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

ANB033 mucosal-healing enrollment is complete, with top-line results anticipated in Q1 2027.

Rhea-AI Summary

First Tracks Biotherapeutics (TRAX) reported a narrower third-quarter net loss and outlined plans to advance ANB033 after positive celiac disease results. Net loss was $31.4 million, or $0.88 per share, versus $41.9 million, or $1.50 per share, a year earlier. Research and development expenses fell to $23.8 million from $33.3 million.

Phase 1b gluten-challenge results showed statistically significant protection against intestinal damage and symptoms, with no safety signals observed. The company anticipates a late-stage celiac trial in 2027, mucosal-healing results in Q1 2027, eosinophilic esophagitis results in Q3 2027, and Phase 2 starts in vitiligo and another indication in H1 2027. An October private placement raised $200 million gross, bringing pro forma cash to $343 million. September-end cash, cash equivalents and investments totaled $155.6 million.

16 points · 1 major

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0 major · 4 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major pointOctober private placement raised $200 million gross, with pro forma cash of $343 million. 11% of market cap
• Moderate pointANB033 intestinal-structure measure changed -0.17 versus -0.66 on placebo; placebo-adjusted difference +0.49, p=0.009.
• Moderate pointANB033 intestinal immune-cell density changed -1.20 versus +18.83 on placebo; placebo-adjusted difference -20.03, p<0.001.
• Moderate pointANB033 symptom scores were statistically lower than placebo from day one throughout the gluten challenge.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Celiac mucosal-healing cohort enrollment is complete; top-line data anticipated in Q1 2027.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Late-stage ANB033 celiac trial is anticipated in 2027.
• Moderate point. Forward-looking: it has not happened yet and may not happen.ANB033 Phase 2 development in vitiligo and another indication is planned for H1 2027.
• Moderate pointQ3 net loss narrowed to $31.4 million, or $0.88/share, versus $41.9 million, or $1.50/share, year-over-year.
• Moderate pointQ3 research and development expenses fell to $23.8 million from $33.3 million year-over-year.

7 minor points

• Minor pointANB033 gluten-challenge cohort was well tolerated, with no safety signals observed.
• Minor pointANB033 has received FDA Fast Track designation for celiac disease.
• Minor point. Forward-looking: it has not happened yet and may not happen.Eosinophilic esophagitis trial enrollment continues; top-line data anticipated in Q3 2027.
• Minor pointANB101 healthy-volunteer Phase 1a trial is completed.
• Minor pointNine-month net loss narrowed to $115.2 million, or $3.25/share, versus $131.5 million, or $4.52/share, year-over-year.
• Minor pointNine-month research and development expenses fell to $83.4 million from $114.1 million year-over-year.
• Minor pointQ3 general and administrative expenses fell to $9.0 million from $11.7 million year-over-year.

Negative

• Moderate pointNine-month general and administrative expenses rose to $37.1 million from $28.2 million year-over-year.
• Moderate pointSeptember-end cash equivalents were $155.627 million versus $238.196 million at year-end; short-term investments fell from $73.442 million to zero.
• Minor pointQ3 interest income fell to $1.495 million from $3.198 million year-over-year.
• Minor pointNine-month interest income fell to $5.387 million from $10.755 million year-over-year.

News Explained

The completed private placement was a sale of securities to selected investors outside a public offering, but the release gives no security type, price or share count, so whether or how much existing common ownership changes cannot be established.

Key Figures

Vh:Cd placebo-adjusted delta: +0.49 (p=0.009) IEL density placebo-adjusted delta: -20.03 (p<0.001) Private placement gross proceeds: $200 million +4 more

Vh:Cd placebo-adjusted delta

+0.49 (p=0.009)

Phase 1b celiac disease Cohort 1

IEL density placebo-adjusted delta

-20.03 (p<0.001)

Phase 1b celiac disease Cohort 1

Private placement gross proceeds

$200 million

Completed in October 2026

Pro forma cash

$343 million

Following the October 2026 private placement

Research and development expenses

$23.8 million vs. $33.3 million

Three months ended September 30, 2026 vs. 2025

General and administrative expenses

$9.0 million vs. $11.7 million

Three months ended September 30, 2026 vs. 2025

Net loss

$31.4 million vs. $41.9 million

Three months ended September 30, 2026 vs. 2025

Previous Earnings Reports

1 past event · Latest: Aug 12

Same Type 1 event

1. Aug 12

   2Q26 earnings

   24h Move

   -4.5%

   Reported a net loss and quarterly expenses, providing the closest prior-quarter financial-results baseline.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

villus height-to-crypt depth ratio, intraepithelial lymphocyte density, fast track designation, private placement

4 terms

villus height-to-crypt depth ratio medical

"LS mean change from baseline in villus height-to-crypt depth (Vh:Cd) ratio"

The villus height-to-crypt depth ratio is a histological measurement of intestinal mucosa obtained by dividing the average length of the villi (finger‑like projections that absorb nutrients) by the average depth of the adjacent crypts (invaginations where new epithelial cells are produced). It is measured on microscope images from biopsies or animal tissue sections and is used as an index of mucosal architecture—higher ratios generally indicate taller, more mature absorptive surface relative to crypt hyperplasia, while lower ratios indicate villus atrophy or increased crypt activity. Values depend on the intestinal region, species, sampling method and how many villi/crypts are averaged, so comparisons should use consistent tissue sites and measurement protocols.

intraepithelial lymphocyte density medical

"LS mean change from baseline in intraepithelial lymphocyte (IEL) density"

The number of lymphocytes located within the epithelial layer of a tissue sample, expressed relative to the epithelial cells or a length/area of epithelium (commonly reported as lymphocytes per 100 epithelial cells or per millimeter). It is measured on a biopsy slide using light microscopy with standard staining and counting rules, and is used as a quantitative marker of local immune activity in the epithelium. Values depend on the tissue site, staining and counting method, and observer technique, so thresholds for “normal” or “elevated” vary by protocol and clinical context.

fast track designation regulatory

"which has already granted ANB033 Fast Track designation"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

private placement financial

"Completed private placement with $200 million in gross proceeds"

A private placement is a sale of securities directly to a selected group of investors, typically institutions or accredited investors, instead of through a public offering. It lets a company raise money faster and with fewer regulatory steps; for existing shareholders it matters because the newly issued shares, often sold at a discount, increase the share count and can dilute their ownership.

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• 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, Nov. 03, 2026 (GLOBE NEWSWIRE) -- 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:
  • 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 here
• Phase 1b Cohort 2 in CeD aims to assess mucosal healing through 12 weeks
  • 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
  • Anticipate initiating a late-stage clinical trial in CeD in 2027
• Phase 1b trial in eosinophilic esophagitis is ongoing
  • Includes a 50-patient cohort assessing subcutaneously administered ANB033 vs. placebo (randomized 1:1) through 12 weeks
  • 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
  • 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 April 20, 2026. As 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. The combined financial statements reflect allocations of certain expenses from the financial statements of AnaptysBio, Inc. including research and development expenses and general 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.
• Research and development expenses were $23.8 million and $83.4 million for the three and nine months ended September 30, 2026, compared to $33.3 million and $114.1 million for the three and nine months ended September 30, 2025. The decrease for the three and nine months ended September 30, 2026 was primarily due to decreased development costs for rosnilimab and ANB032, offset by increased costs relating to the Phase 1 trial for ANB033.
• General and administrative expenses were $9.0 million and $37.1 million for the three and nine months ended September 30, 2026, compared to $11.7 million and $28.2 million for the three and nine months ended September 30, 2025. The increase for the nine months ended September 30, 2026, was due to the allocation of legal costs for the separation of the company from AnaptysBio, Inc. and AnaptysBio, Inc.’s lawsuit with GSK and Tesaro.
• Net loss was $31.4 million and $115.2 million for the three and nine months ended September 30, 2026, or a net loss per share of $0.88 and $3.25, respectively, compared to a net loss of $41.9 million and $131.5 million for the three and nine months ended September 30, 2025, or a net loss per share of $1.50 and $4.52.

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 Private Securities Litigation Reform Act of 1995, including, but not limited to: the potential benefits, efficacy and safety profile of ANB033 and the company’s other product candidates; the company’s regulatory plans for ANB033 in celiac disease; the anticipated timing of the initiation of, enrollment in, and data from, the company’s clinical trials, including top-line data from Cohort 2 of ANB033’s Phase 1b clinical trial in celiac disease and Phase 1b clinical trial in eosinophilic esophagitis, a late-stage trial in celiac disease and Phase 2 development in vitiligo and one additional indication; and potential next steps with regards to the company’s rosnilimab product candidate. Statements including words such as “plan,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

Investor Contact:
Nick Montemarano
Vice President, Investor Relations
858.732.0178
investors@firsttracksbio.com

First Tracks Biotherapeutics, Inc.
Balance Sheets
(in thousands, except share and par value)
(unaudited)

		September 30, 2026				December 31, 2025
ASSETS
Current assets:
Cash and cash equivalents		$	155,627			$	238,196
Short-term investments			—				73,442
Prepaid expenses and other current assets			10,095				4,762
Total current assets			165,722				316,400
Property and equipment, net			979				1,370
Operating lease right-of-use assets			3,755				12,519
Other long-term assets			—				256
Total assets		$	170,456			$	330,545
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	3,949			$	3,111
Accrued expenses			11,723				25,832
Current portion of operating lease liability			2,418				2,080
Total current liabilities			18,090				31,023
Operating lease liability, net of current portion			1,355				12,032
Stockholders’ equity:
Preferred stock, $0.001 par value, 10,000,000 shares authorized and no shares outstanding at September 30, 2026			—				—
Common stock, $0.001 par value, 500,000,000 shares authorized and 35,902,449 shares issued and outstanding at September 30, 2026 and 100 shares authorized and no shares issued or outstanding at December 31, 2025			36				—
Additional paid-in capital			206,907				—
Accumulated other comprehensive loss			—				(24)
Accumulated deficit			(55,932)				—
Net former parent investment			—				287,514
Total stockholders’ equity			151,011				287,490
Total liabilities and stockholders’ equity		$	170,456			$	330,545

First Tracks Biotherapeutics, Inc.
Statements of Operations and Comprehensive Loss
(in thousands, except per share data)
(unaudited)

		Three Months Ended September 30,								Nine Months Ended September 30,
		2026				2025				2026				2025
Operating expenses:
Research and development			23,846				33,322				83,445				114,059
General and administrative			8,998				11,735				37,147				28,176
Total operating expenses			32,844				45,057				120,592				142,235
Loss from operations			(32,844)				(45,057)				(120,592)				(142,235)
Other income (expense), net:
Interest income			1,495				3,198				5,387				10,755
Other expense, net			(7)				—				(9)				(20)
Total other income (expense), net			1,488				3,198				5,378				10,735
Net loss			(31,356)				(41,859)				(115,214)				(131,500)
Other comprehensive loss:
Unrealized gain (loss) on available-for-sale securities			—				53				24				(258)
Comprehensive loss		$	(31,356)			$	(41,806)			$	(115,190)			$	(131,758)
Net loss per common share:
Basic and diluted		$	(0.88)			$	(1.50)			$	(3.25)			$	(4.52)
Weighted-average number of shares outstanding:
Basic and diluted			35,747				27,833				35,423				29,085

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did First Tracks Biotherapeutics report for third-quarter 2026 earnings?

First Tracks reported a $31.4 million net loss, or $0.88 per share, compared with $41.9 million, or $1.50 per share, a year earlier. Research and development expenses were $23.8 million, while general and administrative expenses were $9.0 million.

What did First Tracks Biotherapeutics ANB033 show in the celiac gluten-challenge trial?

ANB033 showed statistically significant protection against gluten-induced intestinal damage and symptoms in Phase 1b Cohort 1. The study assessed prevention of intestinal lining damage through six weeks. Symptom scores were statistically lower than placebo from the first day, and no safety signals were observed.

How is First Tracks Biotherapeutics studying ANB033 in eosinophilic esophagitis?

The ongoing Phase 1b trial includes a 50-patient cohort randomized 1:1 to subcutaneous ANB033 or placebo through 12 weeks.

What is First Tracks Biotherapeutics considering for rosnilimab and ANB101?

First Tracks is assessing strategic options for rosnilimab in rheumatoid arthritis and other indications, while evaluating a development approach for ANB101. The ANB101 assessment incorporates clinical and translational evidence and competitor registrational data anticipated in Q4 2026 for systemic lupus and early 2027 for cutaneous lupus.

How does the AnaptysBio separation affect First Tracks Biotherapeutics financial comparisons?

Financial results before the April 20, 2026 separation include assets, liabilities and expenses related to both companies. This applies to January 1 through April 19, 2026, and the three- and nine-month periods ended September 30, 2025. Combined statements include allocated expenses such as employee compensation, facilities and legal services.