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BCS

Current Report · Items 7.01, 8.01, 9.01 · 8-K

First Tracks Biotherapeutics, Inc.

TRAXNASDAQEQUITYCurrent

Regulation FD Disclosure · Other Events

Item 7.01 Regulation FD Disclosure. On October 12, 2026, First Tracks Biotherapeutics, Inc. (the “Company”) updated its corporate investor presentation, a full copy of which is attached hereto as Exhibit 99.1.…

Filed Oct 13, 2026Accepted Oct 13, 2026, 8:32 AM EDTCIK 2091349Accession 0001193125-26-419761
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Company context

We are a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics for autoimmune and inflammatory diseases. Our clinical-stage pipeline includes rosnilimab, a selective pathogenic T cell depleter, for which we completed a Phase 2b trial for the treatment of moderate-to-severe rheumatoid arthritis (“RA”), ANB033, a CD122 antagonist, in a Phase 1b trial for celiac disease (“CeD”) and eosinophilic esophagitis (“EoE”), and ANB101, a BDCA2 modulator, in a Phase 1a trial.

Current securities

Recent company filings

  1. 4 filingSep 4, 2026
  2. 4 filingAug 18, 2026
  3. 4 filingAug 18, 2026
  4. SCHEDULE 13G filingAug 14, 2026
  5. 424B3 filingAug 13, 2026

Registered securities in this filing

FIRST TRACKS BIOTHERAPEUTICS, INC. · 8-K · Filed 2026-10-13

As filed in this accession. Current/historical status below comes from the governed listing record; the cover itself remains exact to this filing.

Common stock, par value $0.001 per share

Symbol
TRAX
Exchange
NASDAQ
Classification
COMMON
Status
Current
Filing context

Context: C_95048d71-b19d-41fb-853e-4f06dab72225

Dimensions: Not supplied

Accession 000119312526419761 · 1 registered-security cover member

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Disclosure sections

Items 7.01, 8.01, 9.01

Select an item to read the extracted section. The as-filed document remains the primary evidence.

Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure. On October 12, 2026, First Tracks Biotherapeutics, Inc. (the “Company”) updated its corporate investor presentation, a full copy of which is attached hereto as Exhibit 99.1. The information in this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Exchange Act or the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.
Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events. On October 12 2026, the Company issued a press release announcing positive topline data from the first Phase 1b cohort of ANB033 in Celiac Disease. A copy of the press release is filed herewith as Exhibit 99.2.
Filed exhibits (2)
EX-99.2 (by filename) trax-ex99_2.htm

Exhibit 99.2 First Tracks Biotherapeutics Announces Positive Top-Line Results for ANB033 in Gluten-Challenge Study in Celiac Disease • ANB033 achieved a statistically significant and clinically meaningful protective effect on both gluten-induced intestinal damage and symptoms • LS mean change from baseline in Vh:Cd ratio of -0.17 on ANB033 vs. -0.66 on placebo, a +0.49 placebo-adjusted delta (p=0.009) • LS mean change from baseline in IEL density of -1.20 on ANB033 vs. +18.83 on placebo, a -20.03 placebo-adjusted delta (p<0.001) • Prevented an increase in symptoms throughout the entire gluten challenge, with lower CDSD score on ANB033 vs. placebo that was statistically significant from the first day • Well tolerated with no safety signals observed to date • Conference call and webcast today, Monday, Oct. 12, 2026, at 8:30 a.m. ET to discuss these results SAN DIEGO, CA - Oct. 12, 2026 - First Tracks Biotherapeutics, Inc. (Nasdaq: TRAX), a clinical-stage biotechnology company advancing antibody therapeutics that modulate immune pathways implicated in autoimmune and inflammatory diseases, today announced positive top-line results from Cohort 1 (gluten challenge) of ANB033’s Ph…

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