin University Chicago Medical School, moderated by Seth Orlow, MD, PhD from New York University, on the positive interim results from the TREK-DX study of eblasakimab and the limited treatment options currently available to patients with an inadequate response to dupilumab. A replay of the event is available .In May 2024, ASLAN presented new data on investigator-assessed and patient-reported secondary endpoints from the interim analysis of the TREK-DX study. Discontinuation rates were lower for patients treated with eblasakimab (13%, 2/15) compared to those on placebo (43%, 3/7). Time courses for secondary endpoints demonstrated rapid onset of effect for patients treated with eblasakimab, with over half of patients achieving EASI-75 by Week 6 (8/15) and 73% (11/15) achieving EASI-75 by Week 16. These investigator assessments are further supported by patient-reported pruritus scores, which show a rapid reduction in itch, with clear separation observed as early as Week 2. Waterfall plots of individual patient responses show clear and consistent improvements in almost all patients treated with eblasakimab versus placebo. Patients with prior inadequate response to dupilumab showed mean percent change in EASI at Week 16 of 91% reduction (n=6). Topline unblinded data from the full dataset is expected at the end of 2024. First quarter and recent corporate updates In March 2024, in line with evaluating the potential use of eblasakimab as a therapy to treat COPD, ASLAN appointed respiratory experts Dr Ramaswamy Krishnan, MS MPhil PhD, Associate Professor in Emergency Medicine, Harvard Medical School, and Dr Reynold Panettieri, Jr, MD, Vice Chancellor, Translational Medicine and Science, Rutgers University, to ASLAN’s Scientific Advisory Board.In March 2024, ASLAN completed a $5.0 million registered direct offering for the purchase and sale of 5,000,000 of the Company’s American Depositary Shares (“ADSs”), each ADS representing twenty-five (25) ordinary shares, at an offering price of $1.00 per ADS. In addit