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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): November 7, 2025
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
7.01 | Regulation
FD Disclosure. |
On
November 7, 2025, Calidi Biotherapeutics, Inc. (the “Company”) presented new data on its first therapeutic candidate from
its RedTail platform, CLD-401, at the Society of Immunotherapy for Cancer (SITC) Annual Meeting. The Company presented the new data in
a webinar (the “Presentation”) and a poster (the “Poster”). Furnished as Exhibit 99.1 and Exhibit 99.2 hereto
and incorporated by reference herein are the Presentation and Poster, respectively.
By
filing this Current Report on Form 8-K and furnishing the information contained herein, the Company makes no admission as to the materiality
of any information in this report that is required to be disclosed solely by reason of Regulation FD. The information in this Item 7.01
disclosure, including Exhibit 99.1 and Exhibit 99.2, is being furnished and shall not be deemed “filed” for purposes of Section
18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under
that Section. In addition, the information in this Item 7.01 disclosure, including Exhibits 99.1 and Exhibit 99.2, shall not be incorporated
by reference into the filings of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly
set forth by specific reference in such filing.
On
November 10, 2025, the Company issued a press release announcing the presentation of new data on its first therapeutic candidate from
its RedTail platform, CLD-401, at the Society of Immunotherapy for Cancer (SITC) Annual Meeting. A copy of the press release is included
as Exhibit 99.3 hereto and is incorporated by reference herein.
| Item
9.01 | Financial
Statements and Exhibits. |
(d)
Exhibits
| Exhibit |
|
Exhibit
Description |
| 99.1 |
|
Presentation |
| 99.2 |
|
Poster |
| 99.3 |
|
Press Release dated November 10, 2025 |
| 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:
November 10, 2025 |
|
|
| |
By: |
/s/
Andrew Jackson |
| |
Name: |
Andrew
Jackson |
| |
Title: |
Chief
Financial Officer |
