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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 17, 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
1.01 Entry into a Material Definitive Agreement.
On
September 17, 2026, Calidi Biotherapeutics, Inc. (the “Company”) entered into a stock purchase agreement (the “Purchase
Agreement”) with certain accredited investors and/or qualified institutional buyers named therein (the “Purchasers”),
pursuant to which the Company agreed to issue and sell directly to the Purchasers, in a registered direct offering (the “Offering”),
an aggregate of 1,025,640 shares (the “Shares”) of the Company’s common stock, par value $0.0001 per share (the “Common
Stock”), at a purchase price of $1.17 per Share.
The
Offering closed on September 21, 2026. The gross proceeds to the Company from the Offering were approximately $1.2 million, before deducting
estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the Offering for working capital
and general corporate purposes. The Company did not engage an underwriter, placement agent, broker-dealer or other agent in connection
with the Offering, and no underwriting discounts or commissions, placement agent fees or similar compensation were paid in connection
with the sale of the Shares.
The
Shares were offered and sold pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-282456)
(the “Registration Statement”), which was declared effective by the Securities and Exchange Commission (the “SEC”)
on October 10, 2024, the base prospectus included therein and the prospectus supplement dated September 17, 2026, filed with the SEC.
The
Purchase Agreement contains customary representations, warranties and covenants of the Company and the Purchasers. Pursuant to the terms
of the Purchase Agreement, and subject to certain exceptions as set forth therein, the Company agreed that, for a period of 45 days following
the closing of the Offering, it will not issue, offer, sell or otherwise dispose of, or announce the issuance, offer, sale or other disposition
of, any equity securities or equity-linked or related securities without the prior written consent of Purchasers holding more than 50%
in interest of the Shares purchased under the Purchase Agreement. In connection with the Offering, the Company’s directors and
executive officers entered into lock-up agreements pursuant to which, subject to customary exceptions, they agreed not to offer, sell,
contract to sell, pledge or otherwise transfer or dispose of any shares of Common Stock or securities convertible into, exercisable for
or exchangeable for Common Stock for a period of 60 days following the closing of the Offering.
The
foregoing description of the Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the
full text of the form of Purchase Agreement, which is filed as Exhibit 10.1 to this Current Report on Form 8-K (“Form 8-K”)
and is incorporated herein by reference. The legal opinion of Sichenzia Ross Ference Carmel LLP relating to the validity of the securities
issued in the Transactions is filed herewith as Exhibit 5.1.
This
Form 8-K does not constitute an offer to sell or a solicitation of an offer to buy any securities, nor shall there be any sale of any
securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification
under the securities laws of any such state or jurisdiction.
Item
8.01 Other Events.
On
September 17, 2026, the Company issued a press release announcing the Offering. A copy of the press release is furnished as Exhibit 99.1
to this Form 8-K, and is incorporated herein by reference.
Item 9.01
Financial Statements and Exhibits.
(d)
Exhibits.
| Exhibit
No. |
|
Description |
| 5.1 |
|
Opinion of Sichenzia Ross Ference Carmel LLP. |
| 10.1 |
|
Form of the Securities Purchase Agreement. |
| 23.1 |
|
Consent of Sichenzia Ross Ference Carmel, LLP (contained in Exhibit 5.1) |
| 99.1 |
|
Press Release dated September 17, 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 22, 2026 |
|
|
| |
By: |
/s/
Andrew Jackson |
| |
Name: |
Andrew
Jackson |
| |
Title: |
Chief
Financial Officer |
Exhibit
99.1
Calidi
Biotherapeutics Announces $1.2 Million Registered Direct Offering
SAN
DIEGO, September 17, 2026 – Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or the “Company”),
a biotechnology company pioneering the development of targeted genetic medicines, today announced that it has entered into a definitive
stock purchase agreement with certain accredited investors and/or qualified institutional buyers for the purchase and sale of 1,025,640
shares of the Company’s common stock, in a registered direct offering, at a per share purchase price of $1.17.
The
closing of the registered direct offering is expected to occur on or about September 18, 2026, subject to the satisfaction of customary
closing conditions.
The
gross proceeds to Calidi from the registered direct offering, before deducting offering expenses payable by the Company, are expected
to be approximately $1.2 million. Calidi intends to use the net proceeds from the offering for working capital and for general corporate
purposes.
The
securities described above are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-282456), which was
declared effective by the United States Securities and Exchange Commission (“SEC”) on October 10, 2024. The registered direct
offering is being made only by means of a prospectus, including a prospectus supplement, which is part of the effective registration
statement, that will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained,
when available, on the SEC’s website at http://www.sec.gov.
This
press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described therein, nor
shall there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to
registration or qualification under the securities laws of such jurisdiction.
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, the Company’s plans strategies, priorities
and key operational initiatives for fiscal year 2026 and 2027, statements concerning key milestones, including certain pre-clinical data,
planned clinical trials, and statements relating to the safety and efficacy of Calidi’s therapeutic candidates in development.
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 Calidi is not able to raise sufficient capital to support its current and anticipated clinical trials,
the risk that early results of clinical trials do not necessarily predict final results and that one or more of the clinical outcomes
may materially change following more comprehensive review of the data, and as more patient data becomes available, the risk that Calidi
may not receive FDA approval for some or all of its therapeutic candidates; 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
