← Back to GPCR filing summaryOriginal filing text · Part I
Item 2 — Management's Discussion and Analysis
Structure Therapeutics Inc. · 10-Q · Q2 FY2026 · Period ended Jun 30, 2026
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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.
Overview
We are a clinical stage global biopharmaceutical company developing novel oral small molecule therapeutics to treat a wide range of chronic diseases with unmet medical need. Our differentiated technology platform leverages both structure-based drug discovery and our expertise in computational chemistry to discover and develop small molecule therapeutics against G-protein coupled receptors (“GPCRs”). These important receptors regulate numerous and diverse physiological and pathological processes. In fact, approximately one in every three marketed medicines targets GPCR-associated pathways for the treatment of various metabolic, cardiovascular and pulmonary disorders. By leveraging our world-class GPCR know-how, we are designing differentiated small molecule therapies to overcome the limitations of biologics and peptide therapies that target this family of receptors.
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.
Aleniglipron (GSBR-1290) – Oral Small Molecule Selective GLP-1R Agonist for Obesity
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
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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.
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%.
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.
Data from the ACCESS clinical program supported and informed the advancement of aleniglipron into Phase 3 development. The Company received positive end-of-Phase 2 correspondence from the U.S. Food and Drug Administration (“FDA”) and clear guidance on the Phase 3 program.
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.
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.
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.
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.
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ACCG-2671 and ACCG-3535 – Oral Small Molecule Amylin Receptor Agonist for Obesity
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.
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.
GIP and GCG Receptor Oral Small Molecule Obesity Programs
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.
LTSE-2578 – Oral Small Molecule LPA1R Agonist for IPF
We have been developing an antagonist that targets lysophosphatidic acid 1 receptor (“LPA1R”), a GPCR implicated in responses to tissue injury and pro-fibrotic processes, for the treatment of idiopathic pulmonary fibrosis (“IPF”).
We believe LTSE-2578 is a differentiated oral small molecule because it demonstrated potent in vitro and in vivo activity in preclinical IPF models and dose dependent inhibition of histamine release as the pharmacodynamic marker. We have completed IND-enabling trials including 28-day GLP-toxicology trials in dogs and rats. In July 2025, we completed a Phase 1 single and multiple ascending dose clinical trial of LTSE-2578, our oral small molecule antagonist that targets the LPA1R for the treatment of IPF. The randomized, double-blind, placebo-controlled first-in-human clinical trial investigated the safety, tolerability and pharmacokinetics of single and multiple ascending doses of LTSE-2578. In the trial, there was no evidence of any dose-dependent LTSE-2578-related adverse events, including clinical, laboratory and electrocardiogram recordings. No serious adverse events were observed. Having completed the Phase 1 trial, we are considering strategic alternatives for LTSE-2578 as a Phase 2 ready program in non-metabolic indications.
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We are advancing a robust pipeline of small molecule therapeutic candidates for chronic diseases with unmet medical need.
We outsource clinical drug manufacturing, storage, distribution and quality testing to third-party manufacturers. We believe this strategy allows us to maintain a more efficient infrastructure by eliminating the need for us to invest in our own manufacturing facilities, equipment and personnel while also enabling us to focus our expertise and resources on the design and development of our product candidates. We have established a manufacturing plan in the United States and continue to contract in parallel with additional suppliers in the United States and other regions outside of China to diversify the manufacturing of our active pharmaceutical ingredient and drug product. As our development programs progress and we build new process efficiencies, we expect to continually evaluate this strategy with the objective of satisfying demand for registration trials and, if approved, the manufacture, sale and distribution of commercial products.
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.
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.
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We expect to continue to incur significant and increasing expenses and operating losses for the foreseeable future, particularly if and as we continue to invest in our research and development activities and initiate additional clinical trials, expand our product pipeline, hire additional personnel and invest in and grow our business, maintain, expand and protect our intellectual property portfolio, and seek regulatory approvals for and commercialize any approved product candidates. In addition, we have incurred and expect to continue to incur additional costs associated with operating as a public company, including significant legal, audit, accounting, regulatory, consulting, and tax-related services associated with being a public company, compliance with Nasdaq listing and SEC requirements, director and officer insurance premiums and investor relations costs that we did not incur as a private company. As a result, we will need substantial additional capital to develop our product candidates, including to fund Phase 3 clinical trials of aleniglipron, and fund operations for the foreseeable future. Moreover, we may in the future seek to acquire or invest in additional businesses, products, or technologies that we believe could complement or enhance our products, enhance our technical capabilities or otherwise offer growth opportunities, although we currently have no agreements or understandings with respect to any such acquisitions or investments. Until such time as we can generate significant revenue from our products, if ever, we expect to finance our operations through the public or private sale of equity, government or private party grants, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions. If we are unable to obtain additional funding, we could be forced to delay, reduce or eliminate some or all of our research and development programs, product portfolio expansion or any commercialization efforts, which could adversely affect our business prospects, or we may be unable to continue operations. If we raise funds through strategic collaborations or other similar arrangements with third-parties, we may have to relinquish valuable rights to our platform technology, future revenue streams, research programs or product candidates or may have to grant licenses on terms that may not be favorable to us and/or may reduce the value of our ordinary shares. Because of the numerous risks and uncertainties associated with product development, we cannot predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability.
Impact of Geopolitical and Macroeconomic Factors
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.
Components of Our Results of Operations
Operating Expenses
Research and Development
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,
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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.
We are focusing substantially all of our resources on the development of our product candidates and the discovery of new product candidates through our structure-based drug discovery platform. At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of our product candidates.
We expect our research and development expenses to continue to account for a significant portion of our operating expenses, and to increase substantially for the foreseeable future as we advance our product candidates into and through preclinical studies and clinical trials, identify new product candidates and potentially pursue regulatory approval of our product candidates. We anticipate that we will make determinations as to which product candidates to pursue and how much funding to direct to each product candidate on an ongoing basis in response to the results of ongoing and future preclinical studies and clinical trials, such as to conduct Phase 3 clinical trials of aleniglipron.
General and Administrative
Our general and administrative expenses consist primarily of personnel-related costs for personnel in executive, legal, finance and other administrative functions, including salaries, bonuses, benefits and share-based compensation expenses, professional fees for legal, consulting, accounting and tax services, allocated overhead expenses, including rent, equipment, depreciation, information technology costs and utilities, and other general operating expenses not otherwise classified as research and development expenses.
We expect our general and administrative expenses will increase during the next several years as we increase our headcount and expand our infrastructure to support our operations, particularly as a public company. In addition, as a public company, we have incurred and will continue to incur significant legal, accounting, investor relations and other expenses to comply with the reporting requirements of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), the listing standards of Nasdaq, the Sarbanes-Oxley Act, and other applicable securities rules and regulations. Our general and administrative expenses may fluctuate from period to period as we continue to grow.
Interest and Other Income, Net
Interest and other income, net primarily consists of interest income earned on our cash, cash equivalents and short-term investments, including amortization and accretion of premiums and discounts on short-term investments, and foreign currency exchange gains and losses.
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Results of Operations
Comparison of the Three Months Ended June 30, 2026 and 2025
The following table summarizes our consolidated results of operations for the periods indicated (in thousands):
THREE MONTHS ENDED
JUNE 30,
2026 2025
Operating expenses:
Research and development $ 100,057 $ 54,710
General and administrative 18,573 15,741
Total operating expenses 118,630 70,451
Loss from operations (118,630) (70,451)
Interest and other income, net 12,705 8,929
Loss before income tax expense (105,925) (61,522)
Provision for income taxes 234 139
Net loss $ (106,159) $ (61,661)
Research and Development Expenses
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).
The following table summarizes our research and development expenses for the periods indicated (in thousands):
THREE MONTHS ENDED
JUNE 30,
2026 2025
Product candidate:
Aleniglipron (GSBR‑1290) $ 62,871 $ 28,282
ACCG-2671 8,454 9,650
ACCG-3535 3,223 —
Other 25,509 16,778
Total research and development expenses $ 100,057 $ 54,710
General and Administrative Expenses
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.
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Interest and Other Income, Net
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.
Comparison of the Six Months Ended June 30, 2026 and 2025
The following table summarizes our consolidated results of operations for the periods indicated (in thousands):
SIX MONTHS ENDED
JUNE 30,
2026 2025
Operating expenses:
Research and development $ 166,564 $ 97,577
General and administrative 41,445 29,185
Total operating expenses 208,009 126,762
Loss from operations (208,009) (126,762)
Interest and other income, net 26,306 18,505
Loss before provision for income taxes (181,703) (108,257)
Provision for income taxes 424 237
Net loss $ (182,127) $ (108,494)
Research and Development Expenses
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).
The following table summarizes our research and development expenses for the periods indicated (in thousands):
SIX MONTHS ENDED
JUNE 30,
2026 2025
Product candidate:
Aleniglipron (GSBR‑1290) $ 101,057 $ 53,267
ACCG-2671 15,595 15,260
ACCG-3535 5,038 —
Other 44,874 29,050
Total research and development expenses $ 166,564 $ 97,577
General and Administrative Expenses
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
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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.
Interest and Other Income, Net
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.
Liquidity and Capital Resources
Sources of Funds
At-the-Market Offering
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.
2025 Follow-On Offering
In December 2025, we issued and sold (i) 9,961,538 ADSs, including the issuance of 1,500,000 ADSs in connection with the full exercise of the underwriters’ option, and (ii) in lieu of ADSs to certain investors, pre-funded warrants to purchase ordinary shares represented by 1,538,462 ADSs (the “Pre-Funded Warrants”) at a price of $64.9999 per Pre-Funded Warrant, which represents the per ADS public offering price less the $0.0001 per share exercise price for each such Pre-Funded Warrant. We received $701.5 million in net proceeds, after deducting the underwriting discounts and commissions and estimated offering expenses.
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.
Funding Requirements
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.
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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.
To date, we have not generated any revenue from our products. We do not expect to generate any significant product revenue until we successfully develop and obtain regulatory approval for and commercialize our product candidates, and we do not know when, or if, either will occur. We expect to continue to incur significant and increasing expenses and operating losses for the foreseeable future, particularly if and as we continue to invest in our research and development activities and initiate additional clinical trials, expand our product pipeline, hire additional personnel and invest in and grow our business, maintain, expand and protect our intellectual property portfolio, and seek regulatory approvals for and commercialize any approved product candidates. In addition, we have incurred and expect to continue to incur additional costs associated with operating as a public company, including significant legal, audit, accounting, regulatory, tax-related, director and officer insurance, investor relations and other expenses that we did not incur as a private company. Moreover, we may in the future seek to acquire or invest in additional businesses, products, or technologies that we believe could complement or enhance our products, enhance our technical capabilities or otherwise offer growth opportunities, although we currently have no agreements or understandings with respect to any such acquisitions or investments. We are subject to the risks typically related to the development of new product candidates, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business.
We will need substantial additional capital to develop our product candidates, including to fund Phase 3 clinical trials of aleniglipron, and fund operations for the foreseeable future. Our future capital requirements will depend on many factors, including:
● the scope, timing, rate of progress and costs of our preclinical development activities, laboratory testing and clinical trials for our product candidates;
● the number and scope of clinical programs we decide to pursue;
● the cost, timing and outcome of preparing for and undergoing regulatory review of our product candidates;
● the cost and timing of manufacturing our product candidates;
● the cost and timing associated with commercializing our product candidates, if they receive marketing approval;
● the extent to which we acquire or in-license other product candidates and technologies;
● the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;
● our ability to establish and maintain collaborations on favorable terms, if at all;
● our efforts to enhance operational systems and our ability to attract, hire and retain qualified personnel, including personnel to support the development of our product candidates and, ultimately, the sale of our products, following FDA approval;
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● our implementation of operational, financial and management systems; and
● the impact of geopolitical and macroeconomic events, including tariffs, future bank failures, increased geopolitical tensions between the United States and China, various global conflicts and global pandemics on U.S. and global economic conditions including changes in monetary and fiscal policy, tax laws, U.S. political developments and other sources of instability that may impact our ability to access capital on acceptable terms, if at all.
A change in the outcome of any of these or other variables with respect to the development of our product candidates could significantly change the costs and timing associated with the development of that product candidate. Furthermore, our business plans may change in the future, and we will continue to require additional capital to meet operational needs and capital requirements associated with such plans.
Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the public or private sale of equity, government or private party grants, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions.
To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest may be diluted, and the terms of these securities may include liquidation or other preferences and anti-dilution protections that could adversely affect your rights as a holder of our ADSs. Additional debt or preferred equity financing, if available, may involve agreements that include restrictive covenants that may limit our ability to take specific actions, such as incurring debt, making capital expenditures or declaring dividends, which could adversely impact our ability to conduct our business, and may require the issuance of warrants, which could potentially dilute your ownership interest. If we raise funds through strategic collaborations or other similar arrangements with third-parties, we may have to relinquish valuable rights to our platform technology, future revenue streams, research programs or product candidates or may have to grant licenses on terms that may not be favorable to us and/or may reduce the value of our ordinary shares.
If we are unable to obtain additional funding, or funding on acceptable terms, we could be forced to delay, reduce or eliminate some or all of our research and development programs, product portfolio expansion or any commercialization efforts, which could adversely affect our business prospects, or we may be unable to continue operations. Because of the numerous risks and uncertainties associated with product development, we cannot predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability.
Summary Statements of Cash Flows
The following table sets forth the primary sources and uses of cash for the periods presented below (in thousands):
SIX MONTHS ENDED
JUNE 30,
2026 2025
Net cash (used in) provided by:
Operating activities $ (104,881) $ (106,787)
Investing activities (422,447) 82,975
Financing activities 343 1,326
Net decrease in cash and cash equivalents $ (526,985) $ (22,486)
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Cash Flows Used in Operating Activities
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.
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.
Cash Flows (Used in) Provided by Investing Activities
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.
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.
Cash Flows Provided by Financing Activities
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.
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.
Contractual Obligations
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.
Critical Accounting Policies
Our condensed consolidated financial statements have been prepared in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”). The preparation of our condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities as of the date of the condensed consolidated financial statements and the reported expenses incurred during the reporting periods. Our estimates are based on our knowledge of current events and actions we may undertake in the future and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may materially differ from these estimates under different assumptions or conditions.
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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.
Recent Accounting Pronouncements
See “Recent Accounting Pronouncements” in Note 2 to our unaudited interim condensed consolidated financial statements included in Part I. Item 1 “Financial Statements” in this Quarterly Report for additional information.