SYRE 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-11-03

• •Gastroenterology: Advancing three potential first- and best-in-class combination programs in inflammatory bowel disease (“IBD”), a market forecasted to exceed $45 billion by 2035 (includes ulcerative colitis (“UC”) and Crohn’s disease (“CD”))

• •Dermatology: Advancing a potential first- and best-in-class anti-TL1A + IL-17A/F combination program, as well as a potential best-in-class anti-TL1A agent, in hidradenitis suppurativa (“HS”), a market forecasted to exceed $10 billion by 2035

• We are advancing a pipeline of monoclonal antibodies (“mAbs”) for the treatment of immune-mediated diseases. The following table (Figure 1) summarizes our pipeline and development strategy, including our SKYLINE Phase 2 platform trial evaluating SPY120, SPY130, SPY230, and monotherapy components the…

• *SKYLIGHT proof-of-concept study with SPY072 + bimekizumab, serving as a surrogate for internal SPY007 long-acting IL-17A/F antibody.

• 1UC flare (serious), intervertebral disc protrusion, anaemia, urinary tract infection, and acute cholecystitis (serious), each in one subject; all deemed not drug-related.

相对上期删除的文字 · 来源:10-Q · 2026-08-04

• •Advancing a portfolio of next-generation monotherapies - novel antibody candidates engineered for optimized potency, selectivity, and pharmacokinetics (“PK”) against validated targets

• •Evaluating paradigm-changing IBD combinations - fixed-dose combinations of our engineered investigational antibodies designed to enable superior efficacy, safety, and convenience

• •Expansion of our anti-TL1A program into additional indications - pipeline-in-a-product potential in diseases with first-in-class and best-in-class opportunity, starting with rheumatoid arthritis (“RA”), psoriatic arthritis (“PsA”), and axial spondyloarthritis (“axSpA”)

• We are advancing a pipeline of monoclonal antibodies (“mAbs”) for the treatment of IBD and other immune-mediated diseases. The following table (Figure 1) summarizes our pipeline and development strategy, including our SKYLINE Phase 2 platform trial evaluating SPY001, SPY002, SPY003, and pairwise com…

• SKYLINE is currently enrolling subjects into Part B of the trial.

相对上期新增的文字 · 来源:10-Q · 2026-11-03

• 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…

• exchange rates could have a material effect on payments made to foreign suppliers. For the nine months ended September 30, 2026, a majority of our expenditures were denominated in U.S. dollars. A hypothetical 10% change in foreign exchange rates during any of the periods presented would not have had…

相对上期删除的文字 · 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…

相对上期新增的文字 · 来源:10-Q · 2026-11-03

• •We will need to raise additional capital to fund our operations and if we are unable to raise such capital when needed or on acceptable terms, we may be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts and raising additional capital may …

• We will need substantial additional capital to fund our operations, and if we are unable to raise such capital when needed or on acceptable terms, we may be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.

• We do not currently have any products approved for sale and do not generate any revenue from product sales. Accordingly, we expect to rely primarily on equity and/or debt financings to fund our continued operations. Our ability to raise additional funds will depend, in part, on the success of our no…

• and clinical trials and other product development activities, regulatory events, our ability to identify and enter into licensing or other strategic arrangements, and other events or conditions that may affect our value or prospects, as well as factors related to political, financial, economic and m…

• regulatory approval could be very small, we may never become profitable despite obtaining such market share and acceptance of our products.

相对上期删除的文字 · 来源:10-Q · 2026-08-04

• •We will not be able to continue as a going concern if we are unable to raise additional capital when needed and raising additional capital may cause dilution to our stockholders and restrict our operations.

• We will need to raise additional capital, and if we are unable to do so when needed, we will not be able to continue as a going concern.

• We do not currently have any products approved for sale and do not generate any revenue from product sales. Accordingly, we expect to rely primarily on equity and/or debt financings to fund our continued operations. Our ability to raise additional funds will depend, in part, on the success of our no…

• 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.

相对上期新增的文字 · 来源:10-Q · 2026-11-03

• The information set forth below is included herewith for the purpose of providing the disclosures required under “Item 5.03 - Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year” of Form 8-K.

• On October 29, 2026, the Company filed with the Secretary of State of the State of Delaware (i) a Corrected Second Amended and Restated Certificate of Incorporation (the “Corrected COI”) to correct the inadvertent omission from its Second Amended and Restated Certificate of Incorporation of the Seri…

• The foregoing description of the COI Amendment does not purport to be complete and is subject to and qualified in its entirety by reference to the full text of the Corrected COI and Series B Certificate of Elimination, copies of which are attached hereto as Exhibits 3.1 and 3.3 and incorporated here…

• The information set forth below is included herewith for the purpose of providing the disclosures required under “Item 5.02 - Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers” of Form 8-K.

• On November 2, 2026, the Company and each of Dr. Cameron Turtle, Mr. Scott Burrows, Ms. Heidy King-Jones and Dr. Sheldon Sloan amended and restated their respective employment letter agreement (the “Amendments”). The Amendments provide for, among other ministerial changes, (i) an increase to Dr. Tur…

相对上期删除的文字 · 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…