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Form 6-K ASLAN Pharmaceuticals For: Jun 30

August 12, 2022 6:54 AM EDT

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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
August 12, 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 organization)
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 Second Quarter 2022 Financial Results and Corporate Update
On August 12, 2022, ASLAN Pharmaceuticals Limited (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended June 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.
Financial Statements
On August 12, 2022, the Company issued its condensed consolidated financial statements for the six months ended June 30, 2022 (the “Financial Statements”).
A copy of the Financial Statements is attached hereto as Exhibit 99.2 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).
Forward Looking Statements
This Form
6-K
contains forward-looking statements. These statements are based on the current beliefs and expectations of the management of 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
farudodsta
; the safety and efficacy of
eblasakimab
and
farudodstat
; the potential of
eblasakimab
as a
first-in-class
treatment for atopic dermatitis and of
farudodstat
as 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 these risks and uncertainties, which include, without limitation the risk factors described in the Company’s U.S. Securities and Exchange Commission (the “SEC”) filings and reports (Commission File
No. 001-38475),
including the Company’s Annual Report on Form
20-F
filed with the SEC 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.
Exhibits
 
Exhibit
Number
  
Exhibit Description
99.1
  
99.2
  
101.INS
  
XBRL Instance Document
101.SCH
  
XBRL Taxonomy Extension Schema Document
101.CAL
  
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
  
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
  
XBRL Taxonomy Extension Label Linkbase Document
101.PRE
  
XBRL Taxonomy Extension Presentation Linkbase Document
104
  
Cover Page Interactive Data File (embedded within the Inline XBRL document).

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: August 12, 2022

Exhibit 99.1

 

LOGO

PRESS RELEASE

 

 

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

 

  -

Company maintains healthy operating position with US$78.1 million in cash, cash equivalents and short-term investments as of June 30, 2022, runway through late 2023

 

  -

Three abstracts showcasing new findings related to eblasakimab have been accepted as e-posters at the 31st European Academy of Dermatology and Venereology (EADV) Annual Congress, from September 7 to 10, 2022, in Milan, Italy

 

  -

The Phase 2b TREK-AD trial for eblasakimab in moderate-to-severe AD is on track to generate topline data in the first half of 2023

 

  -

Company to host R&D Day; details will follow closer to the date of September 15, 2022

California and Singapore, August 12, 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 second quarter ended June 30, 2022, and provided an update on recent corporate activities.

“This quarter, we advanced our understanding of eblasakimab’s differentiated profile and its role in reducing pruritic neuronal responses – which remains one of the most burdensome symptoms for AD patients – with late-breaking data presented at the Society for Investigative Dermatology meeting,” stated Dr Carl Firth, CEO, ASLAN Pharmaceuticals. “These insights, and those that we are building with the initiation of new research collaborations related to eblasakimab’s unique mechanism of action, contribute key data on the distinct biological effects of eblasakimab’s selective targeting of the Type 2 receptor and its differentiation from current standard-of-care therapies. We look forward to sharing new insights on eblasakimab at the upcoming EADV Annual Congress in September as we continue to progress the TREK-AD trial of eblasakimab in moderate-severe AD and remain on track for a topline data readout from the trial in the first half of 2023.”

Second quarter 2022 and recent business highlights

Eblasakimab

 

   

In May, the Company presented new, late-breaking data on insights related to neuronal itch mechanisms through eblasakimab’s targeting of IL-13Ra1 at the Society for Investigative Dermatology (SID) Annual Meeting. The findings demonstrated that eblasakimab significantly reduced cytokine-enhanced neuronal responses to IL-4 and IL-13-driven itch by more than 40% versus control conditions (p=0.0001), and suggest eblasakimab’s unique mechanism of blocking IL-13Ra1 could provide a molecular basis for the significant reduction of pruritis scores observed in eblasakimab-treated moderate-to-severe AD patients in the Phase 1b clinical trial. Further data from the translational studies will be shared in the second half of 2022.

 

   

In June, the Company initiated a scientific collaboration with Dr Shawn Kwatra from Johns Hopkins University School of Medicine and Dr Madan Kwatra from Duke University Medical Center to explore the distinct role of IL-13 receptor signaling in AD. The collaboration is evaluating how IL-13Ra1-mediated allergic, inflammatory and regulatory pathways are affected by eblasakimab’s selective targeting of the Type 2 receptor. Research findings will be disclosed for presentation during the second half of 2022.


LOGO

 

   

In June, the Company hosted the third episode in its series of Key Opinion Leader (KOL) webinars, the “A4 (Aspects of Atopic Dermatitis and ASLAN004/eblasakimab) Series: ‘Dialogues with International Thought Leaders in Dermatology’”. Peter Lio MD, Clinical Assistant Professor of Dermatology and Pediatrics at Northwestern University, discussed the limitations of the current treatment landscape in AD and the resulting unmet medical needs in patients who do not respond optimally to current standards of care. All three webinar episodes from the A4 series are available for replay here.

Farudodstat (ASLAN003)

 

   

In June, based on emerging clinical data for DHODH inhibitors in inflammatory bowel disease, the Company decided to prioritize the further development of farudodstat in autoimmune skin diseases. A clinical development plan is being finalized and a Phase 2 trial is expected to commence in the first half of 2023.

Anticipated upcoming milestones

 

   

Three abstracts with new data on biomarkers and patient reported outcome measures from the Phase 1b proof-of-concept trial of eblasakimab have been accepted for e-poster presentation at the 31st EADV Annual Congress held in person and virtually, from September 7 to 10, 2022, in Milan, Italy.

 

   

The Company will host a Research and Development (R&D) Day on September 15, 2022, with a hybrid in-person and virtual format. More information will be announced in the weeks ahead.

 

   

Topline data from the Phase 2b TREK-AD trial of eblasakimab is expected in the first half of 2023.

Second quarter 2022 financial highlights

 

   

Cash used in operating activities for the second quarter of 2022 was US$9.7 million compared to US$6.9 million in the same period in 2021.

 

   

Cash, cash equivalents and short-term investments as of June 30, 2022, were US$78.1 million.

 

   

Research and development expenses were US$10.0 million in the second quarter of 2022 compared to US$4.0 million in the second quarter of 2021. The increase was due to clinical development expenses and manufacturing costs related to eblasakimab TREK-AD Phase 2b trial.

 

   

General and administrative expenses were US$2.3 million in the second quarter of 2022 compared to US$3.8 million in the second quarter of 2021.

 

   

Net loss attributable to stockholders for the second quarter of 2022 was US$13.0 million compared to a net loss of US$5.4 million for the second quarter of 2021.

 

   

The weighted average number of American Depositary Shares (ADS) outstanding in the computation of basic loss per share for the second quarter of 2022 was 69.7 million (representing 348.7 million ordinary shares) compared to 69.6 million (representing 347.8 million ordinary shares) for the second quarter of 2021. One ADS is the equivalent of five ordinary shares.


LOGO

ASLAN Pharmaceuticals Limited

CONSOLIDATED BALANCE SHEETS

(In US Dollars)

 

    

December 31, 2021

(audited)

   

June 30, 2022

(audit reviewed)

 

ASSETS

    

CURRENT ASSETS

    

Cash and cash equivalents

   $ 90,167,967     $ 61,576,463  

Short-term investments

     —         16,543,352  
  

 

 

   

 

 

 

Total cash, cash equivalents, and short-term investments

     90,167,967       78,119,815  
  

 

 

   

 

 

 

Other assets

     3,612,846       2,244,246  
  

 

 

   

 

 

 

Total current assets

   $ 93,780,813     $ 80,364,061  
  

 

 

   

 

 

 

NON-CURRENT ASSETS

    

Investment in associate company

     494,728       132,247  

Property, plant and equipment

     34,979       44,596  

Right-of-use assets

     197,746       65,344  

Intangible assets

     9,956       7,896  
  

 

 

   

 

 

 

Total non-current assets

     737,409       250,083  
  

 

 

   

 

 

 

TOTAL ASSETS

   $ 94,518,222     $ 80,614,144  
  

 

 

   

 

 

 

LIABILITIES AND EQUITY

    

CURRENT LIABILITIES

    

Trade payables

   $ 3,116,786     $ 9,442,905  

Other payables

     2,817,909       1,913,020  

Lease liabilities - current

     199,124       50,117  

Financial liabilities at fair value through profit or loss

     223,352       119,351  
  

 

 

   

 

 

 

Total current liabilities

     6,357,171       11,525,393  
  

 

 

   

 

 

 

NON-CURRENT LIABILITIES

    

Long-term borrowings

     30,857,308       36,420,039  
  

 

 

   

 

 

 

Total non-current liabilities

     30,857,308       36,420,039  
  

 

 

   

 

 

 

Total liabilities

     37,214,479       47,945,432  
  

 

 

   

 

 

 

EQUITY ATTRIBUTABLE TO STOCKHOLDERS OF THE COMPANY

    

Ordinary shares

     63,019,962       63,019,962  

Capital surplus

     221,467,061       222,803,698  

Accumulated deficits

     (227,004,332     (252,976,000

Other reserves

     (178,948     (178,948
  

 

 

   

 

 

 

Total equity attributable to stockholders of the Company

     57,303,743       32,668,712  
  

 

 

   

 

 

 

Total equity

     57,303,743       32,668,712  
  

 

 

   

 

 

 

TOTAL LIABILITIES AND EQUITY

   $ 94,518,222     $ 80,614,144  
  

 

 

   

 

 

 


LOGO

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  
     2021     2022     2021     2022  

OPERATING EXPENSES

        

General and administrative expenses

   $ (3,788,772   $ (2,319,516   $ (6,893,836   $ (4,855,050

Research and development expenses

     (4,044,521     (9,980,936     (7,795,493     (19,339,046
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     (7,833,293     (12,300,453     (14,689,329     (24,194,095
  

 

 

   

 

 

   

 

 

   

 

 

 

LOSS FROM OPERATIONS

     (7,833,293     (12,300,453     (14,689,329     (24,194,095
  

 

 

   

 

 

   

 

 

   

 

 

 

NON-OPERATING INCOME AND EXPENSES

        

Other income

     340,076       37,420       340,076       156,749  

Interest income

     20       41,373       157       43,797  

Gain on dilution of subsidiary and recognition of associate

     2,307,735       —         2,307,735       —    

Impairment loss of associate accounted for using equity method

     —         (50,109     —         (50,109

Other gains and losses

     22,451       268,059       319,636       344,683  

Finance costs

     (203,428     (877,300     (614,902     (1,960,321
  

 

 

   

 

 

   

 

 

   

 

 

 

Total non-operating income and expenses

     2,466,854       (580,557     2,352,702       (1,465,201
  

 

 

   

 

 

   

 

 

   

 

 

 

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

     (81,880     (153,871     (81,880     (312,372

LOSS BEFORE INCOME TAX

     (5,448,319     (13,034,881     (12,418,507     (25,971,668

INCOME TAX EXPENSE

     —         —         —         —    
  

 

 

   

 

 

   

 

 

   

 

 

 

NET LOSS FOR THE PERIOD

     (5,448,319     (13,034,881     (12,418,507     (25,971,668
  

 

 

   

 

 

   

 

 

   

 

 

 

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

     —         —         —         —    
  

 

 

   

 

 

   

 

 

   

 

 

 

TOTAL COMPREHENSIVE LOSS FOR THE PERIOD

   $ (5,448,319   $ (13,034,881   $ (12,418,507   $ (25,971,668
  

 

 

   

 

 

   

 

 

   

 

 

 

NET LOSS ATTRIBUTABLE TO:

        

Stockholders of the Company

   $ (5,429,026   $ (13,034,881   $ (12,149,543   $ (25,971,668

Non-controlling interests

     (19,293     —         (268,964     —    
  

 

 

   

 

 

   

 

 

   

 

 

 
   $ (5,448,319   $ (13,034,881   $ (12,418,507   $ (25,971,668
  

 

 

   

 

 

   

 

 

   

 

 

 

TOTAL COMPREHENSIVE LOSS ATTRIBUTABLE TO:

        

Stockholders of the Company

   $ (5,429,026   $ (13,034,881   $ (12,149,543   $ (25,971,668

Non-controlling interests

     (19,293     —         (268,964     —    
  

 

 

   

 

 

   

 

 

   

 

 

 
   $ (5,448,319   $ (13,034,881   $ (12,418,507   $ (25,971,668
  

 

 

   

 

 

   

 

 

   

 

 

 

LOSS PER ORDINARY SHARE

        

Basic and diluted

   $ (0.02   $ (0.04   $ (0.04   $ (0.07
  

 

 

   

 

 

   

 

 

   

 

 

 

LOSS PER EQUIVALENT ADS

        

Basic and diluted

   $ (0.08   $ (0.19   $ (0.20   $ (0.35
  

 

 

   

 

 

   

 

 

   

 

 

 

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

     347,799,933       348,723,365       302,985,377       348,723,365  

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

     69,559,987       69,744,673       60,597,075       69,744,673  

Each ADS represents five ordinary shares


LOGO

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 (also known as ASLAN004), a potential first-in-class antibody targeting the IL-13 receptor, in atopic dermatitis, and farudodstat (also known as ASLAN003), 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 and farudodstat; the potential of eblasakimab as a first-in-class treatment for atopic dermatitis and of farudodstat as 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: [email protected]

  

Ashley R. Robinson

LifeSci Advisors, LLC

Tel: +1 (617) 430-7577

Email: [email protected]



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