Form 8-K
8-K — Calidi Biotherapeutics, Inc.
Accession: 0001493152-26-013236
Filed: 2026-03-27
Period: 2026-03-27
CIK: 0001855485
SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))
Item: Results of Operations and Financial Condition
Item: Regulation FD Disclosure
Item: Financial Statements and Exhibits
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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): March 27, 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 Operations and Financial Condition.
On
March 27, 2026, Calidi Biotherapeutics, Inc. (the “Company”) issued a press release announcing certain financial results
for the fourth quarter and full year ended December 31, 2025, and certain recent corporate developments. A copy of the press release
is incorporated herein by reference and is furnished as Exhibit 99.1.
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
7.01 Regulation FD Disclosure.
The
information under Item 2.02 above is incorporated herein by reference.
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, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the
Exchange Act, or otherwise subject to the liabilities under that section. In addition, the information in this Item 7.01 disclosure,
including Exhibit 99.1, 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.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
Exhibit
Exhibit
Description
99.1
Press Release dated March 27, 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:
March 27, 2026
By:
/s/
Andrew Jackson
Name:
Andrew
Jackson
Title:
Chief
Financial Officer
EX-99.1
EX-99.1
Filename: ex99-1.htm · Sequence: 2
Exhibit
99.1
Calidi
Biotherapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results and Recent Operational Highlights
-
Announced
partnership with Australian CRO to accelerate initiation of CLD-401 clinical trial
-
The
Company has received feedback from the FDA through Type D interactions, and the Company believes its manufacturing and analytical
approaches for CLD-401 are in alignment with FDA guidance; Calidi expects to file an IND by end of 2026
-
Partnered
with Matica Bio around the GMP manufacturing of CLD-401
-
Presented
new data on in situ T-cell engagers (TCEs) at 2026 AACR-IO conference
-
Raised
$6.5 million in public offering and ATM sales
SAN
DIEGO, March 27, 2026 — (GLOBE NEWSWIRE) — Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi” or the
“Company”), a biotechnology company pioneering the development of targeted genetic medicines, today reported its fourth quarter
and full-year 2025 operating and financial results and reviewed recent business highlights.
“We
are extremely excited about the continued progress at Calidi,” said Eric Poma, PhD, CEO of Calidi Biotherapeutics. “We continue
to advance CLD-401, the first lead from our RedTail platform, towards the clinic and have built a world-class scientific advisory board
to aid those efforts. We have also expanded what the RedTail platform can do with our new approach of in situ T-cell engagers.”
Fourth
Quarter 2025 and Recent Corporate Developments
- Partnered
with Avance Clinical, a full-service contract research organization (CRO) with a proven track
record and experience in obtaining regulatory approval and clinical trial initiation in Australia.
The partnership is focused on rapidly initiating a first-in-human clinical trial for CLD-401
in Australia. CLD-401, the Company’s lead asset, is a systemically delivered oncolytic
virus that replicates only in tumor cells. CLD-401 induces high concentrations of IL-15 superagonist
(IL15 SA) expression in the tumor microenvironment while limiting peripheral exposure.
- In
parallel, Calidi is pursuing an IND filing with the FDA by the end of 2026. Calidi has interacted
with the FDA around the Company’s manufacturing and analytical approaches through its
Type D meeting request process. The feedback it has received from the agency supports the
use of this process for the clinical development of CLD-401.
- Partnered
with Matica Bio, a leading CDMO in the field of oncolytic virus manufacturing, for the GMP
manufacturing of CLD-401. Matica has successfully executed multiple oncolytic virus programs
at its state-of-the-art, purpose-built GMP facility in College Station, Texas. That facility
was designed specifically to support complex viral vector modalities like CLD-401.
- Presented
data demonstrating the expression of an in situ T-cell engagers (TCEs) for solid tumors and
the simultaneous expression of a T-cell activating agent (e.g., IL-15 SA) through its systemically
delivered RedTail platform at the AACR Immuno-Oncology (AACR-IO) conference. High expression
of in situ TCE coincident with expression of a T-cell activator in the TME may overcome the
traditional limitations of TCEs in solid tumor.
- Raised
$6.0 million in gross proceeds from an underwritten public offering with new and existing
investors in Q1-2026 and $0.5 million in gross proceeds from the sale of stock under our
ATM in Q4-2025, strengthening the balance sheet and extending Calidi’s cash runway.
Fourth
Quarter 2025 Financial Results
The
company reported a net loss attributable to common stockholders of $4.1 million, or $0.57 per share, for the three months ended December
31, 2025, compared to a net loss attributable to common stockholders of $4.1 million, or $3.23 per share, for the same period in 2024.
Research
and development expenses were $2.4 million for the three months ended December 31, 2025, compared to $1.8 million for the comparable
period in 2024, respectively.
General
and administrative expenses were $2.1 million for the three months ended December 31, 2025, compared to $2.2 million for the comparable
period in 2024, respectively.
Full
Year 2025 Financial Results
The
company reported a net loss attributable to common stockholders of $25.6 million, or $5.95 per share, for the year ended December 31,
2025, compared to a net loss attributable to common stockholders of $23.8 million, or $35.70 per share, for the year ended December 31,
2024.
Research
and development expenses were $9.7 million for the year ended December 31, 2025, compared to $8.9 million for the year ended December
31, 2024, respectively.
General
and administrative expenses were $10.5 million for the year ended December 31, 2025, compared to $12.9 million for the year ended December
31, 2024, respectively.
The
company had approximately $5.6 million in cash and $0.2 million in restricted cash as of December 31, 2025, compared to $9.6 million
in cash and $0.2 million in restricted cash as of December 31, 2024.
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 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, including the Company’s plan to submit an Investigational New Drug (“IND”)
application by the end of 2026, 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, 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, the risk that 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 and substance
of feedback from, regulatory authorities (including that any preliminary interactions with the FDA may not be indicative of future outcomes
or regulatory success); 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.
Contacts:
For
Investors and Media:
Dave Gentry, CEO
RedChip Companies, Inc.
1-407-644-4256
CLDI@redchip.com
CALIDI
BIOTHERAPEUTICS, INC.
CONSOLIDATED
BALANCE SHEETS
(In
thousands, except for par value data)
December 31,
2025
2024
ASSETS
CURRENT ASSETS
Cash
$ 5,600
$ 9,591
Prepaid expenses and other current assets
656
636
Total current assets
6,256
10,227
NONCURRENT ASSETS
Machinery and equipment, net
781
869
Operating lease right-of-use assets, net
1,682
2,934
Other noncurrent assets
138
152
TOTAL ASSETS
$ 8,857
$ 14,182
LIABILITIES AND TOTAL EQUITY
CURRENT LIABILITIES
Accounts payable
$ 595
$ 2,072
Related party accounts payable
18
2
Accrued expenses and other current liabilities
1,276
1,858
Related party accrued expenses and other current liabilities
530
480
Term notes payable, net of discount, including accrued interest
—
251
Related party term notes payable, net of discount, including accrued interest
—
2,702
Related party bridge loan payable, including accrued interest
—
223
Related party other current liability
—
638
Finance lease liability, current
111
66
Operating lease right-of-use liability, current
1,405
1,204
Total current liabilities
3,935
9,496
NONCURRENT LIABILITIES
Operating lease right-of-use liability, noncurrent
277
1,845
Finance lease liability, noncurrent
171
145
Promissory note
600
600
Warrant liability
107
119
Related party warrant liability
8
9
TOTAL LIABILITIES
5,098
12,214
TOTAL EQUITY
3,759
1,968
TOTAL LIABILITIES AND TOTAL EQUITY
$ 8,857
$ 14,182
CALIDI
BIOTHERAPEUTICS, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
(In
thousands, except per share data)
Year Ended December 31,
2025
2024
OPERATING EXPENSES
Research and development
$ (9,737 )
$ (8,878 )
General and administrative
(10,503 )
(12,898 )
Total operating expense
(20,240 )
(21,776 )
Loss from operations
(20,240 )
(21,776 )
OTHER INCOME (EXPENSES), NET
Interest expense
(131 )
(372 )
Interest expense – related party
(76 )
(561 )
Change in fair value of other liabilities and derivatives
1
285
Change in fair value of other liabilities and derivatives – related party
1
39
Grant income
50
181
Gain on sale of investment in Nova Cell
244
—
Other income, net
103
9
Total other income (expenses), net
192
(419 )
LOSS BEFORE INCOME TAXES
(20,048 )
(22,195 )
Income tax provision
(15 )
(14 )
NET LOSS
$ (20,063 )
$ (22,209 )
Net loss attributable to noncontrolling interest
(157 )
(66 )
NET LOSS ATTRIBUTABLE TO CONTROLLING INTEREST
(19,906 )
(22,143 )
Deemed dividend on warrants
(5,673 )
(1,671 )
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
(25,579 )
(23,814 )
Net loss per share; basic and diluted
$ (5.95 )
$ (35.70 )
Weighted average common stock shares outstanding; basic and diluted
4,302
667
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X
- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
+ Details
Name:
dei_WrittenCommunications
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration