First Tracks reports Q2 2026 results, ANB033 gets FDA Fast Track in celiac disease
The company finished enrollment in a gluten-challenge cohort of its Phase 1b celiac trial and expanded a second cohort, while reiterating a cash runway into Q2 2028.
First Tracks Biotherapeutics reported financial results for the quarter ended June 30, 2026 on August 12, 2026, alongside a pipeline update on its lead antibody candidate, ANB033.
The company said it completed enrollment for Cohort 1 (gluten challenge) of Phase 1b ANB033 trial in celiac disease (CeD), with top-line Cohort 1 data reaffirmed for Q4 20261. Cohort 1 is a gluten-challenge study to assess the prevention of mucosal damage through six weeks in 30 patients1.
Cohort 2 of the same trial was enhanced to enroll up to 40 patients including those with a broad range of histologic (Vh:Cd ratio ≤ 2.5) and symptom severity to further inform future development, with top-line data now anticipated in Q1 20271.
The U.S. FDA granted Fast Track designation for ANB033 for the treatment of CeD1, specifically for the treatment of people with CeD on a gluten-free diet1.
Separately, enrollment is ongoing for the Phase 1b ANB033 trial in eosinophilic esophagitis (EoE), with top-line data anticipated in Q3 20271. That EoE study is a 50-patient cohort assessing one dose level of subcutaneously administered ANB033 vs. placebo (randomized 1:1) through 12 weeks1. First Tracks also said it plans to initiate Phase 2 trials in two additional indications in H1 20271.
On other programs, the company's Phase 1a trial of ANB101 in healthy volunteers has completed1, and it is currently assessing ROE-maximizing strategic options to progress the potential development of rosnilimab in rheumatoid arthritis (RA) and other indications1.
On finances, cash, cash equivalents and investments totaled $168.0 million as of June 30, 20261, and the company said it is reiterating cash-runway into Q2 2028, including the expansion of ANB033 into two additional indications in H1 20271. Net loss was $33.4 million and $83.9 million for the three and six months ended June 30, 2026, compared to $42.4 million and $89.6 million for the same periods in 20251. The company noted that its financial results include assets, liabilities and expenses from both First Tracks and AnaptysBio prior to the completed separation on April 20, 2026, with certain expenses allocated from Anaptys's financial statements1.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.