TRAX — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-11-03

• We announced top-line data from a healthy volunteer Phase 1a trial of ANB033 in October 2025 in which no dose-limiting toxicities were observed at any dose tested. A total of 80 subjects were enrolled in the randomized, double-blind, placebo-controlled healthy volunteer Phase 1 trial, where single a…

• On October 12, 2026, we announced top-line results from Cohort 1 (gluten challenge) of ANB033’s Phase 1b trial in celiac disease. Cohort 1 evaluated 32 patients (17 on ANB033 and 15 on placebo) who completed dosing and the gluten challenge at Week 6. Patients received three subcutaneously administer…

• ANB033 demonstrated a statistically significant difference compared to placebo across key histologic endpoints, including least squares (“LS”) mean change in villus height-to-crypt depth (“Vh:Cd”) ratio and intraepithelial lymphocyte (“IEL”) density, as well as symptom endpoints using the Celiac Dis…

• In addition, patients receiving ANB033 reported lower CDSD scores than patients receiving placebo, with a statistically significant difference beginning on the first day. Using the CDSD, symptoms were assessed daily through the entire 14-day gluten challenge. The CDSD is a validated, patient-reporte…

• In Cohort 1, no serious adverse events, no severe adverse events and no adverse events leading to discontinuation were reported in patients receiving ANB033.

Text removed vs the prior filing · source: 10-Q · 2026-08-12

• In September 2025, AnaptysBio announced its intention to separate its business into two independent, publicly traded companies (the “Spin-Off”). The spun-out company, First Tracks Biotherapeutics, would be a clinical-stage biotechnology company focused on the development and potential commercializat…

• First Tracks Biotherapeutics’ historical financial statements have been prepared on a standalone basis and are derived from AnaptysBio consolidated financial statements and accounting records. Therefore, these financial statements reflect, in conformity with U.S. generally accepted accounting princi…

• First Tracks Biotherapeutics’ statements of operations through the date of the Spin-Off reflect allocations of certain expenses, including research and development expenses and administrative expenses, and allocations of certain assets and liabilities from the consolidated financial statements of An…

• We entered into a Separation and Distribution Agreement and a Transition Services Agreement with AnaptysBio to govern the Spin-Off and our relationship with AnaptysBio following the Spin-Off. These agreements will provide for the allocation between First Tracks Biotherapeutics and AnaptysBio of Anap…

• Certain third-party investors (the “Private Placement Investors”) purchased shares of First Tracks Biotherapeutics common stock from First Tracks Biotherapeutics and EcoR1 Capital Fund Qualified, L.P. (the “Selling Stockholder”) in the private placement that closed on April 20, 2026 (the “Private Pl…

Text added vs the prior filing · source: 10-Q · 2026-11-03

• Even if we or any future collaborators initiate and complete clinical trials for our product candidates, these product candidates will not be permitted to be marketed in the United States until approval of a Biologics License Application (“BLA”) from the FDA is received, and will not be permitted to…

• Disruptions at the FDA and other government agencies, including as a result of workforce reductions, leadership changes or government shutdowns, could negatively affect the review of our regulatory submissions, which could negatively impact our business.

• The ability of the FDA to review and approve regulatory submissions can be affected by a variety of factors, including statutory, regulatory and policy changes, inadequate government budget funding levels, a reduction in the FDA’s workforce and its ability to hire and retain key personnel, disruptio…

• Furthermore, all of our therapeutic antibodies are manufactured by starting with cells which are stored in a cell bank. We have one master cell bank for each antibody manufactured in accordance with cGMP and create working cell banks to support cGMP manufacturing, and believe we would have adequate …

• If we need to conduct fundraising activities and we do not raise additional capital in sufficient amounts or on terms acceptable to us, we may be prevented from pursuing development and commercialization efforts, which will have a material adverse effect on our business, operating results and prospe…

Text removed vs the prior filing · source: 10-Q · 2026-08-12

• for clinical trials, our ability to obtain marketing approval, or our ability to provide supply of our products for patients, if approved, could be delayed or stopped.

• narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective.

• Even if we or any future collaborators initiate and complete clinical trials for our product candidates, these product candidates will not be permitted to be marketed in the United States until approval of a Biologics License Application (“BLA”) from the FDA is

• received, and will not be permitted to be marketed in other countries without marketing approval from foreign regulatory authorities. Obtaining approval of a BLA or other marketing approvals is often a lengthy, expensive and uncertain process over which the FDA and foreign regulatory authorities hav…

• Furthermore, all of our therapeutic antibodies are manufactured by starting with cells which are stored in a cell bank. We have one master cell bank for each antibody manufactured in accordance with cGMP and create working cell banks to support cGMP