First patients dosed in aleniglipron (oral small molecule GLP-1 receptor agonist)
Phase 3 ACCOMPLISH program for chronic weight management
Data from Phase 1 SAD clinical trial of ACCG-2671 (oral small molecule dual amylin and calcitonin receptor agonist) and initiation of MAD clinical trial on track for Q3 2026
Topline 72-week aleniglipron ACCESS OLE data on track for Q3 2026;
data from body composition, type 2 diabetes/obesity and SWITCH clinical trials
on track for Q4 2026
Appointed metabolic commercial industry veteran
Cash, cash equivalents and short-term investments of
expected to fund projected operations and key clinical milestones through 2028
“Dosing the first patients in ACCOMPLISH-1 and -2 is a defining milestone for Structure as we advance aleniglipron, our potentially best-in-class oral GLP-1 receptor agonist, toward potential registration,” said
“Obesity is a chronic disease, and people need treatment options that can adapt to their individual goals over time,” continued
Recent and Upcoming Milestones
Aleniglipron – Oral Small Molecule Selective Glucagon-Like Peptide 1 (GLP-1) Receptor Agonist for Chronic Weight Management
The Company announced that the first patients have been dosed in the Phase 3 ACCOMPLISH program, which includes two clinical trials evaluating aleniglipron, a once-daily oral small molecule GLP-1 receptor agonist.
- ACCOMPLISH-1 is evaluating aleniglipron in adults living with obesity or overweight with a weight-related comorbidity and will enroll up to 3,600 patients; ACCOMPLISH-2 is evaluating aleniglipron in adults living with obesity or overweight and type 2 diabetes mellitus (T2DM) and will enroll up to 1,100 patients.
- ACCOMPLISH-1 and ACCOMPLISH-2 are randomized, double-blind, placebo-controlled clinical 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, with three active doses (45 mg, 90 mg or 180 mg) or placebo. Patients will begin treatment at a 2.5 mg starting dose with 4-week titration increments.
- Together, the ACCOMPLISH clinical trials are designed to support global regulatory submissions for aleniglipron in chronic weight management.
- Additional information about ACCOMPLISH-1 and ACCOMPLISH-2, including endpoints, eligibility criteria and enrolling sites, is available at ClinicalTrials.gov under identifiers NCT07654361 and NCT07654374, respectively.
In
Structure plans to report new data from the following aleniglipron clinical trials in the second half of 2026:
- The ACCESS Open Label Extension (OLE) clinical trial is evaluating the tolerability of the dose titration regimen that includes a starting dose of 2.5 mg in placebo crossover patients. The clinical trial will be completed after a total of 72 weeks of treatment, where some participants have been exposed to 180 mg for a certain period of time. Data are expected in Q3 2026.
- The Body Composition clinical trial is assessing the effect of aleniglipron on body fat loss over a 44-week evaluation period. Data are expected in Q4 2026.
- The clinical trial in patients with T2DM with obesity/overweight is evaluating the potential for including participants with T2DM in the Phase 3 program. Data are expected in Q4 2026.
- The SWITCH clinical trial is assessing the transition from an approved injectable GLP-1 receptor agonist to once-daily oral aleniglipron for long-term weight loss maintenance. Data are expected in Q4 2026.
Oral Small Molecule Dual Amylin and Calcitonin Receptor Agonists
- ACCG-2671, an oral small molecule dual amylin and calcitonin receptor agonist, continues to be evaluated in an ongoing Phase 1 single ascending dose (SAD) clinical trial assessing safety, tolerability, pharmacokinetics and food effect in healthy adult participants. Initial data, along with initiation of a multiple ascending dose (MAD) clinical trial, remain on track for Q3 2026.
- The Company plans to initiate a Phase 1 clinical trial of its second oral small molecule dual amylin and calcitonin receptor agonist candidate, ACCG-3535, in Q4 2026, demonstrating continued leadership in the oral small molecule amylin field.
Combination of Oral Small Molecule GLP-1 and Amylin Receptor Agonists
- Preclinical combination data of aleniglipron and ACCG-2671 were presented at the ADA Scientific Sessions in
June 2026 demonstrating additional weight loss compared to each monotherapy in non-human primates. A combination clinical trial is expected to be initiated in Q4 2026.
Appointment of
- Structure has appointed
John Berrios as its CCO.Mr. Berrios brings more than 25 years of commercial leadership experience across the biopharmaceutical industry, with expertise spanning commercial strategy, sales, marketing, operations and market access. Most recently, he served as Head ofU.S . Sales Strategy and Innovation for Obesity and Diabetes at Novo Nordisk and was instrumental in leading the strategic planning and commercial launch of its obesity and diabetes portfolio. Previously, he held senior leadership roles atBayer Pharmaceuticals and AstraZeneca, where he led commercial organizations and supported the launch and growth of multiple products across obesity, diabetes, cardiovascular disease, and other therapeutic areas.
Second Quarter 2026 Financial Highlights
Cash Position: Cash, cash equivalents and short-term investments totaled
Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2026 were
General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2026 were
Net Loss: Net loss for the second quarter of 2026 totaled
About Structure Therapeutics
Structure Therapeutics is a science-driven clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, the Company has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage oral small molecule compounds designed to surpass the scalability limitations of traditional biologic and peptide therapies and be accessible to more people living with obesity around the world. For additional information, please visit www.structuretx.com.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact contained in this press release are statements that could be deemed forward-looking statements, including, without limitation, statements concerning: the Company’s future plans and prospects, including its research and development activities; the design, initiation, enrollment, conduct, timing and completion of the Company’s clinical trials, including the aleniglipron Phase 3 ACCOMPLISH program, the ACCG-2671 multiple ascending dose (MAD) clinical trial, the ACCG-3535 Phase 1 clinical trial and the combination amylin/GLP-1 clinical trial and the timing of topline, interim, or additional data readouts from the Phase 1 single ascending dose (SAD) clinical trial of ACCG-2671, and the aleniglipron ACCESS OLE, Body Composition, SWITCH and type 2 diabetes/obesity clinical trials; the Company’s expectation that the aleniglipron ACCOMPLISH clinical trials will be sufficient to support global regulatory submissions for aleniglipron in chronic weight management; any expectations regarding the potential benefits, tolerability and safety profile, accessibility, scalability, combinability, capability, efficacy, convenience, expected effects, competitive positioning (including any characterization of a product candidate as potential “best-in-class” or “first-in-class”) and future application of aleniglipron, ACCG-2671, ACCG-3535 and any other of the Company’s investigational compounds; any presumption that topline, interim or preliminary data will be representative of, or predictive of, final data from other or later clinical trials; the Company’s ability to support global regulatory submissions for its product candidates and to obtain, maintain and expand regulatory approvals; and the Company’s expectations regarding its cash, cash equivalents and short-term investments and its estimated cash runway, including its ability to fund projected operations and clinical milestones through the end of 2028. In addition, when or if used in this press release, the words and phrases “continue,” “could,” “anticipated,” “believe,” “expect,” “may,” “on track,” “plan,” “potential,” “project,” “remain,” “target,” “suggests,” “to be,” “to begin,” “will,” and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of risks and uncertainties, which include, without limitation: the risk that topline, interim or preliminary data the Company reports are based on a preliminary analysis of then-available efficacy and safety data, and such data may change following a more comprehensive review of the data related to the applicable clinical trial, and such topline, interim or preliminary data may not accurately reflect the complete or final results of a clinical trial; the preliminary nature of clinical results given the length of the applicable clinical trial and sample size, and the fact that results from earlier clinical trials are not necessarily predictive of future results; potential delays in the commencement, enrollment, conduct or completion of the Company’s planned and ongoing clinical trials, including the Phase 3 ACCOMPLISH program; the risk that clinical trial results may not support further development or regulatory approval of aleniglipron, ACCG-2671, ACCG-3535, or the Company’s other therapeutic candidates; the Company’s ability to obtain and maintain regulatory approval of, and ultimately successfully commercialize, its therapeutic candidates; the effect of competitive products or therapeutic approaches on the commercial value of the Company’s product candidates; the Company’s ability to fund its development activities and achieve its development goals; and other risks and uncertainties described in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including the Company’s most recent Quarterly Report on Form 10-Q, and other reports the Company has filed or may file with the SEC from time to time. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Investors:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
212-915-2577
cdavis@lifesciadvisors.com
Jen Robinson
Structure Therapeutics Inc.
ir@structuretx.com
Media:
Dan Budwick
1AB
Dan@1abmedia.com
| Condensed Consolidated Statements of Operations | |||||||||||||||||
| (unaudited) | |||||||||||||||||
| (In thousands) | |||||||||||||||||
| THREE MONTHS ENDED | SIX MONTHS ENDED | ||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||||
| Operating expenses: | |||||||||||||||||
| Research and development | $ | 100,057 | $ | 54,710 | $ | 166,564 | $ | 97,577 | |||||||||
| General and administrative | 18,573 | 15,741 | 41,445 | 29,185 | |||||||||||||
| Total operating expenses | 118,630 | 70,451 | 208,009 | 126,762 | |||||||||||||
| Loss from operations | (118,630 | ) | (70,451 | ) | (208,009 | ) | (126,762 | ) | |||||||||
| Interest and other income, net | 12,705 | 8,929 | 26,306 | 18,505 | |||||||||||||
| Loss before provision for income taxes | (105,925 | ) | (61,522 | ) | (181,703 | ) | (108,257 | ) | |||||||||
| Provision for (benefit from) income taxes | 234 | 139 | 424 | 237 | |||||||||||||
| Net loss | $ | (106,159 | ) | $ | (61,661 | ) | $ | (182,127 | ) | $ | (108,494 | ) | |||||
| Research and development | $ | 7,054 | $ | 3,461 | $ | 12,155 | $ | 6,160 | |||||||||
| General and administrative | 5,580 | 4,048 | 12,118 | 7,267 | |||||||||||||
| Total share-based compensation | $ | 12,634 | $ | 7,509 | $ | 24,273 | $ | 13,427 | |||||||||
| Condensed Consolidated Balance Sheet Data | |||||||
| (unaudited) | |||||||
| (In thousands) | |||||||
| 2026 | 2025 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash, cash equivalents and short-term investments | $ | 1,342,658 | $ | 1,446,197 | |||
| Prepaid expenses and other current assets | 29,370 | 124,106 | |||||
| Total current assets | 1,372,028 | 1,570,303 | |||||
| Property and equipment, net | 6,332 | 6,653 | |||||
| Operating right-of-use assets | 6,060 | 6,245 | |||||
| Other non-current assets | 40,995 | 717 | |||||
| Total assets | $ | 1,425,415 | $ | 1,583,918 | |||
| Liabilities and shareholders’ equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 11,131 | $ | 13,864 | |||
| Accrued expenses and other current liabilities | 52,387 | 46,543 | |||||
| Operating lease liabilities, current portion | 2,595 | 2,878 | |||||
| Total current liabilities | 66,113 | 63,285 | |||||
| Operating lease liabilities, net of current portion | 3,633 | 3,609 | |||||
| Other non-current liabilities | 1,265 | 647 | |||||
| Total liabilities | 71,011 | 67,541 | |||||
| Total shareholders’ equity | 1,354,404 | 1,516,377 | |||||
| Total liabilities and shareholders’ equity | $ | 1,425,415 | $ | 1,583,918 | |||
Source: