Full Press Release Details
Structure Therapeutics Reports Fourth Quarter
and Full Year 2025 Financial Results and Recent Highlights
Positive results from the aleniglipron Phase
2 ACCESS programs in December 2025 demonstrated significant weight loss across all doses and up to 15.3% at 36 weeks
Topline 44-week data from the ACCESS II study
with higher doses expected in Q1 2026
Aleniglipron Phase 3 initiation expected in
Initial data from the ongoing Phase 1 study
of oral small molecule amylin receptor agonist ACCG-2671 and Phase 1 initiation of second oral amylin compound ACCG-3535 expected in 2H
Cash, cash equivalents and short-term investments
of $1.4 billion as of December 31, 2025, expected to provide cash runway through the end of 2028
SAN FRANCISCO, February 26, 2026- Structure Therapeutics
Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic
diseases, with a focus on obesity, today reported financial results for the fourth quarter and full year ended December 31, 2025, and
provided a business update.
"The obesity market is clearly embracing the introduction of
new oral treatment options and Structure Therapeutics is well positioned to capture market share in this important therapeutic area,"
said Raymond Stevens, Ph.D., CEO of Structure Therapeutics. "In 2025, we delivered positive Phase 2b 36-week data for aleniglipron
and advanced ACCG-2671 our first oral small molecule amylin receptor agonist into the clinic. We completed a $748 million financing providing
a strong financial balance sheet to continue advancing aleniglipron which has the potential to be best-in-class. Our broad portfolio positions
us well in the evolving landscape that we believe will favor more accessible oral small molecules, extended maintenance treatment periods,
and fixed dose combinations for specific patient populations and expanded indications. The upcoming 44-week data readout with higher doses
in ACCESS II, expected in the first quarter, will provide a more complete profile of aleniglipron as we prepare for Phase 3 this year,
with additional data readouts expected throughout 2026."
Recent and Upcoming Milestones
Aleniglipron - Oral Small Molecule Selective Glucagon-Like Peptide
1 (GLP-1) Receptor Agonist for the Treatment of Obesity and Overweight
As reported in December 2025, data from the aleniglipron clinical program
included 36-week data from the core Phase 2b ACCESS study and the exploratory ACCESS II study, as well as interim data from the Phase
2 body composition study and the Phase 2b ACCESS open label extension (OLE) study.
Data from the ACCESS, ACCESS II, Body Composition, and the ACCESS OLE
studies provide a strong foundation for the decision to advance aleniglipron into Phase 3 clinical development. The Company expects to
report topline results from the ACCESS II 44-week study in Q1 2026.
The Company has planned an End-of-Phase 2 meeting with the U.S. Food
and Drug Administration (FDA) to align on a Phase 3 registrational program with a starting titration dose of 2.5 mg and the intent to
evaluate multiple maintenance doses. The Company anticipates initiating the Phase 3 program in the second half of 2026.
Supplementary studies enhance competitive profile of aleniglipron:
Oral Small Molecule Amylin Receptor Agonists
Fourth Quarter and Full Year 2025 Financial Highlights
Cash Position: Cash, cash equivalents and short-term investments
totaled $1.4 billion as of December 31, 2025. The Company expects its current cash, cash equivalents and short-term investments to fund
projected operations and key clinical milestones through the end of 2028. This includes costs related to the ongoing aleniglipron ACCESS
OLE, ACCESS II extension study, the supplementary studies, and Phase 3 registrational program in chronic weight management, but excludes
additional costs related to pre-commercialization activities including commercial manufacturing.
Research and Development (R&D) Expenses: R&D expenses
for the fourth quarter of 2025 were $68.7 million, as compared to $33.5 million for the same period in 2024. For the year ended December
31, 2025, R&D expenses were $225.3 million, as compared to $108.8 million for the full year 2024. The increase in R&D expenses
was primarily due to increases related to clinical trial costs, preclinical research and development expenses and employee expenses (primarily
due to an increase in personnel) to support the advancement of our GLP-1R franchise including aleniglipron and a milestone payment under
our collaboration agreement.
General and Administrative (G&A) Expenses: G&A expenses
for the fourth quarter of 2025 were $17.6 million, as compared to $13.6 million for the same period in 2024. For the year ended December
31, 2025, G&A expenses were $61.6 million, as compared to $49.4 million for the full year 2024. The increase in G&A expenses
was primarily due to increases in employee expenses as we expanded our infrastructure to drive and support the growth in our operations.
Other license income: Other license income was $100.0 million for the
fourth quarter of 2025 and the year ended December 31, 2025, consisting of income from the license of certain patents that cover a class
of oral GLP-1 receptor agonists that is different from aleniglipron.
Gains on sale of non-financial assets: Gains on sale of non-financial
assets was $10.2 million for the fourth quarter of 2025 and the year ended December 31, 2025, consisting of the sale of certain early-stage
non-metabolic and non-obesity assets.
Net Income/Loss: Net income for the fourth quarter of 2025 totaled
$33.0 million, with non-cash share-based compensation expense of $8.1 million, compared to a net loss of $36.5 million for the fourth
quarter of 2024 with non-cash share-based compensation expense of $5.8 million. For the year ended December 31, 2025, net loss totaled
$141.2 million, with non-cash share-based compensation expense of $29.0 million, compared to $122.5 million for the full year 2024 with
non-cash share-based compensation expense of $18.8 million.
About Aleniglipron and Structure Therapeutics' Oral Metabolic
Aleniglipron (GSBR-1290) is an investigational oral small molecule
agonist of the GLP-1 receptor, a validated drug target for the treatment of obesity and T2DM. Through Structure Therapeutics' structure-based
drug discovery platform, aleniglipron was designed to be a biased G Protein-Coupled Receptor (GPCR) agonist, which selectively activates
the G-protein signaling pathway. Beyond aleniglipron, Structure Therapeutics is developing next generation oral small molecules including
amylin receptor agonists (ACCG-2671 and ACCG-3535), and other combination GLP-1 receptor agonists candidates targeting the glucose-dependent
insulinotropic polypeptide (GIP), glucagon and apelin receptors.
About Structure Therapeutics
Structure Therapeutics is a science-driven clinical-stage biopharmaceutical
company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic conditions with significant
unmet medical needs. Utilizing its next generation structure-based drug discovery platform, the Company has established a robust GPCR-targeted
pipeline, featuring multiple wholly-owned proprietary clinical-stage oral small molecule compounds designed to surpass the scalability
limitations of traditional biologic and peptide therapies and be accessible to more people living with obesity 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 expected timing of topline data readouts from the ACCESS II
study; the planned initiation of the aleniglipron Phase 3 study and the timing thereof; the expected timing of initial data from the Phase
1 study of ACCG-2671; the Company's anticipated cash runway and uses of cash; the belief that aleniglipron represents a potentially
best-in-class small molecule GLP-1; the belief in market acceptance of oral treatment options for metabolic diseases and that Structure
Therapeutics is well positioned; any expectations regarding the potential benefits, tolerability and safety profile, accessibility, scalability,
combinability, capability, efficacy, convenience, expected effects and future application of aleniglipron; plans and the expected timing
for the meeting with the FDA to finalize the Phase 3 trial design and the Phase 3 program initiation of aleniglipron; the planned initiation
of the Phase 1 clinical study of ACCG-3535 and the timing thereof; and any presumption that topline, interim or preliminary data will
be representative of final data or data in later clinical trials. In addition, when or if used in this press release, the words and phrases
"anticipated," "believe," "expect," "plan," "potential," "to be,"
"will," 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 topline results that the Company reports are based on preliminary analysis of key
efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and