2. Structure Therapeutics Inc. (NASDAQ:GPCR)
Average Upside Potential as of November 21: 185.26%
Structure Therapeutics Inc. (NASDAQ:GPCR) is a clinical-stage biopharmaceutical company focused on discovering and developing innovative oral treatments for chronic metabolic and pulmonary conditions with significant unmet medical needs. Its lead product candidate, GPCR-01, is an oral therapy aimed at treating obesity and related metabolic disorders.
The company recently announced its third-quarter 2024 financial results and corporate updates. It reported a strong financial position as of September 30, with $915.3 million in cash, cash equivalents, and short-term investments. This substantial funding is projected to sustain operations and key clinical milestones, including all GSBR-1290 studies necessary for Phase 3 readiness, until at least 2027.
It announced positive developments for GSBR-1290. This oral small molecule targets the GLP-1 receptor and holds promise as a treatment for obesity. The company initiated a comprehensive development program for GSBR-1290, which includes two Phase 2 clinical trials: ACCESS and ACCESS II. These studies aim to determine optimal dosing strategies and evaluate the drug’s effectiveness in adults with obesity or overweight and weight-related health problems. The first patients have already been enrolled in the ACCESS trial, with the expectation of including higher dosage groups in ACCESS II by year-end. Topline data from both studies is anticipated in late 2025.
While Structure Therapeutics Inc. (NASDAQ:GPCR) has other programs targeting obesity and related conditions, the focus is clearly on GSBR-1290’s progress. This suggests it’s the company’s most promising candidate at this stage. Overall, this progress reveals that it’s well-positioned for success in the industry.
Baron Health Care Fund stated the following regarding Structure Therapeutics Inc. (NASDAQ:GPCR) in its fourth quarter 2023 investor letter:
“Structure Therapeutics Inc. (NASDAQ:GPCR) is a biotechnology company dedicated to making oral small molecule medicines to target the obesity and diabetes market. Recent share weakness has been due to two large pharmaceutical acquisitions in the space: Roche’s purchase of Carmot and AstraZeneca’s in-licensing of Eccogene’s GLP-1 asset. These developments were followed by updates from Structure that implied it had a promising asset, but it might be inferior to Eli Lilly’s first-in-class product. Shares fell as analysts reduced the probability of success surrounding potential peak sales. We think it is too early to reach a final conclusion on the company’s oral small molecule GLP-1, as these data sets are limited in total sample size, and there are compelling arguments for both sides. Given how quickly this space changes and our smaller position sizing due to the aforementioned dynamics, we are monitoring our position and making decisions based on our evolving analysis.
We initiated a small position in Structure Therapeutics Inc., a clinical-stage biotechnology company. Structure is developing an oral small molecule GLP-1 with once daily dosing. We think the GLP-1 class of obesity/diabetes drugs has the potential to be the largest drug class ever and that parts of the market will be particularly well suited to oral medications. Some people find oral medications more convenient than injectables, and oral small molecule drugs are cheaper and easier to manufacture than injectables, which could allow for lower pricing and greater access, particularly in international markets. Structure’s drug is still in its early phase of development, but there is reason to think that it could be successful. The drug was designed through the company’s structure-based drug discovery platform and was designed to selectively activate the G-protein signaling pathway, which should lead to a better efficacy/safety profile. In late September, Structure announced promising results from a Phase 1 multiple ascending dose study in non-diabetic overweight/obese individuals. Although there were only a few patients in the study, the drug impressively demonstrated reductions in mean body weight of up to 4.9% placebo-adjusted after 28 days, which would suggest a best-in-class profile. Then, in December, Structure announced results from its Phase 2a study, including a diabetic cohort and a non-diabetic overweight/obese cohort. The interim data from the obesity cohort continued to look competitive with 4.7% placebo-adjusted weight loss after 56 days. The diabetes data was somewhat underwhelming, with a 1.0% placebo-adjusted HbA1c reduction and 3.3% to 3.5% placebo-adjusted weight loss over 84 days (in comparison, Lilly’s orforglipron showed a 1.5% to 1.7% HbA1c reduction and 4.1% to 6.3% placebo-adjusted weight loss in a similar study). Structure is planning to study additional doses and titration regimens to optimize the drug’s profile in diabetes. Overall, we would characterize the early data as supportive of an active GLP-1 drug that has the potential to be among the leaders in the category. At this point we have a small position in the stock while we await more data to evaluate the competitiveness of Structure’s drug.”
