Structure Therapeutics Files 8-K
Ticker: GPCR · Form: 8-K · Filed: Jun 3, 2024 · CIK: 1888886
| Field | Detail |
|---|---|
| Company | Structure Therapeutics Inc. (GPCR) |
| Form Type | 8-K |
| Filed Date | Jun 3, 2024 |
| Risk Level | low |
| Pages | 6 |
| Reading Time | 7 min |
| Key Dollar Amounts | $0.0001 |
| Sentiment | neutral |
Sentiment: neutral
Topics: corporate-filing, company-update
Related Tickers: GPCR
TL;DR
Structure Therapeutics (GPCR) filed an 8-K on June 3rd, former ShouTi Inc.
AI Summary
Structure Therapeutics Inc. filed an 8-K on June 3, 2024, reporting on other events and financial statements. The company, formerly known as ShouTi Inc. until October 19, 2021, is incorporated in the Cayman Islands and operates in the Pharmaceutical Preparations industry.
Why It Matters
This filing provides an update on the company's corporate activities and financial reporting, which is important for investors to stay informed about the company's status.
Risk Assessment
Risk Level: low — This is a routine filing for corporate information and does not appear to contain any significant new risks or material adverse events.
Key Players & Entities
- Structure Therapeutics Inc. (company) — Registrant
- ShouTi Inc. (company) — Former company name
- June 3, 2024 (date) — Date of earliest event reported
- 20211019 (date) — Date of name change from ShouTi Inc.
FAQ
What is the primary business of Structure Therapeutics Inc.?
Structure Therapeutics Inc. operates in the Pharmaceutical Preparations industry, as indicated by its Standard Industrial Classification code [2834].
When was Structure Therapeutics Inc. formerly known as?
Structure Therapeutics Inc. was formerly known as ShouTi Inc., with the name change occurring on October 19, 2021.
In which jurisdiction is Structure Therapeutics Inc. incorporated?
Structure Therapeutics Inc. is incorporated in the Cayman Islands.
What is the filing date for this 8-K report?
The filing date for this 8-K report is June 3, 2024, which is also the date of the earliest event reported.
What are the main items reported in this 8-K filing?
This 8-K filing reports on Regulation FD Disclosure, Other Events, and Financial Statements and Exhibits.
Filing Stats: 1,734 words · 7 min read · ~6 pages · Grade level 14.7 · Accepted 2024-06-03 08:00:25
Key Financial Figures
- $0.0001 — enting three ordinary shares, par value $0.0001 per ordinary share GPCR Nasdaq Glob
Filing Documents
- tm2414821d7_8k.htm (8-K) — 44KB
- tm2414821d7_ex99-1.htm (EX-99.1) — 22KB
- tm2414821d7_ex99-2.htm (EX-99.2) — 49KB
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- 0001104659-24-067483.txt ( ) — 6548KB
- gpcr-20240603.xsd (EX-101.SCH) — 4KB
- gpcr-20240603_def.xml (EX-101.DEF) — 27KB
- gpcr-20240603_lab.xml (EX-101.LAB) — 36KB
- gpcr-20240603_pre.xml (EX-101.PRE) — 25KB
- tm2414821d7_8k_htm.xml (XML) — 6KB
01 Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure. On June 3, 2024, Structure Therapeutics Inc. (the Company) issued a press release and will be hosting a conference call and webcast to discuss positive topline data from its Phase 2a obesity study and capsule to tablet PK study for its oral non-peptide small molecule GLP-1 receptor agonist, GSBR-1290. Copies of the press release and investor presentation the Company intends to use during the conference call and webcast are attached as Exhibits 99.1 and 99.2 to this Current Report on Form 8-K, respectively. The information set forth in this Item 7.01 and in the press release and investor presentation attached hereto as Exhibits 99.1 and 99.2, respectively, is deemed to be "furnished" and shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that Section. The information set forth in this Item 7.01, including Exhibits 99.1 and 99.2, shall not be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended, except to the extent that the Company specifically incorporates it by reference.
01 Other Events
Item 8.01 Other Events. GSBR-1290 – Phase 2a Topline Results Summary In the Phase 2a obesity study, GSBR-1290 demonstrated a clinically meaningful and statistically significant placebo-adjusted mean decrease in weight of 6.2% (p<0.0001, using least-squares means (LSM) and analyzed based on the primary efficacy estimand using a mixed model for repeated measures) at 12 weeks. At Week 12, 67% of GSBR-1290 treated participants achieved 6% weight loss and 33% achieved 10% weight loss, compared to 0% for placebo. A capsule to tablet PK study designed to explore a new tablet formulation of GSBR-1290 demonstrated a placebo-adjusted mean weight loss of up to 6.9% (p<0.0001, using LSM and analyzed based on the primary efficacy estimand using a mixed model for repeated measures) with the tablet formulation at 12 weeks. In addition, the tablet formulation demonstrated comparable exposure to the prior capsule formulation and pharmacokinetic data support dose proportional exposure and a once-daily dose profile of GSBR-1290. GSBR-1290 demonstrated generally favorable safety and tolerability results following repeated, daily dosing up to 120mg. As expected for the GLP1-RA drug class, leading adverse events (AEs) were gastrointestinal (GI)-related and the two most common AEs were nausea and vomiting. GI-related adverse events were generally observed early in treatment and attenuated after titration was completed. AE-related study discontinuations ranged from 5% in the Phase 2a obesity study to 11% in the capsule to tablet PK study. There were zero cases of drug-induced liver injury or persistent liver enzyme elevations reported across the two studies. GSBR-1290 Phase 2b Obesity Study Expected to Begin in Fourth Quarter 2024 The Company plans to submit an IND to the FDA in the third quarter of 2024 to support initiation of trials in chronic weight management and thereafter initiate a Phase 2b obesity study of GSBR-1290 in the fourth quarter of 2024. The 36-week global stu
Forward Looking Statements
Forward Looking Statements This Current Report on Form 8-K contains "forward-looking 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 potential to become a best-in-class oral small molecule GLP-1RA as well as an ideal backbone for future combination therapeutics for the treatment of obesity and related diseases, any expectations regarding the safety, efficacy, tolerability or once-daily dosing of GSBR-1290, including based on the clinical update from the Company's Phase 2a obesity study and capsule to tablet PK study, and other candidates under development, the ability of GSBR-1290 to treat T2DM, obesity or related indications, the planned IND submission and initiation and number of expected patients of the Company's Phase 2b obesity study and Phase 2 development plan in T2DM and the timing thereof, respectively and the planned timing of the continued development of GSBR-1290. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" 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, efficacy, 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 unce
01 Financial Statements and Exhibits
Item 9.01 Financial Statements and Exhibits. (d) Exhibits. Exhibit No. Description 99.1 Press Release, dated June 3, 2024. 99.2 Investor Presentation, dated June 3, 2024. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
SIGNATURES
SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Structure Therapeutics Inc. Date: June 3, 2024 By: /s/ Raymond Stevens Raymond Stevens, Ph.D. Chief Executive Officer