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SEC 8-K filings with transcript text

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2026
Q3

Q3 2026 Earnings

8-K

Nov 3, 2026

0001193125-26-445405

EX-99.1

2 trax-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

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. 30, 2026, with pro forma cash of $343 million following $200 million private placement completed in Oct. 2026

Third Quarter 2026 Financial Results

• The separation of AnaptysBio, Inc. and First Tracks Biotherapeutics, Inc. was completed on

2026
Q2

Q2 2026 Earnings

8-K

Aug 12, 2026

0001193125-26-346908

Transcript text not available. View on SEC.gov →

2026
Q1

Q1 2026 Earnings

8-K

May 14, 2026

0001193125-26-224124

EX-99.1

2 trax-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

First Tracks Biotherapeutics Announces First Quarter 2026 Financial Results and Provides Business Update

• First Tracks launched April 20th with a two-year cash-runway to advance ANB033 through celiac disease and eosinophilic esophagitis Phase 1b data and plans to initiate Phase 2 trials across four indications

SAN DIEGO, CA — May 14, 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 first quarter ended March 31, 2026, and provided a business update.

“First Tracks Bio launched to advance a focused, high-value immunology portfolio that can create meaningful impact and a future where autoimmune diseases no longer define a patient’s life,” said Daniel Faga, president and chief executive officer. “We remain committed to executing with speed, rigor and financial discipline with a focus on ANB033, a CD122 antagonist, as we prepare for multiple clinical readouts in celiac disease and eosinophilic esophagitis. Additionally, we completed a productive End-of-Phase 2 meeting for rosnilimab with FDA, and we are assessing ROE-maximizing strategic options for this asset, including potential for development in rheumatoid arthritis and other indications.”

ANB033 (CD122 antagonist)

• Phase 1b trial in celiac disease ongoing

o 60-patient trial assessing one dose level of subcutaneously administered ANB033 vs. placebo (randomized 1:1) across two different cohorts

▪ Cohort 1 (n=30) is a gluten-challenge study to assess the prevention of mucosal damage through six weeks

▪ Cohort 2 (n=30) is a study to assess the possibility of mucosal healing through 12 weeks

o Top-line Phase 1b data anticipated in Q4 2026

• Phase 1b trial in eosinophilic esophagitis ongoing

o 50-patient cohort assessing one dose level of subcutaneously administered ANB033 vs. placebo (randomized 1:1) through 12 weeks

o Top-line Phase 1b data anticipated in mid-2027

Rosnilimab (Pathogenic T Cell Depleter)

• Completed End-of-Phase 2 (EOP2) meeting with FDA in Q1 2026. The agency provided constructive feedback on a registrational Phase 3 path in rheumatoid arthritis (RA), a disease with significant remaining patient unmet need

• Currently assessing ROE-maximizing strategic options that may include a global partnership, out-license or asset financing to progress the potential development of rosnilimab in RA and other indications

ANB101 (BDCA2 modulator)

• Phase 1a trial in healthy volunteers nearing completion

First Quarter 2026 Financial Results

• The separation of AnaptysBio, Inc., and First Tracks Biotherapeutics was completed on April 20, 2026. As a result, in the first quarter of 2026, the financial results include assets, liabilities and expenses related to both companies. The combined financial statements reflect allocations of certain expenses from the financial statements of Anaptys including research and development expenses and administrative expenses. These allocations include, but are not limited to, executive management, employee compensation and benefits, facilities and operations, information technology, business development, financial services (such as accounting, audit, and tax), legal, insurance and stock-based compensation.

• Launched First Tracks with $180 million in cash and cash equivalents on April 20, 2026

• Research and development expenses were $34.0 million for the three months ended March 31, 2026, compared to $41.5 million for the three months ended March 31, 2025. The decrease for the three months ended March 31, 2026 was primarily due to decreased development costs for rosnilimab and ANB032 offset by increased costs relating to the phase 1 trials for ANB033.

• General and administrative expenses were $18.9 million for the three months ended March 31, 2026, compared to $9.8 million for the three months ended March 31, 2025. The increase was due primarily to the allocation of legal costs for the separation of the company and non-cash stock compensation costs.

• Net loss was $50.5 million for the three months ended March 31, 2026, compared to a net loss of $47.2 million for the three months ended March 31, 2025.

About First Tracks Biotherapeutics

First Tracks Biotherapeutics is a clinical stage biotechnology company advancing antibody therapies that modulate immune pathways implicated in autoimmune and inflammatory diseases. Its pipeline includes ANB033, a CD122 antagonist in development for celiac disease and eosinophilic esophagitis; rosnilimab, a pathogenic T cell depleter in development for rheumatoid arthritis; and ANB101, a BDCA2 modulator. To learn more, visit www.FirstTracksBio.com or follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the P

About First Tracks Biotherapeutics Inc. Ordinary Shares (TRAX) Earnings

This page provides First Tracks Biotherapeutics Inc. Ordinary Shares (TRAX) earnings call transcripts from SEC 8-K filings along with AI-powered predictions for post-earnings price movements. Our machine learning models analyze historical earnings data, pre-earnings price patterns, volume changes, and volatility to predict 1-day, 5-day, and 20-day returns after each earnings release.

Earnings transcripts are sourced directly from SEC EDGAR filings. Predictions are generated using gradient boosting models trained on TRAX's historical earnings reactions. All predicted returns are shown as percentages, and predicted prices are calculated from the closing price at the time of prediction. Past performance does not guarantee future results.

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