On October 28, 2022 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, 2022, and provided an update on recent corporate activities (Press release, ASLAN Pharmaceuticals, OCT 28, 2022, View Source [SID1234622575]).
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"In the third quarter we presented a number of new and important insights on eblasakimab’s differentiated mechanism of action in neuronal itch and inflammatory pathways, and the potential improvements for AD patients related to itch and sleep loss, which are often the most burdensome symptoms reported by these patients," shared Dr Carl Firth, CEO, ASLAN Pharmaceuticals. "We look forward to the topline readout of Phase 2b data evaluating eblasakimab in biologic naïve moderate-to-severe AD patients in Q2 2023. In the lead up to the new data that we will generate from both TREK-AD and TREK-DX, we are building a robust set of insights from ongoing research collaborations that will be presented early next year, to support eblasakimab’s potential as a differentiated treatment for moderate-to-severe AD with broad therapeutic potential in Type 2-driven inflammatory diseases."
Third quarter 2022 and recent business highlights
Eblasakimab
In August, the Company signed a licensing agreement with Belle.ai for the use of belleStudy digital image capture software across several global sites in the ongoing TREK-AD study of eblasakimab in AD. The easy-to-use solution enables standardized recording of AD disease severity scores through image capture and the technology will allow ASLAN to further enhance its quality control procedures in the TREK-AD study.
In September, three posters with new data on biomarkers, efficacy measures and patient reported outcome measures from the previously reported Phase 1b proof-of-concept trial of eblasakimab were presented at the 31st European Academy of Dermatology and Venereology (EADV) annual congress. The data showed eblasakimab suppresses downstream inflammatory biomarkers of AD, and this effect continues four to six weeks after the last dose administered. Patients treated with eblasakimab demonstrated notable improvements in quality-of-sleep measures and eblasakimab was shown to reduce P-NRS (itch) scores versus placebo, with improvements throughout the eight-week course of treatment across all dose cohorts. The posters can be found in the News and Publications section of the Company’s website.
In September, the Company commenced TREK-DX (TRials in EblasaKimab in Dupilumab eXperienced AD patients), a new clinical trial studying eblasakimab in dupilumab-experienced moderate-to-severe AD patients. The trial consists of a 16-week treatment period and a 12-week safety follow-up period. The primary efficacy endpoint is percentage change in Eczema Area Severity Index (EASI) score from baseline to week 16. In combination with the data from biologic naïve AD patients in the TREK-AD trial, we believe the results from the TREK-DX study in the biologic-experienced population could position eblasakimab as a preferred first choice treatment for moderate-to-severe AD.
The Company hosted a Research and Development Day in September where management gave a comprehensive update on the eblasakimab development program. Dr Peter A Lio, from Northwestern University Feinberg School of Medicine, and Dr Shawn Kwatra, from Johns Hopkins University, discussed the emerging unmet needs, therapeutic landscape and underlying molecular mechanisms in AD and Type 2-driven diseases. A replay of the event and presentation materials can be found in the Investor Relations section of the Company’s website.
In September, the Company presented new translational data on eblasakimab at the late-breaker session of the European Society for Dermatological Research (ESDR) annual meeting. The first data from the ongoing collaboration with Dr Shawn Kwatra and Dr Madan Kwatra showed increased IL-13Rα1 expression on mast cells and eosinophils in skin samples from AD patients, reinforcing the central role of IL-13Rα1 in AD. In human neuron models, eblasakimab significantly reduced neuronal itch sensitization caused by distinct IL-4 and IL-13 itch pathways and an emerging role of IL-13Rα1 signaling in mediating neuronal excitability and sensitivity beyond AD was also identified.
Farudodstat (ASLAN003)
A clinical development plan in skin autoimmune diseases is being finalized and a Phase 2 trial is expected to commence in the first half of 2023.
Anticipated upcoming milestones
First patient enrolled in the TREK-DX trial by the end of 2022.
New translational data highlighting the unique effects of eblasakimab’s mechanism of action will be presented in early 2023.
Topline data from the Phase 2b TREK-AD trial of eblasakimab is expected in Q2 2023.
Third quarter 2022 financial highlights
Cash used in operating activities for the third quarter of 2022 was US$9.1 million compared to US$7.6 million in the same period in 2021.
Cash, cash equivalents and short-term investments as of September 30, 2022, were US$68.9 million.
Research and development expenses were US$8.0 million in the third quarter of 2022 compared to US$5.3 million in the third quarter of 2021. The increase was due to clinical development and manufacturing costs for eblasakimab.
General and administrative expenses were US$2.3 million in the third quarter of 2022 compared to US$2.8 million in the third quarter of 2021.
Net loss attributable to stockholders for the third quarter of 2022 was US$10.9 million compared to a net loss of US$8.6 million for the third quarter of 2021.
The weighted average number of American Depositary Shares (ADS) outstanding in the computation of basic loss per share for the third quarter of 2022 was 69.7 million (representing 348.7 million ordinary shares), the same as the third quarter of 2021. One ADS is the equivalent of five ordinary shares.