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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): January 5, 2024
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 Dr., Suite 200,
San
Diego, CA |
|
92121 |
(Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (858) 794-9600
Not
Applicable
(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 |
|
Name
of each exchange on which registered |
|
|
|
|
|
Common
stock, par value $0.0001 per share |
|
CLDI |
|
NYSE
American LLC |
|
|
|
|
|
Redeemable
warrants, each whole warrant exercisable for one share of common stock at an exercise price of $11.50 per share |
|
CLDIWS |
|
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
7.01 Regulation FD Disclosure.
Calidi
Biotherapeutics, Inc. (the “Company”) intends to issue a letter to its stockholders from the Company’s Chairman and
Chief Executive Officer Allan J. Camaisa, regarding the Company’s recent milestones, clinical progress, and future plans. A copy
of the letter to stockholders is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The
information reported under Item 7.01 in this Current Report on Form 8-K, and Exhibit 99.1 attached hereto are 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 of that section, nor shall it be deemed incorporated by reference in any filing under the Securities
Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing. This Current Report on
Form 8-K will not be deemed an admission as to the materiality of any information contained herein.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
Exhibit
No. |
|
Description |
|
|
|
99.1 |
|
Letter to Stockholders |
104 |
|
Cover
Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
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:
January 8, 2024 |
|
|
|
By: |
/s/
Andrew Jackson |
|
Name: |
Andrew
Jackson |
|
Title: |
Chief
Financial Officer |
Exhibit
99.1
January
5, 2024
Dear
Calidi Biotherapeutics Shareholder,
As
we enter the new year, I want to extend my thanks for your commitment to Calidi Biotherapeutics, and our vision of bringing to market
a next-generation Stem-Cell Based Oncolytic Virus (OV) Platform to defeat Cancer. In the dynamic world of biopharma innovation, 2023
was an extraordinary year for Calidi, marked by significant corporate milestones, and promising clinical and scientific achievements.
The
first half of the year set the stage for the debut of Calidi as a publicly traded company in September. The company also made a key addition
to its leadership team with the appointment of Andrew Jackson as Chief Financial Officer. Mr. Jackson’s extensive experience in
business strategy, SEC compliance, and capital markets positions Calidi for continued financial success.
Alongside
these corporate milestones, Calidi made significant strides in its clinical programs. Drs. Santidrian, Minev, and Jana Portnow, a medical
oncologist at the City of Hope, presented groundbreaking data in December at the 8th Oncolytic Virotherapy Summit in Boston.
Their presentations shared details about the NeuroNova clinical trial design, and safety highlights following the initial dosing of six
patients enrolled in the ongoing clinical trial at City of Hope.
I
remain as optimistic as ever in the future of Calidi, despite the recent biotech sector downturn, and its associated impact to our stock
price on the NYSE American Exchange. My personal optimism is also supported unanimously by Calidi’s analyst coverage. Currently,
we have been classified as “Outperform” by RW Baird, and as a “Buy” from HC Wainwright, with respective price
targets of $9 and $11.
With
comparables in the OV space such as Replimune and Genelux, currently at market caps $500M+ and $368M, and both utilizing a first-generation
standalone/naked Oncolytic Virus product, we see an enormous opportunity for future growth, given the brilliant work that our team is
doing in developing Calidi’s unique, off-the-shelf cell-based delivery platform. As a reminder, this platform is designed to load
the oncolytic viruses into allogeneic stem cells, which we believe will result in the protection and amplification of these viruses until
they reach the target with the potential to significantly enhance their efficacy in clinical settings. Our platform technology is now
being evaluated by Federal agencies, and the state of California for possible research grants. As such, Calidi has tremendous momentum
and unrealized potential ahead of us.
Looking
ahead to 2024, Calidi is thrilled to welcome biopharma verteran, David LaPre to our Board of Directors, effective January 1. We are slated
to formally announce interim results for our NeuroNova (CLD-101/NNV2) clinical trial at the upcoming ASCO conference in June of 2024,
while anticipating first-patient dosing for the SuperNova (CLD-201) clinical trial in the summer of 2024.
My
sincere thanks for your continued support in 2024!
Sincerely,
Allan
J. Camaisa
Chairman
and CEO
This
letter 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,”
“positions,” “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,
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 letter 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 Form S-4 filed on August 2, 2023, on Form S-1 filed on October 6, 2023 and Form 10-Q filed on November
14, 2023.
Calidi
Biotherapeutics, Inc. 4475 Executive Drive, Suite 200, San Diego, CA 92121
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First Light Acquisition (AMEX:FLAG)
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De Sept 2024 à Oct 2024
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