Calidi Biotherapeutics, Inc. (NYSE American: CLDI or “Calidi”), a
clinical-stage biotechnology company developing a new generation of
targeted immunotherapies, today announced the completion of its
business combination with First Light Acquisition Group (FLAG), a
special purpose acquisition company. The common stock and warrants
of Calidi are expected to commence trading on the New York Stock
Exchange American under the ticker symbols “CLDI” and “CLDI WS,”
respectively, on September 13, 2023. The stockholders of FLAG
approved the transaction on August 28, 2023, following approval by
Calidi shareholders. Calidi’s existing management team, including
Chief Executive Officer and Chairman Allan Camaisa, will lead the
combined company.
As a result of this business combination, gross proceeds made
available to Calidi Biotherapeutics, prior to the payment of
transaction expenses and debt repayments, are approximately $28
million, which consists of $25 million in a private capital raise,
cash proceeds of approximately $1 million from FLAG’s trust
account, and approximately $2 million in PIPE and non-redemption
agreements. Estimated transaction expenses and debt repayments
include approximately $13 million and, in addition thereto, a $5
million working capital adjustment for expenses incurred prior to
closing. The Company believes that the proceeds available to the
Company from the transactions will be sufficient to fund its
operations into 2025.
“We founded Calidi in 2014 with a mission to develop a new
generation of targeted immunotherapies that could revolutionize the
treatment of cancer,” said Allan Camaisa, CEO and Chairman of the
Board of Calidi Biotherapeutics. “Our team has worked diligently to
build on decades of research with human stem cells and develop two
novel off-the-shelf platforms designed to directly target and
attack tumor cells throughout the body, and we are proud of our
promising clinical results to-date. Calidi’s cutting-edge platforms
NeuroNova, targeting high-grade gliomas, and SuperNova, targeting
solid tumors, use allogeneic stem cells in our clinical efforts to
bring a universal cancer treatment to a broad patient population
who need access to new treatment options. We look forward to
pushing the boundaries of cell-based virotherapies and continuing
to research novel ways to eradicate cancer in this next step as a
public company.”
“We are proud of this collaboration with Calidi and the
successful outcome of our combination, driven in part by confidence
among our initial FLAG shareholders, who have made additional
financial commitments to further support the company going
forward,” said Tom Vecchiolla, Chief Executive Officer of First
Light Acquisition Group. “We are excited to see Calidi continue to
grow as they transition into a public company and look forward to
their clinical pursuit of new treatment options for patients
everywhere in need.”
Calidi is developing in the clinic first-in-class allogenic stem
cell-based delivery platforms designed to deliver a new generation
of targeted immunotherapies for the treatment of cancer. These
platforms include:
- CLD-101
(NeuroNova): allogeneic neural stem cells loaded with an
oncolytic adenovirus for the treatment of high-grade gliomas (HGG).
In June 2023, the first brain tumor patient was treated at City of
Hope in a multicenter, Phase 1 clinical trial evaluating CLD-101
for the treatment of HGG. The trial is assessing the safety and
tolerability of administering serial doses of CLD-101 in adult
patients with recurrent histologically confirmed HGG (WHO grade III
or IV). Secondary endpoints will evaluate treatment efficacy,
including progression-free and overall survival as well as any
immune response. Interim clinical results are expected in the first
half of 2024. A previously completed open-label, Phase 1,
dose-escalation clinical trial in patients with newly diagnosed
high-grade gliomas demonstrated that CLD-101 was well tolerated and
showed promising preliminary clinical results of efficacy (Study
published in the peer-reviewed journal, The Lancet Oncology,
2021).
- CLD-201
(SuperNova): allogeneic adipose-derived mesenchymal stem
cells (AD-MSC) loaded with tumor-selective CAL1 oncolytic vaccinia
virus for the treatment of advanced metastatic solid tumors. A
previously conducted physician-sponsored clinical trial using
autologous adipose-derived stromal cells demonstrated that the
therapeutic approach was well tolerated and showed early signs of
efficacy in 24 patients with advanced solid tumors and two patients
with acute myeloid leukemia (AML). (Study published in the
peer-reviewed journal: Journal of Translational Medicine, 2019). In
December 2022, Calidi was awarded $3.1 million from the California
Institute for Regenerative Medicine (CIRM) to support the clinical
development of the allogeneic off-the-shelf product CLD-201 through
an Investigational New Drug (IND) application (Allogeneic platform
published in the peer-reviewed journal: Cancers, 2022). Calidi has
conducted the pre-IND meeting with the FDA and expects cGMP final
drug product manufacturing to be completed in the first quarter of
2024. In the second half of 2024, Calidi anticipates initiating a
Phase 1/2 study evaluating CLD-201 in patients with advanced
metastatic solid tumors, including triple-negative breast cancer,
unresectable melanoma, and squamous cell head and neck
carcinoma.
- Proceeds from the business
combination are also expected to support the expansion of Calidi’s
stem cell-based delivery platforms into additional
indications.
Transaction Summary
Calidi Biotherapeutics, a private biotechnology company, and
First Light Acquisition Group, a special purpose acquisition
company, entered into a definitive business combination agreement
on January 9, 2023.
As a result of this business combination, gross proceeds made
available to Calidi Biotherapeutics, prior to the payment of
transaction expenses and debt repayments, are approximately $28
million, which consists of $25 million in a private capital raise,
cash proceeds of approximately $1 million from FLAG’s trust
account, and approximately $2 million in PIPE and non-redemption
agreements. Estimated transaction expenses and debt repayments
include approximately $13 million and, in addition thereto, a $5
million working capital adjustment for expenses incurred prior to
closing. In addition, Calidi has entered into a forward purchase
agreement with a consortium including Meteora Capital LLC, Great
Point Capital LLC, and Funicular Funds, LP for up to $10 million,
and Calidi intends to enter into a purchase agreement for up to $50
million with Lincoln Park Capital Fund, LLC, subject to an
effective registration statement to be filed with the Securities
and Exchange Commission. Both of these opportunities have the
potential to add cash to the balance sheet in the future. The
Company believes that the proceeds available to the Company from
the transactions will be sufficient to fund its operations into
2025.
The description of the business combination contained herein is
only a high-level summary and is qualified in its entirety by
reference to the underlying documents filed with the U.S.
Securities and Exchange Commission. A more detailed description of
the terms of the transaction has been provided in a registration
statement on Form S-4 filed with the U.S. Securities and Exchange
Commission by First Light Acquisition Group.
Advisors
Brookline Capital Markets, a Division of Arcadia Securities,
LLC, acted as placement agent for the private capital raise, a
Calidi Series B Preferred Stock Financing, and as an advisor to
First Light Acquisition Group, Inc. Lewis Brisbois Bisgaard &
Smith LLP acted as legal counsel to Calidi. Weil, Gotshal &
Manges LLP acted as legal counsel to FLAG.
About Calidi Biotherapeutics:
Calidi Biotherapeutics (NYSE: CLDI) is a clinical-stage
immuno-oncology company with proprietary technology designed to arm
the immune system to fight cancer with a novel stem cell-based
therapy delivering a payload to target and kill tumor cells. Calidi
Biotherapeutics is advancing a potent allogeneic stem cell capable
of carrying an anti-tumor payload for use in multiple oncology
indications, including high-grade gliomas and solid tumors.
Calidi’s 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. 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 contains 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. The forward-looking statements contained in this
discussion are based on Calidi’s current expectations and beliefs
concerning future developments and their potential
effects. These statements include, but are not limited
to, statements concerning the adequacy of the proceeds of the
Business Combination to fund Calidi’s operations into 2025,
statements concerning the time period during which Calidi expects
to release interim data on its clinical trials, and statements
concerning the safety and efficacy of Calidi’s product candidates
currently in the clinic, statements related to the expected
availability of capital to fund anticipated clinical trials,
statements related to advancing CLD-101, CLD-201 or another product
candidate through the regulatory approval process, and any
statements related to ongoing clinical trials for CLD-101 or
CLD-201. There can be no assurance that future developments
affecting Calidi will be those that it has anticipated. These
forward-looking statements involve a number of risks, uncertainties
(some of which are beyond Calidi’s control) or other assumptions
that may cause actual results or performance to be materially
different from those expressed or implied by these forward-looking
statements. Factors that may cause actual results to differ
materially from current expectations include, but are not limited
to: the risk that the Company is not able to raise sufficient
capital to support its current and anticipated clinical
trials, the risk that results of a clinical study do not
necessarily predict final results and that one or more of the
clinical outcomes may materially change following more
comprehensive reviews of the data, and as more patient data become
available, the risk that results of a clinical study are subject to
interpretation and additional analyses may be needed and/or may
contradict such results, the risk that the results of previously
conducted studies will not be repeated or observed in ongoing or
future studies involving our product candidates, and the risk that
the current COVID-19 pandemic will impact the Company’s current and
future clinical trials and the timing of the Company’s preclinical
studies and other operations the risk or our inability to meet
stock exchange listing standards in the future; ; changes in
applicable laws or regulations, the evolution of the markets in
which Calidi competes, the inability of Calidi to defend its
intellectual property and satisfy regulatory requirements, the risk
of downturns and a changing regulatory landscape in the highly
competitive pharmaceutical industry, the impact of potential global
conflicts (including the current conflict in Ukraine) may have on
capital markets or on Calidi’s business, and other risks and
uncertainties set forth in the section entitled “Risk Factors” and
“Cautionary Note Regarding Forward-Looking Statements” in the
definitive proxy statement/prospectus dated August 4, 2023
delivered to FLAG’s shareholders and other documents filed or to be
filed with the SEC.
For Investors:
Stephen JasperGilmartin Groupstephen@gilmartinir.com
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