[8-K] First Tracks Biotherapeutics, Inc. Reports Material Event

Rhea-AI Filing Summary

First Tracks Biotherapeutics reported combined first quarter 2026 results and outlined progress across its immunology pipeline following separation from AnaptysBio. The company launched with $180 million in cash and cash equivalents on April 20, 2026 and expects a roughly two‑year cash runway to advance lead programs.

For the three months ended March 31, 2026, research and development expenses were $34.0 million, down from $41.5 million a year earlier, while general and administrative expenses rose to $18.9 million from $9.8 million, mainly due to separation and stock‑based compensation costs. Net loss was $50.5 million compared with $47.2 million in the prior‑year period.

At March 31, 2026, First Tracks reported cash and cash equivalents of $248.5 million, short‑term investments of $38.0 million and total assets of $290.6 million. The update highlighted ongoing Phase 1b trials of ANB033 in celiac disease and eosinophilic esophagitis, an End‑of‑Phase 2 FDA meeting for rosnilimab in rheumatoid arthritis, and a near‑complete Phase 1a trial of ANB101 in healthy volunteers.

Insights

Biotech equity analyst

Early-stage pipeline progressing, cash position solid, losses typical for development-stage biotech.

First Tracks Biotherapeutics is positioning itself as a focused immunology company following its separation from AnaptysBio. The portfolio centers on antibody programs ANB033, rosnilimab and ANB101 targeting autoimmune and inflammatory diseases, with multiple Phase 1b and Phase 2–ready opportunities.

Financially, the company reported Q1 2026 research and development expenses of $33.955 million and general and administrative expenses of $18.856 million, leading to a net loss of $50.484 million. R&D declined versus 2025 while G&A rose due to separation and non‑cash stock compensation costs, which is common around corporate restructurings.

Liquidity is a key point: cash and cash equivalents of $248.469 million plus $37.986 million in short‑term investments at March 31, 2026, and a stated launch cash balance of $180 million on April 20, 2026, underpin the company’s expectation of roughly a two‑year cash runway. Actual duration will depend on trial execution for ANB033 and strategic decisions for rosnilimab after the End‑of‑Phase 2 FDA feedback.

8-K Event Classification

2 items: 2.02, 9.01

2 items

Item 2.02 Results of Operations and Financial Condition Financial

Disclosure of earnings results, typically an earnings press release or preliminary financials.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Key Figures

Net loss: $50.484 million Net loss prior-year: $47.196 million Research and development expenses: $33.955 million +5 more

8 metrics

Net loss $50.484 million Three months ended March 31, 2026

Net loss prior-year $47.196 million Three months ended March 31, 2025

Research and development expenses $33.955 million Three months ended March 31, 2026

General and administrative expenses $18.856 million Three months ended March 31, 2026

Cash and cash equivalents $248.469 million As of March 31, 2026

Short-term investments $37.986 million As of March 31, 2026

Total assets $290.576 million As of March 31, 2026

Launch cash balance $180 million Cash and cash equivalents on April 20, 2026

Key Terms

Phase 1b trial, End-of-Phase 2, CD122 antagonist, pathogenic T cell depleter, +2 more

6 terms

Phase 1b trial medical

"Phase 1b trial in celiac disease ongoing"

A Phase 1b trial is an early stage test of a new medicine or treatment on a small group of people to see if it is safe and to find the best dose. It matters because it helps researchers understand how the treatment works in humans before moving on to larger studies that check if it is effective.

End-of-Phase 2 regulatory

"Completed End-of-Phase 2 (EOP2) meeting with FDA in Q1 2026."

End-of-phase 2 is the development milestone when a drug or medical treatment completes its mid-stage human testing and the sponsor and regulators review the results to decide whether and how to proceed to larger late-stage trials. It matters to investors because this review signals whether the product showed enough benefit and acceptable safety to justify expensive Phase 3 studies, much like passing a major exam before committing to the final, costly year of a degree, and can materially affect a company’s value and funding needs.

CD122 antagonist medical

"with a focus on ANB033, a CD122 antagonist, as we prepare"

A CD122 antagonist is a drug that blocks the CD122 protein, a key part of the receptor that immune signals use to activate certain white blood cells. By preventing those signals, the drug can dial down immune activity—useful for treating autoimmune diseases, preventing transplant rejection, or altering anti‑cancer immune responses. Investors care because such a compound’s effectiveness and side‑effect profile drive clinical trial success and commercial potential, like adjusting a thermostat to change a room’s temperature.

pathogenic T cell depleter medical

"Rosnilimab (Pathogenic T Cell Depleter)"

BDCA2 modulator medical

"ANB101 (BDCA2 modulator)"

autoimmune and inflammatory diseases medical

"modulate immune pathways implicated in autoimmune and inflammatory diseases"

Autoimmune and inflammatory diseases are conditions in which the body's defense system mistakenly attacks healthy tissue or stays active too long, causing pain, swelling, organ damage or chronic symptoms—think of the immune system as an overzealous security guard that faults the building it is protecting. For investors, these diseases matter because they drive demand for long-term treatments, diagnostics and therapies, influence regulatory approval and reimbursement risks, and shape companies’ revenue and growth prospects in healthcare markets.

Understanding 8-K Material Events →

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 14, 2026

FIRST TRACKS BIOTHERAPEUTICS, INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware			001-43177	39-5003207
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
10770 Wateridge Circle, Suite 210
San Diego, California				92121
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s Telephone Number, Including Area Code: 858 362-6295

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common stock, par value $0.001 per share		TRAX		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition.

On May 14, 2026, First Tracks Biotherapeutics, Inc. (“First Tracks”) issued a press release announcing its financial results for the three months ended March 31, 2026. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

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 amended, 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.

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 months ended March 31, 2026, dated May 14, 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:	May 14, 2026	By:	/s/Ajim Tamboli
			Name: Ajim Tamboli Title: Chief Financial Officer

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

o60-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

oTop-line Phase 1b data anticipated in Q4 2026

•Phase 1b trial in eosinophilic esophagitis ongoing

o50-patient cohort assessing one dose level of subcutaneously administered ANB033 vs. placebo (randomized 1:1) through 12 weeks

oTop-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 Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of the release of data from the Company’s clinical trials, including initial data from ANB033's Phase 1b clinical trial in celiac disease and initial data from ANB033's Phase 1b clinical trial in eosinophilic esophagitis; and the projected cash runway for the company. 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

Executive Director, Investor Relations

858.732.0178

investors@firsttracksbio.com

First Tracks Biotherapeutics, Inc.

Combined Balance Sheets

(in thousands)

(unaudited)

		March 31, 2026				December 31, 2025
ASSETS
Current assets:
Cash and cash equivalents		$	248,469			$	238,196
Short-term investments			37,986				73,442
Prepaid expenses and other current assets			2,947				4,762
Total current assets			289,402				316,400
Property and equipment, net			1,174				1,370
Operating lease right-of-use assets			—				12,519
Other long-term assets			—				256
Total assets		$	290,576			$	330,545
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable		$	7,496			$	3,111
Accrued expenses			25,616				25,832
Current portion of operating lease liability			—				2,080
Total current liabilities			33,112				31,023
Operating lease liability, net of current portion			—				12,032
Equity:
Net Parent Investment			257,610				287,514
Accumulated other comprehensive loss			(146	)			(24	)
Total equity			257,464				287,490
Total liabilities and equity		$	290,576			$	330,545

First Tracks Biotherapeutics, Inc.

Combined Statements of Operations and Comprehensive Loss

(in thousands)

(unaudited)

		Three Months Ended March 31,
		2026				2025
Operating expenses:
Research and development		$	33,955			$	41,465
General and administrative			18,856				9,815
Total operating expenses			52,811				51,280
Loss from operations			(52,811	)			(51,280	)
Other income (expense), net:
Interest income			2,328				4,091
Other expense, net			(1	)			(7	)
Total other income, net			2,327				4,084
Net loss			(50,484	)			(47,196	)
Unrealized loss on available-for-sale securities			(122	)			(144	)
Comprehensive loss		$	(50,606	)		$	(47,340	)

FAQ

What were First Tracks Biotherapeutics' Q1 2026 financial results (TRAX)?

First Tracks Biotherapeutics reported a Q1 2026 net loss of $50.5 million, compared with a $47.2 million loss a year earlier. Research and development expenses were $34.0 million and general and administrative expenses were $18.9 million for the three months ended March 31, 2026.

How much cash does First Tracks Biotherapeutics (TRAX) have after the separation?

First Tracks launched on April 20, 2026 with $180 million in cash and cash equivalents. As of March 31, 2026, combined balance sheet data show $248.5 million in cash and cash equivalents and $38.0 million in short-term investments, supporting an expected roughly two-year cash runway.

What are the main pipeline programs for First Tracks Biotherapeutics (TRAX)?

The pipeline includes ANB033, a CD122 antagonist in Phase 1b trials for celiac disease and eosinophilic esophagitis, rosnilimab, a pathogenic T cell depleter with an End-of-Phase 2 FDA meeting in rheumatoid arthritis, and ANB101, a BDCA2 modulator in a near-complete Phase 1a trial.

When will First Tracks Biotherapeutics report key clinical data for ANB033?

Top-line data from ANB033’s Phase 1b trial in celiac disease are anticipated in Q4 2026. Top-line data from the Phase 1b trial in eosinophilic esophagitis are anticipated in mid-2027, providing initial clinical readouts for this lead CD122 antagonist program.

How did operating expenses change for First Tracks Biotherapeutics year over year?

For Q1 2026, research and development expenses were $34.0 million, down from $41.5 million in Q1 2025. General and administrative expenses increased to $18.9 million from $9.8 million, mainly due to separation-related legal costs and non-cash stock-based compensation.

What strategic options is First Tracks Biotherapeutics considering for rosnilimab?

After a constructive End-of-Phase 2 FDA meeting outlining a registrational Phase 3 path in rheumatoid arthritis, the company is assessing ROE-maximizing strategic options, including a global partnership, out-license or asset financing to progress potential development of rosnilimab in rheumatoid arthritis and other indications.

Filing Exhibits & Attachments

2 documents

Press Releases

• EX-99.1 EX-99.1 153.6 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA WITH EMBEDDED LINKBASES DOCUMENT 24.3 KB