Structure Therapeutics Inc.
For the period ended Sep 30, 2026. Filed Nov 9, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 9, 2026
GPCR$21.41+5.2%Stored close · as of Nov 9, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-06.
0001104659-26-092057
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-09.
0001104659-26-124503
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 96 previous paragraphs and 102 current paragraphs.
58 unchanged; 34 reworded; 6 added; 2 removed; 2 previous and 4 current paragraphs rearranged.
Tables are not compared: 16 previous and 16 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (6)
Current report
In September 2026, we reported additional results from the ACCESS OLE trial. The ACCESS OLE was designed to evaluate the tolerability profile of the dosing regimen starting at the 2.5 mg dose for those previously on placebo and to collect up to 72 weeks of data on exposure to aleniglipron, including the 180 mg dose. Participants originally randomized to the 45 mg, 90 mg and 120 mg arms in ACCESS who continued into the OLE and dosed up to 180 mg achieved mean weight loss of 11.6%, 14.4% and 16.2%, respectively, at 72 weeks, with no evidence of weight loss plateau in the two top dose groups. Treatment discontinuations due to treatment-emergent adverse events occurred in fewer than 5% of participants in the OLE. Participants previously assigned to placebo who initiated aleniglipron at a 2.5 mg starting dose demonstrated improved gastrointestinal tolerability compared with the 5 mg starting dose used in the double-blind portion of ACCESS. There were no cases of drug-induced liver injury, and all observed liver enzyme elevations resolved without treatment discontinuation, consistent with prior aleniglipron clinical trials.
Current report
In September 2026, we reported topline results from the single ascending dose (“SAD”) portion of the ACCG-2671 clinical trial, which evaluated safety, tolerability, pharmacokinetics and exploratory pharmacodynamics in 31 healthy adult participants without obesity. Participants received a single dose of 1, 2, 5 or 10 mg of ACCG-2671 or placebo. ACCG-2671 demonstrated rapid absorption, exposure consistent with dose proportionality and a terminal half-life of approximately six days, supporting further evaluation of daily and weekly dosing. There were no serious adverse events, no drug-related treatment-emergent adverse events leading to treatment discontinuation and no cases of drug-induced liver injury. No nausea or vomiting was reported in the placebo, 1 mg or 2 mg cohorts, while gastrointestinal adverse events were observed at the higher doses. Exploratory findings included a mean body weight reduction of 3.3% at Day 24 following a single 10 mg dose in six participants.
Current report
We have begun dosing in the multiple ascending dose (“MAD”) portion of the trial, a randomized, placebo-controlled trial evaluating the safety, tolerability and pharmacokinetics of ACCG-2671 administered for 84 days in participants living with obesity. The trial is evaluating daily and weekly dosing regimens and different titration approaches and includes a cohort receiving a stable dose of an injectable GLP-1 receptor agonist. We anticipate topline results from the MAD portion of the trial in the first half of 2027.
Current report
We expect to initiate a clinical trial evaluating a combination of oral small molecule amylin and GLP-1 receptor agonists in 2027.
Current report
Comparison of the Nine Months Ended September 30, 2026 and 2025
Current report
During the nine months ended September 30, 2025, net cash provided by financing activities was $57.5 million, consisting primarily of proceeds from our sales under the ATM Offering of $57.1 million, net of sales commission.
Removed paragraphs (2)
Previous report
Comparison of the Six Months Ended June 30, 2026 and 2025
Previous report
General and administrative expenses increased by $12.3 million, or 42%, to $41.4 million during the six months ended June 30, 2026, compared to $29.2 million during the six months ended June 30, 2025. The
Reworded paragraphs (34)
Previous wording
You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and the related notes and other financial information included elsewhere in this Quarterly Report on Form 10-Q (“Quarterly Report”). This discussion and other parts of this Quarterly Report contain forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions, that are based on the beliefs of our management, as well as assumptions made by, and information currently available to, our management. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the sections of this Quarterly Report entitled “Forward-Looking Statements” and “Risk Factors,” under Part II. Item 1A. and those discussed in our Annual Report on Form 10-K (“Annual Report”) for the year ended December 31, 2025 filed with the Securities and Exchange Commission (“SEC”) on February 26, 2026.
Current wording
You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and the related notes and other financial information included elsewhere in this Quarterly Report on Form 10-Q (“Quarterly Report”). This discussion and other parts of this Quarterly Report contain forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions, that are based on the beliefs of our management, as well as assumptions made by, and information currently available to, our management. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the sections of this Quarterly Report entitled “Cautionary Note Regarding Forward-Looking Statements” and “Risk Factors,” under Part II. Item 1A. and those discussed in our Annual Report on Form 10-K (“Annual Report”) for the year ended December 31, 2025 filed with the Securities and Exchange Commission (“SEC”) on February 26, 2026.
Previous wording
Our most advanced product candidate to date is aleniglipron, also known as GSBR-1290, an oral small molecule selective glucagon-like-peptide-1 receptor (“GLP-1R”) agonist currently in five ongoing clinical trials for the treatment of obesity, overweight and related conditions. We have two oral small molecule amylin receptor agonists: ACCG-2671, which is currently in Phase 1 clinical development, and ACCG-3535, which we have selected as our second amylin development candidate. Our obesity pipeline also includes multiple preclinical discovery stage small molecules targeting glucose-dependent insulinotropic polypeptide and glucagon receptors. Importantly, these programs have the potential to be developed as monotherapy as well as in fixed dose combination with our backbone GLP-1 or amylin development candidates. These combination products enable us to potentially address diseases beyond obesity including type 2 diabetes mellitus (“T2DM”), heart failure, sleep apnea, chronic kidney disease, osteoarthritis, metabolic dysfunction-associated steatotic liver disease (“MASH”) and potentially even addiction and Parkinson’s disease and Alzheimer’s disease, areas where we are starting to see encouraging data with GLP-1Rs. Our product candidates, as oral small molecules, have the potential to be more accessible medicines than biologics and peptide therapies with potentially differentiated efficacy and safety and, from a manufacturing standpoint, more scalable to meet global demand.
Current wording
Our most advanced product candidate to date is aleniglipron, also known as GSBR-1290, an oral small molecule selective glucagon-like-peptide-1 receptor (“GLP-1R”) agonist currently in five ongoing clinical trials for the treatment of obesity, overweight and related conditions. We have two oral small molecule amylin receptor agonists: ACCG-2671, which is currently in Phase 1/2a clinical development, and ACCG-3535, which we have selected as our second amylin development candidate. Our obesity pipeline also includes multiple preclinical discovery stage small molecules targeting glucose-dependent insulinotropic polypeptide and glucagon receptors. Importantly, these programs have the potential to be developed as monotherapy as well as in fixed-dose combination with our backbone GLP-1 or amylin development candidates. These combination products enable us to potentially address diseases beyond obesity including type 2 diabetes mellitus (“T2DM”), heart failure, sleep apnea, chronic kidney disease, osteoarthritis, metabolic dysfunction-associated steatotic liver disease (“MASH”) and potentially even addiction and Parkinson’s disease and Alzheimer’s disease, areas where we are starting to see encouraging data with GLP-1Rs. Our product candidates, as oral small molecules, have the potential to be more accessible medicines than biologics and peptide therapies with potentially differentiated efficacy and safety and, from a manufacturing standpoint, more scalable to meet global demand.
Previous wording
In the fourth quarter of 2024, we initiated the Phase 2b ACCESS trial, a randomized, double-blind, placebo-controlled, dose-range finding trial of aleniglipron in approximately 220 adult participants living with obesity (BMI ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) with at least one weight-related comorbidity. Participants started at 5 mg of aleniglipron (or placebo) with a 4-week titration schedule, reaching target doses of 45 mg, 90 mg and 120 mg. The primary endpoint was percent change in body weight from baseline to week 36. Secondary endpoints included safety and tolerability of the monthly titration scheme, as well as PK of aleniglipron. In the fourth quarter of 2024, we initiated a randomized, double-blind, placebo-controlled dose-range finding Phase 2 trial of aleniglipron, known as ACCESS II, in approximately 82 adult participants living with obesity or overweight with at least one weight-related comorbidity. The trial was designed to evaluate two
Current wording
In the fourth quarter of 2024, we initiated the Phase 2b ACCESS trial, a randomized, double-blind, placebo-controlled, dose-range finding trial of aleniglipron in approximately 220 adult participants living with obesity (body mass index (“BMI”) ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) with at least one weight-related comorbidity. Participants started at 5 mg of aleniglipron (or placebo) with a 4-week titration schedule, reaching target doses of 45 mg, 90 mg and 120 mg. The primary endpoint was percent change in body weight from baseline to week 36. Secondary endpoints included safety and tolerability of the monthly titration scheme, as well as pharmacokinetics of aleniglipron. In the fourth quarter of 2024, we initiated a randomized, double-blind, placebo-controlled dose-range finding Phase 2 trial of aleniglipron, known as ACCESS II, in approximately 82 adult participants living with obesity or overweight with at least one weight-related
Previous wording
higher doses of aleniglipron. Participants started at 5 mg of aleniglipron (or placebo) and follow a 4-week titration schedule up to target doses of 120 mg, 180 mg and 240 mg.
Current wording
comorbidity. The trial was designed to evaluate two higher doses of aleniglipron. Participants started at 5 mg of aleniglipron (or placebo) and followed a 4-week titration schedule up to target doses of 120 mg, 180 mg and 240 mg.
Previous wording
In February 2025, we completed enrollment in the ACCESS and ACCESS II trials, and in December 2025, we reported topline data from the ACCESS clinical program including 36-week topline data from the core Phase 2b ACCESS trial, 36-week interim data from the exploratory ACCESS II trial, interim data from Phase 2 body composition trial and Phase 2b ACCESS open label extension (“OLE”) trial. In summary, the Phase 2b ACCESS trial demonstrated a placebo-adjusted mean weight loss of 11.3% with 120 mg dose at 36 weeks; the exploratory ACCESS II dose exploration trial demonstrated a placebo-adjusted mean weight loss of 15.3% at 240 mg at 36 weeks. The tolerability profile reflected the well-known gastrointestinal-related adverse events typical of the GLP-1 class, with a favorable overall discontinuation rate of 10.4%.
Current wording
In February 2025, we completed enrollment in the ACCESS and ACCESS II trials, and in December 2025, we reported topline data from the ACCESS clinical program including 36-week topline data from the core Phase 2b ACCESS trial, 36-week interim data from the exploratory ACCESS II trial, interim data from the Phase 2 body composition trial and the Phase 2b ACCESS open label extension (“OLE”) trial. In summary, the Phase 2b ACCESS trial demonstrated a placebo-adjusted mean weight loss of 11.3% with the 120 mg dose at 36 weeks; the exploratory ACCESS II dose exploration trial demonstrated a placebo-adjusted mean weight loss of 15.3% at 240 mg at 36 weeks. The tolerability profile reflected the well-known gastrointestinal-related adverse events typical of the GLP-1 class, with a favorable overall discontinuation rate of 10.4%.
Previous wording
In March 2026, we reported topline data from the aleniglipron clinical program including 44-week topline data from the Phase 2 ACCESS II trial and interim data from the ongoing body composition trial and the ACCESS OLE trial. In summary, the Phase 2 ACCESS II trial demonstrated a placebo-adjusted mean weight loss of 16.3% (39 Ibs; p<0.0001) at the 180 mg dose and 16.0% (37 Ibs; p<0.0001) at the 240 mg dose at 44 weeks. In the ACCESS OLE trial, aleniglipron achieved continued weight loss from 36 weeks, up to 16.2% (40.5 Ibs) with 120 mg after a median follow-up of 20 weeks after the completion of the 36-week double blind treatment period. The ACCESS OLE trial is ongoing to evaluate the tolerability profile of the dosing regimen starting at the 2.5 mg dose for those previously on placebo and to collect up to 72 weeks of data exposure to aleniglipron, including 180 mg dose. We anticipate topline results from the ACCESS OLE trial in the third quarter of 2026. In addition, the body composition trial is ongoing to assess the effect of aleniglipron on body fat loss over a 44-week evaluation period, which includes a 28-week titration period and a starting dose of 2.5 mg and target dose of 180 mg of aleniglipron. The data will be used to inform the size of a sub trial into the Phase 3 program. We anticipate topline results from the body composition trial in the fourth quarter of 2026.
Current wording
In March 2026, we reported topline data from the aleniglipron clinical program including 44-week topline data from the Phase 2 ACCESS II trial and interim data from the ongoing body composition trial and the ACCESS OLE trial. In summary, the Phase 2 ACCESS II trial demonstrated a placebo-adjusted mean weight loss of 16.3% (39 Ibs; p<0.0001) at the 180 mg dose and 16.0% (37 Ibs; p<0.0001) at the 240 mg dose at 44 weeks. In the ACCESS OLE trial, aleniglipron achieved continued weight loss from 36 weeks, up to 16.2% (40.5 Ibs) with 120 mg after a median follow-up of 20 weeks after the completion of the 36-week double blind treatment period.
Previous wording
In addition, we are conducting an ongoing 30-week trial to evaluate the potential to include patients with** **T2DM with obesity/overweight and a starting dose of 2.5 mg and target dose of 180 mg of aleniglipron. We anticipate data from the T2DM trial in the fourth quarter of 2026.
Current wording
We are also conducting an ongoing 30-week trial to evaluate aleniglipron in participants living with** **T2DM and obesity/overweight and a starting dose of 2.5 mg and a target dose of 180 mg. We anticipate data from the T2DM trial in the fourth quarter of 2026.
Previous wording
We are also conducting an ongoing SWITCH trial to assess the transition or switching from an approved injectable GLP-1 receptor agonist to once-daily oral aleniglipron for weight loss maintenance. This trial assesses different aleniglipron starting doses and weight loss maintenance over 12 weeks. We anticipate data from the SWITCH trial in the fourth quarter of 2026.
Current wording
The ongoing SWITCH trial is designed to assess the transition or switching from an approved injectable GLP-1 receptor agonist to once-daily oral aleniglipron for weight loss maintenance. This trial assesses different aleniglipron starting doses and weight loss maintenance over 12 weeks. We anticipate data from the SWITCH trial in the fourth quarter of 2026.
Previous wording
In August 2026, we initiated the Phase 3 ACCOMPLISH program, which includes two clinical trials evaluating aleniglipron. ACCOMPLISH-1 will evaluate aleniglipron in adults living with obesity or overweight with a weight-related comorbidity and will enroll up to 3,600 patients. ACCOMPLISH-2 will evaluate aleniglipron in adults living with obesity or overweight and T2DM and will enroll up to 1,100 patients.
Current wording
In August 2026, we initiated the Phase 3 ACCOMPLISH program, which includes two clinical trials evaluating aleniglipron. ACCOMPLISH-1 will evaluate aleniglipron in adults living with obesity or overweight with a weight-related comorbidity and will enroll up to 3,600 patients. ACCOMPLISH-2 will evaluate aleniglipron in
Previous wording
ACCOMPLISH-1 and ACCOMPLISH-2 are randomized, double-blind, placebo-controlled trials designed to evaluate the long-term efficacy and safety of three maintenance doses of aleniglipron. Participants in the clinicla trials will be randomized to one of four treatment arms to evaluate three doses (45 mg, 90 mg or 180 mg) or placebo. Participants will begin treatment at a 2.5 mg starting dose of aleniglipron or placebo with a 4-week titration schedule. Together, the ACCOMPLISH clinical trials are designed to support regulatory submissions for aleniglipron in chronic weight management.
Current wording
ACCOMPLISH-1 and ACCOMPLISH-2 are randomized, double-blind, placebo-controlled trials designed to evaluate the long-term efficacy and safety of three maintenance doses of aleniglipron. Participants in the clinical trials will be randomized to one of four treatment arms to evaluate three doses (45 mg, 90 mg or 180 mg) or placebo. Participants will begin treatment with aleniglipron at a starting dose of 2.5 mg or placebo with a 4-week titration schedule. Together, the ACCOMPLISH clinical trials are designed to support regulatory submissions for aleniglipron in chronic weight management.
Previous wording
We are advancing our amylin oral small molecule program and have initiated a Phase 1 clinical trial of our lead candidate, ACCG-2671 in December 2025. We expect to report initial Phase 1 Single Ascending Dose (“SAD”) trial results for ACCG-2671 and advance it into Phase 2 Multiple Ascending Dose (“MAD”) trial in the third quarter of 2026.
Current wording
We are advancing our amylin oral small molecule program and initiated a Phase 1/2a clinical trial of our lead candidate, ACCG-2671, in December 2025.
Previous wording
In November 2025, we selected a second DACRA development candidate, ACCG-3535. ACCG-3535 is a unique chemical structure from ACCG-2671. Preclinical ACCG-3535 data indicated high binding affinity to human amylin and calcitonin receptors and balanced potency in human amylin and calcitonin receptor functional assays. In addition, ACCG-3535 demonstrated robust food intake suppression and significant, dose-dependent body weight reduction as a monotherapy in diet-induced obese rats. Combination therapy with semaglutide (both concurrently and as a subsequent add-on to semaglutide) resulted in superior weight loss compared to semaglutide or ACCG-3535 monotherapy. We expect to initiate a Phase 1 trial for ACCG-3535 in the fourth quarter of 2026.
Current wording
In November 2025, we selected a second dual amylin and calcitonin receptor agonist (“DACRA”) development candidate, ACCG-3535. ACCG-3535 is a unique chemical structure from ACCG-2671. Preclinical ACCG-3535 data indicated high binding affinity to human amylin and calcitonin receptors and balanced potency in human amylin and calcitonin receptor functional assays. In addition, ACCG-3535 demonstrated robust food intake suppression and significant, dose-dependent body weight reduction as a monotherapy in diet-induced obese rats. Combination therapy with semaglutide (both concurrently and as a subsequent add-on to semaglutide) resulted in superior weight loss compared to semaglutide or ACCG-3535 monotherapy. We expect to initiate a Phase 1 trial for ACCG-3535 in the fourth quarter of 2026.
Previous wording
Beyond our GLP-1R and amylin receptor programs, we are developing next generation oral incretins for potential combination therapy with GLP-1R or amylin candidates. These include small molecule candidates targeting glucose-dependent insulinotropic polypeptide receptor (“GIPR”) and GCG receptor (“GCGR”), each designed with customized properties to achieve additional benefit. We believe GLP/GIPR modulation has the potential to provide a differentiated treatment in obesity. In our GCG program, we have identified multiple GCGR agonist and dual GLP-1R/GCGR agonist hits for small molecule GCGR modulation. GCG is primarily expressed in the liver and therefore GCGR agonists could play an important role in liver-mediated diseases, specifically MASH.
Current wording
Beyond our GLP-1R and amylin receptor programs, we are developing next generation oral incretins for potential combination therapy with GLP-1R or amylin candidates. These include small molecule candidates targeting glucose-dependent insulinotropic polypeptide receptor (“GIPR”) and GCG receptor (“GCGR”), each designed with customized properties to achieve additional benefit. We believe GLP/GIPR modulation has the potential to provide a differentiated treatment in obesity. In our GCGR program, we have identified multiple GCGR agonist and dual GLP-1R/GCGR agonist hits for small molecule GCGR modulation. GCGR is primarily expressed in the liver and therefore GCGR agonists could play an important role in liver-mediated diseases, specifically MASH.
Previous wording
We are a Cayman Islands exempted company incorporated with limited liability. We were initially formed as a Delaware limited liability company in 2016 under the name ShouTi Inc., and reorganized as a Cayman Islands exempted company in February 2019. Our primary activities to date have included organizing and staffing our company, business and scientific planning, raising capital, conducting research and development activities, entering into strategic and corporate structuring transactions, enabling manufacturing activities in support of our product candidate development efforts, and establishing our intellectual property portfolio, and providing general and administrative support for these activities. We do not have any product candidates approved for sale and have not generated any revenue from our products. Since our inception, we have incurred net operating losses and negative cash flows from operations. We had net losses of $182.1 million and $108.5 million in the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $652.4 million.
Current wording
activities, entering into strategic and corporate structuring transactions, enabling manufacturing activities in support of our product candidate development efforts, and establishing our intellectual property portfolio, and providing general and administrative support for these activities. We do not have any product candidates approved for sale and have not generated any revenue from our products. Since our inception, we have incurred net operating losses and negative cash flows from operations. We had net losses of $326.9 million and $174.2 million in the nine months ended September 30, 2026 and 2025, respectively. As of September 30, 2026, we had an accumulated deficit of $797.2 million.
Previous wording
As of June 30, 2026, we have cash, cash equivalents and short-term investments of $1,342.7 million. We received $100.0 million in the first quarter of 2026 consisting of an upfront license fee for certain patents that cover a class of oral GLP-1 receptor agonists that is different from aleniglipron. Based on our current business plan, we estimate that our existing cash, cash equivalents and short-term investments will be sufficient to fund our projected operations and key clinical milestones through the end of 2028. This includes costs related to the ongoing aleniglipron ACCESS OLE, ACCESS II extension trial, the supplementary trials, and Phase 3 registrational program in chronic weight management, but excludes additional costs related to pre-commercialization activities including commercial manufacturing. We have based this estimate on assumptions that may prove to be wrong, and we may exhaust our available capital resources sooner than we expect.
Current wording
As of September 30, 2026, we have cash, cash equivalents and short-term investments of $1,240.0 million. We received $100.0 million in the first quarter of 2026 consisting of an upfront license fee for certain patents that cover a class of oral GLP-1 receptor agonists that is different from aleniglipron. Based on our current business plan, we estimate that our existing cash, cash equivalents and short-term investments will be sufficient to fund our projected operations and key clinical milestones through the end of 2028. This includes costs related to the Phase 3 registrational program for aleniglipron in chronic weight management, but excludes additional costs related to pre-commercialization activities including commercial manufacturing. We have based this estimate on assumptions that may prove to be wrong, and we may exhaust our available capital resources sooner than we expect.
Previous wording
Although we did not see a significant financial impact to our business operations as a result of recent geopolitical and macroeconomic developments, such as recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures, tariffs, global pandemics, geopolitical tensions between the United States and China, and various global conflicts for the six months ended June 30, 2026, there may be potential impacts to our business in the future that are highly uncertain and difficult to predict, including our ability to raise additional funds, disruptions to the supply chain and the manufacture or shipment of drug substances and finished drug products for our product candidates for use in our research, preclinical studies and clinical trials, impediments to our clinical trial initiation and recruitment, errors or omissions at our clinical sites and the ability of patients to continue in clinical trials, delays in the FDA’s review and approval processes, our ability to effectively operate across different geographies in which our offices are located, any increases in interest rates and economic inflation, bank failures, the impact on the global economy due to various global conflicts, higher prices of supplies, tariffs, changes in monetary and fiscal policy, U.S. political developments and other sources of instability and changes in availability and cost of credit and our ability to access capital. The ultimate impact of these geopolitical and macroeconomic factors, as well as any lasting effects on the way we conduct our business, is highly uncertain and subject to continued change, and we recognize that they may continue to present unique challenges for us.
Current wording
omissions at our clinical sites and the ability of patients to continue in clinical trials, delays in the FDA’s review and approval processes, our ability to effectively operate across different geographies in which our offices are located, any increases in interest rates and economic inflation, bank failures, the impact on the global economy due to various global conflicts, higher prices of supplies, tariffs, changes in monetary and fiscal policy, U.S. political developments and other sources of instability and changes in availability and cost of credit and our ability to access capital. The ultimate impact of these geopolitical and macroeconomic factors, as well as any lasting effects on the way we conduct our business, is highly uncertain and subject to continued change, and we recognize that they may continue to present unique challenges for us.
Previous wording
Our research and development activities primarily consist of discovery, engineering and research associated with our product candidates under development, including preclinical studies and clinical trials. Research and development expenses include personnel-related costs for our management, including salaries, bonuses,
Current wording
Our research and development activities primarily consist of discovery, engineering and research associated with our product candidates under development, including preclinical studies and clinical trials. Research and development expenses include personnel-related costs for our management, including salaries, bonuses, benefits and share-based compensation expenses, consulting services, clinical trial expenses, regulatory expenses, publications, and allocated overhead expenses, including rent, equipment, depreciation, information technology costs and utilities.
Previous wording
Research and development expenses increased by $45.3 million, or 83%, to $100.1 million during the three months ended June 30, 2026, compared to $54.7 million during the three months ended June 30, 2025. The increase in research and development 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).
Current wording
Research and development expenses increased by $75.6 million, or 128%, to $134.6 million during the three months ended September 30, 2026, compared to $59.0 million during the three months ended September 30, 2025. The increase in research and development 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).
Previous wording
General and administrative expenses increased by $2.8 million, or 18%, to $18.6 million during the three months ended June 30, 2026, compared to $15.7 million during the three months ended June 30, 2025. The increase in general and administrative 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, and increases in professional services.
Current wording
General and administrative expenses increased by $7.0 million, or 47%, to $21.8 million during the three months ended September 30, 2026, compared to $14.8 million during the three months ended September 30, 2025. The increase in general and administrative expenses was primarily due to increases in employee expenses as we expanded our infrastructure to drive and support the growth in our operations.
Previous wording
Interest and other income, net, increased by $3.8 million to $12.7 million during the three months ended June 30, 2026, compared to $8.9 million during the three months ended June 30, 2025. The increase in interest and other income, net, was primarily due to an increase in interest income from higher cash, cash equivalents and short-term investment balances.
Current wording
Interest and other income, net, increased by $3.6 million to $11.7 million during the three months ended September 30, 2026, compared to $8.2 million during the three months ended September 30, 2025. The increase in interest and other income, net, was primarily due to an increase in interest income from higher cash, cash equivalents and short-term investment balances.
Previous wording
Research and development expenses increased by $69.0 million, or 71%, to $166.6 million during the six months ended June 30, 2026, compared to $97.6 million during the six months ended June 30, 2025. The increase in research and development 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).
Current wording
Research and development expenses increased by $144.6 million, or 92%, to $301.1 million during the nine months ended September 30, 2026, compared to $156.6 million during the nine months ended September 30, 2025. The increase in research and development 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).
Previous wording
increase in general and administrative 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, and increases in professional services.
Current wording
General and administrative expenses increased by $19.2 million, or 44%, to $63.2 million during the nine months ended September 30, 2026, compared to $44.0 million during the nine months ended September 30, 2025. The increase in general and administrative expenses was primarily due to increases in employee expenses as we expanded our infrastructure to drive and support the growth in our operations.
Previous wording
Interest and other income, net, increased by $7.8 million to $26.3 million during the six months ended June 30, 2026, compared to $18.5 million during the six months ended June 30, 2025. The increase in interest and other income, net, was primarily due to an increase in interest income from higher cash, cash equivalents and short-term investment balances.
Current wording
Interest and other income, net, increased by $11.4 million to $38.1 million during the nine months ended September 30, 2026, compared to $26.7 million during the nine months ended September 30, 2025. The increase in interest and other income, net, was primarily due to an increase in interest income from higher cash, cash equivalents and short-term investment balances.
Previous wording
In August 2025, we entered into a sales agreement (the “ATM Sales Agreement”) with Leerink Partners LLC and Cantor Fitzgerald & Co. (the “ATM Sales Agents”), pursuant to which we may, from time to time, offer and sell our ADSs through the ATM Sales Agents in any manner deemed to be an “at-the-market” offering, initially up to an aggregate offering price of $250.0 million. In September 2025, we sold 3,040,000 ADSs under the ATM Sales Agreement, for gross proceeds of approximately $58.5 million. The net proceeds after deducting sales commissions to the ATM Sales Agents were approximately $57.1 million, and, after further deducting offering expenses were approximately $55.8 million. In May 2026, we amended and restated the ATM Sales Agreement (the “Amended and Restated Sales Agreement”) to remove the aggregate offering amount of ADSs we may offer and sell thereunder (the “ATM Shares”). In connection with the Amended and Restated Sales Agreement, in May 2026, we filed a prospectus supplement (the “Prospectus Supplement”) to the prospectus filed on August 6, 2025 with the SEC as part of our automatic shelf registration statement on Form S-3. We filed the Prospectus Supplement to increase the ATM Shares available to be sold pursuant to the terms of the Amended and Restated Sales Agreement by an additional $150.0 million, for an aggregate offering price of up to $400.0 million. As of the date of this Quarterly Report, approximately $341.5 million remained available for sale.
Current wording
In August 2025, we entered into a sales agreement (the “ATM Sales Agreement”) with Leerink Partners LLC and Cantor Fitzgerald & Co. (the “ATM Sales Agents”), pursuant to which we may, from time to time, offer and sell our ADSs through the ATM Sales Agents in any manner deemed to be an “at-the-market” offering, initially up to an aggregate offering amount of $250.0 million. In September 2025, we sold 3,040,000 ADSs under the ATM Sales Agreement, for gross proceeds of approximately $58.5 million. The net proceeds after deducting sales commissions to the ATM Sales Agents were approximately $57.1 million, and, after further deducting offering expenses were approximately $55.8 million. In May 2026, we amended and restated the ATM Sales Agreement (the “Amended and Restated Sales Agreement”) to remove the aggregate offering amount of ADSs we may offer and sell thereunder (the “ATM Shares”). In connection with the Amended and Restated Sales Agreement, in May 2026, we filed a prospectus supplement (the “Prospectus Supplement”) to the prospectus filed on August 6, 2025 with the SEC as part of our automatic shelf registration statement on Form S-3. We filed the Prospectus Supplement to increase the ATM Shares available to be sold pursuant to the terms of the Amended and Restated Sales Agreement by an additional $150.0 million, for an aggregate offering amount of up to $400.0 million. As of the date of this Quarterly Report, approximately $341.5 million remained available for sale.
Previous wording
As of June 30, 2026, we had cash, cash equivalents and short-term investments of $1,342.7 million and an accumulated deficit of $652.4 million.
Current wording
As of September 30, 2026, we had cash, cash equivalents and short-term investments of $1,240.0 million and an accumulated deficit of $797.2 million.
Previous wording
Since our inception, we have incurred net operating losses and negative cash flows from operations. We had net losses of $182.1 million and $108.5 million in the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $652.4 million. Our primary activities to date have included organizing and staffing our company, business and scientific planning, raising capital, conducting research and development activities, entering into strategic and corporate structuring transactions, enabling manufacturing activities in support of our product candidate development efforts, establishing our intellectual property portfolio, and providing general and administrative support for these activities.
Current wording
Since our inception, we have incurred net operating losses and negative cash flows from operations. We had net losses of $326.9 million and $174.2 million in the nine months ended September 30, 2026 and 2025, respectively. As of September 30, 2026, we had an accumulated deficit of $797.2 million. Our primary activities to date have included organizing and staffing our company, business and scientific planning, raising capital, conducting research and development activities, entering into strategic and corporate structuring transactions, enabling manufacturing activities in support of our product candidate development efforts, establishing our intellectual property portfolio, and providing general and administrative support for these activities.
Previous wording
As of June 30, 2026, we had cash, cash equivalents and short-term investments of $1,342.7 million. We received $100.0 million in the first quarter of 2026 consisting of an upfront license fee for certain patents that cover a class of oral GLP-1 receptor agonists that is different from aleniglipron. Based on our current business plan, we believe that our existing cash, cash equivalents and short-term investments will be sufficient to fund our projected operations for at least the next 12 months from the date of the issuance of our condensed consolidated financial statements. Further, based on our current business plan, we estimate that our existing cash, cash equivalents and short-term investments will be sufficient to fund our projected operations and key clinical milestones through the end of 2028. This includes costs related to the ongoing aleniglipron ACCESS OLE, ACCESS II extension trial, the supplementary trials, and Phase 3 registrational program in chronic weight management, but excludes additional costs related to pre-commercialization activities including commercial manufacturing. We have based this estimate on assumptions that may prove to be wrong, and we may exhaust our available capital resources sooner than we expect.
Current wording
As of September 30, 2026, we had cash, cash equivalents and short-term investments of $1,240.0 million. We received $100.0 million in the first quarter of 2026 consisting of an upfront license fee for certain patents that cover a class of oral GLP-1 receptor agonists that is different from aleniglipron. Based on our current business plan, we believe that our existing cash, cash equivalents and short-term investments will be sufficient to fund our projected operations for at least the next 12 months from the date of the issuance of our condensed consolidated financial statements. Further, based on our current business plan, we estimate that our existing cash, cash equivalents and short-term investments will be sufficient to fund our projected operations and key clinical milestones through the end of 2028. This includes costs related to the Phase 3 registrational program for aleniglipron in chronic weight management, but excludes additional costs related to pre-commercialization activities including commercial manufacturing. We have based this estimate on assumptions that may prove to be wrong, and we may exhaust our available capital resources sooner than we expect.
Previous wording
During the six months ended June 30, 2026, net cash used in operating activities was $104.9 million, consisting of a net loss of $182.1 million, partially offset by a decrease in net operating assets of $57.1 million and non-cash charges of $20.2 million. The decrease in net operating assets was primarily due to a decrease in other receivable, partially offset by an increase in other non-current assets. Non-cash charges consisted primarily of share-based compensation, partially offset by net gain from accretion of net investment discounts. The increase in net loss was primarily due to the increase in operating expenses as we invest in our research and development efforts.
Current wording
During the nine months ended September 30, 2026, net cash used in operating activities was $206.6 million, consisting of a net loss of $326.9 million, partially offset by a decrease in net operating assets of $89.8 million and non-cash charges of $30.5 million. The decrease in net operating assets was primarily due to a decrease in other receivable. Non-cash charges consisted primarily of share-based compensation, partially offset by net gain from accretion of net investment discounts. The increase in net loss was primarily due to the increase in operating expenses as we invest in our research and development efforts.
Previous wording
During the six months ended June 30, 2025, net cash used in operating activities was $106.8 million, consisting of a net loss of $108.5 million and an increase in net operating assets of $3.7 million, partially offset by non-cash charges of $5.4 million. The increase in net loss was primarily due to the increase in operating expenses as we invest in our research and development efforts and operate as a publicly-traded company. Non-cash charges consisted primarily of share-based compensation and non-cash lease expense, partially offset by net gain from accretion of net investment discounts. The increase in net operating assets was primarily due to an increase in prepaid expenses and other current assets, an increase in other non-current assets and a decrease in operating lease liabilities, partially offset by an increase in accrued expenses and other current liabilities and an increase in accounts payable.
Current wording
During the nine months ended September 30, 2025, net cash used in operating activities was $157.8 million, consisting of a net loss of $174.2 million, partially offset by a decrease in net operating assets of $5.8 million and non-cash charges of $10.6 million. The increase in net loss was primarily due to the increase in operating expenses as we invest in our research and development efforts. The decrease in net operating assets was primarily due to an increase in accrued expenses and other current liabilities and an increase in accounts payable, partially offset by an increase in prepaid expenses and other current assets, an increase in other non-current assets and a decrease in operating lease liabilities. Non-cash charges consisted primarily of share-based compensation and non-cash lease expense, partially offset by net gain from accretion of net investment discounts.
Previous wording
During the six months ended June 30, 2026, net cash used in investing activities was $422.4 million, consisting primarily of net purchases of short-term investments.
Current wording
During the nine months ended September 30, 2026, net cash used in investing activities was $372.1 million, consisting primarily of net purchases of short-term investments of $367.3 million and purchases of property and equipment of $4.8 million.
Previous wording
During the six months ended June 30, 2025, net cash provided by investing activities was $83.0 million, consisting primarily of net maturities of short-term investments.
Current wording
During the nine months ended September 30, 2025, net cash provided by investing activities was $33.7 million, consisting primarily of net maturities of short-term investments of $30.6 million, and advance payment received for sale of non-financial asset of $5.2 million.
Previous wording
During the six months ended June 30, 2026, net cash provided by financing activities was $0.3 million, consisting primarily of proceeds from issuance of ordinary shares under employee share plans of $3.0 million, partially offset by payment of taxes on restricted share units withheld for taxes of $2.6 million.
Current wording
During the nine months ended September 30, 2026, net cash provided by financing activities was $1.1 million, consisting primarily of proceeds from issuance of ordinary shares under employee share plans of $4.2 million, partially offset by payment of taxes on restricted share units withheld for taxes of $3.1 million.
Previous wording
As of June 30, 2026, our contractual obligations consist of facilities lease payments totaling $6.9 million, with $3.0 million expected to be paid within the next 12 months. See “Operating Leases” in Note 5 to our unaudited interim condensed consolidated financial statements in Part I. Item 1 “Financial Statements” in this Quarterly Report for additional information.
Current wording
As of September 30, 2026, our contractual obligations consist of facilities lease payments totaling $7.5 million, with $3.2 million expected to be paid within the next 12 months. See “Operating Leases” in Note 5 to our unaudited interim condensed consolidated financial statements in Part I. Item 1 “Financial Statements” in this Quarterly Report for additional information.
Previous wording
Our critical accounting policies and estimates are described in Part II. Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations - Critical Accounting Policies” in our Annual Report. There were no material changes to these accounting policies during the six months ended June 30, 2026.
Current wording
Our critical accounting policies and estimates are described in Part II. Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations - Critical Accounting Policies” in our Annual Report. There were no material changes to these accounting policies during the nine months ended September 30, 2026.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
In addition, the body composition trial is ongoing to assess the effect of aleniglipron on body fat loss over a 44-week evaluation period, which includes a 28-week titration period and a starting dose of 2.5 mg and target dose of 180 mg of aleniglipron. We anticipate topline results from the body composition trial in the fourth quarter of 2026.
Current report — wording carried from elsewhere
adults living with obesity or overweight and T2DM and will enroll up to 1,100 patients. We expect topline data from both trials in the second half of 2028.
Current report — wording carried from elsewhere
We are a Cayman Islands exempted company incorporated with limited liability. We were initially formed as a Delaware limited liability company in 2016 under the name ShouTi Inc., and reorganized as a Cayman Islands exempted company in February 2019. Our primary activities to date have included organizing and staffing our company, business and scientific planning, raising capital, conducting research and development
Current report — wording carried from elsewhere
Although we did not see a significant financial impact to our business operations as a result of recent geopolitical and macroeconomic developments, such as recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures, tariffs, global pandemics, geopolitical tensions between the United States and China, and various global conflicts for the nine months ended September 30, 2026, there may be potential impacts to our business in the future that are highly uncertain and difficult to predict, including our ability to raise additional funds, disruptions to the supply chain and the manufacture or shipment of drug substances and finished drug products for our product candidates for use in our research, preclinical studies and clinical trials, impediments to our clinical trial initiation and recruitment, errors or
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
benefits and share-based compensation expenses, consulting services, clinical trial expenses, regulatory expenses, publications, and allocated overhead expenses, including rent, equipment, depreciation, information technology costs and utilities.
Previous report — wording carried elsewhere
During the six months ended June 30, 2025, net cash provided by financing activities was $1.3 million, consisting primarily of proceeds from issuance of ordinary shares under employee share plans of $1.5 million, partially offset by payment of taxes on restricted share units withheld for taxes of $0.2 million.