STTK — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-11

• SL-325 is a high-affinity DR3 blocking monoclonal antibody. DR3 is the sole known receptor for tumor necrosis factor like ligand 1A ("TL1A"). In our head-to-head preclinical studies, SL-325 blocked TL1A binding to DR3 better than sequence equivalents of leading TL1A blocking antibodies. We believe t…

• We have completed a single ascending dose (“SAD”) and multiple ascending dose (“MAD”) Phase 1 clinical trial evaluating SL-325 in healthy volunteers. The Phase 1 trial was a first-in-human, randomized, placebo-controlled trial evaluating the safety, tolerability, pharmacokinetics (“PK”), receptor oc…

• In June 2026, we shared the following data from our Phase 1 trial of SL-325. SL-325 was well-tolerated by all participants in the trial, with only mild (Grade 1) treatment-related adverse events observed in 12 participants. The favorable safety and tolerability profile is consistent with that of the…

• The PK profile for SL-325 demonstrated dose-proportional increases in Cmax and AUC across all dose levels, with an estimated half-life of approximately 16 days. Accumulation of SL-325 was observed with repeated dosing, at a ratio of 1.64-1.75. Complete inhibition of TL1A binding to DR3 was observed …

• Treatment emergent anti-drug antibodies ("ADA") were detected in 3.7% (2/54) of study participants, and ADA titers remained low in these individuals (maximum titers of 8 and 16). The validated ADA assay has a sensitivity of 5.0 ng/ml and drug tolerance of up to SL-325 concentrations of 160 µg/ml in …

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• SL-325 is a high-affinity DR3 blocking monoclonal antibody. DR3 is the sole known receptor for tumor necrosis factor like ligand 1A ("TL1A"). In our head-to-head preclinical studies, SL-325 blocked TL1A binding to DR3 better than sequence equivalents of leading TL1A blocking antibodies. We believe t…

• TL1A is the sole known signaling ligand for DR3, and TL1A does not signal through any other receptors. Thus, we believe that the clinical safety profile of TL1A blocking antibodies generated to date in clinical trials conducted by other parties derisks the clinical safety profile for DR3 blockade. T…

• DR3 has a distinct expression pattern from TL1A, and, consequently, blocking the receptor may allow a more complete and durable blockade of the axis, which we believe will translate to improved efficacy in patients with IBD. DR3 and TL1A have distinct expression patterns within the gastrointestinal …

• A source of immunogenicity shared by all TL1A blocking antibodies is the formation of immune complexes between soluble TL1A in the blood and the anti-TL1A antibodies. Binding of soluble TL1A in the blood by anti-TL1A antibodies leads to a significant increase in the concentration of total TL1A in th…

• Additionally, there is a high degree of sequence identity between certain third-party anti-TL1A antibodies, including tulisokibart, afimkibart, and duvakitug, and potential third-party combination agents, including vedolizumab, risankizumab, mirikizumab, and guselkumab. This overlap in sequence iden…

Text added vs the prior filing · source: 10-Q · 2026-08-11

• Our management, with the participation of our principal executive officer and our principal financial officer, evaluated, as of the end of the period covered by this Quarterly Report on Form 10-Q, the effectiveness of our disclosure controls and procedures. Based on this evaluation of our disclosure…

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

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• Our management, with the participation of our principal executive officer and our principal financial officer, evaluated, as of the end of the period covered by this Quarterly Report on Form 10-Q, the effectiveness of our disclosure controls and procedures. Based on this evaluation of our disclosure…

• procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act are recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure contro…

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

Text added vs the prior filing · source: 10-Q · 2026-08-11

• Other than as described above, during the three months ended June 30, 2026, none of our directors or Section 16 officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in…

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• On February 2, 2026, Abhinav Shukla, PhD., the Company's Chief Technical Officer, adopted a trading plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act. Dr. Shukla’s 10b5-1 Plan provides for the potential exercise of stock options to purchase up to 16…

• The adoption of Dr. Pandite and Dr. Shukla's 10b5-1 plans were in accordance with both the Company's insider trading policy and SEC rules and regulations, on the date of adoption.

• Other than as described above, during the three months ended March 31, 2026, none of our directors or Section 16 officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined i…