First Tracks Biotherapeutics (NASDAQ: TRAX) presented pipeline updates at the Wells Fargo 21st Annual Healthcare Conference on Wednesday, highlighting its lead asset ANB033 and a cash position expected to sustain operations through the second quarter of 2028.
The company was spun out of AnaptysBio, with operations formally launched on April 20, 2024, following an announced intention dated September 2023. Financing completed the same month to support its early-stage cash runway.
ANB033, a CD122 antagonist targeting both IL-15 and IL-2 signaling through a single antibody, remains the company’s flagship program. Preclinical work and Phase I-A data demonstrated a 98% reduction in CD122-expressing natural killer cells after a single subcutaneous dose. The program is being developed across multiple indications, with clinical data cascading through 2024 and 2025.
For celiac disease, two Phase I-B cohorts are underway. Cohort 1, a gluten-challenge study enrolling patients with villus height-to-crypt depth (VHCD) ratios above 2.0, involves three subcutaneous doses followed by a 14-day gluten challenge; enrollment is complete, with top-line data expected in Q4 2024. Cohort 2, a healing study originally limited to patients with VHCD ratios below 2.0 and subsequently expanded to below 2.5, measures mucosal improvement at week 12 following dosing at weeks 0, 2, and 4. The efficacy target is a delta above 0.25 in VHCD ratio. Cohort 2 data are anticipated in Q1 2025.
ANB033 is also being evaluated in eosinophilic esophagitis (EoE). A Phase I-B trial enrolling 50 patients uses every-other-week dosing through week 12 and is powered to detect differences in eosinophil reduction and disease-specific quality-of-life scores. The program targets roughly 40% of patients who remain non-responsive or minimally responsive to current therapy, including Dupixent, which generated between $2 billion and $3 billion in revenue last year. EoE data are expected in the second half of 2025.
Two additional indications are expected to enter Phase II in the first half of 2027, with Biogen cutaneous lupus results anticipated in Q1 2027 and systemic lupus results in Q4 2024.
The company’s other clinical-stage assets include Rosnilimab, a PD-1 depleter, and ANB101, a BDCA2 depleter targeting plasmacytoid dendritic cells in type I interferon-related diseases, which has completed Phase I-A testing.
Addressing the celiac opportunity, CEO Dan Faga cited a U.S. market estimated at approximately $5 billion for patients who do not respond to a gluten-free diet and have biopsy-confirmed disease—representing roughly a quarter million non-responsive patients in the United States alone.
Shares of First Tracks closed at $41.76, with the stock trading around $42.43 (up 4.86%) on the day of the conference. The shares have surged 120% over the past year, though they have pulled back approximately 8% from a 52-week high of $49.91. The company holds a market capitalization of $1.49 billion and a current ratio of 14.28, with more cash than debt on hand.
“We have a differentiated drug,” Faga said, adding that the asset mix and early clinical profile could support rapid expansion if data continue to look favorable.
