On October 26, 2021 ASLAN Pharmaceuticals (Nasdaq: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, reported financial results for the third quarter ended September 30, 2021, and provided an update on recent corporate activities (Press release, ASLAN Pharmaceuticals, OCT 26, 2021, View Source [SID1234591947]).
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"This quarter, we were pleased to announce positive data from our Phase 1 multiple ascending dose trial of ASLAN004, supporting the potential of this first-in-class antibody as a differentiated, novel treatment for atopic dermatitis," said Dr Carl Firth, CEO, ASLAN Pharmaceuticals. "This quarter we also made key appointments to strengthen our management team and established a scientific advisory board comprised of global thought-leaders in dermatology and immunology. In addition, we expanded our US operations with a new office in Menlo Park, CA. We are entering the fourth quarter with strengthened operating position and poised to advance ASLAN004 in a 300-patient, Phase 2b trial before year-end, as well as advance our DHODH inhibitor, ASLAN003 into clinical trials early next year."
Third quarter 2021 and recent business highlights
Q3 and recent clinical developments
In September, positive top-line results were announced from the double-blind placebo-controlled MAD trial of ASLAN004. In the Intent to Treat (ITT) population, patients treated with ASLAN004 achieved a statistically significant improvement versus placebo in the primary efficacy endpoint of percent change from baseline in the Eczema Area Severity Index (EASI), and also showed significant improvements in other key efficacy endpoints: EASI-50, EASI-75, peak pruritus and the Patient-Oriented Eczema Measure (POEM).
In October, the Company announced a collaboration with renowned inflammatory skin disease expert Dr Emma Guttman-Yassky, MD PhD, to conduct research that will continue throughout ASLAN’s Phase 2b program to identify and characterize the effects of ASLAN004 on disease-associated skin and serum-biomarkers in adults with moderate-to-severe AD. Dr Guttman-Yassky is Chair of the Department of Dermatology at the Icahn School of Medicine at Mount Sinai and a world leader on inflammatory skin diseases. Her research has led to significant breakthroughs in the understanding of the immunologic basis of AD, providing the scientific community with greater clarity on the pathophysiology of the disease, which is complex and multifactorial.
In October, ASLAN-hosted the first in a series of Key Opinion Leader (KOL) webinars: the A4 Series: Aspects of Atopic Dermatitis and ASLAN004. For the first webinar, Associate Professor Jonathan Silverberg, MD PhD MPH, was a guest KOL speaker to discuss the heterogeneity in AD. To access a replay of this event, click here or go to the "Events and Presentations" section in ASLAN’s Investor Relations website at View Source A replay will be archived for 3 months immediately after the event.
Corporate updates
In July, ASLAN secured a loan facility with K2 HealthVentures of up to US$45.0 million of secured debt financing. The facility consists of a US$20.0 million initial term loan funded at closing, with the remaining US$25.0 million subject to certain terms and conditions. The proceeds will be used to advance the clinical development of ASLAN003 as well as for general corporate purposes.
In September, Dr Ferda Cevikbas was appointed as Executive Director, Head of Translational Science. Ferda joined ASLAN from Eli Lilly & Co where she was responsible for translational activities for lebrikizumab and other late-stage immunology projects. Prior to that, she was the Translational Scientist Lead for AD therapy, Eucrisa at Anacor / Pfizer, and held several academic positions at University of California, San Francisco. Ferda has a PhD from the University Hospital of Münster in Germany.
In September, a new Scientific Advisory Board (SAB) chaired by Dr Lawrence Eichenfield, MD FAAD, was established. Dr Eric Simpson, MD MCR, Dr Melinda Jennifer Gooderham, MSc MD FRCPC, Dr Jacob Thyssen, MD PhD DmSci, and Associate Professor Peter Foley, BMedSci MBBS MD FACD, were also appointed as members of the SAB.
In October, ASLAN opened a new office in the US in Menlo Park, California.
Anticipated upcoming milestones
First patient enrolment in global Phase 2b trial of ASLAN004 for AD expected in the fourth quarter of 2021.
Initiation of Phase 2 trial of ASLAN003 in inflammatory bowel disease expected in the first half of 2022.
Third quarter 2021 financial highlights
Cash used in operations for the third quarter of 2021 was US$7.6 million compared to US$2.6 million in the same period in 2020.
Research and development expenses were US$5.3 million in the third quarter of 2021 compared to US$2.2 million in the third quarter of 2020. The increase was driven primarily by preparations for the ASLAN004 Phase 2b clinical trial.
General and administrative expenses were US$2.8 million in the third quarter of 2021 compared to US$1.3 million in the third quarter of 2020. The increase was primarily driven by professional costs related to the debt financing activity completed in July, and the expansion of the US team.
Net loss for the third quarter of 2021 was US$8.6 million compared to a net loss of US$3.5 million for the third quarter of 2020.
Cash and cash equivalents totalled US$100.5 million as of September 30, 2021, compared to US$94.1 million as of June 30, 2021, and US$14.3 million as of December 31, 2020. Management believes that ASLAN’s cash and cash equivalents will be sufficient to fund operations through late 2023.
The weighted average number of ADSs outstanding in the computation of basic loss per share for the third quarter of 2021 was 69.7 million (representing 348 million ordinary shares) compared to 38.0 million (representing 190 million ordinary shares) for the third quarter of 2020. One ADS is the equivalent of five ordinary shares.