0001888886 false True 0001888886 2023-08-10 2023-08-10 0001888886 gpcr:AmericanDepositarySharesAdssEachRepresentingThreeOrdinarySharesParValue0.0001PerOrdinaryShareMember 2023-08-10 2023-08-10 0001888886 gpcr:OrdinarySharesParValue0.0001PerShareMember 2023-08-10 2023-08-10 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 8-K

 

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): August 10, 2023

 

 

 

Structure Therapeutics Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Cayman Islands   001-41608   98-1480821

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

611 Gateway Blvd., Suite 223

South San Francisco, California

  94080
(Address of principal executive offices)   (Zip Code)

 

(Registrant’s telephone number, including area code): (628) 229-9277

 

Not Applicable

(Former name or former address, if changed since last report)

 

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) 

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) 

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) 

 

Securities registered pursuant to Section 12(b) of the Act:

 

    Name Of Each Exchange    
Title of Each Class   Trading Symbol(s)   On Which Registered
American Depositary Shares (ADSs), each representing three ordinary shares, par value $0.0001 per ordinary share   GPCR   Nasdaq Global Market
         
Ordinary shares, par value $0.0001 per share*     Nasdaq Global Market*

 

* Not for trading, but only in connection with the registration of the American Depositary Shares

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company x

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

 

Item 2.02 Results of Operations and Financial Condition.

 

On August 10, 2023, Structure Therapeutics Inc. (the “Company”) issued a press release providing a corporate update and announcing its financial results for the second quarter ended June 30, 2023. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

The information in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit
No.
  Description
     
99.1   Press Release dated August 10, 2023
     
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 hereunto duly authorized.

 

  Structure Therapeutics Inc.
   
Date: August 10, 2023 By: /s/ Raymond Stevens
    Raymond Stevens, Ph.D.
    Chief Executive Officer

 

 

 

 

Exhibit 99.1

 

Structure Therapeutics Reports Second Quarter 2023 Financial Results

and Recent Highlights

 

Completed enrollment in 12-week Phase 2a study of oral GLP-1 receptor agonist, GSBR-1290

 

Topline data from Phase 2a and Phase 1b multiple ascending dose study of GSBR-1290 expected in latter half of fourth quarter 2023

 

SAN FRANCISCO – August 10, 2023 – Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic and cardiopulmonary diseases, today reported financial results for the second quarter June 30, 2023, and highlighted recent corporate achievements.

 

“We have continued our momentum and are on track to report topline data from our fully-enrolled Phase 2a study of GSBR-1290 in individuals living with Type 2 diabetes or obesity toward the end of the year,” said Raymond Stevens, Ph.D., Founder and CEO of Structure Therapeutics. “With the recent announcement of Dr. Ted Love joining our Board, key milestones ahead and our strong cash runway, we believe we are well-positioned to execute on building our oral incretin franchise and have begun activities to prepare for a global Phase 2b study of GSBR-1290 in 2024.”

 

Recent Highlights and Upcoming Milestones

 

GSBR-1290 for Type 2 Diabetes Mellitus (T2DM) and Obesity: Completed patient enrollment in the Phase 1b multiple-ascending dose (MAD), Phase 2a, and Japanese ethnobridging studies. Topline data are expected to be announced in latter half of fourth quarter 2023.

 

·Structure Therapeutics presented data from the Phase 1 single ascending dose clinical study and preclinical data of GSBR-1290 at the 2023 American Diabetes Association (ADA) Annual Meeting in June 2023.

 

·The Company recently completed enrollment in the Phase 2a study of GSBR-1290, enrolling 94 adult participants, including 40 individuals who are overweight or obese and otherwise healthy and 54 individuals who are overweight or obese with T2DM. The study evaluates the efficacy, safety, tolerability, and pharmacokinetics (PK) of GSBR-1290 over twelve weeks.

 

 

 

 

·The Company recently completed enrollment of the ethnobridging study of GSBR-1290. Twelve healthy adult Japanese participants, randomized 3:1 to GSBR-1290 or placebo, and six healthy non-Japanese participants were enrolled to evaluate the safety, tolerability, and PK of single and multiple doses of GSBR-1290 over four weeks.

 

·The Company is also planning to initiate a formulation bridging study to evaluate a tablet formulation of GSBR-1290 before the end of 2023 and has begun a wide range of other enabling activities in preparation for the planned global Phase 2b study in 2024.

 

Next-generation combination GLP-1R candidates

 

·Beyond GSBR-1290, the Company continues to develop next generation combination GLP-1R candidates, including dual GLP-1R/GIPR agonists and amylin agonists, each designed with customized properties to achieve additional benefits.

 

ANPA-0073 and LTSE-2578 for Cardiopulmonary Diseases

 

·The Company presented scientific posters of the discovery and Phase 1 clinical data of ANPA-0073, an oral small molecule agonist of the apelin/APJ receptor and the structure-based drug discovery of LTSE-1578, an oral small molecule antagonist of the LPAR1 receptor for pulmonary diseases at the 2023 American Thoracic Society (ATS) International Conference in May 2023.

 

Corporate

 

·Structure Therapeutics recently announced the appointment of Ted W. Love, M.D. to its Board of Directors. Dr. Love brings more than 30 years of experience in the biopharmaceuticals industry and currently chairs the Biotechnology Innovation Organization (BIO) Board.

 

Second Quarter 2023 Financial Highlights

 

Cash Position: Cash, cash equivalents and short-term investments totaled $224.6 million at June 30, 2023. The Company expects its current cash, cash equivalents and short-term investments to fund operations through expected key clinical milestones through at least 2025.

 

R&D Expenses: Research and development expenses were $19.4 million for the quarter ended June 30, 2023, as compared to $10.2 million for the same period in 2022. The increase was primarily due to the advancement of the Company’s GLP-1R franchise and other research programs, and increases related to personnel expenses primarily due to an increase in personnel.

 

 

 

 

G&A Expenses: General and administrative expenses were $6.6 million for the quarter ended June 30, 2023, as compared to $3.8 million for the same period in 2022. The increase was primarily due to increases in professional service fees associated with operating as a publicly-traded company, and increases related to personnel expenses primarily due to an increase in personnel and stock-based compensation.

 

Net Loss: Net loss totaled $23.3 million for the quarter ended June 30, 2023, with non-cash stock-based compensation expense of $1.7 million, compared to $15.5 million for the same period in 2022 with non-cash stock-based compensation expense of $0.6 million.

 

About Structure Therapeutics

 

Structure Therapeutics is a leading clinical-stage biopharmaceutical company focused on discovering and developing innovative oral treatments for chronic metabolic and cardiopulmonary conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, the company has established a scientifically-driven, GPCR-targeted pipeline, featuring two wholly-owned proprietary clinical-stage small molecule compounds designed to surpass the limitations of traditional biologic and peptide therapies and be accessible to more patients around the world. For additional information, please visit www.structuretx.com.

 

Forward Looking Statements

 

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning the Company’s future plans and prospects, the Company’s anticipated cash runway, any expectations regarding the safety or efficacy of GSBR-1290 and other candidates under development, the ability of GSBR-1290 to treat type 2 diabetes, obesity or related indications, plans with respect to regulatory submissions, the planned timing of the Company’s clinical trials, data results and continued development of GSBR-1290 and next generation combination GLP-1R candidates and expectations regarding an oral development candidate targeting GLP-1R. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to the Company’s ability to advance GSBR-1290, LTSE-2578, ANPA-0073 and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the Company’s therapeutic candidates, the timing and results of preclinical and clinical trials, the Company’s ability to fund development activities and achieve development goals, the impact of any global pandemics, inflation, supply chain issues, rising interest rates and future bank failures on the Company’s business, its ability to protect its intellectual property and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K filed with the SEC on March 30, 2023, Quarterly Report on Form 10-Q filed with the SEC on May 11, 2023, and future reports the Company may file with the SEC from time to time. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

 

 

 

  

STRUCTURE THERAPEUTICS INC.

Condensed Consolidated Statements of Operations

(unaudited)

(In thousands, except per share amounts)

   

   THREE MONTHS ENDED   SIX MONTHS ENDED 
   JUNE 30,   JUNE 30, 
   2023   2022   2023   2022 
Operating expenses:                    
Research and development  $19,411   $10,181   $32,546   $18,673 
General and administrative   6,576    3,779    13,090    8,239 
Total operating expenses   25,987    13,960    45,636    26,912 
Loss from operations   (25,987)   (13,960)   (45,636)   (26,912)
Interest and other income (expense), net   2,825    76    4,524    7 
Loss before provision for income taxes   (23,162)   (13,884)   (41,112)   (26,905)
Provision for income taxes   118    64    143    124 
Net loss   (23,280)   (13,948)   (41,255)   (27,029)
Less: Accretion of redeemable convertible preferred shares to their redemption value       (1,515)       (1,515)
Net loss attributable to ordinary shareholders  $(23,280)  $(15,463)  $(41,255)  $(28,544)
Net loss per share attributable to ordinary shareholders, basic and diluted  $(0.20)  $(1.64)  $(0.44)  $(3.09)
Weighted-average ordinary shares used in computing net loss per share attributable to ordinary shareholders, basic and diluted   114,759    9,435    93,325    9,250 

 

 

 

 

STRUCTURE THERAPEUTICS INC.

Condensed Consolidated Balance Sheet Data

(unaudited)

(In thousands)

  

   JUNE 30,   DECEMBER 31, 
   2023   2022 
Assets          
Current assets:          
Cash, cash equivalents and short-term investments  $224,587   $90,841 
Prepaid expenses and other current assets   3,635    2,248 
Total current assets   228,222    93,089 
Property and equipment, net   1,078    1,031 
Operating right-of-use assets   90    262 
Other non-current assets   38    3,463 
Total assets  $229,428   $97,845 
Liabilities, redeemable convertible preferred shares and shareholders’ equity (deficit)          
Current liabilities:          
Accounts payable  $5,699   $6,009 
Accrued expenses and other current liabilities   9,241    6,741 
Operating lease liabilities, current portion   73    260 
Total current liabilities   15,013    13,010 
Total liabilities   15,013    13,010 
Redeemable convertible preferred shares issuable in series       199,975 
Total shareholders’ equity (deficit)   214,415    (115,140)
Total liabilities, redeemable convertible preferred shares and shareholders’ equity (deficit)  $229,428   $97,845 

  

 

 

 

Investors:

Jun Yoon, Chief Financial Officer

Structure Therapeutics Inc.

ir@structuretx.com

 

Media:

Dan Budwick

1AB

Dan@1abmedia.com

 

 

 

v3.23.2
Cover
Aug. 10, 2023
Document Information [Line Items]  
Document Type 8-K
Amendment Flag false
Document Period End Date Aug. 10, 2023
Entity File Number 001-41608
Entity Registrant Name Structure Therapeutics Inc.
Entity Central Index Key 0001888886
Entity Tax Identification Number 98-1480821
Entity Incorporation, State or Country Code E9
Entity Address, Address Line One 611 Gateway Blvd.
Entity Address, Address Line Two Suite 223
Entity Address, City or Town South San Francisco
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94080
City Area Code 628
Local Phone Number 229-9277
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity Emerging Growth Company true
Elected Not To Use the Extended Transition Period false
American Depositary Shares (ADSs), each representing three ordinary shares, par value $0.0001 per ordinary share  
Document Information [Line Items]  
Title of 12(b) Security American Depositary Shares (ADSs), each representing three ordinary shares, par value $0.0001 per ordinary share
Trading Symbol GPCR
Security Exchange Name NASDAQ
Ordinary shares, par value $0.0001 per share*  
Document Information [Line Items]  
Title of 12(b) Security Ordinary shares, par value $0.0001 per share*
No Trading Symbol Flag true
Security Exchange Name NASDAQ

Structure Therapeutics (NASDAQ:GPCR)
과거 데이터 주식 차트
부터 1월(1) 2024 으로 2월(2) 2024 Structure Therapeutics 차트를 더 보려면 여기를 클릭.
Structure Therapeutics (NASDAQ:GPCR)
과거 데이터 주식 차트
부터 3월(3) 2023 으로 2월(2) 2024 Structure Therapeutics 차트를 더 보려면 여기를 클릭.