Calidi Biotherapeutics Reports Third Quarter 2024 Operating and Financial Results
-- Announced FDA Clearance of the Northwestern University IND Application
for NeuroNova (CLD-101) Clinical Trial in High-Grade Glioma.
-- Presented data supporting RTNova (CLD-400), the company's systemic
antitumor virotherapy platform, at the International Oncolytic
Virotherapy Conference (IOVC) in Rotterdam, Netherlands, the Society for
Immunotherapy of Cancer $(SITC)$ Annual Meeting, and at Immuno US 2024 in
San Diego, California.
-- Raised $2 million in a registered direct offering and concurrent private
placement.
SAN DIEGO, Nov. 12, 2024 (GLOBE NEWSWIRE) -- 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 $(IND.AU)$ 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, CEO
RedChip Companies, Inc.
1-407-644-4256
CLDI@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 --
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