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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): September 21, 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
3.01. Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.
On
September 21, 2026, Calidi Biotherapeutics, Inc. (the “Company”) received a letter (the “Notice”) from staff
of NYSE American LLC (the “Exchange”). The Notice stated that the Company is not in compliance with the stockholders’
equity continued listing standard in Section 1003(a)(ii) of the NYSE American Company Guide (the “Company Guide”). Section
1003(a)(ii) requires a listed company to maintain stockholders’ equity of $4.0 million or more if it has reported losses from continuing
operations and/or net losses in three of its four most recent fiscal years. The Notice stated that the Company reported stockholders’
equity of $3.1 million as of June 30, 2026, and net losses in three of its four most recent fiscal years ended December 31, 2025. It
also stated that the Company is not currently eligible for any exemption from the stockholders’ equity requirements of Section
1003(a) of the Company Guide.
The
Company has until October 21, 2026, to submit a plan (the “Plan”) of actions it has taken or will take to regain compliance
with the continued listing standards by March 21, 2028. The Company intends to timely deliver a Plan to the Exchange. If the Exchange
accepts the plan, the Company will be subject to periodic reviews, including quarterly monitoring for compliance with the Plan. If the
Company does not submit a Plan, or if the Plan is not accepted, delisting proceedings will commence. If the Plan is accepted but the
Company is not in compliance with the continued listing standards by March 21, 2028, or does not make progress consistent with the Plan,
the Exchange staff will initiate delisting proceedings as appropriate. The Company may appeal a staff delisting determination in accordance
with the Company Guide.
The
Notice has no immediate effect on the listing or trading of the Company’s common stock. The common stock will continue to trade
on NYSE American under the symbol “CLDI,” subject to the Company’s compliance with Exchange’s other continued
listing standards. The Exchange will add the Company to its list of noncompliant issuers on its website and will disseminate a “.BC”
indicator with the Company’s ticker symbol to denote the noncompliance. The Notice does not affect the Company’s business
operations or its reporting obligations with the Securities and Exchange Commission.
Item
8.01 Other Events.
On
September 25, 2026, the Company issued a press release relating to the matters described in Item 3.01 of this Current Report on Form
8-K, a copy of which is attached hereto as Exhibit 99.1.
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. These include statements about the Company’s intention to submit a compliance plan, NYSE
American’s acceptance of any such plan, and the Company’s ability to regain compliance with NYSE American’s continued
listing standards. These statements are subject to risks and uncertainties that could cause actual results to differ materially from
those expressed or implied. Those risks include the Company’s ability to raise capital or otherwise increase stockholders’
equity, NYSE American’s evaluation of any plan the Company submits, and the other risks described under “Risk Factors”
in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and subsequent SEC filings. The Company undertakes
no obligation to update any forward-looking statement, except as required by law.
Item 9.01
Financial Statements and Exhibits.
(d)
Exhibits.
| Exhibit
No. |
|
Description |
| 99.1 |
|
Press Release dated September 25, 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:
September 25, 2026 |
|
|
| |
By: |
/s/
Andrew Jackson |
| |
Name: |
Andrew
Jackson |
| |
Title: |
Chief
Financial Officer |
Exhibit
99.1
Calidi
Biotherapeutics Received NYSE American Notification Letter Regarding Stockholders’ Equity Deficiency
SAN
DIEGO, September 25, 2026 – Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or the “Company”),
a biotechnology company pioneering the development of targeted genetic medicines, today announced that on September 21, 2026, the Company
received a notice (the “Notice”) from the staff of NYSE American LLC (the “NYSE American”) that the Company was
not in compliance with the NYSE American’s continued listing standards in Part 10, Section 1003(a)(ii)of the NYSE American Company
Guide (the “Company Guide”)requiring a company to have stockholders’ equity of at least $4.0 million if it has reported
losses from continuing operations and/or net losses in three of its four most recent fiscal years. The Notice also indicates that the
Company is not currently eligible for any exemption in Section 1003(a) of the Company Guide (including the exemption provided for companies
with total value of market capitalization exceeding $50 million among other things).
In
connection with its non-compliance with Section 1003(a)(ii), the Company must submit a plan (the “Plan”) to the NYSE American
by October 21, 2026, advising of actions it has taken or will take to regain compliance with the continued listing standards by March
21, 2028. If the NYSE American determines to accept the Plan, the Company will be notified in writing and will be subject to periodic
reviews, including quarterly monitoring for compliance with the Plan. If the Company does not submit a plan or if the Plan is not accepted,
NYSE American will commence delisting proceedings. Furthermore, if the Plan is accepted but the Company is not in compliance with the
continued listing standards by March 21, 2028, or if the Company does not make progress consistent with the Plan, the NYSE American will
initiate delisting proceedings as appropriate. The Company may appeal a staff delisting determination in accordance with Section 1010
and Part 12 of the Company Guide.
The
Notice has no immediate effect on the listing or trading of the Company’s common stock, par value $0.0001 per share (“Common
Stock”), and the Common Stock will continue to trade on the NYSE American under the symbol “CLDI”, but will have an
added designation of “.BC” to indicate the status of the common stock are “below compliance.” The Notice does
not affect the Company’s ongoing business operations or its reporting requirements with the U.S. Securities and Exchange Commission.
The
Company’s management is reviewing its options to address the deficiencies and expects to submit a compliance plan on or before
the deadline set by the NYSE American.
About
Calidi Biotherapeutics
Calidi
Biotherapeutics (NYSE American: CLDI) is a biotechnology company pioneering the development of targeted therapies with the potential
to deliver genetic medicines to distal sites of disease. The Company’s proprietary RedTail platform features an engineered enveloped
oncolytic virus designed for systemic delivery and targeting of metastatic sites. This advanced enveloped technology is intended to shield
the virus from immune clearance, allowing virotherapy to effectively reach tumor sites, induce tumor lysis, and deliver potent genetic
medicine(s) to metastatic locations.
CLD-401,
the lead candidate from the RedTail platform, currently in IND-enabling studies, targets metastatic non-small cell lung cancer, head
and neck cancer, and other tumor types with high unmet medical need. Calidi continues to advance its pipeline utilizing the RedTail platform
including its novel approach to incorporate in situ T-cell engagers in solid tumors.
Calidi
Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com or view Calidi’s
Corporate Presentation here.
Forward-Looking
Statements
This
press release may contain forward-looking statements for purposes of the “safe harbor” provisions under the United States
Private Securities Litigation Reform Act of 1995. Terms such as “anticipates,” “believe,” “continue,”
“could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,”
“possible,” “potential,” “predicts,” “project,” “should,” “towards,”
“would” as well as similar terms, are forward-looking in nature, but the absence of these words does not mean that a statement
is not forward-looking. These forward-looking statements include, but are not limited to, statements regarding Calidi’s intention
to submit a plan to regain compliance with NYSE American’s continued listing standards, NYSE American’s acceptance of any
such plan, and Calidi’s ability to regain compliance by March 21, 2028. Any forward-looking statements contained in this discussion
are based on Calidi’s current expectations and beliefs concerning future developments and their potential effects and are subject
to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth or implied
in such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that NYSE American does not
accept Calidi’s compliance plan; the risk that Calidi is unable to regain compliance with NYSE American’s continued listing
standards by March 21, 2028, or to make progress consistent with its plan during the plan period; the risk that NYSE American commences
delisting proceedings, the risk that Calidi is not able to raise sufficient capital to support its current and anticipated clinical trials
or to increase its stockholders’ equity; and, risks related to 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.
Other risks and uncertainties are set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking
Statements” in the Company’s annual report filed with the SEC on Form 10-K on March 27, 2026, as may be amended or supplemented
by other reports we file with the SEC from time to time. We disclaim any obligation to update any forward-looking statement to reflect
events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.
Investors
Contact:
IR@calidibio.com
Media
Contact:
PR@calidibio.com
