SPTX 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-11-02

• We have incurred significant operating losses since the inception of our business and expect to continue to generate operating losses for the foreseeable future, and expect that our expenses and operating losses will continue to increase substantially. Our ability to

• generate product revenue sufficient to achieve profitability, if ever, will depend on the successful development and eventual commercialization of any product candidates we may develop. During the nine months ended September 30, 2026 and 2025, we had a net loss of $114.4 million and $50.7 million, r…

• Comparison of the three months ended September 30, 2026 and 2025

• $0.9 million of increased costs associated with advancing our nonclinical and early discovery assets;

• $0.5 million of increased costs associated with employee compensation primarily due to increased headcount to support our research and development operations and salary adjustments; and

相对上期删除的文字 · 来源:10-Q · 2026-08-03

• We have incurred significant operating losses since the inception of our business and expect to continue to generate operating losses for the foreseeable future, and expect that our expenses and operating losses will continue to increase substantially. Our ability to generate product revenue suffici…

• of $88.0 million and $28.2 million, respectively. As of June 30, 2026, we had an accumulated deficit of $202.1 million. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our preclinical studies and planned clinical trials and our expendit…

• $1.5 million of increased costs associated with our GlyphAgo program, which was primarily due to our Phase 1 trial, for which we announced dosing of the first participant in September 2025 and completed the study in the second quarter of 2026, and other development activities as we advance the progr…

• $0.1 million of increased costs associated with our Glyph2BLSD program due to timing of our development activities;

• $0.4 million of increased costs associated with advancing our preclinical and early discovery assets;

相对上期新增的文字 · 来源:10-Q · 2026-11-02

• Additionally, we may in the future utilize an “open-label” clinical trial design for certain of our future clinical trials. An “open-label” clinical trial is one where both the patient and investigator know whether the patient is receiving the investigational product

• indications that we are pursuing. If later-stage clinical trials do not produce favorable results, our ability to obtain regulatory approval for our product candidates will be adversely impacted.

• application, may cause delays in the approval or rejection of an application. The FDA and other comparable regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additio…

相对上期删除的文字 · 来源:10-Q · 2026-08-03

• Additionally, we may in the future utilize an “open-label” clinical trial design for certain of our future clinical trials. An “open-label” clinical trial is one where both the patient and investigator know whether the patient is receiving the investigational product candidate or either an existing …

• preclinical and clinical testing could delay, limit, or prevent marketing approval of a product candidate. Any marketing approval that we may ultimately obtain could be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.