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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): January 28, 2026
CALIDI
BIOTHERAPEUTICS, INC.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
001-40789 |
|
86-2967193 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(I.R.S.
Employer
Identification
No.) |
4475
Executive Drive, Suite 200,
San
Diego, California |
|
92121 |
| (Address
of principal executive offices) |
|
(Zip
Code) |
(858)
794-9600
(Registrant’s
telephone number, including area code)
N/A
(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 (see General Instruction A.2. below):
| ☐ |
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)) |
| Title
of Each Class |
|
Trading
Symbol(s) |
|
Name
of Each Exchange on Which Registered |
| Common
stock, par value $0.0001 per share |
|
CLDI |
|
NYSE
American 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 Operation and Financial Condition
On
January 28, 2026, Calidi Biotherapeutics, Inc. (the “Company”) issued a press release providing corporate updates for the
fiscal year ended December 31, 2025, and updates on key operational initiatives for fiscal year 2026, which also includes certain preliminary,
unaudited financial information.
A
copy of the press release is incorporated herein by reference and is furnished as Exhibit 99.1. The preliminary, unaudited financial
information included in the press release is based on information available to management as of the date of the press release and is
subject to completion of the Company’s financial closing procedures and adjustments, including completion of the audit of the Company’s
financial statements for the fiscal year ended December 31, 2025. Accordingly, such information may differ from the final results to
be reflected in the Company’s audited financial statements and other filings with the Securities and Exchange Commission.
The
information under this Item 2.02 is being furnished and shall not be deemed to be “filed” for the purposes of Section 18
of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such
section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the
“Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item
8.01 Other Events
On
January 28, 2026, the Company issued a press release providing corporate updates for the fiscal year ended December 31, 2025, and updates
on key operational initiatives for fiscal year 2026, which also includes certain preliminary, unaudited financial information. A copy
of the press release is included as Exhibit 99.1 hereto and is incorporated by reference herein.
Forward
Looking Statements
This
Current Report on Form 8-K (including Exhibit 99.1) contains “forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, statements regarding (i) preliminary
or unaudited financial information and the Company’s expectations regarding the completion of its financial closing procedures
and audit for the fiscal year ended December 31, 2025, including the anticipated finalization of results, (ii) the Company’s plans,
strategies, priorities and key operational initiatives for fiscal year 2026, including the Company’s plan to submit an Investigational
New Drug (“IND”) application by the end of 2026. Forward-looking statements are generally identified by words such as “may,”
“will,” “should,” “could,” “would,” “expect,” “intend,” “plan,”
“anticipate,” “estimate,” “believe,” “continue,” “potential,” “target,”
“project,” “forecast,” and similar expressions, or the negative of these terms.
Forward-looking
statements are based on management’s current expectations and assumptions as of the date hereof and are subject to risks and uncertainties
that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. With respect
to the preliminary, unaudited financial information, actual results may differ, and such differences may be material, as a result of
the completion of the Company’s financial closing procedures and audit, including the identification of additional information
that becomes available, completion of management’s review, final adjustments, and other developments that may arise between the
date of the press release and the date that the Company’s financial statements are finalized. With respect to the Company’s
fiscal year 2026 initiatives, including the timing and ability to submit an IND application by the end of 2026, actual results may differ
materially due to, among other things, the timing, cost and results of research and development activities and preclinical studies; interactions
with, and the timing of feedback from, regulatory authorities; changes in applicable laws or regulations; manufacturing and supply chain
matters; the availability of capital and other resources; and changes in business, market, economic or competitive conditions. Additional
factors that could cause actual results to differ materially are described under the heading “Risk Factors” in the Company’s
most recent Annual Report on Form 10-K and subsequent filings with the Securities and Exchange Commission.
The
Company undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this report,
except as required by law.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
| Exhibit |
|
Exhibit
Description |
| 99.1 |
|
Press
Release dated January 28, 2026 |
| 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.
| |
CALIDI
BIOTHERAPEUTICS, INC. |
| Dated:
January 28, 2026 |
|
|
| |
By: |
/s/
Andrew Jackson |
| |
Name: |
Andrew
Jackson |
| |
Title: |
Chief
Financial Officer |