ASLAN Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Corporate Update

• Positive topline data reported in July from TREK-AD, a Phase 2b study of eblasakimab that met the primary endpoint across three dose arms with statistical significance. The data established eblasakimab, a potential first-in-class antibody, as the first biologic in moderate-to-severe atopic dermatitis to demonstrate a competitive efficacy profile with once-monthly dosing from initiation
• Data supports advancement of eblasakimab into Phase 3 clinical development program in 2024
• Readouts from TREK-DX (TRials in EblasaKimab in Dupilumab eXperienced AD patients) Phase 2 study of eblasakimab and FAST-AA (FArudodstat STudy in Alopecia Areata) Phase 2a study of farudodstat both expected in the first quarter of 2024
• Company maintains healthy operating position with $40.9 million in cash and cash equivalents as of June 30, 2023; $12.0 million upfront strategic license payment received in July, expected cash runway extended into the second half of 2024

SAN MATEO, Calif. and SINGAPORE, Aug. 11, 2023 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals ( ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced financial results for the second quarter ended June 30, 2023, and provided an update on recent corporate activities.

“The positive topline data from the TREK-AD Phase 2b study that we announced in July positions eblasakimab as a potential leading therapy in treating atopic dermatitis and other allergic disease. Eblasakimab is the first biologic to demonstrate a monthly dosing regimen from the start of treatment without compromising on efficacy,” said Dr Carl Firth, CEO, ASLAN Pharmaceuticals. “The topline data, in addition to the further analysis still ongoing and the supportive findings from our patient and physician surveys, support our planning of a pivotal Phase 3 study of eblasakimab, which we would expect to initiate in 2024 alongside a global commercial partner. Also this quarter, we presented translational data demonstrating that blockade of the IL-13 receptor with eblasakimab resulted in lower levels of allergy-related Th2 cytokines and pro-inflammatory Th1 cytokines when compared to blockade of the IL-4 receptor, the target of dupilumab, supporting the differentiated clinical profile demonstrated in TREK-AD.

“Additional significant accomplishments achieved during the second quarter include the initiation of the Phase 2 trial for farudodstat in alopecia areata and signing our first licensing agreement for eblasakimab in Japan with leading pharmaceutical company Zenyaku Kogyo, who will conduct additional clinical trials in this important commercial territory. With a catalyst-rich pipeline, including our upcoming data readouts in early 2024 from TREK-DX and FAST-AA, we look forward to providing updates on these important milestones,” he continued.

Second quarter 2023 and recent business highlights

Q2 and recent clinical developments

• In May, two abstracts showcasing new data on eblasakimab and farudodstat were presented at the first International Societies for Investigative Dermatology (ISID) Meeting in Tokyo, Japan. The late-breaker abstract on eblasakimab revealed that selective targeting of IL-13Rα1 with eblasakimab may lead to more efficient reduction of Th2 inflammation without increasing levels of Th1 cytokines, compared to IL-4Rα blockade, in patients with moderate-to-severe atopic dermatitis (AD). The second late-breaker abstract showcased farudodstat’s potential to protect against immune privilege (IP) collapse in alopecia areata (AA). The posters can be accessed in the “Publications” section of ASLAN’s website.
• In May, the first patient was dosed in the FAST-AA study, a Phase 2a proof-of-concept study of farudodstat in patients with severe AA. ASLAN expects to report interim topline data from the study, which investigates farudodstat’s efficacy and safety in patients with at least 50% scalp hair loss over a 12-week treatment period, in the first quarter of 2024.
• In June, ASLAN and Zenyaku Kogyo Co., Ltd (Zenyaku), a leading Japanese pharmaceutical company, announced a strategic licensing agreement to develop and commercialize eblasakimab in AD and all other indications in Japan. ASLAN received an upfront payment of $12.0 million and is eligible to receive up to an additional $123.5 million in development and commercial milestones, plus tiered royalties on sales in double digit percentages ranging up to low twenties. Zenyaku plans to initiate a Phase 1 study of eblasakimab in Japan in the first half of 2024. ASLAN retains an option that can be exercised at any time to reacquire the rights to eblasakimab in Japan in the future.
• In June, data from the Phase 1a single-ascending-dose study of eblasakimab was published in Clinical Immunology, a bimonthly, peer-reviewed journal, supporting eblasakimab’s potential as a novel, differentiated treatment for AD. The publication can be accessed here.
• In June, preclinical data on farudodstat from ASLAN’s research collaboration with Monasterium Laboratories, a leader in the field of skin and hair research, was presented in an oral symposium at the 20^th European Hair Research Society Meeting in Sheffield, UK. The presentation, titled “Exploring the potential of farudodstat, a DHODH inhibitor, as an alopecia areata therapeutic in a novel ex vivo model of human hair follicle immune privilege collapse”, showed that farudodstat has the potential to protect against IP collapse in a new translational human model of AA.
• In July, ASLAN published a perspective article in Annals of Allergy, Asthma and Immunology, in collaboration with Emma Guttmann-Yassky MD, PhD, titled “Targeting type 2 immune activation beyond atopic dermatitis”. The article discusses the potential of a therapeutic like eblasakimab to treat a range of Type 2 driven comorbidities beyond AD. The open access article can be read here.
• In July, ASLAN announced positive topline data from the Phase 2b dose-ranging TREK-AD (TRials with EblasaKimab in Atopic Dermatitis) study of eblasakimab that met the primary endpoint across three dose arms with statistical significance. Eblasakimab is the first biologic in moderate-to-severe AD to demonstrate a competitive efficacy profile with once-monthly dosing from initiation comparable to once every two weeks. ASLAN’s management team hosted a webcast to discuss the topline data, a recording of the webcast and presentation materials are available on ASLAN’s website.
  

Anticipated upcoming milestones

• Additional data from TREK-AD on biomarkers and patient reported outcomes to be submitted for publication at a scientific congress in the fourth quarter of 2023.
• Topline data from the TREK-DX trial of eblasakimab in dupilumab experienced patients is expected in the first quarter of 2024.
• Topline interim data from the FAST-AA study of farudodstat is expected in the first quarter of 2024.
• Phase 1 trial of eblasakimab in Japan is expected to be initiated by Zenyaku in the first half of 2024.
• Meeting with the US Food and Drug Administration and subsequent initiation of the Phase 3 clinical program for eblasakimab is expected to occur in 2024.
  

Second quarter 2023 financial highlights

• As of June 30, 2023, the Company had cash and cash equivalents of $40.9 million. $12.0 million upfront strategic license payment from Zenyaku received in July, extending the Company’s expected cash runway into the second half of 2024.
• Cash used in operations for the second quarter of 2023 was $17.8 million compared to $9.7 million in the same period in 2022. The increased cash burn in the second quarter of 2023 included the settlement of $8.9 million of outstanding payables from the previous quarter.

• Research and development expenses were $11.6 million in the second quarter of 2023 compared to $10.0 million in the second quarter of 2022. The increase was due to higher clinical development and manufacturing costs for the eblasakimab studies.
• General and administrative expenses were $2.8 million in the second quarter of 2023 compared to $2.3 million in the second quarter of 2022.
• Net loss attributable to stockholders for the second quarter of 2023 was $1.9 million compared to a net loss of $13.0 million for the second quarter of 2022. The decrease was due to licensing revenues of $12.0 million recognized in the second quarter of 2023.
• The weighted average number of American Depositary Shares (ADS) outstanding in the computation of basic loss per share for the second quarter of 2023 was 16.4 million (representing 411.1 million ordinary shares) compared to 13.9 million (representing 348.7 million ordinary shares) for the second quarter of 2022. One ADS is the equivalent of twenty-five ordinary shares.