7. Structure Therapeutics Inc. (NASDAQ:GPCR)
Market Cap as of September 26: $2.43 billion
Number of Hedge Fund Holders: 43
Structure Therapeutics Inc. (NASDAQ:GPCR) is a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic and cardiopulmonary diseases, with a focus on G-protein coupled receptors (GPCRs) as a therapeutic target class. It has a pipeline of promising drug candidates targeting various disease areas, including obesity, diabetes, and chronic obstructive pulmonary disease (COPD).
Structure Therapeutics is a promising company in the obesity treatment market with its oral drug GSBR-1290. It has several approved products for various conditions, including X-linked hypophosphatemia, mucopolysaccharidosis VII, long-chain fatty acid oxidation disorders, and homozygous familial hypercholesterolemia.
It recently announced positive results from phase IIa studies of its obesity drug GSBR-1290. The drug showed promising results in reducing weight and has the potential to become a leading oral treatment for obesity. Based on these results, Structure Therapeutics Inc. (NASDAQ:GPCR) plans to start a larger phase IIb study in Q4 2024.
The company plans to submit an application to the FDA in Q3 2024 to start a phase IIb study on GSBR-1290 for obesity. They also plan to start a study on GSBR-1290 for type II diabetes in the second half of 2024.
It exceeded earnings expectations in 3 out of the 4 last quarters, despite a loss per share of $0.18 in Q2 2024. Its pipeline of innovative drug candidates positions the company for significant growth in the obesity and diabetes markets. The company’s recent positive clinical trial results and development plans suggest a promising future.
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.”
