SYRE 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-04

• We are a clinical stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Our pipeline includes extended half-life antibodie…

• Topline induction data from Part A of the SKYLINE trial in UC subjects were presented in April 2026 (SPY001) and June 2026 (SPY002). Baseline characteristics were consistent with expectations (Figure 3). SPY001 and SPY002 were well-tolerated with a safety profile consistent with in-class comparators…

• Figure 3. SPY001 and SPY002 baseline demographics from SKYLINE Part A Induction Topline

• Figure 4. SPY001 and SPY002 safety summary from SKYLINE Part A Induction Topline

• 1Hospitalization for exacerbation of UC in one subject, not drug-related.

相对上期删除的文字 · 来源:10-Q · 2026-05-05

• We are a biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Our pipeline includes extended half-life antibodies targeting α4β7, TL1A, and IL-23 in development as monotherapi…

• SPY001 demonstrates similar potency and selectivity as synthesized vedolizumab in preclinical in vitro models including surface plasmon residence and cellular adhesion assays. We initiated a first-in-human (“FIH”) Phase 1 trial for SPY001 in June 2024. The SPY001 Phase 1 trial was a double blind, pl…

• (“MAD”) component. The trial enrolled 56 healthy adult participants into five SAD cohorts and two MAD cohorts in the main portion of the trial. The primary endpoint was safety, with PK and anti-drug antibodies (“ADA”) serving as secondary endpoints. Additional cohorts were added to the trial to eval…

• Interim results were initially presented in November 2024, with additional data presented in May 2025 with up to eight months of follow up. To date, SPY001 has demonstrated a favorable safety profile across all dose groups, a meaningfully differentiated PK profile supporting potential quarterly or t…

• Initial topline induction results from Part A of the SKYLINE trial in ulcerative colitis subjects were presented in April 2026. 43 subjects were dosed with SPY001 and 41 subjects completed the induction period. Baseline characteristics were consistent with expectations (Figure 4). SPY001 was well to…

相对上期新增的文字 · 来源:10-Q · 2026-08-04

• hypothetical 10% change in interest rates during any of the periods presented would not have had a material effect on the total market value of our cash equivalents and marketable securities as of June 30, 2026. To date, we have not experienced a loss of principal on any of our investments and as of…

• We are also exposed to market risk related to changes in foreign currency exchange rates as a result of our entering into transactions denominated in currencies other than U.S. dollars. Due to the uncertain timing of expected payments in foreign currencies, we do not utilize any forward exchange con…

• Inflation generally affects us by increasing our costs, such as the cost of labor and research and development contract costs. We do not believe inflation has had a material adverse effect on the results of our operations during the three months ended June 30, 2026.

相对上期删除的文字 · 来源:10-Q · 2026-05-05

• We are also exposed to market risk related to changes in foreign currency exchange rates as a result of our entering into transactions denominated in currencies other than U.S. dollars. Due to the uncertain timing of expected payments in foreign currencies, we do not utilize any forward exchange con…

• Inflation generally affects us by increasing our costs, such as the cost of labor and research and development contract costs. We do not believe inflation has had a material adverse effect on the results of our operations during the three months ended March 31, 2026.

相对上期新增的文字 · 来源:10-Q · 2026-08-04

• Our management, with the participation of our principal executive officer and principal financial officer, evaluated, as of the end of the period covered by this Quarterly Report, the effectiveness of our disclosure controls and procedures. Based on the foregoing evaluation of our disclosure control…

• There were no changes in our internal control over financial reporting during the quarter ended June 30, 2026, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

相对上期删除的文字 · 来源:10-Q · 2026-05-05

• Our management, with the participation of our principal executive officer and principal financial officer, evaluated, as of the end of the period covered by this Quarterly Report, the effectiveness of our disclosure controls and procedures. Based on the foregoing evaluation of our disclosure control…

• March 31, 2026, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exch…

• There were no changes in our internal control over financial reporting during the quarter ended March 31, 2026, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

相对上期新增的文字 · 来源:10-Q · 2026-08-04

• common stock in an underwritten public offering for gross proceeds of approximately $316 million and in April 2026, we sold 7,475,000 shares of our common stock in an underwritten public offering for gross proceeds of approximately $463 million. Since stockholder approval of the Series B Conversion …

• candidates, challenges enrolling clinical trial participants, greater governmental regulation, stricter labeling requirements, decreased market potential and potential regulatory delays in the testing or approvals of our product candidates.

• We may not have the financial resources to continue development of, or to modify existing or enter into new collaborations for, a product candidate if we experience any issues that delay or prevent regulatory approval of, or our ability to commercialize, our product candidates. We or our current or …

• could have a material and adverse effect on our business, financial condition, results of operations and prospects.

• From time to time, we estimate the timing of the anticipated accomplishment of various scientific, clinical, regulatory and other product development goals, which we sometimes refer to as milestones. These milestones may include the commencement or completion of nonclinical studies and clinical tria…

相对上期删除的文字 · 来源:10-Q · 2026-05-05

• common stock in an underwritten public offering for gross proceeds of approximately $316 million and in April 2026, we sold 7,475,000 shares of our common stock in an underwritten public offering for gross proceeds of approximately $463 million. Subject to certain beneficial ownership limitations se…

• or otherwise fails to meet expectations, our product candidates may not be accepted or favored by the general public, the medical community or the investment community and potential clinical trial subjects may be discouraged from enrolling in our clinical trials or may discontinue their participatio…

• our current or future clinical trials ultimately may fail to support the approval of our current or any future product candidates.

• We may not have the financial resources to continue development of, or to modify existing or enter into new collaborations for, a product candidate if we experience any issues that delay or prevent regulatory approval of, or our ability to commercialize, our product candidates. We or our current or …

• From time to time, we estimate the timing of the anticipated accomplishment of various scientific, clinical, regulatory and other product development goals, which we sometimes refer to as milestones. These milestones may include the commencement or completion of nonclinical studies and clinical tria…

相对上期新增的文字 · 来源:10-Q · 2026-08-04

• On April 16, 2026, Heidy King-Jones, our Chief Legal Officer and Corporate Secretary, adopted a trading plan intended to satisfy Rule 10b5-1(c) to sell up to 76,000 shares of our common stock over a period ending April 5, 2028, subject to certain conditions, all of which are to be acquired upon the …

• On April 16, 2026, Jeffrey Albers, one of our directors, and Sessions LLC, an investment company of which Mr. Albers is a managing director and owns 10% or more of the equity interest in or otherwise exercises significant influence over, adopted a trading plan intended to satisfy Rule 10b5-1(c) to s…

相对上期删除的文字 · 来源:10-Q · 2026-05-05

• On February 6, 2026, Michael Henderson, one of our directors, adopted a trading plan intended to satisfy Rule 10b5-1(c) to sell up to 100,000 shares of our common stock over a period ending February 27, 2027, subject to certain conditions.