Form 8-K
8-K — Calidi Biotherapeutics, Inc.
Accession: 0001493152-26-023094
Filed: 2026-05-14
Period: 2026-05-14
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): May 14, 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
May 14, 2026, Calidi Biotherapeutics, Inc. (the “Company”) issued a press release announcing certain financial results for
the first quarter ended March 31, 2026, and certain other 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
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, 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 May 14, 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:
May 14, 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 First Quarter 2026 Financial Results and Recent Operational Highlights
- Presented
new data on CLD-401 at the AACR conference in San Diego, CA, detailing the profound immune
changes in the tumor microenvironment induced by CLD-401; IND filing for CLD-401 expected
by end of 2026
- Presented
new data on RedTail at the AACR conference in San Diego, CA detailing the use of the RedTail
platform to create in vivo T-cell engagers that simultaneously express both a T-cell engager
and a T-cell activator at high levels exclusively in the tumor microenvironment; presented
new data on CLD-501, a TROP-2 in vivo T-cell engager
- Demonstrated
$1 million reduction in general and administrative expenses from Q1-2025 to Q1-2026
- Speaker
presentation at ASGCT conference in Boston, MA highlighting IL15-SA expression may dramatically
expand the therapeutic window of IL-15-mediated treatment
- Speaker
presentation at IOVC conference showcasing the ability of the RedTail extracellular enveloped
and CD55-overexpressing virus (EEV) to avoid immune clearance
- Strategic
partnership with TransferAI to drive efficiencies in IND submission process for CLD-401
SAN
DIEGO, May 14, 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 first quarter 2026 operating and
financial results and reviewed recent business highlights.
“We
are excited about the continued progress at Calidi,” said Eric Poma, PhD, Calidi Biotherapeutics CEO. “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.”
First
Quarter 2026 and Recent Corporate Developments
- On
April 21, 2026, presented new data at the American Association of Cancer Research (AACR)
annual meeting in San Diego, California. Data at AACR detailed the profound immune changes
in the tumor microenvironment induced by CLD-401 including the recruitment and activation
of T, NK, NK-T, and gamma delta (γδ) T-cells that lead to a robust therapeutic
response in the immunocompetent animal models. Immune activation of cell types that do not
require antigen expression or HLA positivity represents a potential new mechanism of immune
response that could drive efficacy in patients that have progressed or were refractory to
current immune therapy
- On
April 19, 2026, Calidi presented data at the AACR meeting that showcased RedTail viruses
that can express both a functional T-cell engager, capable of binding targeted solid tumor
cells, and IL-15 SA at high concentrations, allowing for simultaneous T-cell activation and
high expression in situ of a T-cell engager. Localized expression of a T-cell engager and
a T-cell activator may overcome the key challenges seen with T-cell engagers in solid tumors.
The Company presented data on its first in situ T-cell engager, CLD-501, a T-cell engager
targeting TROP2
- Recorded
a $1.0 million reduction in general and administrative expenses from Q1-2025 to Q1-2026,
demonstrating the Company’s commitment to efficient use of capital. The reduction was
primarily due to reduced headcount, consulting, and rent expenses
- On
May 14, 2026, presented as a featured speaker at the American Society for Gene and Cell Therapy
(ASGCT) conference in Boston, Massachusetts, highlighting that the ability of CLD-401 to
induce high levels of IL15-SA expression in the tumor microenvironment while maintaining
low circulating levels may dramatically expand the therapeutic window of IL-15-mediated treatment
- On
April 28, 2026, presented data at the Internation Oncolytic Virus Conference (IOVC) in Reykjavik,
Iceland, showcasing the ability of the RedTail extracellular enveloped and CD55-overexpressing
virus (EEV) to avoid immune clearance, replicate only in target cells, and deliver high concentrations
of genetic medicine to sites of disease
- In
April 2026, entered a collaboration with TransferAI to drive efficiencies in Calidi’s
IND submission for CLD-401 by using TransferAI’s proprietary agentic artificial intelligence
platform, SofieTM, including pre-built and customizable orchestrations for biopharma.
TransferAI’s Sofie platform will work alongside Calidi’s teams, helping orchestrate
complex regulatory workflows while preserving the rigor required for IND submissions, providing
support for Calidi to achieves its goal of submitting the CLD-401 IND by year end
First
Quarter 2026 Financial Results
The
Company reported a net loss attributable to common stockholders of $4.4 million, or $0.43 per share, for the three months ended March
31, 2026, compared to a net loss attributable to common stockholders of $5.0 million, or $2.21 per share, for the same period in 2025.
Research
and development expenses were $2.6 million for the three months ended March 31, 2026, compared to $2.4 million for the comparable period
in 2025.
General
and administrative expenses were $1.6 million for the three months ended March 31, 2026, compared to $2.6 million for the comparable
period in 2025.
The
Company had approximately $6.6 million in cash and $0.2 million in restricted cash as of March 31, 2026, compared to $5.6 million in
cash and $0.2 million in restricted cash as of December 31, 2025.
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:
IR@calidibio.com
For
Media:
PR@calidibio.com
CALIDI
BIOTHERAPEUTICS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands, except for par value data)
March
31,
2026
December
31,
2025
(Unaudited)
ASSETS
CURRENT ASSETS
Cash
$ 6,631
$ 5,600
Prepaid expenses and other current assets
722
656
Total current assets
7,353
6,256
NONCURRENT ASSETS
Machinery and equipment, net
758
781
Operating lease right-of-use assets, net
1,342
1,682
Other noncurrent assets
138
138
TOTAL ASSETS
$ 9,591
$ 8,857
LIABILITIES AND TOTAL EQUITY
CURRENT LIABILITIES
Accounts payable
$ 849
$ 595
Related party accounts payable
51
18
Accrued expenses and other current liabilities
1,313
1,276
Related party accrued expenses and other current liabilities
119
530
Finance lease liability, current
154
111
Operating lease right-of-use liability, current
1,350
1,405
Total current liabilities
3,836
3,935
NONCURRENT LIABILITIES
Operating lease right-of-use liability, noncurrent
6
277
Finance lease liability, noncurrent
147
171
Promissory note
600
600
Warrant liability
62
107
Related party warrant liability
5
8
TOTAL LIABILITIES
4,656
5,098
TOTAL EQUITY
4,935
3,759
TOTAL LIABILITIES AND TOTAL EQUITY
$ 9,591
$ 8,857
CALIDI
BIOTHERAPEUTICS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(In
thousands, except per share data)
Three Months Ended March 31,
2026
2025
(Unaudited)
OPERATING EXPENSES
Research and development
$ (2,587 )
$ (2,425 )
General and administrative
(1,600 )
(2,637 )
Total operating expense
(4,187 )
(5,062 )
Loss from operations
(4,187 )
(5,062 )
OTHER INCOME, NET
Interest expense
(33 )
(34 )
Interest expense – related party
(5 )
(38 )
Change in fair value of other liabilities and derivatives
45
32
Change in fair value of other liabilities and derivatives – related party
3
3
Grant income
—
50
Other income (expense), net
73
(10 )
Total other income, net
83
3
LOSS BEFORE INCOME TAXES
(4,104 )
(5,059 )
Income tax provision
(4 )
(3 )
NET LOSS
$ (4,108 )
$ (5,062 )
Net loss attributable to noncontrolling interest
—
(76 )
NET LOSS ATTRIBUTABLE TO CONTROLLING INTEREST
(4,108 )
(4,986 )
Deemed dividend on warrants
(309 )
—
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
(4,417 )
(4,986 )
Net loss per share; basic and diluted
$ (0.43 )
$ (2.21 )
Weighted average common shares outstanding; basic and diluted
10,308
2,257
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May 14, 2026
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- 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