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Calidi Biotherapeutics (CLDI) narrows Q2 2026 loss and advances CLD-401

(High)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Calidi Biotherapeutics, Inc. reported second quarter 2026 results and pipeline updates. For the three months ended June 30, 2026, net loss attributable to common stockholders was $4.2 million, or $2.94 per share, compared with a net loss of $5.7 million, or $31.75 per share, for the same period in 2025, with prior per-share data adjusted for a 1-for-16 reverse stock split completed in July 2026.

Research and development expenses were $2.6 million, essentially unchanged year over year, while general and administrative expenses decreased to $1.6 million from $3.1 million. Cash was $4.1 million and restricted cash $0.2 million as of June 30, 2026, versus cash of $5.6 million and restricted cash of $0.2 million at December 31, 2025. Total assets were $7.2 million and total equity $3.1 million at quarter end. The company highlighted progress on its RedTail platform and anticipates lead candidate CLD-401 entering the clinic in the first quarter of 2027 targeting metastatic cancers.

Positive

  • Net loss attributable to common stockholders narrowed from $5.7 million to $4.2 million year over year for Q2 2026.
  • General and administrative expenses declined significantly to $1.6 million from $3.1 million, indicating lower overhead spending.
  • The company reaffirmed development plans, expecting lead candidate CLD-401 to enter a phase 1 clinical trial in Q1 2027.

Negative

  • Cash decreased from $5.6 million at December 31, 2025 to $4.1 million at June 30, 2026, reducing liquidity.
  • Total assets declined from $8.9 million to $7.2 million between December 31, 2025 and June 30, 2026.

Filing Explained

As of June 30, 2026, the filing reports $4.1 million in cash; compared with the latest reported quarter’s operating cash use, that balance equals 149.8 days of cash use, a liquidity measure rather than committed financing or proceeds.

Sources and calculations
  • Cash and equivalents vs quarterly operating cash outflow, in days of cash use $6,850,000 / ($4,116,000 / 90) = [object Object]
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, and exhibit attachments filed with this report.
Net loss attributable to common stockholders Q2 2026 $4.2 million Three months ended June 30, 2026
Net loss attributable to common stockholders Q2 2025 $5.7 million Three months ended June 30, 2025
Net loss per share Q2 2026 $2.94 Basic and diluted, three months ended June 30, 2026
General and administrative expenses Q2 2026 $1.6 million Three months ended June 30, 2026
General and administrative expenses Q2 2025 $3.1 million Three months ended June 30, 2025
Cash balance $4.1 million As of June 30, 2026
Total assets $7.2 million As of June 30, 2026
Total equity $3.1 million As of June 30, 2026
oncolytic virus medical
"an engineered enveloped oncolytic virus designed for systemic delivery"
A virus engineered or selected to infect and destroy cancer cells while leaving healthy tissue largely unharmed, often acting like a guided missile that also alerts the immune system to attack tumors. It matters to investors because oncolytic viruses represent a potential new class of cancer treatments that can command large markets if proven safe and effective, but development is costly and outcome-driven, carrying high regulatory and clinical risk.
IND-enabling studies regulatory
"CLD-401, the lead candidate from the RedTail platform, 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.
warrant liability financial
"Warrant liability | | | 63 | | | | 107"
Warrant liability is the financial obligation a company records when it grants warrants—special options giving the holder the right to buy company shares at a set price in the future. It matters to investors because changes in this liability can affect a company's reported earnings and overall financial health, similar to how a pending contract can influence a company's future value.
operating lease right-of-use assets financial
"Operating lease right-of-use assets, net | | | 992"
An operating lease right-of-use (ROU) asset is an accounting entry that shows the value of a leased item you have the legal right to use—like a building, vehicle, or equipment—recorded on a company’s balance sheet along with the corresponding lease obligation. Investors care because it adds to reported assets and liabilities, changing measures like leverage and return on assets much like bringing a long-term rental onto the company’s financial snapshot, which can affect credit terms and valuation.
Net loss attributable to common stockholders $4.2 million Compared with $5.7 million for the same period in 2025
Net loss per share, basic and diluted $2.94 Compared with $31.75 for the same period in 2025
Research and development expenses $2.6 million Comparable to $2.6 million in Q2 2025
General and administrative expenses $1.6 million Down from $3.1 million in Q2 2025
Guidance

The company anticipates CLD-401 entering a phase 1 clinical trial in the first quarter of 2027.

FAQ

What were Calidi Biotherapeutics (CLDI) net results for Q2 2026?

Calidi reported a net loss of $4.2 million attributable to common stockholders for Q2 2026, compared with $5.7 million a year earlier. Net loss per share was $2.94 versus $31.75, with prior-period figures reflecting a 1-for-16 reverse stock split.

How did CLDI’s operating expenses change in the second quarter of 2026?

Total operating expenses were $4.2 million in Q2 2026, down from $5.7 million in Q2 2025. Research and development was stable at about $2.6 million, while general and administrative expenses decreased to $1.6 million from $3.1 million.

What is Calidi Biotherapeutics’ (CLDI) cash position as of June 30, 2026?

As of June 30, 2026, Calidi held $4.1 million in cash and $0.2 million in restricted cash. At December 31, 2025, cash was $5.6 million with the same $0.2 million in restricted cash, indicating lower available cash mid-year.

What are the key pipeline plans Calidi Biotherapeutics (CLDI) outlined?

Calidi plans for lead candidate CLD-401, from its RedTail platform, to enter the clinic in the first quarter of 2027. CLD-401 targets metastatic non-small cell lung cancer, head and neck cancer, and other tumors with high unmet medical need.

How did CLDI’s balance sheet change between December 31, 2025 and June 30, 2026?

Total assets declined to $7.2 million from $8.9 million, while total liabilities decreased to $4.1 million from $5.1 million. Total equity moved to $3.1 million from $3.8 million over the same period.

What share count did Calidi Biotherapeutics (CLDI) report for Q2 2026?

Weighted average common shares outstanding, basic and diluted, were 1,416 thousand for Q2 2026, compared with 180 thousand in Q2 2025. Prior-period share figures were adjusted for a 1-for-16 reverse stock split completed in July 2026.

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

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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): August 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)

 

(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 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.

 

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 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

 

 

 

 

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   9    138 
TOTAL ASSETS  $7,204   $8,857 
LIABILITIES AND TOTAL EQUITY          
CURRENT LIABILITIES          
Accounts payable  $930   $595 
Related party accounts payable       18 
Accrued expenses and other current liabilities   1,131    1,276 
Related 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   5    277 
Finance lease liability, noncurrent   161    171 
Promissory note   600    600 
Warrant liability   63    107 
Related party warrant liability   5    8 
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)   (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   31    (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 

 

# # #

 

 

 

Filing Exhibits & Attachments

5 documents