Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a
clinical-stage biotechnology company developing a new generation of
targeted antitumor virotherapies, today announced that its ending
cash balance at December 31, 2024 was approximately $9.6 million.
Due to Calidi’s bolstered cash balance and success in recent
fundraising, including proceeds resulting from its At-The-Market
Offering Agreement (“ATM”), Calidi terminated its Standby Equity
Purchase Agreement (“SEPA”) with YA II PN, Ltd., an affiliate of
Yorkville Advisors, effective January 23, 2025.
In connection with the SEPA executed in December 2023 and
amended in January 2024, Calidi was granted the option to sell up
to $25 million of common stock over a three-year period, subject to
certain trading volume and beneficial ownership provisions. The
shares underlying the SEPA have not been registered and Calidi did
not exercise any option to sell such shares.
In the fourth quarter of 2024, Calidi secured $9.5 million in
gross proceeds, before deducting expenses, through two public
offerings, supplemented by $2.0 million from warrant exercises and
$3.1 million from its ATM facility. In January 2025, Calidi
announced another public offering that raised an additional $4.25
million in gross proceeds, before deducting expenses. These public
offerings have bolstered Calidi’s cash position, and together with
the availability of the ATM facility, positioned it to meet its
capital needs without relying on the SEPA framework.
“Our decision to terminate the SEPA marks an important milestone
in our financing strategy,” said Allan Camaisa, CEO and Chairman of
the Board of Calidi Biotherapeutics. “With the successful
completion of recent financing activities, we are well-positioned
to focus on our clinical and operational goals and remove a
potential overhang in our stock. This move aligns with our
dedication to enhancing shareholder value while building our
leadership in both targeted systemic and localized antitumor
virotherapies.”
Calidi continues to make strides in the development of its
innovative virotherapy platforms, with recent milestones including
its systemic platform (RTNova enveloped virotherapies) abstract
being accepted for presentation at the American Association for
Cancer Research (AACR) Annual Meeting in April 2025 and IND
clearance by FDA for a Northwestern University-led Phase 1b/2 trial
of CLD-101 for high-grade gliomas with plans to start enrollment in
the first quarter 2025.
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.
Preliminary, Unaudited Financial
Disclosures
The data presented above is preliminary and unaudited, based
upon our estimates, and subject to further internal review by
management and compilation of actual results. Our closing
procedures for the fourth quarter and year ended December 31, 2024
are not yet complete. Our management’s estimates are based upon
preliminary information currently available from our business.
While we expect that our results will be consistent with these
preliminary and unaudited estimates, our actual results may differ
materially from these preliminary estimates.
This preliminary financial information is not a comprehensive
statement of our financial results for this period. Our actual
results may differ materially from these estimates due to the
completion of our financial closing procedures, final adjustments,
and other developments that may arise between now and the time the
closing procedures for the quarter are completed.
This preliminary financial information should not be viewed as a
substitute for our full interim or annual financial statements
prepared in accordance with U.S. generally accepted accounting
principles. Accordingly, you should not place undue reliance on
this preliminary financial information. The preliminary financial
information has been prepared by, and is the responsibility of, our
management. Marcum LLP, our independent registered public
accounting firm, has not audited, reviewed, compiled or performed
any procedures with respect to the accompanying preliminary
financial data. Accordingly, Marcum LLP does not express an opinion
or any other form of assurance with respect thereto.
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, (iii) Form 10-Q filed on August 13, 2024, and (iv)
Form 10-Q filed on November 12, 2024. These reports may be amended
or supplemented by other reports we file with the SEC from time to
time.
Corporate Communications:
Dave Gentry, CEORedChip Companies,
Inc.1-407-644-4256CLDI@redchip.com
Source: Calidi Biotherapeutics, Inc.
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