Calidi Biotherapeutics Reports Third Quarter 2024 Operating and Financial Results
13 November 2024 - 9:29AM
Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a
clinical-stage biotechnology company developing a new generation of
targeted antitumor virotherapies, today reported its operating and
financial results for the third quarter ended September 30, 2024,
and reviewed recent business highlights.
“Calidi continues to advance our development programs while
expanding our industry-leading position in targeted antitumor
virotherapies,” said Allan Camaisa, CEO and Chairman of the Board
of Calidi Biotherapeutics. “In addition, we are pleased that
Northwestern University has received U.S. FDA clearance to advance
our CLD-101 program in the clinic for newly diagnosed high-grade
glioma.”
Third Quarter 2024 and Recent Corporate
Developments
- The U.S. Food and Drug
Administration (FDA) has cleared Northwestern University’s
Investigational New Drug (IND) application for Calidi’s NeuroNova
(CLD-101). CLD-101 is a novel stem-cell based platform designed to
deliver oncolytic viruses to tumors, enhancing their antitumor
effects. The Phase 1b/2 clinical trial in newly diagnosed
high-grade glioma is expected to commence in early 2025 at
Northwestern University.
- Data was presented on RTNova
(CLD-400), Calidi’s systemic antitumor virotherapy platform, at the
International Oncolytic Virotherapy Conference (IOVC) in Rotterdam,
Netherlands, at Immuno US 2024 in San Diego, California and the
Society for Immunotherapy of Cancer (SITC) annual meeting. RTNova
is a systemic treatment designed for reduced elimination by the
humoral immune system. It targets multiple tumor sites, killing
tumor cells while altering the tumor immune microenvironment. This
novel systemic therapeutic approach not only facilitates easier
administration but also broadens the potential patient population
who can benefit from this treatment.
- Calidi announced in October the
completion of a definitive securities purchase agreement with
certain institutional investors, raising $2 million in a registered
direct offering and concurrent private placement.
Third Quarter 2024 Financial Results
The Company reported a net loss of $5.1 million, or $0.65 per
share, for the three months ended September 30, 2024, compared to a
net loss of $2.0 million, or $1.41 per share, for the same period
in 2023.
Research and development expenses were $2.2 million for the
three months ended September 30, 2024, compared to $3.3 million for
the comparable period in 2023, respectively.
General and administrative expenses were $3.1 million for the
three months ended September 30, 2024, compared to $4.0 million for
the comparable period in 2023, respectively.
The Company had approximately $1.9 million in cash and $0.2
million in restricted cash as of both September 30, 2024 and
December 31, 2023.
About Calidi Biotherapeutics:
Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage
immuno-oncology company with proprietary technology designed to arm
the immune system to fight cancer. Calidi’s novel stem cell-based
platforms are utilizing potent allogeneic stem cells capable of
carrying payloads of oncolytic viruses for use in multiple oncology
indications, including high-grade gliomas and solid tumors.
Calidi’s clinical stage off-the-shelf, universal cell-based
delivery platforms are designed to protect, amplify, and potentiate
oncolytic viruses leading to enhanced efficacy and improved patient
safety. Calidi’s preclinical off-the-shelf enveloped virotherapies
are designed to target disseminated solid tumors. This dual
approach can potentially treat, or even prevent, metastatic
disease. Calidi Biotherapeutics is headquartered in San Diego,
California. For more information, please visit
www.calidibio.com.
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, statements concerning upcoming key milestones
(including the reporting of interim clinical results and the dosing
of patients), 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.
Other risks and uncertainties are set forth in the section entitled
“Risk Factors” and “Cautionary Note Regarding Forward-Looking
Statements” in the Company’s Registration Statements filed with the
SEC on (i) Form S-4 filed on August 2, 2023 and the corresponding
prospectus filed on August 4, 2023, and (ii) on Form S-1 filed on
April 15, 2024, and the Company’s periodic reports filed with the
SEC on (i) Form 10-K filed on March 15, 2024, (ii) Form 10-Q filed
on May 14, 2024, and (iii) Form 10-Q filed on August 13, 2024.
These reports may be amended or supplemented by other reports we
file with the SEC from time to time.
For Investors:Dave Gentry, CEORedChip
Companies, Inc.1-407-644-4256CLDI@redchip.com
CALIDI BIOTHERAPEUTICS, INC.CONDENSED
CONSOLIDATED BALANCE SHEETS(In thousands except for par
value data) |
|
|
September 30, 2024 |
|
|
December 31, 2023 |
|
|
|
(Unaudited) |
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
CURRENT ASSETS |
|
|
|
|
|
|
|
Cash |
|
$ |
1,897 |
|
|
$ |
1,949 |
|
Prepaid expenses and other current assets |
|
|
324 |
|
|
|
2,354 |
|
Total current assets |
|
|
2,221 |
|
|
|
4,303 |
|
NONCURRENT ASSETS |
|
|
|
|
|
|
|
Machinery and equipment, net |
|
|
982 |
|
|
|
1,270 |
|
Operating lease right-of-use assets, net |
|
|
3,237 |
|
|
|
4,073 |
|
Other noncurrent assets |
|
|
217 |
|
|
|
373 |
|
TOTAL ASSETS |
|
$ |
6,657 |
|
|
$ |
10,019 |
|
LIABILITIES AND
STOCKHOLDERS’ DEFICIT |
|
|
|
|
|
|
|
CURRENT LIABILITIES |
|
|
|
|
|
|
|
Accounts payable |
|
$ |
3,574 |
|
|
$ |
2,796 |
|
Related party accounts payable |
|
|
— |
|
|
|
81 |
|
Accrued expenses and other current liabilities |
|
|
2,567 |
|
|
|
4,896 |
|
Related party accrued expenses and other current liabilities |
|
|
496 |
|
|
|
536 |
|
Term notes payable, net of discount, including accrued
interest |
|
|
242 |
|
|
|
529 |
|
Related party term notes payable, net of discount, including
accrued interest |
|
|
2,631 |
|
|
|
278 |
|
Related party bridge loan payable, including accrued interest |
|
|
217 |
|
|
|
— |
|
Related party other current liability |
|
|
620 |
|
|
|
— |
|
Finance lease liability, current |
|
|
69 |
|
|
|
81 |
|
Operating lease right-of-use liability, current |
|
|
1,163 |
|
|
|
1,035 |
|
Total current liabilities |
|
|
11,579 |
|
|
|
10,232 |
|
NONCURRENT LIABILITIES |
|
|
|
|
|
|
|
Operating lease right-of-use liability, noncurrent |
|
|
2,161 |
|
|
|
3,037 |
|
Finance lease liability, noncurrent |
|
|
166 |
|
|
|
216 |
|
Warrant liability |
|
|
163 |
|
|
|
623 |
|
Related party warrant liability |
|
|
13 |
|
|
|
48 |
|
Convertible notes payable, including accrued interest |
|
|
1,773 |
|
|
|
— |
|
Related party term notes payable, net of discount, including
accrued interest |
|
|
— |
|
|
|
2,060 |
|
Promissory note |
|
|
600 |
|
|
|
— |
|
Other noncurrent liabilities |
|
|
— |
|
|
|
1,500 |
|
Related party other noncurrent liabilities |
|
|
— |
|
|
|
538 |
|
TOTAL LIABILITIES |
|
|
16,455 |
|
|
|
18,254 |
|
Commitments and contingencies
(Note 11) |
|
|
|
|
|
|
|
STOCKHOLDERS’ DEFICIT |
|
|
|
|
|
|
|
Common stock, $0.0001 par value, 330,000 shares authorized; 9,311
and 3,552 shares issued and outstanding as of September 30, 2024
and December 31, 2023, respectively |
|
|
1 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
107,408 |
|
|
|
91,383 |
|
Non-controlling interest |
|
|
485 |
|
|
|
— |
|
Accumulated other comprehensive loss, net of tax |
|
|
(74 |
) |
|
|
(47 |
) |
Accumulated deficit |
|
|
(117,618 |
) |
|
|
(99,572 |
) |
Total stockholders’ deficit |
|
|
(9,798 |
) |
|
|
(8,235 |
) |
TOTAL LIABILITIES AND
STOCKHOLDERS’ DEFICIT |
|
$ |
6,657 |
|
|
$ |
10,019 |
|
CALIDI BIOTHERAPEUTICS, INC.CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS(In thousands, except
per share data) |
|
|
|
Three Months Ended September
30, |
|
|
|
2024 |
|
|
2023 |
|
|
|
(Unaudited) |
|
OPERATING
EXPENSES |
|
|
|
|
|
|
Research and development |
|
$ |
(2,153 |
) |
|
$ |
(3,251 |
) |
General and administrative |
|
|
(3,073 |
) |
|
|
(3,970 |
) |
Total operating expense |
|
|
(5,226 |
) |
|
|
(7,221 |
) |
Loss from
operations |
|
|
(5,226 |
) |
|
|
(7,221 |
) |
OTHER
INCOME (EXPENSES), NET |
|
|
|
|
|
|
|
|
Interest expense |
|
|
(98 |
) |
|
|
(101 |
) |
Interest expense – related party |
|
|
(134 |
) |
|
|
(223 |
) |
Change in fair value of debt, other liabilities, and
derivatives |
|
|
352 |
|
|
|
845 |
|
Change in fair value of debt, other liabilities, and derivatives –
related party |
|
|
28 |
|
|
|
4,473 |
|
Debt extinguishment |
|
|
— |
|
|
|
(139 |
) |
Debt extinguishment – related party |
|
|
— |
|
|
|
(332 |
) |
Grant income |
|
|
— |
|
|
|
693 |
|
Other income (expense), net |
|
|
8 |
|
|
|
(8 |
) |
Total other income (expenses), net |
|
|
156 |
|
|
|
5,208 |
|
LOSS
BEFORE INCOME TAXES |
|
|
(5,070 |
) |
|
|
(2,013 |
) |
Income tax credit (provision) |
|
|
1 |
|
|
|
(11 |
) |
NET
LOSS |
|
$ |
(5,069 |
) |
|
$ |
(2,024 |
) |
Net loss attributable to noncontrolling interest |
|
|
(15 |
) |
|
|
— |
|
NET LOSS
ATTRIBUTABLE TO CONTROLLING INTEREST |
|
$ |
(5,054 |
) |
|
$ |
(2,024 |
) |
Deemed dividend on warrants |
|
|
— |
|
|
|
— |
|
NET LOSS
ATTRIBUTABLE TO COMMON STOCKHOLDERS |
|
$ |
(5,054 |
) |
|
$ |
(2,024 |
) |
Net loss
per share; basic and diluted |
|
$ |
(0.65 |
) |
|
$ |
(1.41 |
) |
Weighted average
common shares outstanding; basic and diluted |
|
|
7,824 |
|
|
|
1,431 |
|
Calidi Biotherapeutics (AMEX:CLDI)
Historical Stock Chart
From Dec 2024 to Jan 2025
Calidi Biotherapeutics (AMEX:CLDI)
Historical Stock Chart
From Jan 2024 to Jan 2025