First Tracks Biotherapeutics — Third Quarter 2026 Earnings Summary
Financial Performance:
- Research and development expenses were $23.8 million for the three months ended September 30, 2026, compared to $33.3 million in the same period in 2025; for the nine months ended September 30, 2026, expenses were $83.4 million compared to $114.1 million in 2025.
- General and administrative expenses were $9.0 million for the three months ended September 30, 2026, compared to $11.7 million in 2025; for the nine months ended September 30, 2026, expenses were $37.1 million compared to $28.2 million in 2025.
- Net loss was $31.4 million ($0.88 per share) for the three months ended September 30, 2026, compared to $41.9 million ($1.50 per share) in 2025; for the nine months ended September 30, 2026, net loss was $115.2 million ($3.25 per share) compared to $131.5 million ($4.52 per share) in 2025.
- Cash, cash equivalents, and investments totaled $155.6 million as of September 30, 2026, down from $311.6 million (including $238.2 million cash and $73.4 million short-term investments) as of December 31, 2025.
- Total assets were $170.5 million as of September 30, 2026, compared to $330.5 million as of December 31, 2025.
- Total stockholders' equity was $151.0 million as of September 30, 2026, compared to $287.5 million as of December 31, 2025.
- Interest income was $1.5 million for the three months ended September 30, 2026, compared to $3.2 million in 2025; for the nine months ended September 30, 2026, interest income was $5.4 million compared to $10.8 million in 2025.
Guidance and Future Outlook:
- Anticipates initiating a late-stage clinical trial for ANB033 in celiac disease in 2027.
- Anticipates initiating Phase 2 development of ANB033 in vitiligo and one additional indication in the first half of 2027.
- Anticipates reporting top-line data from the celiac disease mucosal-healing cohort (Cohort 2) in Q1 2027.
- Anticipates reporting top-line data from the Phase 1b trial in eosinophilic esophagitis in Q3 2027.
- Plans to continue engaging with the FDA regarding the next phase of development for ANB033 in celiac disease.
Business Segments and Product Lines:
- ANB033 (CD122 antagonist):
- Phase 1b Cohort 1 in celiac disease (gluten challenge) achieved a statistically significant and clinically meaningful protective effect on gluten-induced intestinal damage and symptoms.
- LS mean change from baseline in villus height-to-crypt depth ratio was -0.17 on ANB033 versus -0.66 on placebo (placebo-adjusted delta +0.49, p=0.009).
- LS mean change from baseline in intraepithelial lymphocyte density was -1.20 on ANB033 versus +18.83 on placebo (placebo-adjusted delta -20.03, p<0.001).
- ANB033 prevented an increase in symptoms throughout the gluten challenge with a statistically significant lower Celiac Disease Symptom Diary score from the first day.
- ANB033 was well tolerated with no safety signals observed in Cohort 1.
- Enrollment for Phase 1b Cohort 2 (mucosal healing) is complete.
- Phase 1b trial in eosinophilic esophagitis is ongoing with a 50-patient cohort assessing subcutaneously administered ANB033 versus placebo.
- Rosnilimab (Pathogenic T cell depleter):
- Currently assessing return-on-equity-maximizing strategic options to progress development in rheumatoid arthritis and other indications.
- ANB101 (BDCA2 modulator):
- Phase 1a trial in healthy volunteers is complete.
- Evaluating a potential development approach informed by clinical evidence and competitor registrational data in systemic lupus erythematosus (anticipated Q4 2026) and cutaneous lupus erythematosus (anticipated early 2027).
- ANB033 (CD122 antagonist):
Other Key Points:
- Completed a private placement in October 2026 with $200 million in gross proceeds, resulting in pro forma cash of $343 million.
- The separation of AnaptysBio, Inc. and First Tracks Biotherapeutics, Inc. was completed on April 20, 2026; financial results for periods prior to this date include assets, liabilities, and expenses related to both companies.
- ANB033 has received Fast Track designation from the FDA.
- The increase in general and administrative expenses for the nine months ended September 30, 2026, was due to the allocation of legal costs for the separation from AnaptysBio and AnaptysBio's lawsuit with GSK and Tesaro.
- The decrease in research and development expenses for the nine months ended September 30, 2026, was primarily due to decreased development costs for rosnilimab and ANB032, offset by increased costs for the ANB033 Phase 1 trial.
- Company
- FIRST TRACKS BIOTHERAPEUTICS INC
- Sector
- Healthcare
- Industry
- Biotechnology