TRAX 8-K
First Tracks Biotherapeutics, Inc. (TRAX)
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
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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:
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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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 August 12, 2026, First Tracks Biotherapeutics, Inc. (“First Tracks”) issued a press release announcing its financial results for the three and six months ended June 30, 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 |
Press release issued by First Tracks Biotherapeutics, Inc. regarding its financial results for the three and six months ended June 30, 2026, dated August 12, 2026. |
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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.
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FIRST TRACKS BIOTHERAPEUTICS, INC. |
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Date: |
August 12, 2026 |
By: |
/s/ Ajim Tamboli |
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Name: Ajim Tamboli |
Exhibit 99.1
First Tracks Biotherapeutics Announces Second Quarter 2026 Financial Results and Provides Business Update
SAN DIEGO, CA — Aug. 12, 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 second quarter ended June 30, 2026, and provided a business update.
“First Tracks continues to execute against a broad development strategy for our potentially best-in-class CD122 antagonist, ANB033, and anticipates treating patients across four indications in 2027. We believe ANB033 is uniquely positioned to deliver differentiated clinical and biological outcomes across multiple immune-mediated diseases,” said Daniel Faga, president and chief executive officer. “In celiac disease, FDA’s Fast Track designation for ANB033 underscores both the urgency of the significant unmet need for patients and the potential of this program. We will report top-line data from Cohort 1 of the Phase 1b trial in Q4 2026, evaluating ANB033's potential to prevent gluten-induced mucosal injury. Cohort 2 of this study is enrolling patients with disease across a wide range of histologic and symptom severity at baseline with the goal of generating deeper insights into timing to mucosal healing and disease biology. We anticipate reporting these data in Q1 2027, followed by top-line data from our Phase 1b trial of ANB033 in eosinophilic esophagitis in Q3 2027.”
ANB033 (CD122 antagonist)
ANB101 (BDCA2 modulator)
Rosnilimab (Pathogenic T cell depleter)
Second Quarter 2026 Financial Results
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; potential benefits, efficacy, and safety profile of the Company’s product candidates and the Company’s projected cash runway. 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
First Tracks Biotherapeutics, Inc.
Balance Sheets
(in thousands, except share and par value)
(unaudited)
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June 30, 2026 |
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December 31, 2025 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
168,018 |
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$ |
238,196 |
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Short-term investments |
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— |
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73,442 |
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Prepaid expenses and other current assets |
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9,727 |
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4,762 |
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Total current assets |
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177,745 |
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316,400 |
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Property and equipment, net |
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1,071 |
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1,370 |
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Operating lease right-of-use assets |
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4,324 |
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12,519 |
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Other long-term assets |
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— |
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256 |
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Total assets |
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$ |
183,140 |
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$ |
330,545 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
2,553 |
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$ |
3,111 |
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Accrued expenses |
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7,458 |
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25,832 |
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Current portion of operating lease liability |
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2,436 |
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2,080 |
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Total current liabilities |
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12,447 |
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31,023 |
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Operating lease liability, net of current portion |
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1,897 |
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12,032 |
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Stockholders’ equity: |
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Preferred stock $0.001 par value, 10,000,000 shares authorized and no shares outstanding at June 30, 2026 |
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— |
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— |
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Common stock, $0.001 par value, 500,000,000 shares authorized and 35,390,679 shares issued and outstanding at June 30, 2026 and 100 shares authorized and no shares, issued or outstanding at December 31, 2025 |
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35 |
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— |
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Additional paid-in capital |
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193,337 |
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— |
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Accumulated other comprehensive loss |
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— |
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(24 |
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Accumulated deficit |
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(24,576 |
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— |
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Net former parent investment |
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— |
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287,514 |
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Total stockholders’ equity |
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168,796 |
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287,490 |
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Total liabilities and stockholders’ equity |
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$ |
183,140 |
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$ |
330,545 |
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First Tracks Biotherapeutics, Inc.
Statements of Operations and Comprehensive Loss
(in thousands)
(unaudited)
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Three Months Ended |
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Six Months Ended |
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2026 |
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2025 |
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2026 |
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2025 |
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Operating expenses: |
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Research and development |
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25,644 |
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39,272 |
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59,599 |
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80,737 |
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General and administrative |
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9,293 |
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6,626 |
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28,149 |
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16,441 |
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Total operating expenses |
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34,937 |
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45,898 |
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87,748 |
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97,178 |
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Loss from operations |
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(34,937 |
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(45,898 |
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(87,748 |
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(97,178 |
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Other income (expense), net: |
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Interest income |
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1,564 |
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3,466 |
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3,892 |
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7,557 |
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Other expense, net |
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(1 |
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(13 |
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(2 |
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(20 |
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Total other income (expense), net |
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1,563 |
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3,453 |
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3,890 |
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7,537 |
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Net loss |
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(33,374 |
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(42,445 |
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(83,858 |
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(89,641 |
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Other comprehensive loss: |
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Unrealized gain (loss) on available-for-sale securities |
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146 |
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(167 |
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24 |
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(311 |
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Comprehensive loss |
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$ |
(33,228 |
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$ |
(42,612 |
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$ |
(83,834 |
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$ |
(89,952 |
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Net loss per common share: |
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Basic and diluted |
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$ |
(0.95 |
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$ |
(1.47 |
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$ |
(2.40 |
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$ |
(3.02 |
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Weighted-average number of shares outstanding: |
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Basic and diluted |
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35,003 |
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28,810 |
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35,003 |
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29,722 |
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