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
OfficerStructure Therapeutics Inc.ir@structuretx.com
Media:Dan Budwick1ABDan@1abmedia.com
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