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Form 8-K

sec.gov

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

Documents

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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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Period Type:

duration

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