Form 8-K Alaunos Therapeutics, For: Jun 29
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
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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:
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Securities registered pursuant to Section 12(b) of the Act:
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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 8.01 - Other Events.
On June 29, 2026, Alaunos Therapeutics, Inc. (the “Company”) issued a press release announcing a new preclinical statistical analysis of liver weight adjusted for body fat percentage from the Company’s previously reported non-Good Laboratory Practice (“non-GLP”) diet-induced obesity mouse Study 1 of ALN1003, the Company’s investigational oral, non-hormonal, non-incretin small-molecule metabolic candidate.
The press release reported that, in the 48-day DIO Study 1, ALN1003-treated animals had lower liver weight than controls after adjustment for body fat percentage in a standard ANCOVA analysis, with the same conclusion confirmed using heteroscedasticity-robust HC3 standard errors as a sensitivity analysis. The Company stated that this statistical finding indicates that the lower liver weight associated with ALN1003 treatment was not fully explained by measured body fat percentage in this model. The Company further stated that the finding is directionally consistent with previously disclosed liver marker, selected histology, HOMA-IR, and adipose endocrine biomarker findings.
The press release also notes that the findings are based on non-GLP preclinical studies and should be interpreted with appropriate caution. ALN1003 has not been evaluated in human clinical trials, and its safety and efficacy in humans have not been established. Findings from mouse studies may not translate to human disease.
Alaunos has also published a non-confidential investor presentation titled Obesity and Metabolic Disorders Program — Results of Studies of ALN1003 in Diet-Induced Obese Mouse Model (May 2026), containing integrated data summaries, statistical analyses, representative liver histology images, and study conclusions referenced in the press release. The presentation is available on the Investors section of the Company’s website.
A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. The information in this Item 8.01, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 – Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
Description |
99.1 |
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104 |
Cover Page Interactive Data File (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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Alaunos Therapeutics, Inc. |
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Date: |
June 29, 2026 |
By: |
/s/ Holger Weis |
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Name: |
Holger Weis |
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Title: |
Chief Executive Officer |
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ATTACHMENTS / EXHIBITS
XBRL TAXONOMY EXTENSION SCHEMA WITH EMBEDDED LINKBASES DOCUMENT
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