On April 28, 2023 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 first quarter ended March 31, 2023, and provided an update on recent corporate activities (Press release, ASLAN Pharmaceuticals, APR 28, 2023, View Source [SID1234630665]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We have made strong progress in the first quarter of the year by completing enrollment in our TREK-AD Phase 2b trial, testing eblasakimab as a novel treatment for moderate-to-severe atopic dermatitis (AD), and we look forward to reporting topline data from this study in early July 2023," said Dr Carl Firth, CEO, ASLAN Pharmaceuticals. "We have also advanced farudodstat into a Phase 2a, proof-of-concept study in alopecia areata (AA) expected to commence enrollment in the second quarter of 2023. AA is a common autoimmune disease that is associated with a severe psychological burden yet there are few effective treatments that are safe for long-term use. Farudodstat potently inhibits key drivers of AA disease pathophysiology and has the potential to be a novel, first-in-class treatment. This quarter we also announced strong support from BVF Partners and additional investors on a $20 million financing which we expect will enable sufficient runway for the company as we look forward to three possible clinical readouts in the next 12 months."
First quarter 2023 and recent business highlights
Q1 and recent clinical developments
•
In January, ASLAN and Thermo Fisher Scientific Inc (NYSE: TMO) announced a partnership to manufacture a high concentration formulation of eblasakimab for Phase 3 clinical trials. Thermo Fisher will manufacture this formulation of eblasakimab that ASLAN has developed, allowing up to 400 mg to be administered in a single, subcutaneous injection and suitable for use with different devices.
•
In February, the final patient was enrolled in the TREK-AD (Trials with EblasaKimab in Atopic Dermatitis) study, a Phase 2b, dose-ranging, randomized, double-blind, placebo-controlled clinical trial of eblasakimab in adults with moderate-to-severe AD. ASLAN expects to report topline data from the study that is evaluating the efficacy and safety of eblasakimab in biologic naïve AD patients over a 16-week treatment period in early July 2023.
•
In February, ASLAN announced the advancement of its clinical program to investigate farudodstat in a Phase 2a, proof-of-concept trial as a potential first-in-class treatment for AA. Farudodstat is 30-fold more potent than approved drugs in its class and has demonstrated a well-tolerated safety profile. The trial will recruit around 60 AA patients in the US and enrollment is expected to begin in the second quarter of 2023. The interim, topline readout following the first 12-week treatment period is expected in the first quarter of 2024 and will inform the design of the subsequent, Phase 2b, dose-ranging study.
•
In March, two abstracts showcasing new data on eblasakimab were accepted for poster presentation at the first meeting of the International Societies for Investigative Dermatology (ISID), taking place from May 10 to 13, 2023, in Tokyo, Japan. The abstracts published online in the Journal of Investigative Dermatology explore eblasakimab’s efficacy across different body regions in AD patients including difficult-to-treat areas, such as the head and neck, and its potential for alleviating the underlying itch and hypersensitized sensory nerve fibers through multiple molecular pathways in AD.
•
In April, two additional late-breaker abstracts were accepted for presentation at the ISID meeting. The late-breaker abstract on eblasakimab and the differences between IL-13Rα1 and IL4R blockade on Type 2 and Type 1 signalling in AD was accepted for oral presentation and the late-breaker abstract on the role of farudodstat in a human ex vivo model of AA was accepted for poster presentation. Additional details from the late-breaker abstracts will be shared after presentation at the conference.
Corporate updates
•
In February, ASLAN announced that it entered into a definitive purchase agreement (Purchase Agreement) to raise gross proceeds of approximately $20 million resulting from the sale of its ordinary shares (or pre-funded warrants) and accompanying purchase warrants, at a purchase price of $0.178 per ordinary share (or the equivalent of $4.45 per American Depositary Share ("ADS") after giving effect to the ADS Ratio Change described below) to BVF Partners, K2 HealthVentures and certain existing investors. In addition, ASLAN has the potential to receive up to an additional $80 million in proceeds if all purchase warrants issued in connection with the Purchase Agreement are fully exercised.
•
In March, ASLAN’s management team hosted a virtual farudodstat Research and Development Day with Key Opinion Leader, Brett King, MD PhD, Associate Professor of Dermatology, Yale University School of Medicine, to discuss the unmet medical need in AA and the potential for farudodstat to be a novel, first-in-class treatment for AA patients. A replay of the event and presentation materials are available within the Investor Relations section of ASLAN’s website.
•
In March, Alan Bianchi was appointed as Commercial Lead Advisor for eblasakimab. Alan is a biopharmaceutical marketing executive with extensive product commercialization and launch experience in dermatology and immunology. He held the role of Head, HCP marketing at Sanofi for the US launch of dupilumab and, most recently, was the Executive Director and US Marketing Lead for the global launch of tralokinumab at LEO Pharma.
Anticipated upcoming milestones
•
New clinical and translational data on eblasakimab will be presented at the ISID Meeting in Tokyo, Japan, including a podium presentation for the late-breaker abstract. New translational data on farudodstat will be shared as a poster presentation. Posters will be available to view at the meeting from May 10, 2023, and will be uploaded to the "Publications" section of ASLAN’s website.
•
The first patient is expected to be enrolled in the farudodstat Phase 2a, proof-of-concept study in AA in the second quarter of 2023.
•
Topline data from the Phase 2b TREK-AD trial of eblasakimab is expected in early July 2023.
•
Topline data from the TREK-DX trial of eblasakimab is expected in the first quarter of 2024.
•
Topline interim data from the farudodstat Phase 2a, proof-of-concept study in AA is expected in the first quarter of 2024.
First quarter 2023 financial highlights
•
As of March 31, 2023, the Company had cash, cash equivalents and short-term investments of $57.5 million.
•
Cash used in operations for the first quarter of 2023 was $19.3 million compared to $7.2 million in the same period in 2022.
•
Research and development expenses were $14.1 million in the first quarter of 2023 compared to $9.4 million in the first quarter of 2022. The increase was due to higher clinical development and manufacturing costs for the eblasakimab studies and activities to support the commencement of the farudodstat Phase 2a, proof-of concept study.
•
General and administrative expenses were $4.0 million in the first quarter of 2023 compared to $2.5 million in the first quarter of 2022. The increase was mainly driven by costs related to financing activities completed in the first quarter and increase in corporate activities.
•
Net loss attributable to stockholders for the first quarter of 2023 was $19.1 million compared to a net loss of $12.9 million for the first quarter of 2022.
•
The weighted average number of ADSs outstanding in the computation of basic loss per share for the first quarter of 2023 was 14.8 million (representing 370.7 million ordinary shares) compared to 13.9 million (representing 348.7 million ordinary shares) for the first quarter of 2022.
•
At the opening of trading on the Nasdaq Capital Market on March 13, 2023, the Company effected a change in the ratio of its ADSs to its ordinary shares from one (1) ADS representing five (5) ordinary shares to one (1) ADS representing twenty-five (25) ordinary shares (ADS Ratio Change). For the Company’s existing ADS holders, the ADS Ratio Change had the same effect as a one-for-five reverse ADS split. [Except as otherwise indicated, all information in this press release gives retroactive effect to the ADS Ratio Change.