Form 8-K
8-K — First Tracks Biotherapeutics, Inc.
Accession: 0001193125-26-224124
Filed: 2026-05-14
Period: 2026-05-14
CIK: 0002091349
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Results of Operations and Financial Condition
Item: Financial Statements and Exhibits
Documents
8-K — trax-20260514.htm (Primary)
EX-99.1 (trax-ex99_1.htm)
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8-K
8-K (Primary)
Filename: trax-20260514.htm · Sequence: 1
8-K
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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
EX-99.1
EX-99.1
Filename: trax-ex99_1.htm · Sequence: 2
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 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
)
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