Structure Therapeutics Reports Third Quarter 2023 Financial Results and Recent Highlights
15 November 2023 - 8:10AM
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 third quarter ended September
30, 2023, and highlighted recent corporate achievements.
“Our recent Phase 1b data support the potential of GSBR-1290 as
a promising, differentiated oral GLP-1 receptor agonist with
once-daily dosing,” said Raymond Stevens, Ph.D., Founder and CEO of
Structure Therapeutics. “Following the completion of our recent
$300 million equity financing in October, we believe we are well
positioned to advance and accelerate the development of GSBR-1290
as well as our entire oral incretin franchise.”
Recent Highlights and Upcoming Milestones
GSBR-1290 for Type 2 Diabetes Mellitus (T2DM) and
Obesity
- The Company reported topline data from the 28-day Phase 1b
multiple ascending dose (MAD) study in September 2023. GSBR-1290
demonstrated significant weight loss of up to 4.9%
(placebo-adjusted) supporting once-daily dosing, and an encouraging
safety profile with no adverse event-related discontinuations.
- The Company expects to report topline data from the type 2
diabetes (T2DM) cohort of the Phase 2a study in December 2023,
along with results from the Japanese ethno-bridging study of
GSBR-1290.
- Topline data from the obesity cohort of the Phase 2a study are
expected in the first half of 2024.
- The Company plans to initiate global Phase 2b studies in T2DM
and obesity in the second half of 2024. In preparation for these
studies, Structure has initiated a formulation bridging study to
evaluate a tablet formulation of GSBR-1290.
Next-generation combination GLP-1R
candidates
- The Company continues to develop next generation combination
GLP‑1R candidates, including dual GLP‑1R/GIPR agonists and amylin
receptor agonists, each designed with customized properties to
achieve additional benefits. Development candidates for each
program are expected to be selected in 2024.
Corporate
- In October 2023, Structure completed a private placement equity
financing, raising approximately $300 million in gross proceeds
before deducting placement agent fees and other private placement
expenses.
Third Quarter 2023 Financial Highlights
Cash Position: Cash, cash equivalents and
short-term investments totaled $205.4 million at September 30,
2023. The Company expects its current cash, cash equivalents and
short-term investment, together with the $300 million in gross
proceeds from the financing completed in October 2023, to fund
operations and expected key clinical milestones through at least
2026.
R&D Expenses: Research and development
expenses were $17.5 million for the quarter ended September 30,
2023, as compared to $9.2 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, clinical study
activities and increases related to employee expenses, primarily
due to an increase in personnel.
G&A Expenses: General and administrative
expenses were $8.6 million for the quarter ended September 30,
2023, as compared to $3.5 million for the same period in 2022. The
increase was primarily due to increases in professional services
associated with employee related expenses as the Company expanded
its infrastructure to drive and support the growth in its
operations as a publicly-traded company.
Net Loss: Net loss totaled $23.9 million for
the quarter ended September 30, 2023, with non-cash stock-based
compensation expense of $1.9 million, compared to $12.4 million for
the same period in 2022 with non-cash stock-based compensation
expense of $0.6 million.
About Structure TherapeuticsStructure
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 interim unaudited condensed consolidated financial
statements, future plans and prospects, expected cash runway and
the Company’s ability to fund development activities and achieve
development goals and key clinical milestones; the clinical data
from Structure’s Phase 1b MAD study of GSBR-1290, the clinical
update from Structure’s Phase 2a study of GSBR-1290 in patients
with T2DM and obesity, any expectations regarding the safety,
efficacy or tolerability of GSBR-1290 and other candidates under
development, the ability of GSBR-1290 to treat T2DM, obesity or
related indications, the planned initiation and study design of
Structure’s Phase 2b studies for GSBR-1290 in patients with T2DM
and obesity and the timing thereof; the planned timing of the
Company’s 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, finalization of review of the Company’s interim
unaudited condensed consolidated financial statements, including
for the three months ended September 30, 2022, risks and
uncertainties related to the preliminary nature of the results due
to length of the study and sample size, the risks that unblinded
data is not consistent with blinded data, 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 impact of any data
collection omissions at any of our clinical sites, 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 August 10, 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 |
|
NINE MONTHS
ENDED |
|
SEPTEMBER 30, |
|
SEPTEMBER 30, |
|
|
2023 |
|
|
2022 |
|
|
|
2023 |
|
|
2022 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
17,515 |
|
|
$ |
9,160 |
|
|
$ |
50,061 |
|
|
$ |
27,833 |
|
General and administrative |
|
8,630 |
|
|
|
3,533 |
|
|
|
21,720 |
|
|
|
11,772 |
|
Total
operating expenses |
|
26,145 |
|
|
|
12,693 |
|
|
|
71,781 |
|
|
|
39,605 |
|
Loss from
operations |
|
(26,145 |
) |
|
|
(12,693 |
) |
|
|
(71,781 |
) |
|
|
(39,605 |
) |
Interest and
other income (expense), net |
|
2,688 |
|
|
|
349 |
|
|
|
7,212 |
|
|
|
356 |
|
Loss before
provision for income taxes |
|
(23,457 |
) |
|
|
(12,344 |
) |
|
|
(64,569 |
) |
|
|
(39,249 |
) |
Provision
for income taxes |
|
405 |
|
|
|
73 |
|
|
|
548 |
|
|
|
197 |
|
Net
loss |
|
(23,862 |
) |
|
|
(12,417 |
) |
|
|
(65,117 |
) |
|
|
(39,446 |
) |
Less: Accretion of redeemable convertible preferred shares to their
redemption value |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(1,515 |
) |
Net loss
attributable to ordinary shareholders |
$ |
(23,862 |
) |
|
$ |
(12,417 |
) |
|
$ |
(65,117 |
) |
|
$ |
(40,961 |
) |
Net loss per
share attributable to ordinary shareholders, basic and diluted |
$ |
(0.21 |
) |
|
$ |
(1.27 |
) |
|
$ |
(0.65 |
) |
|
$ |
(4.34 |
) |
Weighted-average ordinary shares used in computing net loss per
share attributable to ordinary shareholders, basic and diluted |
|
114,948 |
|
|
|
9,780 |
|
|
|
100,613 |
|
|
|
9,428 |
|
|
|
|
|
|
|
|
|
|
|
|
|
STRUCTURE THERAPEUTICS INC.Condensed
Consolidated Balance Sheet Data(unaudited)(In
thousands) |
|
|
|
|
|
|
|
SEPTEMBER 30, |
|
DECEMBER 31, |
|
2023 |
|
2022 |
Assets |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash, cash equivalents and short-term investments |
$ |
205,424 |
|
$ |
90,841 |
Prepaid expenses and other current assets |
|
4,535 |
|
|
2,248 |
Total current assets |
|
209,959 |
|
|
93,089 |
Property and equipment, net |
|
2,408 |
|
|
1,031 |
Operating right-of-use assets |
|
3,653 |
|
|
262 |
Other non-current assets |
|
350 |
|
|
3,463 |
Total assets |
$ |
216,370 |
|
$ |
97,845 |
Liabilities, redeemable convertible preferred shares and
shareholders’ equity (deficit) |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts payable |
$ |
3,319 |
|
$ |
6,009 |
Accrued expenses and other current liabilities |
|
15,955 |
|
|
6,741 |
Operating lease liabilities, current portion |
|
817 |
|
|
260 |
Total current liabilities |
|
20,091 |
|
|
13,010 |
Operating lease liabilities, net of current portion |
|
3,034 |
|
|
— |
Other non-current liabilities |
|
281 |
|
|
— |
Total liabilities |
|
23,406 |
|
|
13,010 |
Redeemable convertible preferred shares issuable
in series |
|
— |
|
|
199,975 |
Total shareholders’ equity (deficit) |
|
192,964 |
|
|
(115,140 |
Total liabilities, redeemable convertible preferred shares and
shareholders’ equity (deficit) |
$ |
216,370 |
|
$ |
97,845 |
|
|
|
|
|
|
Investors:Danielle
KeatleyStructure Therapeutics Inc.ir@structuretx.com
Media:Dan Budwick1ABDan@1abmedia.com
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