- Recruitment completed in June for the expansion cohort of the Multiple Ascending Dose (MAD) trial of ASLAN004, underway for the treatment of patients with moderate-to-severe atopic dermatitis
- Topline, unblinded data from approximately 27 additional patients expected at the end of the third quarter of 2021
- On track to initiate Phase 2b clinical trial for ASLAN004 in 4Q 2021
SINGAPORE, Aug. 06, 2021 (GLOBE NEWSWIRE) -- 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 second quarter ended June 30, 2021, and provided an update on recent corporate activities.
“We have continued to make significant progress in 2021, completing the enrolment of 27 additional patients into the expansion cohort of our MAD study of ASLAN004 and establishing a strong financial position to advance the clinical development of both ASLAN004 and ASLAN003, said Dr Carl Firth, CEO, ASLAN Pharmaceuticals. “Earlier this year, we announced positive interim data from three dose cohorts, supporting the potential of ASLAN004 as a novel, first-in-class antibody targeting the IL-13 receptor with differentiated efficacy and safety profile. At the end of the third quarter, we expect to announce new, unblinded data from the MAD study from approximately 27 additional patients.”
Second quarter 2021 and recent business highlights
Clinical development
ASLAN004
- In May, new data from the Single Ascending Dose study were presented in a late-breaking poster presentation at the 2021 Society for Investigative Dermatology virtual meeting. The data demonstrated ASLAN004’s favourable tolerability profile as an IL-13Rα1 inhibitor and its potential as a differentiated treatment method for atopic dermatitis. The data will also be published in the fall edition of the Journal of Investigative Dermatology.
- In June, recruitment of 27 patients into the expansion cohort of the double-blind placebo-controlled MAD study was completed. Topline data is expected to be announced at the end of the third quarter 2021.
ASLAN003
- ASLAN is preparing to advance ASLAN003 as a candidate for the potential treatment of autoimmune gastrointestinal and skin diseases. The initiation of a Phase 2 clinical trial for ASLAN003 in inflammatory bowel disease is planned for early 2022.
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.
Anticipated upcoming milestones
- Completion of MAD clinical study of ASLAN004 in moderate-to-severe atopic dermatitis (AD) patients with topline results expected at the end of the third quarter of 2021.
- Initiation of Phase 2b study of ASLAN004 for AD expected in the last quarter of 2021.
- Initiation of Phase 2 study of ASLAN003 in inflammatory bowel disease in early 2022.
Second quarter 2021 financial highlights
- Cash used in operations for the second quarter of 2021 was US$6.9 million compared to US$3.0 million in the same period in 2020.
- Research and development expenses were US$4.0 million in the second quarter of 2021 compared to US$1.9 million in the second quarter of 2020. The increase was driven primarily by preparations for the ASLAN004 Phase 2b clinical trials.
- General and administrative expenses were US$3.8 million in the second quarter of 2021 compared to US$1.8 million in the second quarter of 2020. The increase was driven by costs related to the financing activities completed in the first half of the year and employee costs.
- Net loss for the second quarter of 2021 was US$5.5 million compared to a net loss of US$4.0 million for the second quarter of 2020. The company booked a gain of US$2.3 million on dilution of its subsidiary and recognition of its associate in the second quarter of 2021.
- Cash and cash equivalents totalled US$94.1 million as of June 30, 2021, compared to US$14.3 million as of December 31, 2020, and included the combined gross proceeds raised of approximately US$101.6 million from the financing activities conducted in the second quarter of 2021. With the proceeds from these financing activities and the loan facility secured from K2 HealthVentures, 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 second quarter of 2021 was 69.6 million (representing 348 million ordinary shares) compared to 38 million (representing 190 million ordinary shares) for the second quarter of 2020. Following the financing activities in the second quarter of 2021, the number of ADSs outstanding on 30 June 2021 was 69.6 million (representing 348 million ordinary shares). One ADS is the equivalent of five ordinary shares.
ASLAN Pharmaceuticals Limited
CONSOLIDATED BALANCE SHEETS
(In US Dollars)
| December 31, 2020 (audited) | June 30, 2021 (unaudited) | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 14,324,371 | $ | 94,120,158 | ||||
| Other receivables | 528,841 | - | ||||||
| Prepayments | 511,208 | 615,212 | ||||||
| Financial assets at fair value through profit or loss | 137,926 | - | ||||||
| Total current assets | 15,502,346 | 94,735,370 | ||||||
| NON-CURRENT ASSETS | ||||||||
| Investment in associates company | - | 818,560 | ||||||
| Property, plant and equipment | 13,387 | 8,678 | ||||||
| Right-of-use assets | 462,550 | 330,148 | ||||||
| Intangible assets | 160 | 12,016 | ||||||
| Refundable deposits | 103,307 | 120,050 | ||||||
| Total non-current assets | 579,404 | 1,289,452 | ||||||
| TOTAL ASSETS | $ | 16,081,750 | $ | 96,024,822 | ||||
| LIABILITIES AND EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Trade payables | $ | 2,319,558 | $ | 2,046,787 | ||||
| Other payables | 4,280,409 | 2,791,630 | ||||||
| Current portion of long-term borrowing | 2,900,971 | - | ||||||
| Current portion of long-term borrowing from related parties | 617,912 | - | ||||||
| Lease liabilities - current | 271,624 | 281,309 | ||||||
| Financial liabilities at fair value through profit or loss | 267,000 | - | ||||||
| Total current liabilities | 10,657,474 | 5,119,726 | ||||||
| NON-CURRENT LIABILITIES | ||||||||
| Long-term borrowings | 15,183,421 | 15,214,780 | ||||||
| Lease liabilities - non-current | 281,149 | 63,322 | ||||||
| Other non-current liabilities | 111,990 | 272,242 | ||||||
| Total non-current liabilities | 15,576,560 | 15,550,344 | ||||||
| Total liabilities | 26,234,034 | 20,670,070 | ||||||
| EQUITY ATTRIBUTABLE TO STOCKHOLDERS OF THE COMPANY | ||||||||
| Ordinary shares | 61,826,237 | 63,013,589 | ||||||
| Capital surplus | 123,582,460 | 220,352,368 | ||||||
| Accumulated deficits | (195,682,714) | (207,832,257) | ||||||
| Other reserves | (178,948) | (178,948) | ||||||
| Total equity attributable to stockholders of the Company | (10,452,965) | 75,354,752 | ||||||
| NON-CONTROLLING INTERESTS | 300,681 | - | ||||||
| Total equity | (10,152,284) | 75,354,752 | ||||||
| TOTAL LIABILITIES AND EQUITY | $ | 16,081,750 | $ | 96,024,822 | ||||
ASLAN Pharmaceuticals Limited
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(In US Dollars, other than shares or share data)
| For the Three Months Ended June 30 | For the Six Months Ended June 30 | |||||||||||
| 2020 | 2021 | 2020 | 2021 | |||||||||
| NET REVENUE | $ | - | $ | - | $ | - | $ | - | ||||
| COST OF REVENUE | - | - | - | - | ||||||||
| GROSS PROFIT | - | - | - | - | ||||||||
| OPERATING EXPENSES | ||||||||||||
| General and administrative expenses | (1,790,880) | (3,788,772) | (2,788,423) | (6,893,836) | ||||||||
| Research and development expenses | (1,892,559) | (4,044,521) | (4,247,175) | (7,795,493) | ||||||||
| Total operating expenses | (3,683,439) | (7,833,293) | (7,035,598) | (14,689,329) | ||||||||
| LOSS FROM OPERATIONS | (3,683,439) | (7,833,293) | (7,035,598) | (14,689,329) | ||||||||
| NON-OPERATING INCOME AND EXPENSES | ||||||||||||
| Other income | - | 340,076 | - | 340,076 | ||||||||
| Interest income | 114 | 20 | 216 | 157 | ||||||||
| Gain on dilution of subsidiary and recognition of associate | - | 2,307,735 | - | 2,307,735 | ||||||||
| Other gains and losses | (65,816) | 22,451 | 391,435 | 319,636 | ||||||||
| Finance costs | (338,612) | (203,428) | (677,637) | (614,902) | ||||||||
| Total non-operating income and expenses | (404,314) | 2,466,854 | (285,986) | 2,352,702 | ||||||||
| Share in losses of associated company, accounted for using equity method | - | (81,880) | - | (81,880) | ||||||||
| LOSS BEFORE INCOME TAX | (4,087,753) | (5,448,319) | (7,321,584) | (12,418,507) | ||||||||
| INCOME TAX EXPENSE | - | - | - | - | ||||||||
| NET LOSS FOR THE PERIOD | (4,087,753) | (5,448,319) | (7,321,584) | (12,418,507) | ||||||||
| OTHER COMPREHENSIVE LOSS | ||||||||||||
| Items that will not be reclassified subsequently to profit or loss: | ||||||||||||
| Unrealized loss on investments in equity instruments at fair value through other comprehensive income | (39,324) | - | (74,331) | - | ||||||||
| TOTAL COMPREHENSIVE LOSS FOR THE PERIOD | $ | (4,127,077) | $ | (5,448,319) | $ | (7,395,915) | $ | (12,418,507) | ||||
| NET LOSS ATTRIBUTABLE TO: | ||||||||||||
| Stockholders of the Company | $ | (3,959,184) | $ | (5,429,026) | $ | (7,005,889) | $ | (12,149,543) | ||||
| Non-controlling interests | (128,569) | (19,293) | (315,695) | (268,964) | ||||||||
| $ | (4,087,753) | $ | (5,448,319) | $ | (7,321,584) | $ | (12,418,507) | |||||
| TOTAL COMPREHENSIVE LOSS ATTRIBUTABLE TO: | ||||||||||||
| Stockholders of the Company | $ | (3,998,508) | $ | (5,429,026) | $ | (7,080,220) | $ | (12,149,543) | ||||
| Non-controlling interests | (128,569) | (19,293) | (315,695) | (268,964) | ||||||||
| $ | (4,127,077) | $ | (5,448,319) | $ | (7,395,915) | $ | (12,418,507) | |||||
| LOSS PER ORDINARY SHARE | ||||||||||||
| Basic and diluted | $ | (0.02) | $ | (0.02) | $ | (0.04) | $ | (0.04) | ||||
| LOSS PER EQUIVALENT ADS | ||||||||||||
| Basic and diluted | $ | (0.10) | $ | (0.08) | $ | (0.20) | $ | (0.20) | ||||
| Weighted-average number of ordinary shares in the computation of basic loss per ordinary share | 189,954,970 | 347,799,933 | 189,954,970 | 302,985,377 | ||||||||
| Weighted-average number of ADS in the computation of basic loss per ADS | 37,990,994 | 69,559,987 | 37,990,994 | 60,597,075 | ||||||||
Each ADS represents five ordinary shares.
Media and IR contacts
| Emma Thompson Spurwing Communications Tel: +65 6206 7350 Email: ASLAN@spurwingcomms.com | Ashley R. Robinson LifeSci Advisors, LLC Tel: +1 (617) 430-7577 Email: arr@lifesciadvisors.com |
About ASLAN Pharmaceuticals
ASLAN Pharmaceuticals (Nasdaq:ASLN) is a clinical-stage immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients. ASLAN is currently evaluating ASLAN004, a potential first-in-class antibody targeting the IL-13 receptor, in atopic dermatitis, and ASLAN003, a potent oral inhibitor of DHODH, which is being developed for autoimmune disease. ASLAN has a team in the Bay Area and in Singapore. For additional information, please visit www.aslanpharma.com or follow ASLAN on LinkedIn.
Forward looking statements
This release and the accompanying financial information, if any, contains forward-looking statements. These statements are based on the current beliefs and expectations of the management of ASLAN Pharmaceuticals Limited and/or its affiliates (the "Company"). These forward-looking statements may include, but are not limited to, statements regarding the Company’s business strategy and clinical development plans; the Company’s plans to develop and commercialise ASLAN003 and ASLAN004; the safety and efficacy of ASLAN003 and ASLAN004; the Company’s plans and expected timing with respect to clinical trials, clinical trial enrolment and clinical trial results for ASLAN003 and ASLAN004; the potential for ASLAN003 and ASLAN004 as treatments for autoimmune disease and atopic dermatitis, respectively; the total amount of the debt financing to be provided by the loan facility with K2 HealthVentures; and the Company’s belief that its cash and cash equivalents will be sufficient to fund operations into late 2023. The Company’s estimates, projections and other forward-looking statements are based on management's current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and inherently involve significant known and unknown risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of many risks and uncertainties, which include, unexpected safety or efficacy data observed during preclinical or clinical studies; clinical site activation rates or clinical trial enrolment rates that are lower than expected; the impact of the COVID-19 pandemic on the Company’s business and the global economy; general market conditions; changes in the competitive landscape; and the Company’s ability to obtain sufficient financing to fund its strategic and clinical development plans. Other factors that may cause actual results to differ from those expressed or implied in such forward-looking statements are described in the Company’s US Securities and Exchange Commission filings and reports (Commission File No. 001-38475), including the Company’s Annual Report on Form 20-F filed with the US Securities and Exchange Commission on April 23, 2021. All statements other than statements of historical fact are forward-looking statements. The words “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan,” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes are intended to identify estimates, projections, and other forward-looking statements. Estimates, projections, and other forward-looking statements speak only as of the date they were made, and, except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement.
