SEPN 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-11

• We are a clinical-stage biotechnology company pioneering a new era of GPCR oral small molecule drug discovery powered by our proprietary Native Complex Platform®. Our industrial-scale platform aims to unlock the full potential of GPCR therapies and has led to the discovery and development of our dee…

• On April 13, 2026, we announced the dosing of the first participants in our Phase 1 clinical trial of SEP-479, our oral small molecule PTH1R agonist being developed for the treatment of patients with hypoparathyroidism. The Phase 1 clinical trial is a single-ascending dose (“SAD”) and multiple-ascen…

• We have incurred significant operating losses since our inception, except for the year ended December 31, 2023. Our revenue to date has been generated solely from research services. Since our founding, we have devoted substantially all of our resources to organizing and staffing our company, busines…

• Our net loss was $8.6 million and $21.5 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $175.9 million. We have incurred net losses in each year since inception, except for the year ended December 31, 2023. We expect to…

• We expect to continue to incur significant and increasing net operating losses for the next several years as we:

相对上期删除的文字 · 来源:10-Q · 2025-11-10

• We are a clinical-stage biotechnology company with a world-class team of G protein-coupled receptor (“GPCR”) experts and drug developers advancing cutting-edge science to unlock the full potential of GPCR therapies for patients with significant unmet needs. Our proprietary Native Complex Platform™ i…

• In September 2025, we provided an update on SEP-479, our oral small molecule parathyroid hormone 1 receptor (“PTH1R”) agonist program for hypoparathyroidism. In February 2025, we discontinued the Phase 1 clinical trial for SEP-786 as a result of observations of hyperbilirubinemia. The findings from …

• We announced in September 2025 that we had selected a new PTH1R development candidate, SEP-479. We presented preclinical data for SEP-479 from a translational rat thyroparathyroidectomy model demonstrating that SEP-479 achieved sustained normalization of serum calcium and phosphate levels over a 28-…

• We observed no significant inhibition of UGT1A1 or other transporters for SEP-479 and no hyperbilirubinemia in any of the non-clinical studies to date for SEP-479, including the 7-day cynomolgus monkey study at supratherapeutic doses. SEP-479 was generally well-tolerated in the completed 28-day GLP …

• In August 2025, we announced the dosing of the first participants in our Phase 1 clinical trial of SEP-631, a selective oral small molecule Mas-related G protein-coupled receptor X2 (“MRGPRX2”) negative allosteric modulator being developed for the treatment of chronic spontaneous urticaria and other…

相对上期新增的文字 · 来源:10-Q · 2026-05-11

• Risks Related to Limited Operating History, Financial Position and Capital Requirements

• We have a limited operating history and have incurred significant operating losses since our inception and expect to incur significant losses for the foreseeable future.

• Pharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. We are a clinical-stage biotechnology company with a limited operating history, which may make it difficult to evaluate the success of our business to date and assess our future viabilit…

• We have no products approved for commercial sale and have not generated any revenue from product sales to date, and we continue to incur significant research and development and other expenses related to our preclinical and clinical development and ongoing operations. As a result, we are not profita…

• Even if we succeed in developing and obtaining marketing approval for one or more of our product candidates, we may never generate revenue that is significant enough to achieve profitability. If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or an…

相对上期删除的文字 · 来源:10-Q · 2025-11-10

• Disruptions at the FDA, the SEC and other U.S. government agencies caused by reduction in staffing, funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed,…

• Currently, federal agencies in the U.S. are operating under a federal government shutdown due to expiration of the continuing resolution on September 30, 2025 and the current U.S. administration is focused on reducing costs of the federal government generally, including significantly reducing the nu…

• Disruptions and personnel turnover, as a result of leadership changes, staff reductions or otherwise, at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. Changes and c…

• October 1, 2025, the U.S. federal government entered a shutdown suspending services deemed non-essential as a result of the failure by Congress to enact regular appropriations for the 2026 fiscal year. If a prolonged government shutdown occurs or a widespread freeze on federal funding continues or o…

• Unfavorable macroeconomic conditions, political instability and geopolitical events could adversely affect our business, financial condition, stock price, and results of operations.

相对上期新增的文字 · 来源:10-Q · 2026-05-11

• On March 20, 2026, Daniel Long, D.Phil., our Senior Vice President, Drug Discovery, adopted a pre-arranged trading plan for the sale, at the times and prices specified in the plan, of up to an aggregate of 45,000 shares of our common stock (comprised of shares issuable upon the exercise of option aw…

• During the three months ended March 31, 2026, no other directors or officers (as defined in Rule 16a-1(f) of the Exchange Act) of the Company adopted, modified, or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement” as each term is defined in Item 408 of Regulat…

相对上期删除的文字 · 来源:10-Q · 2025-11-10

• None of our directors or officers (as defined in Rule 16a-1(f) of the Exchange Act) adopted or terminated a Rule 10b5-1 trading plan or arrangement or a non-Rule 10b5-1 trading plan or arrangement, as defined in Item 408(c) of Regulation S-K, during the fiscal quarter ended September 30, 2025 covere…