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Structure Therapeutics Reports Second Quarter 2025 Financial Results and Recent Highlights Topline data from oral small molecule GLP-1 receptor agonist aleniglipron ACCESS and ACCESS II studies on track for year-end 2025

Key Takeaway: Structure Therapeutics has reported its second-quarter financial results for 2025, highlighting significant progress in its clinical studies for the oral small molecule GLP-1 receptor agonist aleniglipron. The company remains on track for topline data readouts from its ongoing ACCESS and ACCESS II studies by the end of 2025. Additionally, it has expanded its clinical development program and anticipates initiating a Phase 1 study for another candidate, ACCG-2671, by year-end 2025. Structure Therapeutics also maintains a strong cash position to support its operations and pipeline development.

Market Sentiment Analysis

POSITIVE FACTORS

  • Topline data from aleniglipron studies on track for year-end 2025.
  • Strong financial position with $786.5 million expected to support operations through at least 2027.
  • Initiation of new clinical studies to enhance aleniglipron's competitive positioning.

CONCERNS & RISKS

  • Net loss of $61.7 million reported for Q2 2025, an increase from $26 million in Q2 2024.
  • R&D expenses rose significantly, potentially impacting financial resources.

Full Press Release Details

Structure Therapeutics Reports Second Quarter
2025 Financial Results and Recent Highlights
Topline data from oral small molecule GLP-1
receptor agonist aleniglipron ACCESS and ACCESS II studies on track for year-end 2025 readouts
Aleniglipron clinical development program expanded
to optimize competitive positioning and Phase 3 program
Oral small molecule amylin
receptor agonist (ACCG-2671) Phase 1 initiation anticipated by year-end 2025
Strong financial position with cash, cash equivalents
and short-term investments of $786.5 million as of June 30, 2025 expected to fund projected operations and key clinical milestones through
SAN FRANCISCO, August 6, 2025-
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 second quarter ended June 30,
2025, and provided a business update.
"The ACCESS and ACCESS II studies for aleniglipron, our once-daily
oral small molecule GLP-1 program, remain on track for topline data readouts by the end of the year," said Raymond Stevens, Ph.D.,
CEO of Structure Therapeutics. "With our continued confidence in aleniglipron's profile, we have initiated additional supplementary
studies to ensure we are well positioned for Phase 3 and to maximize the therapeutic and competitive potential of this program. By the
end of 2025, we also plan to initiate the Phase 1 study of ACCG-2671, which we believe represents the most advanced oral small molecule
amylin agonist in development. As the obesity field shifts towards combinability of multiple targets and long-term weight loss maintenance,
we are excited to lead the way with a highly scalable pipeline of oral small molecule medicines designed to address the substantial unmet
needs in obesity management and related metabolic diseases."
Recent and Upcoming Milestones
Aleniglipron (GSBR-1290)- Oral Small Molecule Selective Glucagon-Like
Peptide 1 (GLP-1) Receptor Agonist for the Treatment of Obesity and Overweight
Ongoing ACCESS and ACCESS II Studies
The fully enrolled ACCESS and ACCESS II studies are on track for topline
36-week data readouts by year-end 2025.
Expanded Data Collection from ACCESS and ACCESS II Studies
Structure Therapeutics has implemented
extensions to the ongoing ACCESS and ACCESS II studies:
- Following the initial 36-week efficacy evaluation, patients will now continue on their assigned dose to 44 weeks, which allows
for collection of an additional eight weeks of double-blinded safety, tolerability, and efficacy data in the study. Overall, this extension
will provide additional longer-term data in the two potentially higher dose arms of 180 mg and 240 mg. Per protocol and as previously
planned, a formal unblinded efficacy assessment at 36 weeks is expected by year-end 2025.
Three Additional Aleniglipron Studies
Structure Therapeutics is also conducting three new aleniglipron clinical
studies as planned that will generate additional data to competitively position aleniglipron and further support the design of the Phase
Oral Small Molecule Amylin Receptor Agonists for the Treatment of
Obesity or Overweight with Comorbidities
Oral Small Molecule Metabolic Pipeline and Potential Combinations:
Oral Small Molecule Lysophosphatidic Acid 1 Receptor (LPA1R) Program
for Idiopathic Pulmonary Fibrosis (IPF)
Structure Therapeutics has successfully finished a Phase 1 single and
multiple ascending dose clinical study of LTSE-2578, an oral small molecule antagonist that targets the LPA1R for the treatment of IPF.
In the study there was no evidence of any dose-dependent LTSE-2578-related adverse events, including clinical, laboratory and electrocardiogram
recordings. No SAEs were observed in the study.
Second Quarter 2025 Financial Highlights
Cash Position: Cash, cash equivalents and short-term investments
totaled $786.5 million on June 30, 2025. The Company expects its current cash, cash equivalents and short-term investments to fund
projected operations and key clinical milestones through at least 2027. For aleniglipron, this includes the ongoing ACCESS and ACCESS
II studies, extension studies, and the three new clinical studies announced, but excludes Phase 3 registrational studies.
Research and Development (R&D) Expenses: R&D expenses
for the second quarter of 2025 were $54.7 million, as compared to $22.1 million for the same period in 2024. The increase in R&D expenses
was primarily due to increases related to pre-clinical research and development expenses, clinical trial costs and personnel-related expenses
due to an increase in headcount to support the advancement of our GLP-1R franchise including aleniglipron.
General and Administrative (G&A) Expenses: G&A expenses
for the second quarter of 2025 were $15.7 million, as compared to $11.3 million for the same period in 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
as a publicly-traded company.
Net Loss: Net loss for the second quarter of 2025 totaled $61.7
million, with non-cash share-based compensation expense of $7.5 million, compared to $26.0 million for the second quarter of 2024 with
non-cash share-based compensation expense of $4.2 million.
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 and cardiopulmonary 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 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 expected timing of topline data from the ACCESS and ACCESS
II studies; the planned initiation of the ACCG-2671 Phase 1 study and the timing thereof; the Company's anticipated cash runway
and uses of cash; the belief that ACCG-2671 represents one of the most advanced oral small molecule amylin agonists in development; the
belief that the Company is well positioned to lead with a highly scalable pipeline of oral small molecule medicines designed to address
the substantial unmet needs in obesity management and related metabolic diseases; the potential benefits of expanding data collection
from the ACCESS and ACCESS II studies; the Company's plans to conduct three new aleniglipron studies, including the study design
and timing thereof; the expected timing for declaring a second amylin receptor agonist oral small molecule development candidate; and
the expected timing for long term chronic GLP-toxicology studies of ANPA-0073;; and any expectations regarding the safety, efficacy or
tolerability of aleniglipron, ACCG-2671, ANPA-0073, LTSE-2578 and other candidates under development. In addition, when or if used in
this press release, the words and phrases "anticipated," "believe," "expect," "may," "on
track," "plan," "potential," "suggests," "to be," "to begin," "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 the results from earlier clinical studies not necessarily being predictive of future results; potential delays
in the commencement, enrollment and completion of the Company's planned clinical studies, the Company's ability to advance
aleniglipron, ACCG-2671, ANPA-0073, LTSE-2578, and its other therapeutic candidates, obtain regulatory approval of, and ultimately commercialize
the Company's therapeutic candidates; competitive products or approaches limiting the commercial value of the Company's product
candidates; the timing and results of preclinical and clinical studies; the Company's ability to fund development activities and
achieve development goals; the Company's reliance on third parties, including clinical research organizations, manufacturers, suppliers
and collaborators, over which it may not always have full control; the impact of any global pandemics, inflation, tariffs, changes in
monetary and fiscal policy, supply chain issues, rising interest rates, future bank failures and other macroeconomic factors 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 latest Quarterly Report on Form 10-Q and future

Frequently Asked Questions

What are the ACCESS and ACCESS II studies?

These are clinical studies for aleniglipron, assessing its efficacy and safety.

When will topline data for aleniglipron be available?

Topline data from the studies is expected by the end of 2025.

What is Structure Therapeutics’ financial position?

As of June 30, 2025, the company has $786.5 million in cash and investments.

What upcoming study is planned for ACCG-2671?

The Phase 1 study for ACCG-2671 is anticipated to start by the end of 2025.

What is the focus of Structure Therapeutics’ pipeline?

The pipeline focuses on oral small molecules for obesity and related metabolic diseases.

Last updated: Aug 6, 2025