Form 8-K

8-K — Calidi Biotherapeutics, Inc.

Accession: 0001493152-26-037840

Filed: 2026-08-13

Period: 2026-08-13

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)

the Securities Exchange Act of 1934

Date

of Report (Date of earliest event reported): August 13, 2026

CALIDI

BIOTHERAPEUTICS, INC.

(Exact

name of registrant as specified in its charter)

Delaware

001-40789

86-2967193

(State

or other jurisdiction

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 ☒

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.

August 13, 2026, Calidi Biotherapeutics, Inc. (the “Company”) issued a press release announcing certain financial results

for the second quarter ended June 30, 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.

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

Description

99.1

Press Release dated August 13, 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:

August 13, 2026

By:

/s/

Andrew Jackson

Name:

Andrew

Jackson

Title:

Chief

Financial Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit

99.1

Calidi

Biotherapeutics Reports Second Quarter 2026 Financial Results and Recent Business Highlights

- Received

positive pre-IND feedback from the U.S. FDA for CLD-401, indicating agreement on the

current development strategy toward a first-in-human study targeting first patient dosing

in Q1 2027

- Showcased

the versatility of its RedTail platform

at the 2026 ASCO Annual Meeting with new CLD-501 data demonstrating the simultaneous

in situ delivery of a TROP-2-targeted tumor-localized T-cell engager (TCE) alongside a T-cell

amplifier; the Company is also advancing its EpCam-targeted in situ TCE program,

representing an important advancement of the RedTail platform

- Strengthened

its Board of Directors with the addition of Corsee Sanders, Ph.D., former executive

of Genentech/Roche and Celgene

- Reduced

general and administrative expenses by

$1.5 million, or 48%, in the second quarter of 2026 versus the same period in the prior

year

SAN

DIEGO, August 13, 2026 - Calidi Biotherapeutics,

Inc. (NYSE American: CLDI) (“Calidi” or the “Company”), a biotechnology company pioneering the development

of targeted genetic medicines, today reported financial and operating results for the three months ended June 30, 2026, and reviewed

recent business highlights.

“Throughout

the second quarter, Calidi continued to advance

its RedTail platform and redefine the potential of oncolytic viruses and genetic medicine,” said Eric Poma, Ph.D., Calidi

Biotherapeutics CEO. “We anticipate CLD-401, the lead drug candidate from our RedTail platform, entering the clinic

during the first quarter of 2027. In addition, we have expanded what the RedTail platform can do with our new approach of in situ

T-cell engagers.”

Second

Quarter 2026 and Recent Business Developments

● In

the pre-IND meeting, the FDA and Calidi agreed on key aspects of the CMC and non-clinical

programs, and the FDA provided feedback on the overall design for the proposed first-in-human

clinical study. This pre-IND (Type B) interaction builds upon the engagement and alignment

achieved through early scientific advice as part of a Type D interaction with the FDA.

● Presented

preclinical data at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

on CLD-501, the lead compound from Calidi’s in situ TCE approach. CLD-501 is a systemically

delivered virotherapy designed to selectively target tumors and simultaneously enable the

high-level in situ expression of a TROP-2 TCE and IL-15 superagonist (IL-15 SA). The

Company also presented preclinical data on CLD-401, its lead program. CLD-401 is a

systemically delivered virotherapy designed to selectively target tumors and enable high-level

expression of IL-15 SA, a known T- and NK-cell activator, driving profound immune changes

in the tumor microenvironment, including the recruitment and activation of NK, NK-T, and

gamma delta (γδ) T-cells that lead to a robust therapeutic response in immunocompetent

animal models.

● Strengthened

its Board of Directors with the addition of Corsee Sanders, Ph.D. Dr. Sanders served

as strategic advisor to Celgene’s Chief Medical Officer following Celgene’s acquisition

of Juno where she was an Executive Vice President of Development Operations. She also served

as Transition Advisor to Bristol Myers Squibb following its acquisition of Celgene.

Dr. Sanders held numerous leadership positions over the course of 23 years at Genentech/Roche,

including Senior Vice President, Global Head of Clinical Operations and Industry Collaboration.

● Reduced

general and administrative expenses by $1.5 million, or 48%, in the second

quarter of 2026 compared with the same period in 2025. The Company will continue its

tight focus on expense management to ensure sufficient capital to advance its

pipeline

Second

Quarter 2026 Financial Results

Calidi

reported a net loss attributable to common stockholders of $4.2 million, or $2.94 per share, for the second quarter of 2026, compared

with a net loss attributable to common stockholders of $5.7 million, or $31.75 per share, for the same period in 2025. Prior-period

share and per-share amounts have been adjusted to reflect the Company’s 1-for-16 reverse stock split completed in July 2026.

Research

and development expenses were $2.6 million for the second quarter of 2026, unchanged from the second quarter of 2025.

General

and administrative expenses were $1.6 million for the second quarter of 2026, compared with $3.1 million for the comparable

period in 2025.

The

Company had $4.1 million in cash and $0.2 million in restricted cash as of June 30, 2026, compared with $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 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, including the Company’s plan to dose the first patient in a phase

1 trial in Q1 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, with respect to the Company’s fiscal year 2026 and 2027 initiatives, including the timing and

ability to open a phase 1 clinical study in Q1 2027, 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.

Investors

Contact:

IR@calidibio.com

Media

Contact:

PR@calidibio.com

CALIDI

BIOTHERAPEUTICS, INC.

CONDENSED

CONSOLIDATED BALANCE SHEETS

(In

thousands, except for par value data)

June

30,

2026

December

31,

2025

(Unaudited)

ASSETS

CURRENT ASSETS

Cash

$ 4,071

$ 5,600

Prepaid

expenses and other current assets

1,357

656

Total current assets

5,428

6,256

NONCURRENT ASSETS

Machinery

and equipment, net

775

781

Operating

lease right-of-use assets, net

992

1,682

Other

noncurrent assets

138

TOTAL

ASSETS

$ 7,204

$ 8,857

LIABILITIES

AND TOTAL EQUITY

CURRENT LIABILITIES

Accounts

payable

$ 930

$ 595

party accounts payable

—

Accrued

expenses and other current liabilities

1,131

1,276

party accrued expenses and other current liabilities

—

530

Finance

lease liability, current

167

111

Operating

lease right-of-use liability, current

1,009

1,405

Total

current liabilities

3,237

3,935

NONCURRENT LIABILITIES

Operating

lease right-of-use liability, noncurrent

277

Finance

lease liability, noncurrent

161

171

Promissory

note

600

Warrant

liability

107

party warrant liability

TOTAL LIABILITIES

4,071

5,098

TOTAL

EQUITY

3,133

3,759

TOTAL

LIABILITIES AND TOTAL EQUITY

$ 7,204

$ 8,857

CALIDI

BIOTHERAPEUTICS, INC.

CONDENSED

CONSOLIDATED STATEMENTS OF OPERATIONS

(In

thousands, except per share data)

Three

Months Ended June 30,

2026

2025

(Unaudited)

OPERATING

EXPENSES

Research

and development

$ 2,558

$ 2,593

General

and administrative

1,592

3,071

Total

operating expense

4,150

5,664

Loss from operations

(4,150 )

(5,664 )

OTHER

INCOME (EXPENSE), NET

Interest

expense

(29 )

Interest

expense – related party

(6 )

(23 )

Change

in fair value of other liabilities and derivatives

(1 )

(18 )

Change

in fair value of other liabilities and derivatives – related party

—

(1 )

Other

income (expense), net

(22 )

Total

other expense, net

(5 )

(93 )

LOSS

BEFORE INCOME TAXES

(4,155 )

(5,757 )

Income

tax provision

(5 )

(4 )

NET

LOSS

$ (4,160 )

$ (5,761 )

Net

loss attributable to noncontrolling interest

—

(46 )

NET

LOSS ATTRIBUTABLE TO CONTROLLING INTEREST

(4,160 )

(5,715 )

NET

LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS

(4,160 )

(5,715 )

Net

loss per share; basic and diluted

$ (2.94 )

$ (31.75 )

Weighted

average common shares outstanding; basic and diluted

1,416

180

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