Risk Factors Update Summary
- Reported clinically meaningful topline data from a Phase 2a trial, including significant reductions in HbA1c and weight at 12 weeks in T2DM.
- Addition of LPA1R treatment for progressive pulmonary fibrosis with conditional recommendation for nintedanib. This expands treatment options.
- Completed dosing of Phase 2a study in T2DM and obesity, with topline data reported.
- Completed Private Placement in October 2023, raising approximately $300 million in gross proceeds.
- Increase in accumulated deficit from $117 million to $206 million, indicating continued significant and increasing operating losses.
- Increased federal NOL carryforwards from $66 million to $84 million in 2023.
- Interim Phase 2a obesity cohort data showed significant weight reductions at 8 weeks.
- Net proceeds from a recent share purchase agreement totaled approximately $281.5 million.
- Delay in reporting full 12-week obesity data due to a data collection omission for 24 participants.
- Phase 2b study for obesity expected to be initiated in the fourth quarter of 2024.
- State NOLs increased from $74.6 million to $146.5 million in 2023.
- Completion of IPO in February 2023, raising net proceeds of $166.7 million, providing financial support for operations.
- Pursuing contracts with alternative suppliers outside China for active pharmaceutical ingredients due to potential disruptions.
- Reporting of topline data for Phase 2a clinical trial in December 2023, showing encouraging safety profile and significant weight loss.
- Completed Phase 1 SAD and MAD study for GSBR-1290, demonstrating significant weight loss.
- Phase 2a obesity data to be reported in the latter half of the second quarter of 2024.
- Dependence on third parties for manufacturing may cause delays and increased costs.
- Data collection omission at a clinical site impacting Phase 2a study for GSBR-1290, leading to delays in data reporting.
- Potential disruptions if collaborations with Schrödinger are unsuccessful or terminated.
- Completed Phase 1 Japanese ethnobridging study showing substantial weight reduction in participants.
- Interim Phase 2a obesity cohort data showing significant weight reduction at 8 weeks, with full 12-week data expected in Q2 2024.
- Potential delays in enrolling additional participants due to data collection omission, potentially further delaying the clinical trial.
- Initiated Phase 2a proof-of-concept study in T2DM and obesity, with dosing and topline data reported.
- Increased competition from companies using AI for drug discovery may impact effectiveness.
Full Text Changes in Most Recent 10-K
Intended use: review the highlighted statements. These are additions to the risk factors disclosure in the most recent 10-K filing compared to the previous 10-K filing. Deleted and moved text is less important and is shown for context.
To view the full company filings, click on the following link to be taken to the SEC EDGAR database landing page for the company: https://www.sec.gov/edgar/browse/?CIK=1888886&owner=exclude
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