8-K

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

EX-99.1

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 8^th 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

XML

Cover	Jan. 05, 2024
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 05, 2024
Entity File Number	001-40789
Entity Registrant Name	Calidi Biotherapeutics, Inc.
Entity Central Index Key	0001855485
Entity Tax Identification Number	86-2967193
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	4475 Executive Dr.
Entity Address, Address Line Two	Suite 200
Entity Address, City or Town	San Diego
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92121
City Area Code	(858)
Local Phone Number	794-9600
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false
Common stock, par value $0.0001 per share
Title of 12(b) Security	Common stock, par value $0.0001 per share
Trading Symbol	CLDI
Security Exchange Name	NYSEAMER
Redeemable warrants, each whole warrant exercisable for one share of common stock at an exercise price of $11.50 per share
Title of 12(b) Security	Redeemable warrants, each whole warrant exercisable for one share of common stock at an exercise price of $11.50 per share
Trading Symbol	CLDIWS
Security Exchange Name	NYSEAMER