6-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

OF THE SECURITIES EXCHANGE ACT OF 1934

October 28, 2022

(Commission File No. 001-38475)

 

ASLAN PHARMACEUTICALS LIMITED

(REG. NO. 289175)

(Translation of registrant’s name into English)

 

CAYMAN ISLANDS

(Jurisdiction of incorporation or organisation)

3 Temasek Avenue

Level 18 Centennial Tower

Singapore 039190

(Address of registrant’s principal executive office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F Form 40-F

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101 (b) (1):

Yes No

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101 (b) (7):

Yes No

 

 

 


Announcement of Third Quarter 2022 Financial Results and Corporate Update

 

On October 28 2022, ASLAN Pharmaceuticals Limited (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended September 30, 2022, and providing an update on recent corporate activities.

 

A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.

 

The information contained in this Form 6-K is hereby incorporated by reference into the Company’s Registration Statement on Form F-3 (File No. 333-234405), Registration Statement on Form F-3 (File No. 333-252575), Registration Statement on Form F-3 (File No. 333-254768), Registration Statement on Form S-8 (File No. 333-252118) and Registration Statement on Form S-8 (File No. 333-263843).

 

Exhibits

 

 

 

 

Exhibit
Number

 

Exhibit Description

 

 

99.1

 

Press release dated October 28, 2022.

 

 

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereto duly authorized.

 

 

 

ASLAN PHARMACEUTICALS LIMITED

(Registrant)

 

 

By:

/s/ Kiran Kumar Asarpota

 

Name:

Kiran Kumar Asarpota

Title:

Chief Operating Officer

Date: October 28, 2022

 

 


EX-99.1

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Exhibit 99.1

PRESS RELEASE

ASLAN PHARMACEUTICALS REPORTS THIRD QUARTER 2022 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

-
Company maintains healthy operating position with US$68.9 million in cash, cash equivalents and short-term investments as of September 30, 2022; expected runway through late 2023
-
New TREK-DX clinical program studying eblasakimab’s potential in dupilumab experienced atopic dermatitis (AD) patients on track to enroll first patient by the end of 2022
-
The Phase 2b TREK-AD trial for eblasakimab in biologic naïve moderate-to-severe AD patients is on track and anticipated to generate topline data in Q2 2023

San Mateo, California, and Singapore, October 28, 2022 – 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 third quarter ended September 30, 2022, and provided an update on recent corporate activities.

“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

 

 

 

 

 


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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.

 

 

 

 

 


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ASLAN Pharmaceuticals Limited

CONSOLIDATED BALANCE SHEETS

(In US Dollars)

 

 

December 31, 2021
(audited)

 

 

September 30, 2022
(unaudited)

 

ASSETS

 

 

 

 

 

 

CURRENT ASSETS

 

 

 

 

 

 

Cash and cash equivalents

 

$

90,167,967

 

 

$

57,752,827

 

Short-term investments

 

 

 

 

 

11,196,343

 

Total cash, cash equivalents, and short-term investments

 

 

90,167,967

 

 

 

68,949,170

 

Other assets

 

 

3,612,846

 

 

 

3,225,270

 

Total current assets

 

$

93,780,813

 

 

$

72,174,440

 

NON-CURRENT ASSETS

 

 

 

 

 

 

Investment in associate company

 

 

494,728

 

 

 

54,102

 

Property, plant and equipment

 

 

34,979

 

 

 

44,064

 

Right-of-use assets

 

 

197,746

 

 

 

332,803

 

Intangible assets

 

 

9,956

 

 

 

6,866

 

Total non-current assets

 

 

737,409

 

 

 

437,835

 

TOTAL ASSETS

 

$

94,518,222

 

 

$

72,612,275

 

LIABILITIES AND EQUITY

 

 

 

 

 

 

CURRENT LIABILITIES

 

 

 

 

 

 

Trade payables

 

$

3,116,786

 

 

$

11,043,988

 

Other payables

 

 

2,817,909

 

 

 

2,724,539

 

Lease liabilities - current

 

 

199,124

 

 

 

282,737

 

Financial liabilities at fair value through profit or loss

 

 

223,352

 

 

 

143,712

 

Total current liabilities

 

 

6,357,171

 

 

 

14,194,976

 

NON-CURRENT LIABILITIES

 

 

 

 

 

 

Long-term borrowings

 

 

30,857,308

 

 

 

36,352,304

 

Total non-current liabilities

 

 

30,857,308

 

 

 

36,352,304

 

Total liabilities

 

 

37,214,479

 

 

 

50,547,280

 

EQUITY ATTRIBUTABLE TO STOCKHOLDERS OF THE COMPANY

 

 

 

 

 

 

Ordinary shares

 

 

63,019,962

 

 

 

63,019,962

 

Capital surplus

 

 

221,467,061

 

 

 

223,129,687

 

Accumulated deficits

 

 

(227,004,332

)

 

 

(263,905,706

)

Other reserves

 

 

(178,948

)

 

 

(178,948

)

Total equity attributable to stockholders of the Company

 

 

57,303,743

 

 

 

22,064,995

 

Total equity

 

 

57,303,743

 

 

 

22,064,995

 

TOTAL LIABILITIES AND EQUITY

 

$

94,518,222

 

 

$

72,612,275

 

 

 

 

 

 

 


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ASLAN Pharmaceuticals Limited

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(In US Dollars, other than shares or share data)

 

 

For the Three Months Ended
September 30

 

 

For the Nine Months Ended
September 30

 

 

 

2021

 

 

2022

 

 

2021

 

 

2022

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

General and administrative expenses

 

 

(2,768,498

)

 

 

(2,318,889

)

 

 

(9,653,235

)

 

 

(7,173,938

)

Research and development expenses

 

 

(5,261,740

)

 

 

(7,975,962

)

 

 

(13,057,003

)

 

 

(27,315,008

)

Total operating expenses

 

 

(8,030,238

)

 

 

(10,294,851

)

 

 

(22,710,238

)

 

 

(34,488,946

)

LOSS FROM OPERATIONS

 

 

(8,030,238

)

 

 

(10,294,851

)

 

 

(22,710,238

)

 

 

(34,488,946

)

NON-OPERATING INCOME AND EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

Other income

 

 

4,271

 

 

 

66,677

 

 

 

335,959

 

 

 

223,427

 

Interest income

 

 

20

 

 

 

86,642

 

 

 

177

 

 

 

130,439

 

Other gains and losses

 

 

103,130

 

 

 

246,923

 

 

 

1,250,241

 

 

 

541,496

 

Finance costs

 

 

(498,150

)

 

 

(937,111

)

 

 

(1,113,052

)

 

 

(2,897,432

)

Total non-operating income and expenses

 

 

(390,729

)

 

 

(536,869

)

 

 

473,325

 

 

 

(2,002,070

)

Share in losses of associated company, accounted for using equity
   method

 

 

(133,523

)

 

 

(78,144

)

 

 

(215,403

)

 

 

(390,516

)

LOSS BEFORE INCOME TAX

 

 

(8,554,490

)

 

 

(10,909,864

)

 

 

(22,452,316

)

 

 

(36,881,532

)

INCOME TAX EXPENSE

 

 

 

 

 

(19,842

)

 

 

 

 

 

(19,842

)

NET LOSS FOR THE PERIOD

 

 

(8,554,490

)

 

 

(10,929,706

)

 

 

(22,452,316

)

 

 

(36,901,374

)

TOTAL COMPREHENSIVE LOSS FOR THE PERIOD

 

$

(8,554,490

)

 

$

(10,929,706

)

 

$

(22,452,316

)

 

$

(36,901,374

)

NET LOSS ATTRIBUTABLE TO:

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders of the Company

 

$

(8,554,490

)

 

$

(10,929,706

)

 

$

(22,452,316

)

 

$

(36,901,374

)

 

 

$

(8,554,490

)

 

$

(10,929,706

)

 

$

(22,452,316

)

 

$

(36,901,374

)

TOTAL COMPREHENSIVE LOSS ATTRIBUTABLE TO:

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders of the Company

 

$

(8,554,490

)

 

$

(10,929,706

)

 

$

(22,452,316

)

 

$

(36,901,374

)

 

 

$

(8,554,490

)

 

$

(10,929,706

)

 

$

(22,452,316

)

 

$

(36,901,374

)

LOSS PER ORDINARY SHARE

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.02

)

 

$

(0.03

)

 

$

(0.07

)

 

$

(0.11

)

LOSS PER EQUIVALENT ADS

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.12

)

 

$

(0.16

)

 

$

(0.35

)

 

$

(0.53

)

Weighted-average number of ordinary shares in the computation of
   basic loss per ordinary share

 

348,317,020

 

 

348,723,365

 

 

318,318,133

 

 

348,723,365

 

Weighted-average number of ADS in the computation of basic loss
   per ADS

 

69,663,404

 

 

69,744,673

 

 

63,663,627

 

 

69,744,673

 

Each ADS represents five ordinary shares

 

 

 

 

 


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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 eblasakimab, a potential first-in-class antibody targeting the IL-13 receptor, in atopic dermatitis, and farudodstat, a potent oral inhibitor of the enzyme DHODH, in autoimmune disease. ASLAN has a team in California and in Singapore. For additional information please visit www.aslanpharma.com or follow ASLAN on LinkedIn.
 

Forward looking statements

This release 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 commercialize eblasakimab and farudodstat; the safety and efficacy of eblasakimab and farudodstat; the Company’s plans and expected timing with respect to clinical trials, clinical trial enrollment and clinical trial results for eblasakimab andfarudodstat; the potential of eblasakimabas a first-in-class treatment for atopic dermatitis and of farudodstatas a treatment for autoimmune disease; and the Company’s cash runway. 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 enrollment rates that are lower than expected; the impact of the COVID-19 pandemic or the ongoing conflict between Ukraine and Russia 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 March 25, 2022. 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.

Ends

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