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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 | |
#
# #