CLDI Calidi Biotherapeutics Inc

Three upcoming posters, including an update from ongoing Phase 1 trial of Calidi’s CLD-101 program, to be presented at 2024 ASCO Annual Meeting

Presented new data on the mechanisms of action of Calidi’s novel immunotherapies at the AACR Annual Meeting

Unveiled RTNova systemic platform allowing for ease of administration and ability to target multiple tumor types

Completed $6.1 million public offering

Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted virotherapies, today reported its first quarter 2024 operating and financial results and reviewed recent business highlights.

“Calidi’s current focus is on raising additional capital and implementing continued cost cutting measures in order to advance our promising pipeline of novel immunotherapies designed to successfully target and eliminate solid tumors across the body. We plan to present three posters at ASCO including an update from our ongoing trial with City of Hope for recurrent high-grade glioma,” said Allan Camaisa, CEO and Chairman of the Board at Calidi Biotherapeutics. “In parallel to our clinical progress, Calidi has strengthened our preclinical programs through our powerful R&D engine, unveiled our novel systemic delivery platform to target diverse tumor types, and executed a capital raise to strengthen our balance sheet. We believe these efforts will help propel the company through important milestones including an interim clinical update from our ongoing Phase 1 trial and the initiation of the Phase 1 trial with Northwestern University anticipated in the third quarter of 2024, subject to additional capital being raised.”

First Quarter 2024 and Recent Corporate Developments

• Announced upcoming poster presentations at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The posters will include an update from the Phase 1 trial in collaboration with City of Hope for CLD-101 in recurrent high-grade glioma. Additional posters will focus on preclinical data from the company’s RTNova (CLD-400) and CLD-201 platforms.
• Presented new data at the American Association for Cancer Research Annual Meeting (AACR) supporting CLD-101 and CLD-201’s first-in-class use of stem cells to protect and potentiate antitumor virotherapies. The results of experiments, conducted in collaboration with City of Hope, provide further detail around the unique stem cell-based mode of delivery and the therapeutic potential at the core of Calidi’s novel technology.
• Highlighted the company’s novel RTNova systemic platform, a targeted enveloped virotherapy, that has demonstrated preclinically the ability to resist inactivation by human serum and an ability to target diverse tumor types. This novel therapeutic approach has the potential to be available to a diverse patient population with different forms of cancer while remaining cost-effective and easy to administer.
• Closed public offering of 15,197,500 shares of common stock and accompanying warrants, with gross proceeds of $6.1 million.

First Quarter 2024 Financial Results

The company reported a net loss of $7.2 million, or $0.20 per share, for the three months ended March 31, 2024, compared to a net loss of $6.5 million, or $0.75 per share, for the same period in 2023.

Research and development expenses were $2.7 million for the three months ended March 31, 2024, compared to $2.6 million for the comparable period in 2023, respectively.

General and administrative expenses were $4.0 million for the three months ended March 31, 2024, compared to $2.8 million for the comparable period in 2023, respectively.

The company had approximately $1.2 million in cash and $0.2 million in restricted cash as of March 31, 2024, compared to $1.9 million in cash and $0.2 million in restricted cash as of December 31, 2023.

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 .

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 Form S-4 filed on August 2, 2023, on Form S-1 filed on October 6, 2023, on Form S-1 filed on January 29, 2024, as amended on February 7, 2024, on Form 10-K filed on March 15, 2024, and Final Prospectus filed on April 17, 2024.

CALIDI BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except for par value data)

(Unaudited)

 

 

 

 

 

March 31, 2024

 

December 31, 2023

 

 

 

 

 

ASSETS

 

 

 

 

 

 

CURRENT ASSETS

 

 

 

 

 

 

Cash

 

$

1,143

 

 

$

1,949

 

Prepaid expenses and other current assets

 

 

793

 

 

 

2,354

 

Total current assets

 

 

1,936

 

 

 

4,303

 

NONCURRENT ASSETS

 

 

 

 

 

 

Machinery and equipment, net

 

 

1,165

 

 

 

1,270

 

Operating lease right-of-use assets, net

 

 

3,798

 

 

 

4,073

 

Other noncurrent assets

 

 

506

 

 

 

373

 

TOTAL ASSETS

 

$

7,405

 

 

$

10,019

 

LIABILITIES AND STOCKHOLDERS’ DEFICIT

 

 

 

 

 

 

CURRENT LIABILITIES

 

 

 

 

 

 

Accounts payable

 

$

3,805

 

 

$

2,796

 

Related party accounts payable

 

 

94

 

 

 

81

 

Accrued expenses and other current liabilities

 

 

4,566

 

 

 

4,896

 

Related party accrued expenses and other current liabilities

 

 

536

 

 

 

536

 

Term notes payable, net of discount, including accrued interest

 

 

555

 

 

 

529

 

Related party term notes payable, net of discount, including accrued interest

 

 

2,455

 

 

 

278

 

Convertible notes payable, including accrued interest

 

 

1,021

 

 

 

—

 

Related party bridge loan payable, including accrued interest

 

 

205

 

 

 

—

 

Related party other current liability

 

 

567

 

 

 

—

 

Finance lease liability, current

 

 

74

 

 

 

81

 

Operating lease right-of-use liability, current

 

 

1,075

 

 

 

1,035

 

Total current liabilities

 

 

14,953

 

 

 

10,232

 

NONCURRENT LIABILITIES

 

 

 

 

 

 

Operating lease right-of-use liability, noncurrent

 

 

2,756

 

 

 

3,037

 

Finance lease liability, noncurrent

 

 

197

 

 

 

216

 

Convertible notes payable, including accrued interest

 

 

3,375

 

 

 

—

 

Warrant liability

 

 

647

 

 

 

623

 

Related party warrant liability

 

 

50

 

 

 

48

 

Related party term notes payable, net of discount, including accrued interest

 

 

—

 

 

 

2,060

 

Other noncurrent liabilities

 

 

—

 

 

 

2,038

 

TOTAL LIABILITIES

 

 

21,978

 

 

 

18,254

 

STOCKHOLDERS’ DEFICIT

 

(14,573

)

 

 

(8,235

)

TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT

$

7,405

 

 

$

10,019

 

CALIDI BIOTHERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share data)

(Unaudited)

 

 

 

 

 

Three Months Ended March 31,

 

 

2024

 

2023

OPERATING EXPENSES

 

 

 

 

 

 

Research and development

 

$

(2,743

)

 

$

(2,622

)

General and administrative

 

 

(4,009

)

 

 

(2,792

)

Total operating expense

 

 

(6,752

)

 

 

(5,414

)

Loss from operations

 

 

(6,752

)

 

 

(5,414

)

OTHER INCOME (EXPENSES), NET

 

 

 

 

 

 

Interest expense

 

 

(98

)

 

 

(67

)

Interest expense – related party

 

 

(155

)

 

 

(150

)

Interest expense

 

 

(157

)

 

 

(150

)

Change in fair value of debt, other liabilities, and derivatives

 

 

(198

)

 

 

(1,026

)

Change in fair value of debt, other liabilities, and derivatives – related party

 

 

(1

)

 

 

(487

)

Change in fair value of debt, other liabilities, and derivatives

 

 

(1

)

 

 

(487

)

Grant income

 

 

—

 

 

 

691

 

Other expense, net

 

 

(17

)

 

 

(5

)

Total other expenses, net

 

 

(469

)

 

 

(1,044

)

LOSS BEFORE INCOME TAXES

 

 

(7,221

)

 

 

(6,458

)

Income tax provision

 

 

(4

)

 

 

(4

)

NET LOSS

 

$

(7,225

)

 

$

(6,462

)

Net loss per share; basic and diluted

 

$

(0.20

)

 

$

(0.75

)

Weighted average common shares outstanding; basic and diluted

 

 

35,552

 

 

 

8,655

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20240514985028/en/

For Investors: Stephen Jasper Gilmartin Group stephen@gilmartinir.com

For Media: Stephen Thesing ir@calidibio.com