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Structure TherapeuticsD
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2026-08-06
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Investor releaseQuarter not tagged2026-08-06

Structure Therapeutics Reports Second Quarter 2026 Financial Results and Recent Highlights

GlobeNewswire
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 John Berrios as Chief Commercial Officer Cash, cash equivalents and short-term investments of $1.3 billion as of June 30, 2026 expected to fund projected operations and key clinical milestones through 2028 SAN FRANCISCO, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today reported financial results for the second quarter ended June 30, 2026 and provided a business update including the initiation of the Phase 3 ACCOMPLISH program evaluating aleniglipron for chronic weight management. “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 Raymond Stevens, Ph.D., Chief Executive Officer of Structure Therapeutics. “As we enter this next stage of development, the appointment of John Berrios as our Chief Commercial Officer adds tremendous experience in obesity, diabetes, market access and commercialization to our senior leadership team, particularly given his leadership role in the GLP-1 space.” “Obesity is a chronic disease, and people need treatment options that can adapt to their individual goals over time,” continued Dr. Stevens. “We are building a comprehensive portfolio of oral small molecule medicines designed to provide greater choice, flexibility and accessibility across the treatment journey, from initial weight loss through long-term weight maintenance. As an important component of this strategy, we are advancing ACCG-2671, our potentially first-in-class oral small molecule dual amylin and calcitonin receptor agonist and remain on track to report initial single ascending dose data and initiate a multiple…Read full document

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 John Berrios as Chief Commercial Officer Cash, cash equivalents and short-term investments of $1.3 billion as of June 30, 2026 expected to fund projected operations and key clinical milestones through 2028 SAN FRANCISCO, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today reported financial results for the second quarter ended June 30, 2026 and provided a business update including the initiation of the Phase 3 ACCOMPLISH program evaluating aleniglipron for chronic weight management. “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 Raymond Stevens, Ph.D., Chief Executive Officer of Structure Therapeutics. “As we enter this next stage of development, the appointment of John Berrios as our Chief Commercial Officer adds tremendous experience in obesity, diabetes, market access and commercialization to our senior leadership team, particularly given his leadership role in the GLP-1 space.” “Obesity is a chronic disease, and people need treatment options that can adapt to their individual goals over time,” continued Dr. Stevens. “We are building a comprehensive portfolio of oral small molecule medicines designed to provide greater choice, flexibility and accessibility across the treatment journey, from initial weight loss through long-term weight maintenance. As an important component of this strategy, we are advancing ACCG-2671, our potentially first-in-class oral small molecule dual amylin and calcitonin receptor agonist and remain on track to report initial single ascending dose data and initiate a multiple ascending dose clinical trial in the third quarter. We also look forward to initiating our combination GLP-1 and amylin receptor agonist clinical trial later this year. We believe these programs have the potential to provide meaningful, sustained weight and metabolic benefits through convenient and accessible oral treatment options.” 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 June 2026, data from the Phase 2b ACCESS clinical trial of aleniglipron were published in Nature Medicine and highlighted in an oral presentation at the American Diabetes Association's (ADA) 86th Scientific Sessions. The publication and presentation detailed dose-dependent, clinically meaningful and statistically significant reductions in body weight, with continued weight loss beyond 36 weeks and up to 16.2% at 44 weeks observed during the open-label extension. 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%. 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 John Berrios as Chief Commercial Officer (CCO) 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 of U.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 at Bayer 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 $1.3 billion as of June 30, 2026, compared to $1.5 billion as of March 31, 2026. The Company expects its current cash, cash equivalents and short-term investments to fund projected operations and key clinical milestones through the end of 2028, including costs related to the ongoing aleniglipron ACCESS OLE, ACCESS II extension clinical trial, the supplementary clinical trials, and Phase 3 registrational program in chronic weight management, but excludes additional costs related to pre-commercialization activities including commercial manufacturing. Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2026 were $100.1 million, as compared to $54.7 million for the same period in 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). General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2026 were $18.6 million, as compared to $15.7 million for the same period in 2025. The increase in G&A expenses was primarily due to increases in employee expenses as the Company expanded its infrastructure to drive and support the growth in operations as a publicly-traded company, and increases in professional services. Net Loss: Net loss for the second quarter of 2026 totaled $106.2 million, with non-cash share-based compensation expense of $12.6 million, compared to a net loss of $61.7 million for the same period in 2025, with non-cash share-based compensation expense of $7.5 million. About Structure TherapeuticsStructure 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 StatementsThis 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, [email protected] Jen RobinsonStructure Therapeutics [email protected] Media:Dan [email protected]

Investor releaseQuarter not tagged2026-05-24

This Biotech Stock Is Up 355%. One Fund Added a $169 Million Position Last Quarter

Motley Fool
On May 15, 2026, Deep Track Capital disclosed a new position in Alumis (NASDAQ:ALMS), acquiring 6,772,595 shares—an estimated $169.31 million trade based on quarterly average pricing. According to a May 15, 2026 SEC filing, Deep Track Capital reported acquiring 6,772,595 shares of Alumis (NASDAQ:ALMS) during the first quarter of 2026. The estimated transaction value was $169.31 million, based on the period’s average unadjusted closing price. As of March 31, 2026, the fund’s Alumis stake was valued at $149.20 million, reflecting both the purchase and stock price changes during the quarter. Top five holdings after the filing: As of Friday, shares of Alumis were priced at $22.02, up about 355% over the past year and well outperforming the S&P 500, which is up about 28% in the same period. Alumis develops clinical-stage biopharmaceutical products targeting autoimmune and neuroinflammatory diseases, with lead assets including ESK-001 and A-005. The firm operates a research-driven business model focused on advancing proprietary TYK2 inhibitors through clinical trials toward potential commercialization. It targets healthcare providers and patients affected by autoimmune disorders such as plaque psoriasis, systemic lupus erythematosus, and neurodegenerative diseases. Alumis is a biotechnology company specializing in the development of novel therapies for autoimmune and neuroinflammatory conditions. It leverages expertise in allosteric TYK2 inhibition to advance a pipeline of differentiated clinical candidates. With a focus on unmet medical needs, Alumis aims to establish a competitive edge through innovative science and targeted clinical development strategies. Deep Track has a history of making concentrated healthcare investments, and Alumis fits that playbook as a late-stage biotech with multiple shots on goal and several potentially value-defining catalysts over the next year.The story is increasingly centered on envudeucitinib, the company's TYK2 inhibitor for autoimmune diseases. Recent Phase 3 psoriasis data showed PASI 90 response rates of 68.0% and 62.1% by Week 24, with PASI 100 rates reaching 41.0% and 39.5%. Management says it remains on track to submit an NDA in the fourth quarter of this year, while potentially pivotal Phase 2b lupus data are expected in the third quarter.CEO Martin Babler said the results reinforce the drug's potential to "reshape the…Read full document

On May 15, 2026, Deep Track Capital disclosed a new position in Alumis (NASDAQ:ALMS), acquiring 6,772,595 shares—an estimated $169.31 million trade based on quarterly average pricing. According to a May 15, 2026 SEC filing, Deep Track Capital reported acquiring 6,772,595 shares of Alumis (NASDAQ:ALMS) during the first quarter of 2026. The estimated transaction value was $169.31 million, based on the period’s average unadjusted closing price. As of March 31, 2026, the fund’s Alumis stake was valued at $149.20 million, reflecting both the purchase and stock price changes during the quarter. Top five holdings after the filing: As of Friday, shares of Alumis were priced at $22.02, up about 355% over the past year and well outperforming the S&P 500, which is up about 28% in the same period. Alumis develops clinical-stage biopharmaceutical products targeting autoimmune and neuroinflammatory diseases, with lead assets including ESK-001 and A-005. The firm operates a research-driven business model focused on advancing proprietary TYK2 inhibitors through clinical trials toward potential commercialization. It targets healthcare providers and patients affected by autoimmune disorders such as plaque psoriasis, systemic lupus erythematosus, and neurodegenerative diseases. Alumis is a biotechnology company specializing in the development of novel therapies for autoimmune and neuroinflammatory conditions. It leverages expertise in allosteric TYK2 inhibition to advance a pipeline of differentiated clinical candidates. With a focus on unmet medical needs, Alumis aims to establish a competitive edge through innovative science and targeted clinical development strategies. Deep Track has a history of making concentrated healthcare investments, and Alumis fits that playbook as a late-stage biotech with multiple shots on goal and several potentially value-defining catalysts over the next year.The story is increasingly centered on envudeucitinib, the company's TYK2 inhibitor for autoimmune diseases. Recent Phase 3 psoriasis data showed PASI 90 response rates of 68.0% and 62.1% by Week 24, with PASI 100 rates reaching 41.0% and 39.5%. Management says it remains on track to submit an NDA in the fourth quarter of this year, while potentially pivotal Phase 2b lupus data are expected in the third quarter.CEO Martin Babler said the results reinforce the drug's potential to "reshape the psoriasis treatment landscape" and described envudeucitinib as a potential "pipeline in a pill" with opportunities across additional immune-mediated diseases.Financially, Alumis ended the quarter with $569.5 million in cash, cash equivalents, and marketable securities and expects that capital to fund operations into the fourth quarter of 2027.For long-term investors, the thesis is straightforward. If upcoming lupus data and the planned psoriasis filing go well, today's valuation could look conservative. If either disappoints, the stock's remarkable run may prove difficult to sustain. Before you buy stock in Alumis, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Alumis wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $477,813!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,320,088!* Now, it’s worth noting Stock Advisor’s total average return is 986% — a market-crushing outperformance compared to 208% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of May 24, 2026. Jonathan Ponciano has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Guardant Health. The Motley Fool has a disclosure policy. This Biotech Stock Is Up 355%. One Fund Added a $169 Million Position Last Quarter was originally published by The Motley Fool

Investor releaseQuarter not tagged2026-05-08

Structure Therapeutics Reports First Quarter 2026 Financial Results and Recent Highlights

GlobeNewswire
Reported positive results from aleniglipron Phase 2 ACCESS II study with up to 16.3% body weight loss, demonstrating highest efficacy among oral GLP-1RAs at the 44-week time point and potentially comparable efficacy to injectable GLP1-RAs Data from ACCESS OLE expected in Q3 2026; Data from the Body Composition and Type 2 Diabetes/Obesity data expected in Q4 2026 Positive end-of-Phase 2 feedback received from FDA; aleniglipron Phase 3 initiation on track for Q3 2026 Initial data from Phase 1 single ascending dose (SAD) study of oral small molecule amylin receptor agonist ACCG-2671 and initiation of multiple ascending dose (MAD) study expected in Q3 2026; Phase 1 initiation of second oral amylin candidate ACCG-3535 expected in Q4 2026 Aleniglipron, amylin and combination data to be presented at the American Diabetes Association (ADA) 86th Scientific Sessions in June 2026 Cash, cash equivalents and short-term investments of $1.5 billion as of March 31, 2026, expected to provide cash runway through the end of 2028 SAN FRANCISCO, May 07, 2026 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today reported financial results for the first quarter ended March 31, 2026, and provided a business update. “With positive end of Phase 2 feedback received from the FDA for aleniglipron, we are well positioned to start our Phase 3 registrational program for chronic weight management in the third quarter,” said Raymond Stevens, Ph.D., CEO of Structure Therapeutics. “We are also looking forward to our aleniglipron presentation along with presentations on our oral amylin and GLP-1 combination program at the upcoming ADA meeting. With our Phase 1 clinical data for our oral amylin candidate ACCG-2671 anticipated in the third quarter and additional aleniglipron data later this year, our broad portfolio positions us well in the evolving landscape that we believe will favor more accessible oral small molecules, extended maintenance treatment, and fixed dose oral combinations for specific patient populations and expanded indications.” Recent and Upcoming Milestones Aleniglipron - Oral Small Molecule Selective Glucagon-Like Peptide 1 (GLP-1) Receptor Agonist for the Treatment of Obesity and Overweight In March 2026, the Comp…Read full document

Reported positive results from aleniglipron Phase 2 ACCESS II study with up to 16.3% body weight loss, demonstrating highest efficacy among oral GLP-1RAs at the 44-week time point and potentially comparable efficacy to injectable GLP1-RAs Data from ACCESS OLE expected in Q3 2026; Data from the Body Composition and Type 2 Diabetes/Obesity data expected in Q4 2026 Positive end-of-Phase 2 feedback received from FDA; aleniglipron Phase 3 initiation on track for Q3 2026 Initial data from Phase 1 single ascending dose (SAD) study of oral small molecule amylin receptor agonist ACCG-2671 and initiation of multiple ascending dose (MAD) study expected in Q3 2026; Phase 1 initiation of second oral amylin candidate ACCG-3535 expected in Q4 2026 Aleniglipron, amylin and combination data to be presented at the American Diabetes Association (ADA) 86th Scientific Sessions in June 2026 Cash, cash equivalents and short-term investments of $1.5 billion as of March 31, 2026, expected to provide cash runway through the end of 2028 SAN FRANCISCO, May 07, 2026 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today reported financial results for the first quarter ended March 31, 2026, and provided a business update. “With positive end of Phase 2 feedback received from the FDA for aleniglipron, we are well positioned to start our Phase 3 registrational program for chronic weight management in the third quarter,” said Raymond Stevens, Ph.D., CEO of Structure Therapeutics. “We are also looking forward to our aleniglipron presentation along with presentations on our oral amylin and GLP-1 combination program at the upcoming ADA meeting. With our Phase 1 clinical data for our oral amylin candidate ACCG-2671 anticipated in the third quarter and additional aleniglipron data later this year, our broad portfolio positions us well in the evolving landscape that we believe will favor more accessible oral small molecules, extended maintenance treatment, and fixed dose oral combinations for specific patient populations and expanded indications.” Recent and Upcoming Milestones Aleniglipron - Oral Small Molecule Selective Glucagon-Like Peptide 1 (GLP-1) Receptor Agonist for the Treatment of Obesity and Overweight In March 2026, the Company reported data from the aleniglipron clinical program included 44-week topline data from the Phase 2 ACCESS II study, as well as interim data from body composition study and Phase 2b ACCESS open label extension (OLE) study. The Phase 2 ACCESS II study 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. The ongoing ACCESS OLE study achieved continued weight loss up to 16.2% (40.5 lbs) observed with 120 mg dose at 56 weeks. No weight loss plateau was observed in any of the studies. Data from the ACCESS, ACCESS II, Body Composition, and the ACCESS OLE studies provide a strong foundation for the decision to advance aleniglipron into Phase 3 clinical development. The Company expects to report topline results from the ACCESS OLE and Body Composition studies in Q3 and Q4 2026, respectively. The Company received positive end-of-Phase 2 feedback from the U.S. Food and Drug Administration (FDA) and clear guidance on the Phase 3 program with a starting titration dose of 2.5 mg and the intent to evaluate multiple doses. The Company anticipates initiating the Phase 3 program in Q3 2026. The Company is also conducting supplementary studies to enhance the competitive profile of aleniglipron, including: Ongoing study of ACCESS OLE 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. Data are expected in Q3 2026. Ongoing Body Composition study 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. These data will be used to inform the size of a sub study into the Phase 3 program. Data are expected in Q4 2026. Ongoing 30-week study in patients with type 2 diabetes mellitus (T2DM) with obesity/overweight and a starting dose of 2.5 mg and target dose of 180 mg of aleniglipron to evaluate the potential for including participants with T2DM in the Phase 3 obesity program. Data are expected in Q4 2026. Ongoing SWITCH study to assess the transition or switching from an approved injectable GLP-1 receptor agonist to once-daily oral aleniglipron for weight loss maintenance. This study assesses different aleniglipron starting doses and weight loss maintenance over 12 weeks. Data are expected in Q4 2026. Oral Small Molecule Amylin Receptor Agonists In December 2025, the Company advanced ACCG-2671 into a Phase 1 clinical study as the industry’s most advanced oral small molecule amylin therapy for the treatment of obesity. ACCG-2671 is being evaluated in an ongoing single ascending dose (SAD) study to measure safety, tolerability, pharmacokinetics, and food-effect of single ascending doses in healthy adult participants with data anticipated in 2H 2026. In addition, the Company expects to initiate a multiple ascending dose (MAD) study in Q3 2026. In November 2025, the Company declared a second oral small molecule dual amylin calcitonin receptor agonist development candidate, ACCG-3535. ACCG-3535, which is a unique chemical structure compared to ACCG-2671, 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. The Company expects to initiate a Phase 1 clinical study of ACCG-3535 in Q4 2026. Multiple presentations at ADA, taking place from June 5–8, 2026 Details of the presentations are as follows: Title: ACCESS Trial: Dose-Ranging Evaluation of Aleniglipron, an Oral Small Molecule Nonpeptide GLP-1RA, Demonstrates Meaningful Weight Reductions in People Living with Obesity and Overweight Session: Oral Presentations - Human Studies in Obesity Treatment: Emerging Therapeutic Options and Strategies for Decision-Making (1032-OR) Speaker: Julio Rosenstock, MD, University of Texas Southwestern Medical Center Date: Friday, June 5: 12:45 p.m. – 1:00 p.m. CT Title: Safety, Tolerability, and Efficacy of Aleniglipron in Doses up to 240 mg in People Living with Obesity: The Phase 2 ACCESS II Trial Session: General Poster Session (2637-P) Date: Monday, June 8: 12:30 p.m. – 1:30 p.m. CT Title: Exploring a Lower Starting Dose of Aleniglipron, an Oral Small Molecule GLP-1RA, to Improve GI Tolerability in Obesity: Beyond the ACCESS Trials Session: Late Breaking Poster Session (3101-LB) Date: Sunday, June 7: 12:30 p.m. – 1:30 p.m. CT Title: Combination Treatment of Oral Small Molecule GLP-1 Receptor Agonist Aleniglipron and Small Molecule Amylin Receptor Agonist ACCG-2671 Demonstrated Additional Weight Loss than Monotreatment in Obese NHPs Session: Late Breaking Poster Session (3061-LB) Date: Sunday, June 7: 12:30 p.m. – 1:30 p.m. CT Title: Comparison of Conditioned Taste Avoidance Profiles between GLP-1 Peptides, Amylin Peptides, and Small Molecule Amylin Receptor Agonists Session: Late Breaking Poster Session (3062-LB) Date: Sunday, June 7: 12:30 p.m. – 1:30 p.m. CT Additional information about the ADA 2026 Scientific Sessions is available at the ADA meeting website (American Diabetes Association). First Quarter 2026 Financial Highlights Cash Position: Cash, cash equivalents and short-term investments totaled $1.5 billion as of March 31, 2026. The Company 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. The Company expects its current cash, cash equivalents and short-term investments to fund projected operations and key clinical milestones through the end of 2028. This includes costs related to the ongoing aleniglipron ACCESS OLE, ACCESS II extension study, the supplementary studies, and Phase 3 registrational studies in chronic weight management, but excludes additional costs related to pre-commercialization activities including commercial manufacturing. Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2026 were $66.5 million, as compared to $42.9 million for the same period in 2025. The increase in R&D expenses was primarily due to increases related to clinical trial costs, preclinical research and development expenses and employee expenses (primarily due to an increase in personnel) to support the advancement of our GLP-1R franchise including aleniglipron. General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2026 were $22.9 million, as compared to $13.4 million for the same period in 2025. The increase in G&A expenses was primarily due to increases in employee expenses as we expanded our infrastructure to drive and support the growth in our operations and professional services. Net Loss: Net loss for the first quarter of 2026 totaled $76.0 million, with non-cash share-based compensation expense of $11.6 million, compared to $46.8 million for the same period in 2025 with non-cash share-based compensation expense of $5.9 million. About Aleniglipron and Structure Therapeutics’ Oral Metabolic Franchise Aleniglipron (GSBR-1290) is an investigational orally-available, small molecule agonist of the GLP-1 receptor, a validated drug target for the treatment of obesity and T2DM. Through Structure Therapeutics’ structure-based drug discovery platform, aleniglipron was designed to be a biased G Protein-Coupled Receptor (GPCR) agonist, which selectively activates the G-protein signaling pathway. Beyond aleniglipron, Structure Therapeutics is developing next generation oral small molecules including amylin receptor agonists (ACCG-2671 and ACCG-3535), and other combination GLP-1 receptor agonists candidates targeting the glucose-dependent insulinotropic polypeptide (GIP), glucagon and apelin receptors. About Structure Therapeutics Structure Therapeutics is a science-driven clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, the Company has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage oral small molecule compounds designed to surpass the scalability limitations of traditional biologic and peptide therapies and be accessible to more people living with obesity around the world. For additional information, please visit www.structuretx.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning: the Company’s future plans and prospects; the expected timing of ACCESS OLE and Body Composition studies data readouts; the planned initiation of the aleniglipron Phase 3 study and the timing thereof; the expected timing of initial data from the Phase 1 study of ACCG-2671; the planned initiation of the ACCG-3535 Phase 1 study and the timing thereof; the belief that data to date from the ACCESS, ACCESS II, Body Composition, and the ACCESS OLE studies support and inform aleniglipron advancement into Phase 3 clinical development; the Company’s anticipated cash runway and uses of cash; any expectations regarding the potential benefits, tolerability and safety profile, accessibility, scalability, combinability, capability, efficacy, convenience, expected effects and future application of aleniglipron; any presumption that topline, interim or preliminary data will be representative of final data or data in later clinical trials. In addition, when or if used in this press release, the words and phrases "anticipated," "believe," "expect," "potential," "to be," "will," and similar expressions and their variants, as they relate to the Company, may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the Company's forward-looking statements due to a variety of risks and uncertainties, which include, without limitation: risks and uncertainties related to topline results that the Company reports are based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; the preliminary nature of the results due to the length of the study and sample size and the results from earlier clinical studies not necessarily being predictive of future results; potential delays in the commencement, enrollment and completion of the Company's planned Phase 3 clinical program and other clinical studies; disruptions to the operations of the FDA or other U.S. governmental agencies or comparable foreign regulatory authorities caused by funding shortages, leadership changes, or staffing reductions; the Company's ability to advance aleniglipron, ACCG-2671, LTSE-2578, ACCG-3535, and its other therapeutic candidates, obtain regulatory approval of, and ultimately commercialize the Company's therapeutic candidates; competitive products or approaches limiting the commercial value of the Company's product candidates; the timing and results of preclinical and clinical studies; the Company's ability to fund development activities and achieve development goals; the Company's reliance on third parties, including clinical research organizations, manufacturers, suppliers and collaborators, over which it may not always have full control; general geopolitical and macroeconomic conditions, including as a result of tariffs and various global conflicts; the Company's ability to protect its intellectual property; and other risks and uncertainties described in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's latest Annual Report on Form 10-K and future reports the Company 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 [email protected] Jun Yoon Structure Therapeutics Inc. [email protected] Media: Dan Budwick 1AB [email protected]

Investor releaseQuarter not tagged2026-04-16

How Will Mounjaro and Zepbound Sales Aid LLY's Upcoming Q1 Results?

Zacks
Eli Lilly LLY has emerged as a dominant force in the cardiometabolic market, driven by strong demand for its blockbuster GLP-1 therapies, Mounjaro for type II diabetes (T2D) and Zepbound for obesity. Although both drugs have been on the market for just over three years, they have become LLY’s key top-line drivers. In 2025, the drugs generated combined sales of $36.5 billion, comprising around 56% of Eli Lilly’s total revenues. Investors will be closely watching the sales performance of Mounjaro and Zepbound when LLY reports its first-quarter 2026 results on April 30. The robust performance of Mounjaro and Zepbound in the recent quarters has largely been driven by improved domestic supply following the expansion of manufacturing capacity. Additionally, sales of both drugs have been boosted by their rollout across new international markets. The robust momentum of its GLP-1 franchise is a key driver underpinning Eli Lilly’s upbeat 2026 revenue outlook of $80-$83 billion. We believe that stronger penetration in the U.S. market and rising adoption in international markets likely fueled growth in both drugs in the first quarter of 2026. However, some headwinds are expected from lower pricing. Beyond cardiometabolic health, Lilly’s broader portfolio, including the oncology drug Verzenio and immunology drug Taltz, also continues to deliver steady growth. The company’s newly launched drugs, including Omvoh and Ebglyss in immunology, Jaypirca in oncology, and Kisunla in neuroscience, are all contributing to top-line growth. Eli Lilly and Novo Nordisk NVO presently dominate the obesity market. Mounjaro and Zepbound directly compete with NVO’s semaglutide medicines, Ozempic for T2D and Wegovy for obesity. Like Eli Lilly, Novo Nordisk also generates a substantial portion of revenues from both drugs. Novo Nordisk secured the long-awaited FDA approval for its oral Wegovy pill to treat obesity and reduce cardiovascular risk in late December, followed by its commercial launch in early January. This marked a major milestone, making Wegovy the first GLP-1 RA available in an oral form for weight management. Compared with injectable formulations, the pill offers a far more convenient administration option. Earlier this month, Eli Lilly also secured FDA approval for its GLP-1 obesity pill, Foundayo (orforglipron), and was subsequently launched in the United States, making it a di…Read full document

Eli Lilly LLY has emerged as a dominant force in the cardiometabolic market, driven by strong demand for its blockbuster GLP-1 therapies, Mounjaro for type II diabetes (T2D) and Zepbound for obesity. Although both drugs have been on the market for just over three years, they have become LLY’s key top-line drivers. In 2025, the drugs generated combined sales of $36.5 billion, comprising around 56% of Eli Lilly’s total revenues. Investors will be closely watching the sales performance of Mounjaro and Zepbound when LLY reports its first-quarter 2026 results on April 30. The robust performance of Mounjaro and Zepbound in the recent quarters has largely been driven by improved domestic supply following the expansion of manufacturing capacity. Additionally, sales of both drugs have been boosted by their rollout across new international markets. The robust momentum of its GLP-1 franchise is a key driver underpinning Eli Lilly’s upbeat 2026 revenue outlook of $80-$83 billion. We believe that stronger penetration in the U.S. market and rising adoption in international markets likely fueled growth in both drugs in the first quarter of 2026. However, some headwinds are expected from lower pricing. Beyond cardiometabolic health, Lilly’s broader portfolio, including the oncology drug Verzenio and immunology drug Taltz, also continues to deliver steady growth. The company’s newly launched drugs, including Omvoh and Ebglyss in immunology, Jaypirca in oncology, and Kisunla in neuroscience, are all contributing to top-line growth. Eli Lilly and Novo Nordisk NVO presently dominate the obesity market. Mounjaro and Zepbound directly compete with NVO’s semaglutide medicines, Ozempic for T2D and Wegovy for obesity. Like Eli Lilly, Novo Nordisk also generates a substantial portion of revenues from both drugs. Novo Nordisk secured the long-awaited FDA approval for its oral Wegovy pill to treat obesity and reduce cardiovascular risk in late December, followed by its commercial launch in early January. This marked a major milestone, making Wegovy the first GLP-1 RA available in an oral form for weight management. Compared with injectable formulations, the pill offers a far more convenient administration option. Earlier this month, Eli Lilly also secured FDA approval for its GLP-1 obesity pill, Foundayo (orforglipron), and was subsequently launched in the United States, making it a direct competitor to NVO’s Wegovy pill. The obesity space has garnered much of the spotlight over the past year due to the sizeable and still underpenetrated market opportunity. Smaller biotech firms, like Viking Therapeutics VKTX and Structure Therapeutics GPCR, are also advancing GLP-1–based therapies to challenge the incumbents. Viking Therapeutics’ dual GIPR/GLP-1 receptor agonist, VK2735, is being developed both as oral and subcutaneous formulations for the treatment of obesity. Viking Therapeutics plans to advance oral VK2735 into phase III development for obesity in the third quarter of 2026. Structure Therapeutics’ phase II ACCESS study on its oral GLP-1 RA, aleniglipron, for obesity, met its primary and all key secondary endpoints. Structure Therapeutics expects to initiate the late-stage program of aleniglipron in obesity in the second half of 2026. Shares of Eli Lilly have lost 15.8% year to date compared with the industry’s 2.5% decline. The company has also underperformed the sector and the S&P 500 during the same time frame, as seen in the chart below. Image Source: Zacks Investment Research From a valuation standpoint, LLY stock is expensive. Going by the price/earnings ratio, the company’s shares currently trade at 24.87 forward earnings, higher than 17.14 for the industry. However, the stock is trading below its five-year mean of 34.56. Image Source: Zacks Investment Research Estimates for Eli Lilly’s 2026 earnings have improved from $33.98 to $34.32 per share in the past 60 days, and estimates for 2027 earnings have improved from $41.89 to $42.00 per share over the same time frame. Image Source: Zacks Investment Research Eli Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Novo Nordisk A/S (NVO) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report Viking Therapeutics, Inc. (VKTX) : Free Stock Analysis Report Structure Therapeutics Inc. Sponsored ADR (GPCR) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-04-08

Guggenheim Remains Bullish on Eli Lilly (LLY) Ahead of Q1 2026 Results

Insider Monkey

Eli Lilly and Company (NYSE:LLY) is included in our list of the 14 hedge fund favorites with strong setup in 2026. On March 30, 2026, Guggenheim updated its model ahead of the first-quarter data and lowered the firm’s price target for Eli Lilly and Company (NYSE:LLY) from $1,168 to $1,163, while keeping a “Buy” rating. The update came in anticipation of the company’s Q1 2026 results. This update coincides with ongoing analyst attention toward Eli Lilly and Company (NYSE:LLY)’s positioning in the rapidly expanding oral obesity market. RBC Capital reaffirmed its “Outperform” rating and $1,250 price target for the stock on March 16, 2026. The firm highlighted that the updated 44-week Phase 2 ACCESS II data for Structure Therapeutics’ aleniglipron appear similar to Eli Lilly and Company (NYSE:LLY)’s Phase 2 data for orforglipron, with no visibly superior profile. According to the investment firm, the data contribute to the competitive debate about oral obesity therapies and may indicate the emergence of a new competitor for market share. However, Eli Lilly and Company (NYSE:LLY)’s own catalyst remains the firm’s primary focus, with orforglipron’s April 10, 2026, PDUFA date and potential launch expected to be the more significant driver of the stock. Eli Lilly and Company (NYSE:LLY) is a healthcare company that specializes in human pharmaceutical products and offers cardiometabolic health & oncology products. While we acknowledge the potential of LLY as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and 15 Stocks That Will Make You Rich in 10 Years. Disclosure: None. Follow Insider Monkey on Google News.

Investor releaseQuarter not tagged2026-02-27

Structure Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Highlights

GlobeNewswire
Positive results from the aleniglipron Phase 2 ACCESS programs in December 2025 demonstrated significant weight loss across all doses and up to 15.3% at 36 weeks Topline 44-week data from the ACCESS II study with higher doses expected in Q1 2026 Aleniglipron Phase 3 initiation expected in 2H 2026 Initial data from the ongoing Phase 1 study of oral small molecule amylin receptor agonist ACCG-2671 and Phase 1 initiation of second oral amylin compound ACCG-3535 expected in 2H 2026 Cash, cash equivalents and short-term investments of $1.4 billion as of December 31, 2025, expected to provide cash runway through the end of 2028 SAN FRANCISCO, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update. “The obesity market is clearly embracing the introduction of new oral treatment options and Structure Therapeutics is well positioned to capture market share in this important therapeutic area,” said Raymond Stevens, Ph.D., CEO of Structure Therapeutics. “In 2025, we delivered positive Phase 2b 36-week data for aleniglipron and advanced ACCG-2671 our first oral small molecule amylin receptor agonist into the clinic. We completed a $748 million financing providing a strong financial balance sheet to continue advancing aleniglipron which has the potential to be best-in-class. Our broad portfolio positions us well in the evolving landscape that we believe will favor more accessible oral small molecules, extended maintenance treatment periods, and fixed dose combinations for specific patient populations and expanded indications. The upcoming 44-week data readout with higher doses in ACCESS II, expected in the first quarter, will provide a more complete profile of aleniglipron as we prepare for Phase 3 this year, with additional data readouts expected throughout 2026.” Recent and Upcoming Milestones Aleniglipron - Oral Small Molecule Selective Glucagon-Like Peptide 1 (GLP-1) Receptor Agonist for the Treatment of Obesity and Overweight As reported in December 2025, data from the aleniglipron clinical program included 36-week data from the core Phase 2b ACCESS study and the exploratory…Read full document

Positive results from the aleniglipron Phase 2 ACCESS programs in December 2025 demonstrated significant weight loss across all doses and up to 15.3% at 36 weeks Topline 44-week data from the ACCESS II study with higher doses expected in Q1 2026 Aleniglipron Phase 3 initiation expected in 2H 2026 Initial data from the ongoing Phase 1 study of oral small molecule amylin receptor agonist ACCG-2671 and Phase 1 initiation of second oral amylin compound ACCG-3535 expected in 2H 2026 Cash, cash equivalents and short-term investments of $1.4 billion as of December 31, 2025, expected to provide cash runway through the end of 2028 SAN FRANCISCO, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update. “The obesity market is clearly embracing the introduction of new oral treatment options and Structure Therapeutics is well positioned to capture market share in this important therapeutic area,” said Raymond Stevens, Ph.D., CEO of Structure Therapeutics. “In 2025, we delivered positive Phase 2b 36-week data for aleniglipron and advanced ACCG-2671 our first oral small molecule amylin receptor agonist into the clinic. We completed a $748 million financing providing a strong financial balance sheet to continue advancing aleniglipron which has the potential to be best-in-class. Our broad portfolio positions us well in the evolving landscape that we believe will favor more accessible oral small molecules, extended maintenance treatment periods, and fixed dose combinations for specific patient populations and expanded indications. The upcoming 44-week data readout with higher doses in ACCESS II, expected in the first quarter, will provide a more complete profile of aleniglipron as we prepare for Phase 3 this year, with additional data readouts expected throughout 2026.” Recent and Upcoming Milestones Aleniglipron - Oral Small Molecule Selective Glucagon-Like Peptide 1 (GLP-1) Receptor Agonist for the Treatment of Obesity and Overweight As reported in December 2025, data from the aleniglipron clinical program included 36-week data from the core Phase 2b ACCESS study and the exploratory ACCESS II study, as well as interim data from the Phase 2 body composition study and the Phase 2b ACCESS open label extension (OLE) study. The Phase 2b ACCESS study demonstrated a placebo-adjusted mean weight loss of 11.3% with the 120 mg dose at 36 weeks. No plateau of weight loss was observed. The exploratory ACCESS II study with higher doses of 180 mg and 240 mg demonstrated a placebo-adjusted mean weight loss of 15.3% with the 240 mg dose at 36 weeks. No plateau of weight loss was observed. No adverse event-related treatment discontinuations were observed when utilizing the new lower starting titration dose of 2.5 mg in the ACCESS OLE and the Body Composition studies. Data from the ACCESS, ACCESS II, Body Composition, and the ACCESS OLE studies provide a strong foundation for the decision to advance aleniglipron into Phase 3 clinical development. The Company expects to report topline results from the ACCESS II 44-week study in Q1 2026. The Company has planned an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to align on a Phase 3 registrational program with a starting titration dose of 2.5 mg and the intent to evaluate multiple maintenance doses. The Company anticipates initiating the Phase 3 program in the second half of 2026. Supplementary studies enhance competitive profile of aleniglipron: Ongoing ACCESS OLE study to evaluate the tolerability of the 2.5 mg starting titration dose regimen for those participants rolling over from the placebo arm and to collect up to 72 weeks of data. Ongoing study to assess the transition from an approved injectable GLP-1 receptor agonist to once-daily oral aleniglipron for weight loss maintenance. This study assesses different aleniglipron starting doses and weight loss maintenance over 12 weeks. Ongoing body composition study to assess the effect of aleniglipron on body fat loss over a 40-week evaluation period, which includes a 28-week titration period and a starting dose of 2.5 mg. These data will be used to inform the inclusion of potential body composition endpoints and the appropriate number of participants for a sub-study within the Phase 3 program. Ongoing 38-week study in patients with type 2 diabetes mellitus (T2DM) with obesity/overweight to evaluate the potential for including participants with T2DM in the Phase 3 obesity program. Oral Small Molecule Amylin Receptor Agonists In December 2025, Structure Therapeutics advanced ACCG-2671 into a Phase 1 clinical study as the industry’s most advanced oral small molecule amylin therapy for the treatment of obesity. ACCG-2671 is being evaluated in an ongoing single ascending dose (SAD) study to measure safety, tolerability, pharmacokinetics, and food-effect of single ascending doses of ACCG-2671 in healthy adult participants. Data are anticipated in the second half of 2026. Structure Therapeutics declared a second oral small molecule dual amylin calcitonin receptor agonist development candidate, ACCG-3535. ACCG-3535, which has a unique chemical structure compared to ACCG-2671, 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. Structure Therapeutics expects to initiate a Phase 1 clinical study of ACCG-3535 in the second half of 2026. Fourth Quarter and Full Year 2025 Financial Highlights Cash Position: Cash, cash equivalents and short-term investments totaled $1.4 billion as of December 31, 2025. The Company expects its current cash, cash equivalents and short-term investments to fund projected operations and key clinical milestones through the end of 2028. This includes costs related to the ongoing aleniglipron ACCESS OLE, ACCESS II extension study, the supplementary studies, and Phase 3 registrational program in chronic weight management, but excludes additional costs related to pre-commercialization activities including commercial manufacturing. Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2025 were $68.7 million, as compared to $33.5 million for the same period in 2024. For the year ended December 31, 2025, R&D expenses were $225.3 million, as compared to $108.8 million for the full year 2024. The increase in R&D expenses was primarily due to increases related to clinical trial costs, preclinical research and development expenses and employee expenses (primarily due to an increase in personnel) to support the advancement of our GLP-1R franchise including aleniglipron and a milestone payment under our collaboration agreement. General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2025 were $17.6 million, as compared to $13.6 million for the same period in 2024. For the year ended December 31, 2025, G&A expenses were $61.6 million, as compared to $49.4 million for the full year 2024. The increase in G&A expenses was primarily due to increases in employee expenses as we expanded our infrastructure to drive and support the growth in our operations. Other license income: Other license income was $100.0 million for the fourth quarter of 2025 and the year ended December 31, 2025, consisting of income from the license of certain patents that cover a class of oral GLP-1 receptor agonists that is different from aleniglipron. Gains on sale of non-financial assets: Gains on sale of non-financial assets was $10.2 million for the fourth quarter of 2025 and the year ended December 31, 2025, consisting of the sale of certain early-stage non-metabolic and non-obesity assets. Net Income/Loss: Net income for the fourth quarter of 2025 totaled $33.0 million, with non-cash share-based compensation expense of $8.1 million, compared to a net loss of $36.5 million for the fourth quarter of 2024 with non-cash share-based compensation expense of $5.8 million. For the year ended December 31, 2025, net loss totaled $141.2 million, with non-cash share-based compensation expense of $29.0 million, compared to $122.5 million for the full year 2024 with non-cash share-based compensation expense of $18.8 million. About Aleniglipron and Structure Therapeutics’ Oral Metabolic Franchise Aleniglipron (GSBR-1290) is an investigational oral small molecule agonist of the GLP-1 receptor, a validated drug target for the treatment of obesity and T2DM. Through Structure Therapeutics’ structure-based drug discovery platform, aleniglipron was designed to be a biased G Protein-Coupled Receptor (GPCR) agonist, which selectively activates the G-protein signaling pathway. Beyond aleniglipron, Structure Therapeutics is developing next generation oral small molecules including amylin receptor agonists (ACCG-2671 and ACCG-3535), and other combination GLP-1 receptor agonists candidates targeting the glucose-dependent insulinotropic polypeptide (GIP), glucagon and apelin receptors. About Structure Therapeutics Structure Therapeutics is a science-driven clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, the Company has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage oral small molecule compounds designed to surpass the scalability limitations of traditional biologic and peptide therapies and be accessible to more people living with obesity around the world. For additional information, please visit www.structuretx.com. Forward- Looking Statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning: the Company’s future plans and prospects; the expected timing of topline data readouts from the ACCESS II study; the planned initiation of the aleniglipron Phase 3 study and the timing thereof; the expected timing of initial data from the Phase 1 study of ACCG-2671; the Company’s anticipated cash runway and uses of cash; the belief that aleniglipron represents a potentially best-in-class small molecule GLP-1; the belief in market acceptance of oral treatment options for metabolic diseases and that Structure Therapeutics is well positioned; any expectations regarding the potential benefits, tolerability and safety profile, accessibility, scalability, combinability, capability, efficacy, convenience, expected effects and future application of aleniglipron; plans and the expected timing for the meeting with the FDA to finalize the Phase 3 trial design and the Phase 3 program initiation of aleniglipron; the planned initiation of the Phase 1 clinical study of ACCG-3535 and the timing thereof; and any presumption that topline, interim or preliminary data will be representative of final data or data in later clinical trials. In addition, when or if used in this press release, the words and phrases “anticipated,” “believe,” “expect,” “plan,” “potential,” “to be,” “will,” and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of risks and uncertainties, which include, without limitation: risks and uncertainties related to topline results that the Company reports are based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial, the preliminary nature of the results due to the length of the study and sample size and the results from earlier clinical studies not necessarily being predictive of future results; potential delays in the commencement, enrollment and completion of the Company’s planned clinical studies; the Company’s ability to advance aleniglipron, ACCG-2671, ANPA-0073, LTSE-2578, ACCG-3535, and its other therapeutic candidates, obtain regulatory approval of, and ultimately commercialize the Company’s therapeutic candidates; competitive products or approaches limiting the commercial value of the Company’s product candidates; the timing and results of preclinical and clinical studies; the Company’s ability to fund development activities and achieve development goals; the Company's reliance on third parties, including clinical research organizations, manufacturers, suppliers and collaborators, over which it may not always have full control; general geopolitical and macroeconomic conditions, including as a result of tariffs and various global conflicts; the Company’s ability to protect its intellectual property; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s latest Annual Report on Form 10-K and future reports the Company 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 [email protected] Jun Yoon Structure Therapeutics Inc. [email protected] Media: Dan Budwick 1AB [email protected]

Investor releaseQuarter not tagged2025-11-07

Structure Therapeutics Reports Third Quarter 2025 Financial Results and Recent Highlights

GlobeNewswire
Topline 36-week data from oral small molecule GLP-1 receptor agonist aleniglipron ACCESS and ACCESS II studies on track for readouts by year-end 2025 Oral small molecule amylin receptor agonist (ACCG-2671) Phase 1 study initiation anticipated by year-end 2025; second oral amylin receptor agonist (ACCG-3535) development candidate declared Strong financial position with cash, cash equivalents and short-term investments of $799.0 million as of September 30, 2025 SAN FRANCISCO, Nov. 06, 2025 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today reported financial results for the third quarter ended September 30, 2025, and provided a business update. “We are on schedule to report topline data by year-end 2025 from both the ACCESS and ACCESS II studies of aleniglipron, our once-daily oral small molecule GLP-1 receptor agonist for the treatment of obesity,” said Raymond Stevens, Ph.D., CEO of Structure Therapeutics. “In parallel, we plan to initiate a Phase 1 study of ACCG-2671, which we believe to be the most advanced oral small molecule amylin receptor agonist in development, and we have declared a second amylin development candidate to further enhance our leadership position with oral small molecules engaging this attractive target. We believe the future of obesity treatment lies in multiple options and includes oral, combinable, and broadly accessible therapies—principles that define and differentiate our pipeline and development strategy. These upcoming milestones mark meaningful progress toward realizing that vision.” Recent and Upcoming Milestones Aleniglipron (GSBR-1290) - Oral Small Molecule Selective Glucagon-Like Peptide 1 (GLP-1) Receptor Agonist for the Treatment of Obesity and Overweight ACCESS and ACCESS II Studies on track for topline 36-week data readouts by year-end 2025 ACCESS is a Phase 2b randomized placebo-controlled, 36-week study that enrolled approximately 220 adults with obesity, or overweight with at least one weight-related comorbidity, evaluating doses up to 120 mg of aleniglipron with a four-week titration schedule. An Open Label Extension of the ACCESS study is ongoing. ACCESS II is a Phase 2 randomized placebo-controlled study that enrolled approximately 80 adults with ob…Read full document

Topline 36-week data from oral small molecule GLP-1 receptor agonist aleniglipron ACCESS and ACCESS II studies on track for readouts by year-end 2025 Oral small molecule amylin receptor agonist (ACCG-2671) Phase 1 study initiation anticipated by year-end 2025; second oral amylin receptor agonist (ACCG-3535) development candidate declared Strong financial position with cash, cash equivalents and short-term investments of $799.0 million as of September 30, 2025 SAN FRANCISCO, Nov. 06, 2025 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today reported financial results for the third quarter ended September 30, 2025, and provided a business update. “We are on schedule to report topline data by year-end 2025 from both the ACCESS and ACCESS II studies of aleniglipron, our once-daily oral small molecule GLP-1 receptor agonist for the treatment of obesity,” said Raymond Stevens, Ph.D., CEO of Structure Therapeutics. “In parallel, we plan to initiate a Phase 1 study of ACCG-2671, which we believe to be the most advanced oral small molecule amylin receptor agonist in development, and we have declared a second amylin development candidate to further enhance our leadership position with oral small molecules engaging this attractive target. We believe the future of obesity treatment lies in multiple options and includes oral, combinable, and broadly accessible therapies—principles that define and differentiate our pipeline and development strategy. These upcoming milestones mark meaningful progress toward realizing that vision.” Recent and Upcoming Milestones Aleniglipron (GSBR-1290) - Oral Small Molecule Selective Glucagon-Like Peptide 1 (GLP-1) Receptor Agonist for the Treatment of Obesity and Overweight ACCESS and ACCESS II Studies on track for topline 36-week data readouts by year-end 2025 ACCESS is a Phase 2b randomized placebo-controlled, 36-week study that enrolled approximately 220 adults with obesity, or overweight with at least one weight-related comorbidity, evaluating doses up to 120 mg of aleniglipron with a four-week titration schedule. An Open Label Extension of the ACCESS study is ongoing. ACCESS II is a Phase 2 randomized placebo-controlled study that enrolled approximately 80 adults with obesity, or overweight with at least one weight-related comorbidity, evaluating higher doses of aleniglipron (180 mg and 240 mg) with a four-week titration schedule. Following the initial 36-week evaluation, patients continue in the study to 44 weeks, which allows for collection of an additional eight weeks of double-blinded safety, tolerability, and efficacy data. Three supplementary studies ongoing to generate additional data to competitively position aleniglipron and further support the design of the Phase 3 program Study to assess a maintenance switching strategy from an approved injectable GLP-1 receptor agonist to aleniglipron – Enrollment is ongoing in this maintenance switching study which is evaluating the transition from an approved injectable GLP-1 receptor agonist to once-daily oral aleniglipron for weight loss maintenance. This study will assess the starting dose and the weight loss maintenance over 12 weeks. Body composition study – This fully-enrolled Phase 2 randomized placebo-controlled study is assessing the effect of aleniglipron on body fat loss measured via DEXA over a 40-week evaluation period. These data will be used to support the inclusion of body composition endpoints into the Phase 3 program. Study in patients with type 2 diabetes mellitus (T2DM) with obesity/overweight – Enrollment is ongoing in this Phase 2 randomized placebo-controlled study which is assessing aleniglipron at doses of up to 240 mg in patients living with obesity or overweight with T2DM. Data from the 38-week study will be used to support the inclusion of a cohort of patients with T2DM in the Phase 3 obesity program. Oral Small Molecule Amylin Receptor Agonists for the Treatment of Obesity or Overweight with Comorbidities ACCG-2671 – Investigational new drug enabling activities for ACCG-2671 are ongoing, with the initiation of a first-in-human Phase 1 clinical study expected by year-end 2025. ACCG-3535 – A second dual amylin and calcitonin receptor agonist development candidate, ACCG-3535, has been selected. ACCG-3535 is a unique chemical structure from ACCG-2671. Preclinical ACCG-3535 data were recently presented at Obesity Week 2025 demonstrating 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. Third Quarter 2025 Financial Highlights Cash Position: Cash, cash equivalents and short-term investments totaled $799.0 million as of September 30, 2025. The Company expects its current cash, cash equivalents and short-term investments to fund projected operations and key clinical milestones through at least 2027. For aleniglipron, this includes costs related to the ongoing ACCESS and ACCESS II studies, extension studies, the supplementary studies, and Phase 3 readiness activities, but excludes Phase 3 registrational studies. Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2025 were $59.0 million, as compared to $32.6 million for the same period in 2024. The increase in R&D expenses was primarily due to increases related to clinical trial costs, preclinical research and development expenses and employee expenses (primarily due to an increase in personnel) to support the advancement of our GLP-1R franchise including aleniglipron. General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2025 were $14.8 million, as compared to $13.2 million for the same period in 2024. The increase in G&A expenses was primarily due to increases in employee expenses as we expanded our infrastructure to drive and support the growth in our operations as a publicly-traded company. Net Loss: Net loss for the third quarter of 2025 totaled $65.7 million, with non-cash share-based compensation expense of $7.5 million, compared to $34.0 million for the third quarter of 2024 with non-cash share-based compensation expense of $6.0 million. About Structure Therapeutics Structure Therapeutics is a science-driven clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, the Company has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage oral small molecule compounds designed to surpass the scalability limitations of traditional biologic and peptide therapies and be accessible to more patients around the world. For additional information, please visit www.structuretx.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning: the Company’s future plans and prospects; the expected timing of topline data readouts from the ACCESS and ACCESS II studies; the planned initiation of the ACCG-2671 Phase 1 study and the timing thereof; the Company’s anticipated cash runway and uses of cash; the belief that ACCG-2671 represents one of the most advanced oral small molecule amylin agonists in development; the Company’s plans to conduct supplementary aleniglipron studies, including the study design, expected use of data from these studies and timing thereof; the planned initiation of the Phase 2 study in patients with obesity or overweight and T2DM and the timing thereof; and any expectations regarding the safety, efficacy or tolerability of aleniglipron, ACCG-2671, ACCG-3535, and other candidates under development. In addition, when or if used in this press release, the words and phrases “anticipate,” “believe,” “expect,” “may,” “on track,” “plan,” “potential,” “prepare,” “to be,” “will,” and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of risks and uncertainties, which include, without limitation: risks and uncertainties related to the results from earlier clinical studies not necessarily being predictive of future results; potential delays in the commencement, enrollment and completion of the Company’s planned clinical studies, the Company’s ability to advance aleniglipron, ACCG-2671, ACCG-3535, ANPA-0073, LTSE-2578, and its other therapeutic candidates, obtain regulatory approval of, and ultimately commercialize the Company’s therapeutic candidates; competitive products or approaches limiting the commercial value of the Company’s product candidates; the timing and results of preclinical and clinical studies; the Company’s ability to fund development activities and achieve development goals; the Company's reliance on third parties, including clinical research organizations, manufacturers, suppliers and collaborators, over which it may not always have full control; general geopolitical and macroeconomic conditions, including as a result of tariffs and various global conflicts; the Company’s ability to protect its intellectual property; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s latest Quarterly Report on Form 10-Q and future reports the Company 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: Danielle Keatley Structure Therapeutics Inc. [email protected] Media: Dan Budwick 1AB [email protected]

Investor releaseQuarter not tagged2025-08-20

Viking Therapeutics Crashes 42% On Mixed Results For Its Weight-Loss Pill

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Viking Therapeutics stock crashed Tuesday — losing more than a third of its value — on mixed results for its weight-loss pill.

Investor releaseQuarter not tagged2025-08-07

Structure Therapeutics Reports Second Quarter 2025 Financial Results and Recent Highlights

GlobeNewswire
Topline data from oral small molecule GLP-1 receptor agonist aleniglipron ACCESS and ACCESS II studies on track for year-end 2025 readouts Aleniglipron clinical development program expanded to optimize competitive positioning and Phase 3 program Oral small molecule amylin receptor agonist (ACCG-2671) Phase 1 initiation anticipated by year-end 2025 Strong financial position with cash, cash equivalents and short-term investments of $786.5 million as of June 30, 2025 expected to fund projected operations and key clinical milestones through at least 2027 SAN FRANCISCO, Aug. 06, 2025 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today reported financial results for the second quarter ended June 30, 2025, and provided a business update. “The ACCESS and ACCESS II studies for aleniglipron, our once-daily oral small molecule GLP-1 program, remain on track for topline data readouts by the end of the year,” said Raymond Stevens, Ph.D., CEO of Structure Therapeutics. “With our continued confidence in aleniglipron’s profile, we have initiated additional supplementary studies to ensure we are well positioned for Phase 3 and to maximize the therapeutic and competitive potential of this program. By the end of 2025, we also plan to initiate the Phase 1 study of ACCG-2671, which we believe represents the most advanced oral small molecule amylin agonist in development. As the obesity field shifts towards combinability of multiple targets and long-term weight loss maintenance, we are excited to lead the way with a highly scalable pipeline of oral small molecule medicines designed to address the substantial unmet needs in obesity management and related metabolic diseases.” Recent and Upcoming Milestones Aleniglipron (GSBR-1290) - Oral Small Molecule Selective Glucagon-Like Peptide 1 (GLP-1) Receptor Agonist for the Treatment of Obesity and Overweight Ongoing Phase 2b ACCESS and Phase 2 ACCESS II Studies The fully enrolled ACCESS and ACCESS II studies are on track for topline 36-week data readouts by year-end 2025. ACCESS enrolled approximately 220 adults living with obesity, or overweight with at least one weight-related comorbidity, and is designed to evaluate doses up to 120 mg of aleniglipron with a slower four-…Read full document

Topline data from oral small molecule GLP-1 receptor agonist aleniglipron ACCESS and ACCESS II studies on track for year-end 2025 readouts Aleniglipron clinical development program expanded to optimize competitive positioning and Phase 3 program Oral small molecule amylin receptor agonist (ACCG-2671) Phase 1 initiation anticipated by year-end 2025 Strong financial position with cash, cash equivalents and short-term investments of $786.5 million as of June 30, 2025 expected to fund projected operations and key clinical milestones through at least 2027 SAN FRANCISCO, Aug. 06, 2025 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today reported financial results for the second quarter ended June 30, 2025, and provided a business update. “The ACCESS and ACCESS II studies for aleniglipron, our once-daily oral small molecule GLP-1 program, remain on track for topline data readouts by the end of the year,” said Raymond Stevens, Ph.D., CEO of Structure Therapeutics. “With our continued confidence in aleniglipron’s profile, we have initiated additional supplementary studies to ensure we are well positioned for Phase 3 and to maximize the therapeutic and competitive potential of this program. By the end of 2025, we also plan to initiate the Phase 1 study of ACCG-2671, which we believe represents the most advanced oral small molecule amylin agonist in development. As the obesity field shifts towards combinability of multiple targets and long-term weight loss maintenance, we are excited to lead the way with a highly scalable pipeline of oral small molecule medicines designed to address the substantial unmet needs in obesity management and related metabolic diseases.” Recent and Upcoming Milestones Aleniglipron (GSBR-1290) - Oral Small Molecule Selective Glucagon-Like Peptide 1 (GLP-1) Receptor Agonist for the Treatment of Obesity and Overweight Ongoing Phase 2b ACCESS and Phase 2 ACCESS II Studies The fully enrolled ACCESS and ACCESS II studies are on track for topline 36-week data readouts by year-end 2025. ACCESS enrolled approximately 220 adults living with obesity, or overweight with at least one weight-related comorbidity, and is designed to evaluate doses up to 120 mg of aleniglipron with a slower four-week titration schedule. ACCESS II enrolled approximately 80 adults living with obesity, or overweight with at least one weight-related comorbidity, and is designed to evaluate higher doses of aleniglipron (180 mg and 240 mg) with a slower four-week titration schedule. Expanded Data Collection from ACCESS and ACCESS II Studies Structure Therapeutics has implemented extensions to the ongoing ACCESS and ACCESS II studies: ACCESS Open Label Extension (OLE) – All patients in the Phase 2b ACCESS study are provided an option to roll over into the OLE and receive aleniglipron after completing the double-blinded randomized portion of the study. This will allow collection of data on longer-term weight loss effects, expand the overall safety database and provide aleniglipron access to patients enrolled in the blinded portion of the study who opt in to the extension. ACCESS II Extension – Following the initial 36-week efficacy evaluation, patients will now continue on their assigned dose to 44 weeks, which allows for collection of an additional eight weeks of double-blinded safety, tolerability, and efficacy data in the study. Overall, this extension will provide additional longer-term data in the two potentially higher dose arms of 180 mg and 240 mg. Per protocol and as previously planned, a formal unblinded efficacy assessment at 36 weeks is expected by year-end 2025. Three Additional Aleniglipron Studies Structure Therapeutics is also conducting three new aleniglipron clinical studies as planned that will generate additional data to competitively position aleniglipron and further support the design of the Phase 3 program. Phase 2 study to assess a maintenance switching strategy from an approved injectable GLP-1 receptor agonist to aleniglipron – Specifically, this maintenance switching study will evaluate the transition from an approved injectable GLP-1 receptor agonist to once-daily oral aleniglipron for weight loss maintenance. This study will assess the starting dose and the weight loss maintenance over 12 weeks. Enrollment is expected to start in the third quarter of 2025. Phase 2 body composition study – This study will assess the effect of aleniglipron on body fat loss over a 40-week evaluation period. These data will be used to incorporate body composition endpoints into the Phase 3 program. Enrollment is expected to start in the third quarter of 2025. Phase 2 study in patients with type 2 diabetes mellitus (T2DM) – This placebo-controlled study in patients with obesity or overweight and T2DM is anticipated to start in the fourth quarter of 2025. Data from the 38-week study may be used to support the inclusion of a cohort of T2DM in the Phase 3 obesity program. Oral Small Molecule Amylin Receptor Agonists for the Treatment of Obesity or Overweight with Comorbidities ACCG-2671 – Investigational new drug (IND) enabling activities for ACCG-2671 are ongoing; Structure Therapeutics plans to initiate a first-in-human Phase 1 clinical study by year-end 2025. New preclinical data for ACCG-2671 was presented in a late-breaking poster session at the American Diabetes Association 85th Scientific Sessions in June 2025. ACCG-2671 demonstrated high binding affinity and balanced potency in human calcitonin receptor and amylin receptor functional assays. In diet-induced obese rats, oral administration of ACCG-2671 resulted in significant, dose-dependent body weight reductions. Combination therapy with semaglutide (both as add-on and concurrent treatment) resulted in superior weight loss compared to monotherapy of either compound. Oral Small Molecule Metabolic Pipeline and Potential Combinations: Oral Small Molecule glucose-dependent insulinotropic polypeptide receptor (GIPR) Program: Structure Therapeutics is developing a GIPR selective agonist and antagonist and GLP-1R/GIPR combinations to treat obesity and related diseases. Oral Small Molecule glucagon receptor (GCGR) Program: Structure Therapeutics is developing a GCGR selective agonist and GLP-1R/GCGR combinations for the treatment of obesity and related diseases. Oral Small Molecule apelin (APJR) Program: Structure Therapeutics is evaluating ANPA-0073, a Phase 2 ready biased APJR agonist for potential selective or muscle-sparing weight loss. The Company has finished a Phase 1 single-ascending and multiple-ascending dose study, in which ANPA-0073 was generally well-tolerated with no serious adverse events (SAEs) reported. Long-term chronic GLP-toxicology studies are currently underway and expected to be completed by the end of 2025. Oral Small Molecule Lysophosphatidic Acid 1 Receptor (LPA1R) Program for Idiopathic Pulmonary Fibrosis (IPF) Structure Therapeutics has successfully finished a Phase 1 single and multiple ascending dose clinical study of LTSE-2578, an oral small molecule antagonist that targets the LPA1R for the treatment of IPF. In the study there was no evidence of any dose-dependent LTSE-2578-related adverse events, including clinical, laboratory and electrocardiogram recordings. No SAEs were observed in the study. Second Quarter 2025 Financial Highlights Cash Position: Cash, cash equivalents and short-term investments totaled $786.5 million on June 30, 2025. The Company expects its current cash, cash equivalents and short-term investments to fund projected operations and key clinical milestones through at least 2027. For aleniglipron, this includes the ongoing ACCESS and ACCESS II studies, extension studies, and the three new clinical studies announced, but excludes Phase 3 registrational studies. Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2025 were $54.7 million, as compared to $22.1 million for the same period in 2024. The increase in R&D expenses was primarily due to increases related to pre-clinical research and development expenses, clinical trial costs and personnel-related expenses due to an increase in headcount to support the advancement of our GLP-1R franchise including aleniglipron. General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2025 were $15.7 million, as compared to $11.3 million for the same period in 2024. The increase in G&A expenses was primarily due to increases in employee expenses as we expanded our infrastructure to drive and support the growth in our operations as a publicly-traded company. Net Loss: Net loss for the second quarter of 2025 totaled $61.7 million, with non-cash share-based compensation expense of $7.5 million, compared to $26.0 million for the second quarter of 2024 with non-cash share-based compensation expense of $4.2 million. About Structure Therapeutics Structure Therapeutics is a science-driven clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic and cardiopulmonary conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, the Company has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage oral small molecule compounds designed to surpass the scalability limitations of traditional biologic and peptide therapies and be accessible to more patients around the world. For additional information, please visit www.structuretx.com. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning: the Company’s future plans and prospects; the expected timing of topline data from the ACCESS and ACCESS II studies; the planned initiation of the ACCG-2671 Phase 1 study and the timing thereof; the Company’s anticipated cash runway and uses of cash; the belief that ACCG-2671 represents one of the most advanced oral small molecule amylin agonists in development; the belief that the Company is well positioned to lead with a highly scalable pipeline of oral small molecule medicines designed to address the substantial unmet needs in obesity management and related metabolic diseases; the potential benefits of expanding data collection from the ACCESS and ACCESS II studies; the Company’s plans to conduct three new aleniglipron studies, including the study design and timing thereof; the expected timing for declaring a second amylin receptor agonist oral small molecule development candidate; and the expected timing for long term chronic GLP-toxicology studies of ANPA-0073;; and any expectations regarding the safety, efficacy or tolerability of aleniglipron, ACCG-2671, ANPA-0073, LTSE-2578 and other candidates under development. In addition, when or if used in this press release, the words and phrases “anticipated,” “believe,” “expect,” “may,” “on track,” “plan,” “potential,” “suggests,” “to be,” “to begin,” “will,” and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of risks and uncertainties, which include, without limitation: risks and uncertainties related to the results from earlier clinical studies not necessarily being predictive of future results; potential delays in the commencement, enrollment and completion of the Company’s planned clinical studies, the Company’s ability to advance aleniglipron, ACCG-2671, ANPA-0073, LTSE-2578, and its other therapeutic candidates, obtain regulatory approval of, and ultimately commercialize the Company’s therapeutic candidates; competitive products or approaches limiting the commercial value of the Company’s product candidates; the timing and results of preclinical and clinical studies; the Company’s ability to fund development activities and achieve development goals; the Company's reliance on third parties, including clinical research organizations, manufacturers, suppliers and collaborators, over which it may not always have full control; the impact of any global pandemics, inflation, tariffs, changes in monetary and fiscal policy, supply chain issues, rising interest rates, future bank failures and other macroeconomic factors on the Company’s business, its ability to protect its intellectual property and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s latest Quarterly Report on Form 10-Q and future reports the Company 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: Danielle Keatley Structure Therapeutics Inc. [email protected] Media: Dan Budwick 1AB [email protected]

Investor releaseQuarter not tagged2025-05-09

Structure Therapeutics Reports First Quarter 2025 Financial Results and Recent Highlights

GlobeNewswire
Topline data from oral small molecule aleniglipron (GSBR-1290) Phase 2b ACCESS and ACCESS II studies anticipated by year-end 2025 Oral small molecule amylin receptor agonist (ACCG-2671) Phase 1 initiation anticipated by year-end 2025; New preclinical data to be presented at American Diabetes Association (ADA) 85th Scientific Sessions in June 2025 Strong financial position with cash, cash equivalents and short-term investments of $836.9 million SAN FRANCISCO, May 08, 2025 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, including obesity, today reported financial results for the first quarter ended March 31, 2025, and provided a business update. “We are excited by the recent advancements in the oral small molecule GLP-1 field, which will meaningfully expand access and options for patients with obesity and related diseases,” said Raymond Stevens, Ph.D., CEO of Structure Therapeutics. “We continue to make strong progress with the Phase 2b ACCESS and ACCESS II studies for aleniglipron, our once-daily oral small molecule GLP-1 program, which are on track for data readout by the end of the year. In addition, we are on track to initiate the Phase 1 study of ACCG-2671, which we believe is the most advanced oral small molecule amylin program in development, by the end of 2025. We’re advancing our powerful foundation for the future of fixed-dose combination therapies which is best addressed with oral small molecules and to make these medicines more broadly accessible and convenient to patients.” Recent and Upcoming Milestones Aleniglipron (GSBR-1290) – Oral Small Molecule Selective GLP-1 Receptor Agonist for the Treatment of Obesity or Overweight with Co-Morbidities The Phase 2b ACCESS and ACCESS II studies are fully enrolled and on track for topline 36-week data by year-end 2025. ACCESS enrolled approximately 220 adults living with obesity, or overweight with a weight-related comorbidity, and is designed to evaluate doses up to 120 mg of aleniglipron with a 4-week titration regimen. ACCESS II enrolled approximately 80 adults living with obesity, or overweight with a weight-related comorbidity, and is designed to evaluate higher doses of aleniglipron (180 mg and 240 mg) with 4-week titration increments. The Phase 2b ACCESS and ACCE…Read full document

Topline data from oral small molecule aleniglipron (GSBR-1290) Phase 2b ACCESS and ACCESS II studies anticipated by year-end 2025 Oral small molecule amylin receptor agonist (ACCG-2671) Phase 1 initiation anticipated by year-end 2025; New preclinical data to be presented at American Diabetes Association (ADA) 85th Scientific Sessions in June 2025 Strong financial position with cash, cash equivalents and short-term investments of $836.9 million SAN FRANCISCO, May 08, 2025 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, including obesity, today reported financial results for the first quarter ended March 31, 2025, and provided a business update. “We are excited by the recent advancements in the oral small molecule GLP-1 field, which will meaningfully expand access and options for patients with obesity and related diseases,” said Raymond Stevens, Ph.D., CEO of Structure Therapeutics. “We continue to make strong progress with the Phase 2b ACCESS and ACCESS II studies for aleniglipron, our once-daily oral small molecule GLP-1 program, which are on track for data readout by the end of the year. In addition, we are on track to initiate the Phase 1 study of ACCG-2671, which we believe is the most advanced oral small molecule amylin program in development, by the end of 2025. We’re advancing our powerful foundation for the future of fixed-dose combination therapies which is best addressed with oral small molecules and to make these medicines more broadly accessible and convenient to patients.” Recent and Upcoming Milestones Aleniglipron (GSBR-1290) – Oral Small Molecule Selective GLP-1 Receptor Agonist for the Treatment of Obesity or Overweight with Co-Morbidities The Phase 2b ACCESS and ACCESS II studies are fully enrolled and on track for topline 36-week data by year-end 2025. ACCESS enrolled approximately 220 adults living with obesity, or overweight with a weight-related comorbidity, and is designed to evaluate doses up to 120 mg of aleniglipron with a 4-week titration regimen. ACCESS II enrolled approximately 80 adults living with obesity, or overweight with a weight-related comorbidity, and is designed to evaluate higher doses of aleniglipron (180 mg and 240 mg) with 4-week titration increments. The Phase 2b ACCESS and ACCESS II studies are fully enrolled and on track for topline 36-week data by year-end 2025. ACCESS enrolled approximately 220 adults living with obesity, or overweight with a weight-related comorbidity, and is designed to evaluate doses up to 120 mg of aleniglipron with a 4-week titration regimen. ACCESS enrolled approximately 220 adults living with obesity, or overweight with a weight-related comorbidity, and is designed to evaluate doses up to 120 mg of aleniglipron with a 4-week titration regimen. ACCESS II enrolled approximately 80 adults living with obesity, or overweight with a weight-related comorbidity, and is designed to evaluate higher doses of aleniglipron (180 mg and 240 mg) with 4-week titration increments. ACCESS II enrolled approximately 80 adults living with obesity, or overweight with a weight-related comorbidity, and is designed to evaluate higher doses of aleniglipron (180 mg and 240 mg) with 4-week titration increments. ACCG-2671 – Oral Small Molecule Amylin Receptor Agonist for the Treatment of Obesity or Overweight with Co-Morbidities Investigational new drug (IND) enabling activities for ACCG-2671 are ongoing; Structure Therapeutics plans to initiate a first-in-human Phase 1 clinical study by year-end 2025. Investigational new drug (IND) enabling activities for ACCG-2671 are ongoing; Structure Therapeutics plans to initiate a first-in-human Phase 1 clinical study by year-end 2025. New preclinical data for ACCG-2671 will be presented in a late-breaking poster session at the American Diabetes Association (ADA) 85th Scientific Sessions on June 22, 2025. New preclinical data for ACCG-2671 will be presented in a late-breaking poster session at the American Diabetes Association (ADA) 85th Scientific Sessions on June 22, 2025. Oral Small Molecule Pipeline and Potential Combinations: Oral Small Molecule GLP-1R in additional indications: Structure Therapeutics is studying GLP-1 receptor agonists in additional indications outside of obesity, including Parkinson’s disease (PD). Preclinical data in PD will be presented in a late-breaking poster session at the ADA 85th Scientific Sessions on June 22, 2025. Oral Small Molecule GLP-1R in additional indications: Structure Therapeutics is studying GLP-1 receptor agonists in additional indications outside of obesity, including Parkinson’s disease (PD). Preclinical data in PD will be presented in a late-breaking poster session at the ADA 85th Scientific Sessions on June 22, 2025. Oral Small Molecule GIPR Program: Structure Therapeutics is developing a GIPR selective agonist and antagonist and GLP-1R/GIPR combinations to treat obesity and associated diseases. Oral Small Molecule GIPR Program: Structure Therapeutics is developing a GIPR selective agonist and antagonist and GLP-1R/GIPR combinations to treat obesity and associated diseases. Oral Small Molecule GCGR Program: Structure Therapeutics is developing a GCGR selective agonist and GLP-1R/GCGR combinations for the treatment of obesity and related diseases. Oral Small Molecule GCGR Program: Structure Therapeutics is developing a GCGR selective agonist and GLP-1R/GCGR combinations for the treatment of obesity and related diseases. Oral Small Molecule APJR Program: Structure Therapeutics is evaluating ANPA-0073, a Phase 2 ready biased APJR agonist for potential selective or muscle-sparing weight loss. The Company has completed a Phase 1 single-ascending and multiple-ascending dose study, in which ANPA-0073 was generally well-tolerated with no serious adverse events reported. Long term chronic GLP-toxicology studies are currently underway and expected to be completed in 2025. Oral Small Molecule APJR Program: Structure Therapeutics is evaluating ANPA-0073, a Phase 2 ready biased APJR agonist for potential selective or muscle-sparing weight loss. The Company has completed a Phase 1 single-ascending and multiple-ascending dose study, in which ANPA-0073 was generally well-tolerated with no serious adverse events reported. Long term chronic GLP-toxicology studies are currently underway and expected to be completed in 2025. First Quarter 2025 Financial Highlights Cash Position: Cash, cash equivalents and short-term investments totaled $836.9 million on March 31, 2025. The Company expects its current cash, cash equivalents and short-term investments to fund projected operations and key clinical milestones through at least 2027, including aleniglipron studies for Phase 3 readiness but excluding Phase 3 registrational studies. Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2025 were $42.9 million, as compared to $20.7 million for the same period in 2024. The increase was primarily due to increases related to preclinical research and development expenses, clinical trial costs and personnel-related expenses due to an increase in headcount to support the advancement of our GLP-1R franchise including aleniglipron. General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2025 were $13.4 million, as compared to $11.3 million for the same period in 2024. The increase was primarily due to increases in personnel-related expenses as we expanded our infrastructure to drive and support the growth in our operations as a publicly-traded company, partially offset by a decrease in consulting services. Net Loss: Net loss for the first quarter of 2025 totaled $46.8 million, with non-cash share-based compensation expense of $5.9 million, compared to $26.0 million for the first quarter of 2024 with non-cash share-based compensation expense of $2.7 million. About Structure Therapeutics Structure Therapeutics is a science-driven clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic and cardiopulmonary conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, the Company has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage oral small molecule compounds designed to surpass the scalability limitations of traditional biologic and peptide therapies and be accessible to more patients around the world. For additional information, please visit www.structuretx.com. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning: the Company’s future plans and prospects; the expected timing of topline data from the ACCESS and ACCESS II studies; the planned initiation of the ACCG-2671 Phase 1 study and the timing thereof; the expected completion of long term chronic GLP-toxicology studies; the Company’s anticipated cash runway and uses of cash; the belief that the oral small molecule approach gives Structure Therapeutics the opportunity to create more scalable, cost-effective treatments to meet the needs of patients with obesity and other related diseases, without compromising on efficacy or safety; the belief that Structure Therapeutics is well-positioned with one of the most robust oral small molecule metabolic franchises in the industry; and any expectations regarding the safety, efficacy or tolerability of aleniglipron, ACCG-2671, ANPA-0073 and other candidates under development. In addition, when or if used in this press release, the words and phrases “anticipated,” “expect,” “on track,” “plan,” “potential,” “to be,” and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to the results from earlier clinical studies not necessarily being predictive of future results, potential delays in the commencement, enrollment and completion of the Company’s planned clinical studies, the Company’s ability to advance aleniglipron, ACCG-2671, ANPA-0073, LTSE-2578, and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the Company’s therapeutic candidates, competitive products or approaches limiting the commercial value of the Company’s product candidates, the timing and results of preclinical and clinical studies, the Company’s ability to fund development activities and achieve development goals, the Company's reliance on third parties, including clinical research organizations, manufacturers, suppliers and collaborators, over which it may not always have full control, the impact of any global pandemics, inflation, tariffs, changes in monetary and fiscal policy, supply chain issues, rising interest rates, future bank failures and other macroeconomic factors on the Company’s business, its ability to protect its intellectual property and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s latest Annual Report on Form 10-K and future reports the Company 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. STRUCTURE THERAPEUTICS INC. Condensed Consolidated Statements of Operations (unaudited) (In thousands) THREE MONTHS ENDED MARCH 31, 2025 2024 Operating expenses: Research and development $ 42,867 $ 20,679 General and administrative 13,444 11,336 Total operating expenses 56,311 32,015 Loss from operations (56,311 ) (32,015 ) Interest and other income, net 9,576 6,008 Loss before provision for income taxes (46,735 ) (26,007 ) Provision for (benefit from) income taxes 98 29 Net loss $ (46,833 ) $ (26,036 ) STRUCTURE THERAPEUTICS INC. Condensed Consolidated Balance Sheet Data (unaudited) (In thousands) MARCH 31, DECEMBER 31, 2025 2024 Assets Current assets: Cash, cash equivalents and short-term investments $ 836,882 $ 883,518 Prepaid expenses and other current assets 12,740 7,693 Total current assets 849,622 891,211 Property and equipment, net 3,518 3,478 Operating right-of-use assets 7,313 3,535 Other non-current assets 6,096 5,106 Total assets $ 866,549 $ 903,330 Liabilities and shareholders’ equity Current liabilities: Accounts payable $ 8,710 $ 8,024 Accrued expenses and other current liabilities 25,306 26,299 Operating lease liabilities, current portion 2,471 1,698 Total current liabilities 36,487 36,021 Operating lease liabilities, net of current portion 5,116 2,164 Other non-current liabilities 308 302 Total liabilities 41,911 38,487 Total shareholders’ equity 824,638 864,843 Total liabilities and shareholders’ equity $ 866,549 $ 903,330 Investors: Danielle Keatley Structure Therapeutics Inc. [email protected] Media: Dan Budwick 1AB [email protected]

Investor releaseQuarter not tagged2025-04-18

Eli Lilly jumps as results from weight-loss pill study rival competitor’s

TipRanks
Shares of Eli Lilly (LLY) jumped on Thursday morning after the company announced topline Phase 3 results from ACHIEVE-1, evaluating the safety and efficacy of orforglipron compared to placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. Commenting on the news, Leerink said that the once-daily oral GLP-1 pill showed similar efficacy and safety relative to weekly injectable semaglutide, made by Novo Nordisk (NVO). Discover outperforming stocks and invest smarter with Top Smart Score Stocks. Discover outperforming stocks and invest smarter with Top Smart Score Stocks. Filter, analyze, and streamline your search for investment opportunities using Tipranks' Stock Screener. Filter, analyze, and streamline your search for investment opportunities using Tipranks' Stock Screener. PRIMARY ENDPOINT MET: Eli Lilly announced topline Phase 3 results from ACHIEVE-1, evaluating the safety and efficacy of orforglipron compared to placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. Orforglipron is the first oral small molecule glucagon-like peptide-1 receptor agonist, taken without food and water restrictions, to successfully complete a Phase 3 trial. If approved, the company is confident in its ability to launch orforglipron worldwide without supply constraints. This would further Lilly’s mission to reduce chronic diseases like type 2 diabetes, which is expected to impact an estimated 760 million adults by 2050. In the first Phase 3 trial of the ACHIEVE program, orforglipron met the primary endpoint of superior A1C reduction compared to placebo at 40 weeks, lowering A1C by an average of 1.3% to 1.6% from a baseline of 8%, using the efficacy estimand. In a key secondary endpoint, more than 65% of participants taking the highest dose of orforglipron achieved an A1C less than or equal to 6.5%, which is below the American Diabetes Association’s defined threshold for diabetes. In an additional key secondary endpoint, participants taking orforglipron lost an average of 16.0 lbs at the highest dose. Given that participants had not yet reached a weight plateau at the time the study ended, it appears that full weight reduction was not yet attained. The overall safety profile of orforglipron in ACHIEVE-1 was consistent with the established GLP-1 class. Overall treatment discontinuation rat…Read full document

Shares of Eli Lilly (LLY) jumped on Thursday morning after the company announced topline Phase 3 results from ACHIEVE-1, evaluating the safety and efficacy of orforglipron compared to placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. Commenting on the news, Leerink said that the once-daily oral GLP-1 pill showed similar efficacy and safety relative to weekly injectable semaglutide, made by Novo Nordisk (NVO). Discover outperforming stocks and invest smarter with Top Smart Score Stocks. Discover outperforming stocks and invest smarter with Top Smart Score Stocks. Filter, analyze, and streamline your search for investment opportunities using Tipranks' Stock Screener. Filter, analyze, and streamline your search for investment opportunities using Tipranks' Stock Screener. PRIMARY ENDPOINT MET: Eli Lilly announced topline Phase 3 results from ACHIEVE-1, evaluating the safety and efficacy of orforglipron compared to placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. Orforglipron is the first oral small molecule glucagon-like peptide-1 receptor agonist, taken without food and water restrictions, to successfully complete a Phase 3 trial. If approved, the company is confident in its ability to launch orforglipron worldwide without supply constraints. This would further Lilly’s mission to reduce chronic diseases like type 2 diabetes, which is expected to impact an estimated 760 million adults by 2050. In the first Phase 3 trial of the ACHIEVE program, orforglipron met the primary endpoint of superior A1C reduction compared to placebo at 40 weeks, lowering A1C by an average of 1.3% to 1.6% from a baseline of 8%, using the efficacy estimand. In a key secondary endpoint, more than 65% of participants taking the highest dose of orforglipron achieved an A1C less than or equal to 6.5%, which is below the American Diabetes Association’s defined threshold for diabetes. In an additional key secondary endpoint, participants taking orforglipron lost an average of 16.0 lbs at the highest dose. Given that participants had not yet reached a weight plateau at the time the study ended, it appears that full weight reduction was not yet attained. The overall safety profile of orforglipron in ACHIEVE-1 was consistent with the established GLP-1 class. Overall treatment discontinuation rates due to adverse events were 6%, 4% and 8% for orforglipron vs. 1% with placebo. No hepatic safety signal was observed. Lilly expects to submit orforglipron for weight management to global regulatory agencies by the end of this year, with the submission for the treatment of type 2 diabetes anticipated in 2026. PICTURE-PERFECT: Calling the results “picture-perfect,” Leerink notes Eli once-daily oral GLP-1 pill showed similar efficacy and safety relative to weekly injectable semaglutide, made by Novo Nordisk. Importantly, the press release stated that “no hepatic safety signal was observed.” The firm expects the next orforglipron Phase 3 topline result in Q3 2025, and it expects orforglipron to be approved in 2026. Leerink reiterates an Outperform rating on Eli Lilly’s shares. HIGHLY COMPETITIVE: JPMorgan says Eli Lilly released Phase 3 data for orforglipron in type 2 diabetes today, and overall the results suggest a “highly competitive profile” for the drug. Orforglipron was highly efficacious on HbA1c, but weight loss was the primary focus for investors and here orforglipron showed a 6.3% placebo adjusted reduction from baseline at its highest dose, which is largely comparable to Wegovy and in line with Street expectations for 5%-6% weight loss, the firm tells investors in a research note. JPMorgan adds that tolerability looks manageable with only an 8% discontinuation rate on the high dose. JPMorgan has an Overweight rating on Eli Lilly shares. HIGHLY FAVORABLE FOR STRUCTURE: In a separate note, JPMorgan says Eli Lilly’s Phase 3 data for orforglipron in type 2 diabetes suggest a “highly competitive profile” for the drug. The firm views the data as its base case scenario, whereby Structure Therapeutics (GPCR) shares could be up double-digit percent in this scenario on a “highly favorable read-through” and Viking Therapeutics (VKTX) could move mid-single-digit in either direction. JPMorgan’s focus was primarily on orfoglipron’s tolerability profile with the extended titration, and here the data is highlighted by an 8% discontinuation rate on the highest dose versus low-teens expectations. The firm sees the data as “helping derisk the category,” giving more confidence that Structure can also bring tolerability of aleniglipron to reasonable levels. For Viking, the read-through is not as direct, and today’s data “clearly helps derisk a strong” first in class oral competitor from Lilly, which could limit the potential of late entrant injectable assets, says JPMorgan. However, the firm believes the data “still leaves a clear role” for Viking’s “highly tolerable” oral VK-2735. PRICE ACTION: In morning trading, shares of Eli Lilly have climbed over 13% to $832.05, while Structure Therapeutics moved 10% higher to $20.37. Trading lower following the news, Viking Therapeutics has dropped more than 3% to $22.81. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See the top stocks recommended by analysts >> Read More on LLY: Disclaimer & DisclosureReport an Issue JPMorgan says Lilly data ‘highly favorable’ for Structure Therapeutics JPMorgan says Lilly data ‘highly favorable’ for Structure Therapeutics Eli Lilly rises 16.3% Eli Lilly rises 16.3% Early notable gainers among liquid option names on April 17th Early notable gainers among liquid option names on April 17th Eli Lilly rises 13.0% Eli Lilly rises 13.0% Unusually active option classes on open April 17th Unusually active option classes on open April 17th

As of 2026-08-08 • Updated weeklySource: Earnings sourceIngestion runbook