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

March 19, 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 fourth quarter and full year 2019 financial results and corporate update

 

On March 18, 2020, ASLAN Pharmaceuticals issued a press release announcing the financial results for the fourth quarter and full year ended 31 December 2019 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 March 18, 2020 regarding announcement of fourth quarter and full year 2019 financial results 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:

VP Finance

Date: March 19, 2020

 

 

asln-ex991_6.htm

Exhibit 99.1

PRESS RELEASE

 

 

 

ASLAN PHARMACEUTICALS REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

Singapore, 18 March 2020 – ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage immunology and oncology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today reported financial results for the quarter and full year ended 31 December 2019 and provided an update on its clinical activities.

Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: “2019 marked a year of change for ASLAN as we focused our development efforts on the highly promising ASLAN004, a fully human monoclonal antibody that binds to the IL-13 receptor α1 subunit (IL-13Rα1), for the treatment of atopic dermatitis (AD) and asthma. The data we announced last December from our ongoing multiple ascending dose (MAD) study in AD was very encouraging, showing early signs of efficacy and a favourable side effect profile, and we believe that ASLAN004 has the potential to be a best-in-disease treatment for AD. The second dose cohort is recruiting well and we plan to wait until the end of cohort 3 to announce additional data, when the full dataset can be unblinded rather than releasing additional blinded data at the end of cohort 2. Our recent fundraising has positioned us well to complete the study and, at the same time, prepare to initiate a Phase 2b study in early 2021 as the next step in our development plan.”

Fourth quarter 2019 and recent business highlights

Clinical development

ASLAN004

 

•

Initiated a randomised, double-blind, placebo-controlled MAD study in October to evaluate 3 doses of ASLAN004 (between 200mg and 600mg) in moderate to severe AD patients following the successful completion of the Single Ascending Dose clinical trial in healthy volunteers.

 

 

•

In December, preliminary results from the first patients treated with ASLAN004 showed early signs of efficacy in the low dose cohort. In a review of unclean blinded data, the Eczema Area and Severity Index (EASI) scores of the 3 patients who had completed at least one month of dosing were reduced by 85%, 70% and 59% from baseline and the EASI score continued to fall at 4 weeks with maximal efficacy expected at 6 to 8 weeks.

 

 

•

Following a meeting of the Data Monitoring Committee in late December, the second dose cohort began recruiting patients in Singapore. Recruitment currently appears unaffected by the COVID-19 pandemic and the trial is on track to complete in 2H 2020.  Rather than announcing additional blinded data at the end of cohort 2, ASLAN plans to wait until the end of cohort 3, when data from all 3 dose cohorts can be unblinded. ASLAN expects to announce this unblinded, interim data in 3Q 2020, and will then open the expansion cohort at the selected dose.

 

ASLAN003

 

•

Published preclinical data in Haematologica Journal that showed ASLAN003’s potential as a potent human dihydroorotate dehydrogenase (DHODH) inhibitor and novel target for differentiation therapy with a favourable toxicity profile.

 

AhR antagonist

 

•

In September, ASLAN transferred the global rights to all of the assets related to aryl hydrocarbon receptor (AhR) antagonists, originally discovered and developed by ASLAN and its collaborators, to JAGUAHR Therapeutics, a joint venture with Bukwang Pharmaceutical.

 

 

•

JAGUAHR will identify a lead development compound to develop as a new immuno-oncology therapeutic

 

 

targeting the AhR pathway and file an Investigational New Drug (IND) application. Bukwang will invest US$5 million in JAGUAHR in two tranches to fund the development of the assets.

 

Additional Pipeline Programs

 

•

Announced topline data from the TreeTopp study of varlitinib in second line biliary tract cancer in October.

 

Corporate updates

 

•

Elected existing board member Andrew Howden as non-executive Chairman of the board and separated the roles of Chairman and Chief Executive Officer to maintain high standards of corporate governance.

 

 

•

Secured a US$3 million loan facility provided by the company’s Chairman, members of the board, and several major investors in October.

 

 

•

Successfully closed US$15 million public offering of 5,893,206 American Depositary Shares at a public offering price of US$2.50 per ADS in December supported by new investors, including the exercise in full of the underwriter’s option to purchase additional ADSs.

 

Anticipated upcoming milestones for ASLAN004

 

•

Interim, unblinded data from the 3 dose cohorts (up to 24 patients) expected in 3Q 2020, and initiation of the expansion cohort (an additional 18 patients).

 

 

•

Completion of MAD clinical trial in moderate-to-severe AD patients in 4Q 2020.

 

 

•

Opening of clinical trial sites in Australia and filing of IND application with the US FDA in the middle of 2020

 

 

•

Initiation of Phase 2b study of ASLAN004 for AD in 1H 2021.

 

Fourth quarter 2019 financial results

 

•

Cash used in operations for the quarter ended 31 December 2019 was US$5.1 million compared to US$9.6 million in the same period in 2018.

 

 

•

Research and development expenses were US$2.7 million, general and administrative expenses were US$3.3 million for the fourth quarter of 2019, compared to US$9.2 million and US$1.9 million respectively in the same period in 2018.

 

 

•

Net loss for the fourth quarter of 2019 was US$29.6 million compared to a net loss of US$11.2 million for the fourth quarter of 2018. This reflects a one-off impairment charge of US$23 million related to the write-down of varlitinib in the fourth quarter of 2019. Excluding the non-cash impairment charge, net loss for the fourth quarter of 2019 was US$6.5 million compared to a net loss of US$11.2 million for the fourth quarter of 2018.  

 

Full Year 2019 financial highlights

 

•

Cash used in operations for year ended 31 December 2019 was US$25.8 million compared to US$39.5 million in the same period in 2018.

 

 

•

Research and development expenses were US$16.6 million, general and administrative expenses were US$8.5 million for the full year 2019, compared to US$31.8 million and US$10.5 million respectively in the same period in 2018.

 

 

•

Net loss for the full year 2019 was US$47.0 million including a one-off impairment charge of US$23 million related to the write-down of varlitinib in the fourth quarter of 2019. Excluding the non-cash impairment charge, net loss for the full year 2019 was US$23.9 million compared to a net loss of US$42.2 million for the full year 2018.  

 

 

•

Cash, cash equivalents and short-term investments totaled US$22.2 million as of 31 December 2019 compared to US$28.9 million as of 31 December 2018.

 

 

ASLAN Pharmaceuticals Limited Consolidated Balance Sheets1 December 31, 2018 and 2019
(in U.S. dollars, audited)

 

 

 

2018

 

 

2019

 

ASSETS

 

 

 

 

 

 

CURRENT ASSETS

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

28,908,901

 

 

$

22,203,031

 

Prepayments

 

 

183,599

 

 

 

68,923

 

Total current assets

 

 

29,092,500

 

 

 

22,271,954

 

 

 

 

 

 

 

 

 

 

NON-CURRENT ASSETS

 

 

 

 

 

 

 

 

Financial assets at fair value through profit or loss

 

 

60,004

 

 

 

68,256

 

Financial assets at fair value through other comprehensive income

 

 

187,244

 

 

 

132,160

 

Property, plant and equipment

 

 

288,418

 

 

 

38,333

 

Right-of-use assets

 

 

-

 

 

 

727,866

 

Intangible assets

 

 

23,080,592

 

 

2,845

 

Refundable deposits

 

 

172,080

 

 

 

108,076

 

Total non-current assets

 

 

23,788,338

 

 

 

1,077,536

 

 

 

 

 

 

 

 

 

 

TOTAL ASSETS

 

$

52,880,838

 

 

$

23,349,490

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND EQUITY

 

 

 

 

 

 

 

 

CURRENT LIABILITIES

 

 

 

 

 

 

 

 

Trade payables

 

$

5,315,737

 

 

$

1,871,843

 

Other payables

 

 

2,682,661

 

 

 

3,246,842

 

Lease liabilities – current

 

 

-

 

 

 

264,543

 

Total current liabilities

 

 

7,998,398

 

 

 

5,383,228

 

 

 

 

 

 

 

 

 

 

NON-CURRENT LIABILITIES

 

 

 

 

 

 

 

 

Financial liabilities at fair value through profit or loss

 

 

-

 

 

 

262,350

 

Long-term borrowings

 

 

13,974,794

 

 

 

17,065,305

 

Long-term borrowing from related parties

 

 

-

 

 

 

566,176

 

Lease liabilities – non-current

 

 

-

 

 

 

490,835

 

Other non-current liabilities

 

 

289,613

 

 

 

184,870

 

Total non-current liabilities

 

 

14,264,407

 

 

 

18,569,536

 

 

 

 

 

 

 

 

 

 

TOTAL LIABILITIES

 

 

22,262,805

 

 

 

23,952,764

 

 

 

 

 

 

 

 

 

 

EQUITY ATTRIBUTABLE TO STOCKHOLDERS OF THE COMPANY

 

 

 

 

 

 

 

 

Ordinary shares

 

 

51,627,219

 

 

 

61,366,844

 

Capital surplus

 

 

111,459,672

 

 

 

116,495,710

 

Accumulated deficits

 

 

(132,468,858)

 

 

 

(179,484,825)

 

Other reserves

 

 

-

 

 

 

(55,084)

 

Total equity attributable to stockholders of the Company

 

 

30,618,033

 

 

 

(1,677,355)

 

 

 

 

 

 

 

 

 

 

NON-CONTROLLING INTERESTS

 

 

-

 

 

 

1,074,081

 

 

 

 

 

 

 

 

 

 

Total equity

 

 

30,618,033

 

 

 

(603,274)

 

 

 

 

 

 

 

 

 

 

TOTAL LIABILITIES AND EQUITY

 

$

52,880,838

 

 

$

23,349,490

 

 

 

 

ASLAN Pharmaceuticals Limited

Consolidated statements of comprehensive income(loss)1
(in U.S. dollars, audited)

 

 

 

Three Months Ended December 31

 

 

Twelve Months Ended December 31

 

 

 

2018

 

 

2019

 

 

2018

 

 

2019

 

NET REVENUE

 

$

-

 

 

$

-

 

 

$

-

 

 

$

3,000,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

COST OF REVENUE

 

 

-

 

 

 

(17,741)

 

 

 

 

 

 

 

(407,259)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GROSS PROFIT

 

 

-

 

 

 

(17,741)

 

 

 

-

 

 

 

2,592,741

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

General and administrative expenses

 

 

(1,900,675)

 

 

 

(3,258,197)

 

 

 

(10,513,707)

 

 

 

(8,511,699)

 

Research and development expenses

 

 

(9,203,972)

 

 

 

(2,702,625)

 

 

 

(31,834,364)

 

 

 

(16,586,617)

 

Total operating expenses

 

 

(11,104,647)

 

 

 

(5,960,822)

 

 

 

(42,348,071)

 

 

 

(25,098,316)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

OTHER OPERATING INCOME AND EXPENSES

 

 

-

 

 

 

(23,073,400)

 

 

 

-

 

 

 

(23,073,400)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

LOSS FROM OPERATIONS

 

 

(11,104,647)

 

 

 

(29,016,481)

 

 

 

(42,348,071)

 

 

 

(45,578,975)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NON-OPERATING INCOME AND EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

28,636

 

 

 

6,193

 

 

 

268,330

 

 

 

150,610

 

Other income

 

 

-

 

 

 

-

 

 

 

187,244

 

 

 

-

 

Other gains and losses

 

 

42,708

 

 

 

289,268

 

 

 

213,243

 

 

 

(327,558)

 

Finance costs

 

 

(158,537)

 

 

 

(293,110)

 

 

 

(491,904)

 

 

 

(901,612)

 

Total non-operating income and expenses

 

 

(87,193)

 

 

 

(576,185)

 

 

 

176,913

 

 

 

(1,078,560)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

LOSS BEFORE INCOME TAX

 

 

(11,191,840)

 

 

 

(29,592,666)

 

 

 

(42,171,158)

 

 

 

(46,657,535)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

INCOME TAX EXPENSE

 

 

-

 

 

 

(12,712)

 

 

 

(14,439)

 

 

 

(408,002)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET LOSS FOR THE YEAR

 

 

(11,191,840)

 

 

 

(29,605,378)

 

 

 

(42,185,597)

 

 

 

(47,065,537)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

-

 

 

 

(46,038)

 

 

 

-

 

 

 

(55,084)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

TOTAL COMPREHENSIVE LOSS FOR THE YEAR

 

$

(11,191,840)

 

 

$

(29,651,416)

 

 

$

(42,185,597)

 

 

$

(47,120,621)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET LOSS ATTRIBUTABLE TO:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders of the Company

 

 

(11,191,840)

 

 

 

(29,555,808)

 

 

 

(42,185,597)

 

 

 

(47,015,967)

 

Non-controlling interests

 

 

-

 

 

 

(49,570)

 

 

 

-

 

 

 

(49,570)

 

 

 

$

(11,191,840)

 

 

$

(29,605,378)

 

 

$

(42,185,597)

 

 

$

(47,065,537)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

TOTAL COMPREHENSIVE LOSS ATTRIBUTABLE TO:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders of the Company

 

$

(11,191,840)

 

 

$

(29,601,846)

 

 

$

(42,185,597)

 

 

$

(47,071,051)

 

Non-controlling interests

 

 

-

 

 

 

(49,570)

 

 

 

-

 

 

 

(49,570)

 

 

 

$

(11,191,840)

 

 

$

(29,651,416)

 

 

$

(42,185,597)

 

 

 

(47,120,621)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

LOSS PER SHARE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.07)

 

 

$

(0.18)

 

 

$

(0.28)

 

 

$

(0.29)

 

Weighed-avg. Outstanding Shares (in thousand)

 

 

160,249

 

 

 

168,754

 

 

 

149,739

 

 

 

162,392

 

1 Financial statements in US dollars are prepared by the company and are audited by certified public accountant as of 31 Dec 2019.

Ends

 

Media and IR contacts

 

 

Emma Thompson Spurwing Communications Tel: +65 6751 2021

Email: ASLAN@spurwingcomms.com

 

 

 

 

About ASLAN Pharmaceuticals

ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497) is a clinical-stage immunology and oncology 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 a small molecule inhibitor targeting oncology. ASLAN’s partners include Almirall, Array BioPharma, Bristol-Myers Squibb, and CSL. 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, the Company’s plans to develop and commercialise its product candidates, the safety and efficacy of the Company’s product candidates, the Company’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for the Company’s product candidates. 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 these risks and uncertainties, which include, without limitation the risk factors described in the Company’s US Securities and Exchange Commission filings and reports (Commission File No. 001-38475), including the Company’s prospectus dated May 8, 2018 filed with the US Securities and Exchange Commission on such date.  

 

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.