# EDGAR Filing Document

**Accession Number:** 0001855485
**File Stem:** 0001641172-25-022791
**Filing Date:** 2025-8
**Character Count:** 17392
**Document Hash:** 80a8e54d5ae5961c0e64f040cc235f1b
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001641172-25-022791.hdr.sgml**: 20250808

**ACCESSION NUMBER**: 0001641172-25-022791

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20250808

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250808

**DATE AS OF CHANGE**: 20250808

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Calidi Biotherapeutics, Inc.
- **CENTRAL INDEX KEY:** 0001855485
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 862967193
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-40789
- **FILM NUMBER:** 251199011

**BUSINESS ADDRESS:**
- **STREET 1:** 4475 EXECUTIVE DRIVE
- **STREET 2:** SUITE 200
- **CITY:** SAN DIEGO
- **STATE:** CA
- **ZIP:** 92121
- **BUSINESS PHONE:** 858-794-9600

**MAIL ADDRESS:**
- **STREET 1:** 4475 EXECUTIVE DRIVE
- **STREET 2:** SUITE 200
- **CITY:** SAN DIEGO
- **STATE:** CA
- **ZIP:** 92121

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** First Light Acquisition Group, Inc.
- **DATE OF NAME CHANGE:** 20210406

?xml version='1.0' encoding='ASCII'?

**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): August 8, 2025**

**CALIDI BIOTHERAPEUTICS, INC.**

**(Exact name of registrant as specified in its charter)**

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| | | |
|:---|:---|:---|
| **Delaware** | **001-40789** | **86-2967193** |
| **(State or other jurisdiction**<br> **of incorporation)** | **(Commission**<br> **File Number)** | **(I.R.S. Employer**<br> **Identification No.)** |

---

---

| | |
|:---|:---|
| **4475 Executive Drive, Suite 200,**<br> **San Diego, California** | **92121** |
| **(Address of principal executive offices)** | **(Zip Code)** |

---

**(858) 794-9600**

**(Registrant's telephone number, including area code)**

**N/A**

**(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** | **Name of Each Exchange on Which Registered** |
| Common stock, par value $0.0001 per share CLDI | 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 2.02** **Results of Operations and Financial Condition.**

On August 8, 2025, Calidi Biotherapeutics, Inc. (the "Company") issued a press release announcing certain financial results for the second quarter ended June 30, 2025, and certain recent corporate developments. A copy of the press release is incorporated herein by reference and is furnished as Exhibit 99.1.

The information under this Item 2.02 is being furnished and shall not be deemed to be "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of such section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the "Securities Act"), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

**Item 7.01** **Regulation FD Disclosure.**

The information under Item 2.02 above is incorporated herein by reference.

By filing this Current Report on Form 8-K and furnishing the information contained herein, the Company makes no admission as to the materiality of any information in this report that is required to be disclosed solely by reason of Regulation FD. The information in this Item 7.01 disclosure, including Exhibit 99.1, is 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 under that Section. In addition, the information in this Item 7.01 disclosure, including Exhibits 99.1, shall not be incorporated by reference into the filings of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

**Item 9.01 Financial Statements and Exhibits.**

(d) Exhibits

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| | |
|:---|:---|
| Exhibit | **Exhibit Description** |
| 99.1 | [Press release dated August 8, 2025](ex99-1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

**SIGNATURES**

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.** | **CALIDI BIOTHERAPEUTICS, INC.** |
| Dated: August 8, 2025 |  |  |
|  | By: | */s/ Andrew Jackson&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;* |
|  | Name: | Andrew Jackson |
|  | Title: | Chief Financial Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![](ex99-1_001.jpg)

**Calidi Biotherapeutics Reports Second Quarter 2025 Financial Results and Recent Operational Highlights**

● *Presented preclinical data at the American Society of Clinical Oncology (ASCO) on CLD-401 demonstrating biological efficacy IL-15 superagonist delivery to metastatic tumor sites and reduced immune clearance through engineered CD55 membrane expression; IND filing expected by the end of 2026* 

● *Received FDA Fast Track Designation for CLD-201, a first-in-class stem-cell loaded intratumoral viral therapy for the treatment of patients with soft tissue sarcoma* 

● *Raised $4.6 million gross proceeds through a warrant inducement offering with existing investors that further strengthens the company's balance sheet and extends its runway* 

 

SAN DIEGO, August 8, 2025 — (Business Wire) — Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi"), a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, today reported its second quarter 2025 operating and financial results and reviewed recent business highlights.

"We are extremely excited about the progress at Calidi," said Eric Poma, PhD, CEO of Calidi Biotherapeutics. "We believe our RedTail platform, with its ability to protect virus from immune clearance and induce tumor lysis and the delivery of potent therapeutic genetic medicines to metastatic sites through systemic administration, will be a substantial breakthrough in the field of oncolytic viruses and tumor-targeted gene therapies. We look forward to leveraging our scientific, operational and capital markets experience to continue building on Calidi's strong platforms."

**Second Quarter 2025 and Recent Corporate Developments**

● Presented new preclinical data surrounding CLD-401, the first lead compound from Calidi's proprietary RedTail platform, at the American Society for Clinical Oncology (ASCO) on May 30<sup>th</sup> in Chicago, IL., demonstrating enhanced biological efficacy in syngeneic tumor models through the delivery of IL15 superagonist to metastatic tumors sites after systemic administration. Calidi also demonstrated the engineered expression of CD55 on the enveloped virus, allowing the virus to avoid immune clearance and enabling systemic administration. The systemic administration of the CD55-expressing enveloped virus allows Calidi to target metastatic disease patients with high unmet need.

● Raised $4.6 million in gross proceeds from a warrant inducement offering with existing investors despite a challenging financing environment for the biotech industry, increasing the total gross proceeds raised in all offerings in 2025 to $15.7 million.

● Granted Fast Track Designation to CLD-201 by the U.S. Food and Drug Administration (FDA) for the treatment of patients with soft tissue sarcoma. CLD-201 is a first-in-class stem cell loaded intratumoral oncolytic viral therapy that has demonstrated significant advantages over current intratumoral oncolytic viral approaches. An IND for a Phase 1 study was successfully opened for CLD-201 in Q1-2025.

**Second Quarter 2025 Financial Results**

The company reported a net loss attributable to common stockholders of $5.7 million, or $1.99 per share, for the three months ended June 30, 2025, compared to a net loss attributable to common stockholders of $7.4 million, or $16.75 per share, for the same period in 2024.

Research and development expenses were $2.6 million for the three months ended June 30, 2025, compared to $2.2 million for the comparable period in 2024.

General and administrative expenses were $3.1 million for the three months ended June 30, 2025, compared to $3.6 million for the comparable period in 2024.

The company had approximately $5.3 million in cash and $0.1 million in restricted cash as of June 30, 2025, compared to $9.6 million in cash and $0.2 million in restricted cash as of December 31, 2024.

**About Calidi Biotherapeutics**

Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage immuno-oncology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease. The company's proprietary Redtail platform features an engineered enveloped oncolytic virus designed for systemic delivery and targeting of metastatic sites. This advanced enveloped technology is intended to shield the virus from immune clearance, allowing virotherapy to effectively reach tumor sites, induce tumor lysis, and deliver potent gene therapies to metastatic locations.

The lead candidate from the Redtail platform, currently in IND-enabling studies, targets non-small cell lung cancer, ovarian cancer, and other tumor types with high unmet medical need. Additionally, Calidi is developing protected virotherapies, in clinical-stage, for intratumoral and localized administration, focusing on a subset of injectable cancer indications.

Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit **<u>www.calidibio.com</u>**.

**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 key milestones, including certain pre-clinical data, 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 annual report filed with the SEC on Form 10-K on March 31, 2025, as may be amended or supplemented by other reports we file with the SEC from time to time.

**Contacts:**

**For Investors and Media:**

Dave Gentry, CEO

RedChip Companies, Inc.

1-407-644-4256

**<u>CLDI@redchip.com</u>**

**CALIDI BIOTHERAPEUTICS, INC.**

**CONDENSED CONSOLIDATED BALANCE SHEETS**

(*In thousands except for par value data*)

---

| | | |
|:---|:---|:---|
|  | **June 30,**<br> **2025** | **December 31,**<br> **2024** |
|  | **(Unaudited)** | |
| **ASSETS** |  |  |
| CURRENT ASSETS |  |  |
| &nbsp;&nbsp;&nbsp;Cash | $5279 | $9591 |
| &nbsp;&nbsp;&nbsp;Prepaid expenses and other current assets | 770 | 636 |
| Total current assets | 6049 | 10227 |
| NONCURRENT ASSETS |  |  |
| &nbsp;&nbsp;&nbsp;Machinery and equipment, net | 929 | 869 |
| &nbsp;&nbsp;&nbsp;Operating lease right-of-use assets, net | 2333 | 2934 |
| &nbsp;&nbsp;&nbsp;Other noncurrent assets | 40 | 152 |
| TOTAL ASSETS | $9351 | $14182 |
| **LIABILITIES AND TOTAL EQUITY** |  |  |
| CURRENT LIABILITIES |  |  |
| &nbsp;&nbsp;&nbsp;Accounts payable | $1215 | $2072 |
| &nbsp;&nbsp;&nbsp;Related party accounts payable | 12 | 2 |
| &nbsp;&nbsp;&nbsp;Accrued expenses and other current liabilities | 1493 | 1858 |
| &nbsp;&nbsp;&nbsp;Related party accrued expenses and other current liabilities | 441 | 480 |
| &nbsp;&nbsp;&nbsp;Term notes payable, net of discount, including accrued interest |  | 251 |
| &nbsp;&nbsp;&nbsp;Related party term notes payable, net of discount, including accrued interest | 775 | 2702 |
| &nbsp;&nbsp;&nbsp;Related party bridge loan payable, including accrued interest |  | 223 |
| &nbsp;&nbsp;&nbsp;Related party other current liability |  | 638 |
| &nbsp;&nbsp;&nbsp;Finance lease liability, current | 113 | 66 |
| &nbsp;&nbsp;&nbsp;Operating lease right-of-use liability, current | 1304 | 1204 |
| Total current liabilities | 5353 | 9496 |
| NONCURRENT LIABILITIES |  |  |
| &nbsp;&nbsp;&nbsp;Operating lease right-of-use liability, noncurrent | 993 | 1845 |
| &nbsp;&nbsp;&nbsp;Finance lease liability, noncurrent | 226 | 145 |
| &nbsp;&nbsp;&nbsp;Promissory note | 600 | 600 |
| &nbsp;&nbsp;&nbsp;Warrant liability | 96 | 119 |
| &nbsp;&nbsp;&nbsp;Related party warrant liability | 7 | 9 |
| TOTAL LIABILITIES | 7275 | 12214 |
| TOTAL EQUITY | 2076 | 1968 |
| TOTAL LIABILITIES AND TOTAL EQUITY | $9351 | $14182 |

---

**CALIDI BIOTHERAPEUTICS, INC.**

**CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS**

*(In thousands, except per share data)*

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| | | |
|:---|:---|:---|
|  | **Three Months Ended June 30,** | **Three Months Ended June 30,** |
|  | **2025** | **2024** |
|  | **(Unaudited)** | **(Unaudited)** |
| **OPERATING EXPENSES** |  |  |
| &nbsp;&nbsp;&nbsp;Research and development | $(2593) | $(2167) |
| &nbsp;&nbsp;&nbsp;General and administrative | (3071) | (3605) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total operating expense | (5664) | (5772) |
| Loss from operations | (5664) | (5772) |
| **OTHER INCOME (EXPENSES), NET** |  |  |
| &nbsp;&nbsp;&nbsp;Interest expense | (29) | (108) |
| &nbsp;&nbsp;&nbsp;Interest expense – related party | (23) | (165) |
| &nbsp;&nbsp;&nbsp;Change in fair value of other liabilities and derivatives | (18) | 86 |
| &nbsp;&nbsp;&nbsp;Change in fair value of other liabilities and derivatives – related party | (1) | 9 |
| &nbsp;&nbsp;&nbsp;Grant income |  | 181 |
| &nbsp;&nbsp;&nbsp;Other expense, net | (22) | 10 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total other income (expenses), net | (93) | 13 |
| **LOSS BEFORE INCOME TAXES** | $(5757) | $(5759) |
| &nbsp;&nbsp;&nbsp;Income tax provision | (4) | (8) |
| **NET LOSS** | $(5761) | $(5767) |
| Net loss attributable to noncontrolling interest | (46) |  |
| **NET LOSS ATTRIBUTABLE TO CONTROLLING INTEREST** | (5715) | (5767) |
| Deemed dividend on warrants |  | (1671) |
| **NET LOSS ATTRIBUTABLE TO COMMON**<br> **STOCKHOLDERS** | (5715) | (7438) |
| **Net loss per share; basic and diluted** | $(1.99) | $(16.75) |
| **Weighted average common shares outstanding; basic and diluted** | 2877 | 444 |

---