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First Tracks Biotherapeutics TRAX

First Tracks Biotherapeutics reports Q3 2026 financial results

Item 2.02 Reports results

Form
8-K
Filed
Importance
Major
  1. ANB033 showed statistically significant protection against gluten-induced intestinal damage in celiac disease trial
  2. Completed enrollment for Phase 1b ANB033 trial in celiac disease with top-line data expected in Q1 2027
  3. Raised $200 million in private placement, pro forma cash of $343 million

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The reading, claim by claim

  1. Under Item 2.02, it said it issued a press release that day announcing financial results for the three and nine months ended September 30, 2026, attached as Exhibit 99.1.
  2. Item 2.02 states that the information, including Exhibit 99.1, shall not be deemed 'filed' for purposes of Section 18 of the Securities Exchange Act of 1934.
  3. It also says the information shall not be incorporated by reference into other filings, except as expressly set forth by specific reference.
  4. The report is signed by Ajim Tamboli, Chief Financial Officer.
  5. The press release says cash, cash equivalents and investments totaled $155.6 million as of Sept.
  6. It also says the April 20, 2026 separation of AnaptysBio, Inc. and First Tracks affects how earlier periods are presented.

6 of 9 claims matched the filing text.

Not found in the filing text

  • 30, 2026.
  • It reports pro forma cash of $343 million after a $200 million private placement completed in Oct.
  • 2026.

For perspective, checked against its own source

From the 10-Q for the quarter ended September 30, 2026

  • In its 10-Q for the quarter ended September 30, 2026, First Tracks reported net income of -$31.4 million.

From the filing

Item 2.02 Results of Operations and Financial Condition.

Item 2.02 Results of Operations and Financial Condition.

On November 3, 2026, First Tracks Biotherapeutics, Inc. ("First Tracks") issued a press release announcing its financial results for the three and nine months ended September 30, 2026.1 1A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.1

The information in this Item 2.02, including Exhibit 99.1 to this Current Report on Form 8-K, shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended2, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in the accompanying Exhibit 99.1 shall not be incorporated by reference into any registration statement or other document filed by First Tracks with the Securities and Exchange Commission, whether made before or after the date of this Current Report on Form 8-K, regardless of any general incorporation language in such filing (or any reference to this Current Report on Form 8-K generally), except as shall be expressly set forth by specific reference in such filing.3

Item 9.01 Financial Statements and Exhibits.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number

Exhibit Title or Description

99.1

Press release issued by First Tracks Biotherapeutics, Inc. regarding its financial results for the three and nine months ended September 30, 2026, dated November 3, 2026 .

104

Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

FIRST TRACKS BIOTHERAPEUTICS, INC.

Date:

November 3, 2026

By:

/s/ Ajim Tamboli4

Name: Ajim Tamboli4

Title: Chief Financial Officer4

First Tracks Biotherapeutics Reports Third Quarter 2026 Financial Results and Provides Business Update

• Announced ANB033 achieved a statistically significant and clinically meaningful protective effect on both gluten-induced intestinal damage and symptoms in Cohort 1 (gluten challenge) of Phase 1b trial in celiac disease (CeD) • Completed enrollment for Cohort 2 (mucosal healing) of Phase 1b ANB033 trial in CeD; top-line data anticipated in Q1 2027

• Anticipate initiating late-stage clinical trial for ANB033 in CeD in 2027

• Enrollment ongoing for Phase 1b ANB033 trial in eosinophilic esophagitis; top-line data anticipated in Q3 2027 • Anticipate initiating Phase 2 development of ANB033 in vitiligo and one additional indication in H1 2027

• Completed private placement with $200 million in gross proceeds; pro forma cash of $343 million

SAN DIEGO, CA — Nov. 3, 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 reported financial results for the third quarter ended Sept. 30, 2026, and provided a business update.

"ANB033, a subcutaneously administered CD122 antagonist designed to inhibit signaling of both IL-15 and IL-2 on immune cells, demonstrated statistically significant protection against gluten-induced intestinal damage and symptoms and was well tolerated in the Phase 1b gluten-challenge cohort. These data support our plans to progress ANB033 into late-stage development in 2027 in celiac disease as a potential treatment to prevent both acute symptoms and intestinal damage from gluten exposure despite general adherence to a gluten-free diet," said Daniel Faga, president and chief executive officer. "We will continue to work with regulators, clinicians and the patient community to advance ANB033. We anticipate initiating Phase 2 development in vitiligo and one additional indication in the first half of 2027, and reporting top-line results from the celiac disease mucosal-healing cohort in the first quarter of 2027 and in eosinophilic esophagitis in the third quarter of 2027."

ANB033 (CD122 antagonist)

• Phase 1b Cohort 1 in CeD is a gluten-challenge study to assess the prevention of mucosal damage through six weeks:

o Announced positive top-line results in October 2026 –

▪ ANB033 achieved a statistically significant and clinically meaningful protective effect on both gluten-induced intestinal damage and symptoms

▪ Least squares (LS) mean change from baseline in villus height-to-crypt depth (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 intraepithelial lymphocyte (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 a lower Celiac Disease Symptom Diary score on ANB033 vs . placebo that was statistically significant from the first day

▪ Well tolerated with no safety signals observed

▪ Full press release can be found at https://ir.firsttracksbio.com/news-releases/news-release-details/first-tracks-biotherapeutics-announces-positive-top-line-results

• Phase 1b Cohort 2 in CeD aims to assess mucosal healing through 12 weeks o Enrollment complete with top-line data anticipated in Q1 2027 • Plan to continue to engage with regulatory agencies, including the U.S. Food and Drug Administration (FDA), which has already granted ANB033 Fast Track designation, to discuss and align on the next phase of development for ANB033 in CeD o Anticipate initiating a late-stage clinical trial in CeD in 2027 • Phase 1b trial in eosinophilic esophagitis is ongoing o Includes a 50-patient cohort assessing subcutaneously administered ANB033 vs . placebo (randomized 1:1) through 12 weeks o Top-line data anticipated in Q3 2027 • Plan to initiate Phase 2 development of ANB033 in vitiligo and one additional indication in H1 2027

Rosnilimab (Pathogenic T cell depleter)

• Currently assessing return-on-equity-maximizing strategic options to progress the potential development of rosnilimab in rheumatoid arthritis and other indications

ANB101 (BDCA2 modulator) • Phase 1a trial in healthy volunteers completed o Currently evaluating a potential development approach informed by clinical and translational evidence, as well as competitor registrational data in systemic lupus erythematosus and cutaneous lupus erythematosus anticipated in Q4 2026 and early 2027, respectively

Cash Position

• Cash, cash equivalents and investments totaled $155.6 million as of Sept.5 530, 2026, with pro forma cash of $343 million following $200 million private placement completed in Oct.5 520265

Third Quarter 2026 Financial Results

• The separation of AnaptysBio, Inc. and First Tracks Biotherapeutics, Inc. was completed on April 20, 2026.6 6As a result, for the period from January 1, 2026 to April 19, 2026 and for the three and nine months ended September 30, 2025, the financial results include assets, liabilities, and expenses related to both companies.6 The combined financial statements reflect allocations of certain expenses from the finan

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Data on this page was fetched . The filing on SEC.gov is the record.