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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* |
|
True |
|
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.
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
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Structure Therapeutics (NASDAQ:GPCR)
Historical Stock Chart
From May 2024 to Jun 2024
Structure Therapeutics (NASDAQ:GPCR)
Historical Stock Chart
From Jun 2023 to Jun 2024