asln-6k_20201109.htm

 

 

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

November 9, 2020

(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)

83 CLEMENCEAU AVENUE

#12-03 UE SQUARE

SINGAPORE 239920

(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 2020 financial results and corporate update

 

On November 9, 2020, ASLAN Pharmaceuticals Limited issued a press release announcing financial results for the third quarter ended 30 September 2020 and provided an update on its clinical activities.

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

Exhibits

Exhibit
Number

 

Exhibit Description

 

 

99.1

 

Press release dated November 9, 2020 regarding 3Q20 financial release and corporate update.

 


 


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: November 9, 2020

 

 

asln-ex991_6.htm

Exhibit 99.1

PRESS RELEASE

 

 

 

ASLAN PHARMACEUTICALS REPORTS THIRD QUARTER 2020 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

Singapore, 9 November 2020 – 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, 2020 and provided an update on its clinical activities.

Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: “The third quarter saw great progress being made on multiple fronts for ASLAN. We resumed our multiple ascending dose (MAD) study of ASLAN004 following the lifting of COVID-19 restrictions and quickly completed recruitment of the second cohort, which we believe is an indicator of the scale of the unmet need we aim to address in atopic dermatitis. Recruitment of the third cohort is underway from sites in the US, Australia and Singapore, and we expect to announce new, unblinded data in early 2021. The move of our primary listing to the US is now complete and aligned with our plans to initiate a global Phase 2b study in atopic dermatitis in 2021 and new clinical studies of ASLAN003 in autoimmune disease.

Third quarter 2020 and recent business highlights

Clinical development ASLAN004

 

Investigational New Drug application submitted to the US Food and Drug Administration became effective and Clinical Trial Notification cleared by the Therapeutics Goods Administration in Australia.

 

 

Seven new clinical sites opened in the US and Australia designed to support recruitment of patients into the ongoing MAD study.

 

 

Initiated recruitment of patients into third dose cohort in October at sites in the US, Australia and Singapore following successful safety review of second cohort that resumed recruitment in August. ASLAN004 was found to be well tolerated at 400mg and the Data Monitoring Committee (DMC) recommend that the MAD study continue as planned.

 

ASLAN003

 

Announced plans to develop ASLAN003, ASLAN’s next generation inhibitor of dihydroorotate dehydrogenase (DHODH), in autoimmune conditions, such as multiple sclerosis, following review of the data generated on ASLAN003 and discussions with experts in the field. ASLAN believes that ASLAN003 has a potential best in class profile as a potent oral DHODH inhibitor targeting autoimmune indications.

 

Appointed renowned neurologist Professor Gavin Giovannoni, Chair of Neurology, Blizard Institute, Barts and The London School of Medicine and Dentistry, as a scientific advisor to the Company. ASLAN will work with Professor Giovannoni on the clinical development plan of ASLAN003.

 

Based on previous observations of anti-viral activity against Dengue and Zika viruses, ASLAN recently determined that ASLAN003 has nanomolar potency against SARS-CoV-2 in Vero E6 cells (EC50 = 1.4 nM) and is assessing the potential of ASLAN003 as a treatment for COVID-19 and other viral infections.

Corporate updates

 

Appointed Dr Kenneth Kobayashi as Chief Medical Officer. Dr Kobayashi most recently worked at Dermira, where he was responsible for the development of lebrikizumab, and previously held roles at Novartis and LEO Pharma. Dr Kobayashi brings more than 25 years of experience in drug development, clinical practice and regulatory affairs as a Dermatology expert.

 


 

Movement of primary listing to the Nasdaq Global Market and delisting from the Taipei Exchange completed in August. ASLAN has retained its listing of American Depositary Shares (ADS) on Nasdaq in the United States.

Anticipated upcoming milestones

 

Interim, unblinded data on ASLAN004 from the 3 dose cohorts (up to 24 patients) and initiation of the expansion cohort (an additional 18 patients) expected in early 2021.

 

 

Completion of MAD clinical study of ASLAN004 in moderate-to-severe atopic dermatitis (AD) patients expected in 1H 2021.

 

Initiation of Phase 2b study of ASLAN004 for AD expected in 2021.

 

Third quarter 2020 financial highlights

 

Cash used in operations for the third quarter of 2020 was US$2.6 million compared to US$7.0 million in the same period in 2019.

 

 

Research and development expenses were US$2.2 million in the third quarter of 2020 compared to US$4.1 million in the third quarter of 2019. The decrease was driven by the completion of clinical studies related to varlitinib.

 

 

General and administrative expenses were US$1.3 million in the third quarter of 2020 compared to US$1.1 million in the third quarter of 2019.

 

 

Net loss for the third quarter of 2020 was US$3.5 million compared to a net loss of US$5.2 million for the third quarter of 2019.

 

 

Cash, cash equivalents and short-term investments totaled US$12.1 million as of September 30, 2020 (this includes US$0.9 million of cash received in connection with the ADS scheme that will be paid to our depository agent in 4Q 2020) compared to US$22.2 million as of 31 December 2019. Weighted average ADS outstanding for the third quarter of 2020 was 38.0 million (or equivalent) compared to 32.0 million (or equivalent) for the third quarter of 2019. One ADS is the equivalent of five ordinary shares.

 

 

 


ASLAN Pharmaceuticals Limited CONSOLIDATED BALANCE SHEET1 (in US dollars)

 

 

 

December 31, 2019 (audited)

 

 

September 30, 2020 (unaudited)

 

ASSETS

 

 

 

 

 

 

CURRENT ASSETS

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

22,203,031

 

 

$

12,060,285

 

Prepayments

 

 

68,923

 

 

 

341,979

 

     Total current assets

 

 

22,271,954

 

 

 

12,402,264

 

NON-CURRENT ASSETS

 

 

 

 

 

 

 

 

Financial assets at fair value through profit or loss

 

 

68,256

 

 

 

59,002

 

Financial assets at fair value through other comprehensive income

 

 

132,160

 

 

 

57,829

 

Property, plant and equipment

 

 

38,333

 

 

 

19,942

 

Right-of-use assets

 

 

727,866

 

 

 

528,751

 

Intangible assets

 

 

2,845

 

 

402

 

Refundable deposits

 

 

108,076

 

 

 

108,542

 

     Total non-current assets

 

 

1,077,536

 

 

 

774,468

 

TOTAL ASSETS

 

$

23,349,490

 

 

$

13,176,732

 

LIABILITIES AND EQUITY

 

 

 

 

 

 

 

 

CURRENT LIABILITIES

 

 

 

 

 

 

 

 

Trade payables

 

$

1,871,843

 

 

$

2,248,833

 

Other payables

 

 

3,246,842

 

 

 

2,575,322

 

Lease liabilities – current

 

 

264,543

 

 

 

207,212

 

Other current liabilities

 

 

 

 

 

 

918,150

 

     Total current liabilities

 

 

5,383,228

 

 

 

5,949,517

 

NON-CURRENT LIABILITIES

 

 

 

 

 

 

 

 

Financial liabilities at fair value through profit or loss

 

 

262,350

 

 

 

262,350

 

Long-term borrowings

 

 

17,065,305

 

 

 

17,499,074

 

Long-term borrowing from related parties

 

 

566,176

 

 

 

603,704

 

Lease liabilities - non-current

 

 

490,835

 

 

 

351,935

 

Other non-current liabilities

 

 

184,870

 

 

 

253,596

 

     Total non-current liabilities

 

 

18,569,536

 

 

 

18,970,659

 

  Total liabilities

 

 

23,952,764

 

 

 

24,920,176

 

EQUITY ATTRIBUTABLE TO STOCKHOLDERS OF THE COMPANY

 

 

 

 

 

 

 

 

Ordinary shares

 

 

61,366,844

 

 

 

61,366,844

 

Capital surplus

 

 

116,495,710

 

 

 

116,495,710

 

Accumulated deficits

 

 

(179,484,825)

 

 

 

(189,966,716)

 

Other reserves

 

 

(55,084)

 

 

 

(129,415)

 

     Total equity attributable to stockholders of the Company

 

 

(1,677,355)

 

 

 

(12,233,577)

 

NON-CONTROLLING INTERESTS

 

 

1,074,081

 

 

 

490,133

 

   Total equity

 

 

(603,274)

 

 

 

(11,743,444)

 

TOTAL LIABILITIES AND EQUITY

 

$

23,349,490

 

 

$

13,176,732

 

 

 

 

 


 

 

ASLAN Pharmaceuticals Limited

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)1
(in US dollars, unaudited)

 

 

 

For the Three Months Ended September 30

 

 

For the Nine Months Ended September 30

 

 

 

2019

 

 

2020

 

 

2019

 

 

2020

 

NET REVENUE

 

$

-

 

 

$

-

 

 

$

3,000,000

 

 

$

-

 

COST OF REVENUE

 

 

-

 

 

 

-

 

 

 

(425,000

)

 

 

-

 

GROSS PROFIT

 

 

-

 

 

 

-

 

 

 

2,575,000

 

 

 

-

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

General and administrative expenses

 

$

(1,111,697

)

 

$

(1,347,487

)

 

 

(5,253,502

)

 

$

(4,135,910

)

Research and development expenses

 

 

(4,145,827

)

 

 

(2,185,322

)

 

 

(13,883,992

)

 

 

(6,432,497

)

Total operating expenses

 

 

(5,257,524

)

 

 

(3,532,809

)

 

 

(19,137,494

)

 

 

(10,568,407

)

LOSS FROM OPERATIONS

 

 

(5,257,524

)

 

 

(3,532,809

)

 

 

(16,562,494

)

 

 

(10,568,407

)

NON-OPERATING INCOME AND EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

206

 

 

 

222

 

 

 

144,417

 

 

 

438

 

Other gains and losses

 

 

199,054

 

 

 

(199,005

)

 

 

(38,290

)

 

 

192,430

 

Finance costs

 

 

(206,596

)

 

 

(243,516

)

 

 

(608,502

)

 

 

(921,153

)

Total non-operating income and expenses

 

 

(7,336

)

 

 

(442,299

)

 

 

(502,375

)

 

 

(728,285

)

LOSS BEFORE INCOME TAX

 

 

(5,264,860

)

 

 

(3,975,108

)

 

 

(17,064,869

)

 

 

(11,065,839

)

INCOME TAX EXPENSE

 

 

79,710

 

 

 

230,853

 

 

 

(395,290

)

 

 

230,853

 

NET LOSS FOR THE PERIOD

 

 

(5,185,150

)

 

 

(3,744,255

)

 

 

(17,460,159

)

 

 

(11,065,839

)

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

 

 

(9,046

)

 

 

-

 

 

 

(9,046

)

 

 

(74,331

)

TOTAL COMPREHENSIVE LOSS FOR THE PERIOD

 

$

(5,194,196

)

 

$

(3,744,255

)

 

$

(17,469,205

)

 

$

(11,140,170

)

NET LOSS ATTRIBUTABLE TO:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders of the Company

 

 

(5,194,196

)

 

 

(3,476,002

)

 

 

(17,460,159

)

 

 

(10,481,891

)

Non-controlling interests

 

 

  -

 

 

 

(268,253

)

 

 

  -

 

 

 

(583,948

)

 

 

 

(5,194,196

)

 

 

(3,744,255

)

 

 

(17,460,159

)

 

 

(11,065,839

)

TOTAL COMPREHENSIVE LOSS ATTRIBUTABLE TO:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders of the Company

 

 

(5,194,196

)

 

 

(3,476,002

)

 

 

(17,469,205

)

 

 

(10,556,222

)

Non-controlling interests

 

 

  -

 

 

 

(268,253

)

 

 

  -

 

 

 

(583,948

)

 

 

 

(7,930,967

)

 

 

(4,127,077

)

 

 

(12,275,009

)

 

 

(11,140,170

)

LOSS PER SHARE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.03

)

 

$

(0.02

)

 

$

(0.11

)

 

$

(0.06

)

Weighed-avg. shares outstanding (in thousands)

 

 

160,249

 

 

 

189,955

 

 

 

160,249

 

 

 

189,955

 

 

1 Financial statements in US dollars are prepared by the company and are unaudited as of September 30, 2020.

Ends

 

 


Media and IR contacts

 

 

Emma Thompson Spurwing Communications Tel: +65 6751 2021

Email: ASLAN@spurwingcomms.com

Robert Uhl Westwicke Partners Tel: +1 858 356 5932

Email: robert.uhl@westwicke.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. Led by a senior management team with extensive experience in global development and commercialisation, ASLAN has a clinical portfolio comprised of a first-in-class monoclonal therapy, ASLAN004, that is being developed in atopic dermatitis and other immunology indications, and ASLAN003, which it plans to develop for autoimmune disease. For additional information please visit www.aslanpharma.com.

 

 

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 ASLAN004 and ASLAN003; the safety and efficacy of ASLAN004 and ASLAN003; the Company’s plans and expected timing with respect to clinical trials and clinical trial results for ASLAN004 and ASLAN003; the potential for ASLAN004 to deliver a best-in-disease treatment for people with atopic dermatitis; the potential for ASLAN003 to have a best in class profile as a potent oral DHODH inhibitor targeting autoimmune indications; the potential for ASLAN003 to be a treatment for COVID-19 and other viral infections; and the scale of the unmet need in atopic dermatitis. 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 16, 2020.

 

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.