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Calidi Biotherapeutics narrows Q3 loss to $3.65M

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Form Type
8-K

Rhea-AI Filing Summary

Calidi Biotherapeutics, Inc. (CLDI) reported a third-quarter 2026 net loss attributable to common stockholders of $3.646 million, compared with $10.822 million a year earlier. The 2025 quarter included a $5.673 million noncash deemed dividend on warrants; there was no such charge in 2026. Research and development expense was $2.703 million versus $2.361 million, while general and administrative expense fell 39% to $1.642 million from $2.687 million. Cash was $3.9 million and restricted cash was $0.2 million as of September 30, 2026.

Calidi received $1.2 million in gross proceeds from an at-the-market registered direct offering that closed September 18, 2026. A restructuring plan executed November 6, predominantly through a reduction in headcount, is expected to save $3 million on an annualized basis. Preclinical CLD-401 data showed complete tumor eradication in 80% of EMT6 breast cancer tumor-bearing mice versus 0% in the control arm. In an MB49 bladder cancer model, it retained antitumor activity with intravenous or intratumoral delivery. Calidi also presented preclinical data on its in situ T-cell engager candidates.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Net loss attributable to common stockholders $3.646 million Three months ended September 30, 2026; $10.822 million in the comparable 2025 quarter, which included a $5.673 million noncash deemed dividend on warrants.
Research and development expense $2.703 million Third quarter 2026; $2.361 million in the third quarter of 2025.
General and administrative expense $1.642 million Third quarter 2026; $2.687 million in the third quarter of 2025, a 39% decrease as reported.
Gross proceeds $1.2 million At-the-market registered direct offering closed September 18, 2026.
Expected annualized savings $3 million Expected from the restructuring plan executed November 6, 2026.
Cash $3.9 million As of September 30, 2026; $5.6 million as of December 31, 2025.
Restricted cash $0.2 million As of September 30, 2026.
Complete tumor eradication 80% Preclinical EMT6 breast cancer tumor-bearing mice; 0% in the control arm.
at-the-market registered direct offering financial
"gross proceeds from an at-the-market registered direct offering"
A securities offering in which a company sells newly registered shares directly into the open market at prevailing market prices through a broker-dealer acting as sales agent, using an existing registration statement or shelf registration. It combines the mechanics of an “at-the-market” (continuous sales into the trading market at current prices) with the regulatory status of a registered direct offering (securities sold under a registration that permits direct placement without a firm underwriting syndicate). The result is a flexible, incremental way to raise capital: sales occur opportunistically into regular trading rather than as a single priced deal, and transactions are executed through an agent rather than through a traditional underwritten offering; because shares are sold at market prices over time, the amount raised and timing are variable and each sale is typically immediately tradable.
deemed dividend on warrants financial
"a $5.7 million non-cash charge for a deemed dividend on warrants"
oncolytic viruses medical
"the potential of oncolytic viruses and genetic medicine"
Engineered or naturally occurring viruses that are used to treat cancer by selectively infecting and killing tumor cells and by triggering an anti-cancer immune response; they are designed or chosen to replicate preferentially in cancerous tissue while sparing normal cells. Delivery can be local (injected into tumors) or systemic, and their use is regulated as a form of biological therapy because they are live, replicating agents with safety and containment considerations.
syngeneic tumor models medical
"systemic administration in syngeneic tumor models"
Syngeneic tumor models are laboratory tests in which cancer cells are implanted into animals that are genetically identical to the donor, so the recipient’s immune system is intact and reacts naturally to the tumor. For investors, these models matter because they give early, realistic signals about how immune-based therapies and cancer drugs might work in a living immune system—think of them as dress rehearsals that reveal whether a treatment can engage the body’s defenses before moving to costly human trials.
in situ T-cell engager medical
"Calidi’s in situ T-cell engager (“TCE”) platform"
A therapy that directs a patient’s own T cells to attack diseased cells at the site of the disease by physically linking or activating immune cells and target cells within the body. Think of it as a molecular matchmaker or bridge that brings a T cell into close contact with a specific diseased cell so the T cell can kill it; the “in situ” part means this engagement happens locally inside the body rather than being done externally. Investors care because this approach defines a distinct product type with specific manufacturing, clinical trial, safety, and regulatory considerations that affect development timelines and commercial potential.
IND-enabling studies regulatory
"currently in IND-enabling studies"
Ind-enabling studies are early research efforts that test whether a new drug or treatment is safe and effective enough to move forward in development. They are like preliminary tests to ensure a product works as intended before investing more resources into large-scale trials. For investors, these studies are important because successful results can signal potential progress toward bringing a new product to market, impacting its future value.
Net loss attributable to common stockholders $3.646 million Compared with $10.822 million in the third quarter of 2025; the 2025 quarter included a $5.673 million noncash deemed dividend on warrants, and the 2026 quarter had no such charge.
Research and development expense $2.703 million Compared with $2.361 million in the third quarter of 2025.
General and administrative expense $1.642 million Compared with $2.687 million in the third quarter of 2025; the company reported a 39% decrease.
Cash $3.9 million As of September 30, 2026.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What net loss did CLDI report for the third quarter of 2026?

Calidi reported a $3.646 million net loss attributable to common stockholders for the third quarter of 2026, compared with $10.822 million in the third quarter of 2025. The 2025 amount included a $5.673 million noncash deemed dividend on warrants; there was no such charge in the 2026 quarter.

What T-cell engager concentration did Calidi report in tumors?

Calidi reported that intravenous delivery of its in situ T-cell engager platform generated approximately 10 ng/mL of EpCAM-targeted TCE directly within tumors. The presentation included CLD-501, a TROP-2-targeted candidate, and CLD-502, an EpCAM-targeted candidate.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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0001855485false00018554852026-11-132026-11-130001855485dei:FormerAddressMember2026-11-132026-11-13

 

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): November 13, 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)

(IRS Employer
Identification No.)

 

 

 

 

 

5580 Morehouse Drive, Suite 120

 

San Diego, California

 

92121

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 858 794-9600

 

 

4475 Executive Drive, Suite 200

San Diego, California 92121

(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:

☐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))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, $0.0001 par value

 

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 November 13, 2026, Calidi Biotherapeutics, Inc. (the “Company”) issued a press release announcing certain financial results for the third quarter ended September 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.

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 No. 

 

Description

99.1

 

Press Release dated November 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: November 13, 2026

 

 

 

 

 

 

 

 

 

 

 

 

By:

 

/s/ Andrew Jackson

 

 

 

 

Name:

 

Andrew Jackson

 

 

 

 

Title:

 

Chief Financial Officer

 

 


Exhibit 99.1

 

img117647863_0.jpg

 

Calidi Biotherapeutics Reports Third Quarter 2026 Financial Results and Recent Business Highlights

 

- Continued to advance the development of CLD-401 towards the clinic

- Presented new CLD-401 data and in situ TCE platform advances at the ESMO Congress 2026

- Received $1.2 million gross proceeds from at-the-market registered direct offering

- Reduced general and administrative expenses by $1.0 million, or 39%, in the third quarter of 2026 versus the same period in the prior year

 

SAN DIEGO, November 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 September 30, 2026, and reviewed recent business highlights.

“Throughout the third quarter, Calidi continued to advance its RedTail platform for systemic and local delivery and redefine the potential of oncolytic viruses and genetic medicine,” said Eric Poma, Ph.D., Calidi Biotherapeutics CEO. “In particular, CLD-401 demonstrated remarkable anti-tumor activity with systemic administration in syngeneic tumor models and continues to progress towards the clinic.”

Third Quarter 2026 and Recent Business Developments

•
Presented two posters at the European Society for Medical Oncology (ESMO) Congress 2026 on October 24, 2026. The presentations showcased new data from the Company’s RedTail platform, a systemically delivered virotherapy platform engineered to selectively target tumors, remodel the tumor microenvironment, and enable high-level expression of therapeutic genetic payloads directly within tumors.
o
Preclinical data on Calidi’s lead program, CLD-401, showed complete tumor eradication in 80% of EMT6 breast cancer tumor-bearing mice versus 0% in the control arm. CLD-401 was engineered for systemic delivery, and new data from an MB49 bladder cancer model show it retains antitumor activity with either systemic intravenous or localized intratumoral administration, supporting flexible delivery approaches across tumor accessibility and disease settings.
o
Presented preclinical data from Calidi’s in situ T-cell engager (“TCE”) platform, including CLD-501, its TROP-2-targeted candidate, and CLD-502, its EpCAM-targeted candidate. Following intravenous delivery, the platform generated approximately 10 ng/mL of EpCAM-targeted TCE directly within tumors, and both targeted TCEs demonstrated antigen-dependent, does-responsive T-cell mediated cytotoxicity.
•
Received $1.2 million gross proceeds from an at-the-market registered direct offering that closed on September 18, 2026.
•
Reduced general and administrative expenses by $1.0 million, or 39%, in the third quarter of 2026 versus the same period in the prior year. Reduced general and administrative expenses by $3.6 million, or 42%, in the nine months ended September 30, 2026, versus the same period in the prior year. On November 6, 2026, Calidi executed a restructuring plan, predominantly through a

 

reduction in headcount, that is expected to save $3 million on an annualized basis to extend the Company’s cash runway to reduce costs, extend the Company's operating runway, and preserve capital while pursuing additional financing.

 

Third Quarter 2026 Financial Results

 

Calidi reported a $3.6 million net loss attributable to common stockholders for the third quarter of 2026, compared to a net loss attributable to common stockholders of $10.8 million for the third quarter of 2025, which included a $5.7 million non-cash charge for a deemed dividend on warrants. There was no such charge during the third quarter of 2026.

 

Research and development expenses were $2.7 million for the third quarter of 2026, compared to $2.4 million for the same quarter in 2025.

 

General and administrative expenses were $1.6 million for the third quarter of 2026, compared to $2.7 million for the same quarter in 2025.

 

The Company had $3.9 million in cash and $0.2 million in restricted cash as of September 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 the second half of 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 the second half of 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 par value data)

 

 

 

September 30,
2026

 

 

December 31,
2025

 

 

 

(unaudited)

 

 

 

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash

 

$

3,947

 

 

$

5,600

 

Restricted cash, current

 

 

219

 

 

 

100

 

Prepaid expenses and other current assets

 

 

570

 

 

 

556

 

Total current assets

 

 

4,736

 

 

 

6,256

 

Noncurrent assets:

 

 

 

 

 

 

Restricted cash, noncurrent

 

 

-

 

 

 

119

 

Machinery and equipment, net

 

 

704

 

 

 

781

 

Operating lease right-of-use assets, net

 

 

83

 

 

 

1,682

 

Other noncurrent assets

 

 

-

 

 

 

19

 

Total assets

 

$

5,523

 

 

$

8,857

 

 

 

 

 

 

 

 

LIABILITIES AND TOTAL EQUITY

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,347

 

 

$

595

 

Related party accounts payable

 

 

-

 

 

 

18

 

Accrued expenses and other current liabilities

 

 

1,517

 

 

 

1,186

 

Related party accrued expenses and other current liabilities

 

 

-

 

 

 

530

 

Promissory note and accrued interest, current

 

 

668

 

 

 

90

 

Operating leases, current

 

 

53

 

 

 

1,405

 

Finance leases, current

 

 

141

 

 

 

111

 

Total current liabilities

 

 

3,726

 

 

 

3,935

 

Noncurrent liabilities:

 

 

 

 

 

 

Operating leases, noncurrent

 

 

30

 

 

 

277

 

Finance leases, noncurrent

 

 

132

 

 

 

171

 

Promissory note, noncurrent

 

 

-

 

 

 

600

 

Warrant liability

 

 

4

 

 

 

107

 

Related party warrant liability

 

 

-

 

 

 

8

 

Total liabilities

 

 

3,892

 

 

 

5,098

 

Total equity

 

 

1,631

 

 

 

3,759

 

Total liabilities and total equity

 

$

5,523

 

 

$

8,857

 

 

 


 

CALIDI BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except par value data)

 

 

 

Three months ended September 30,

 

 

 

2026

 

 

2025

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

$

2,703

 

 

$

2,361

 

General and administrative

 

 

1,642

 

 

 

2,687

 

Total operating expenses

 

 

4,345

 

 

 

5,048

 

Loss from operations

 

 

(4,345

)

 

 

(5,048

)

Other income (expense), net:

 

 

 

 

 

 

Interest expense

 

 

(29

)

 

 

(31

)

Interest expense - related party

 

 

(8

)

 

 

(10

)

Change in fair value of other liabilities and
   derivatives

 

 

59

 

 

 

(93

)

Change in fair value of other liabilities and
   derivatives - related party

 

 

5

 

 

 

(7

)

Other income, net

 

 

681

 

 

 

18

 

Total other income (expense), net

 

 

708

 

 

 

(123

)

Loss before income taxes

 

 

(3,637

)

 

 

(5,171

)

Provision for income taxes

 

 

(9

)

 

 

(10

)

Net loss

 

 

(3,646

)

 

 

(5,181

)

Net loss attributable to noncontrolling interest

 

 

-

 

 

 

(32

)

Net loss attributable to controlling interest

 

 

(3,646

)

 

 

(5,149

)

Deemed dividend on warrants

 

 

-

 

 

 

(5,673

)

Net loss attributable to common stockholders

 

$

(3,646

)

 

$

(10,822

)

Net loss per share - basic and diluted

 

$

(1.47

)

 

$

(35.25

)

Weighted average shares outstanding - basic
   and diluted

 

 

2,476

 

 

 

307

 

 

###

 

 


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