News
Calidi Biotherapeutics Reports First Quarter 2024 Operating and Financial Results
Three upcoming posters, including an update on the ongoing Phase 1 trial of Calidi’s CLD-101 program, to be presented at the 2024 ASCO Annual Meeting
Presented new data on the mechanisms of action of Calidi’s new immunotherapies at the AACR Annual Meeting
RTNova systemic platform revealed, enabling ease of administration and ability to target multiple tumor types
Completed public offering of US$6.1 million
SAN DIEGO, May 14, 2024–(BUSINESS WIRE)–Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted virotherapies, today released its first quarter 2024 operating and financial results and reviewed highlights of recent deals.
“Calidi’s current focus is on raising additional capital and implementing ongoing cost-cutting measures in order to advance our promising pipeline of novel immunotherapies designed to successfully target and eliminate solid tumors throughout the body. We plan to present three posters at ASCO , including an update on our ongoing study with City of Hope for recurrent high-grade glioma,” said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics. “In parallel with our clinical progress, Calidi has strengthened our preclinical programs through our powerful R&D engine, unveiled our new 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 study and the initiation of the Phase 1 study with Northwestern University expected in the third quarter of 2024, subject to funding. of additional capital.”
Q1 2024 and recent corporate developments
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Announced upcoming poster presentations at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Posters will include an update on 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.
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Presented new data at the American Association for Cancer Research (AACR) Annual Meeting supporting the pioneering use of CLD-101 and CLD-201 stem cells to protect and enhance antitumor virotherapies. The results of the experiments, conducted in collaboration with City of Hope, provide further details about the unique stem cell-based mode of delivery and the therapeutic potential at the heart of Calidi’s new technology.
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He highlighted the company’s new RTNova systemic platform, a targeted enveloped virotherapy, which has pre-clinically demonstrated the ability to resist inactivation by human serum and the ability to target multiple tumor types. This new therapeutic approach has the potential to be available to a diverse population of patients with different forms of cancer, while remaining cost-effective and easy to administer.
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Closed public offering of 15,197,500 common shares and subscription warrants, with gross proceeds of US$6.1 million.
The story continues
First Quarter 2024 Financial Results
The company reported a net loss of $7.2 million, or 20 cents per share, for the three months ended March 31, 2024, compared to a net loss of $6.5 million, or $0.20 per share. $0.75 per share, in 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 on December 31, 2023.
About Calidi Bioterapeutica
Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage immuno-oncology company with proprietary technology designed to weaponize the immune system to fight cancer. Calidi’s new stem cell-based platforms are utilizing potent allogeneic stem cells capable of carrying oncolytic virus payloads for use in multiple oncology indications, including high-grade gliomas and solid tumors. Calidi’s universal, ready-to-use cell-based delivery platforms are designed to protect, amplify and potentiate oncolytic viruses, leading to greater efficacy and improved patient safety. Calidi’s ready-to-use preclinical 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 of the United States Private Securities Litigation Reform Act of 1995. Terms such as “anticipate”, “believe”, “continue”, “could” , “estimate”, “expect”, “intend”, “may”, “could”, “plan”, “possible”, “potential”, “predict”, “project”, “should”, “toward” , “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 regarding future important milestones (including the reporting of interim clinical results and patient dosing), planned clinical trials, and statements regarding 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 regarding 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 will not be able to raise sufficient capital to support its current and anticipated clinical trials, the risk that early clinical trial results will not necessarily predict the results finals and that one or more clinical outcomes may change materially following a more comprehensive review of the data, and as more patient data becomes available, the risk increases that Calidi will not receive FDA approval for some or all of its therapeutic candidates . Other risks and uncertainties are set forth in the section titled “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 in the Final Prospectus filed on 17 April 2024.
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CALIDI BIOTHERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEET (In thousands, except for nominal value data) (Unaudited) |
||||||||
|
March 31, |
December 31th, |
|||||||
|
ACTIVE |
||||||||
|
CURRENT ASSETS |
||||||||
|
Money |
$ |
1,143 |
$ |
1,949 |
||||
|
Prepaid expenses and other current assets |
793 |
2,354 |
||||||
|
Total current assets |
1,936 |
4,303 |
||||||
|
NON-CURRENT ASSETS |
||||||||
|
Machines and equipment, liquids |
1,165 |
1,270 |
||||||
|
Operating lease right-of-use assets, net |
3,798 |
4,073 |
||||||
|
Other non-current assets |
506 |
373 |
||||||
|
TOTAL ASSETS |
$ |
7,405 |
$ |
10,019 |
||||
|
LIABILITIES AND SHAREHOLDER DEFICIT |
||||||||
|
CURRENT LIABILITIES |
||||||||
|
Bills to pay |
$ |
3,805 |
$ |
2,796 |
||||
|
Accounts payable with related parties |
94 |
81 |
||||||
|
Accumulated expenses and other current liabilities |
4,566 |
4,896 |
||||||
|
Accumulated expenses with related parties and other current liabilities |
536 |
536 |
||||||
|
Term notes payable, net of discount, including accrued interest |
555 |
529 |
||||||
|
Notes payable to related parties, 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 liabilities |
567 |
– |
||||||
|
Finance lease liabilities, current |
74 |
81 |
||||||
|
Operating lease right-of-use liabilities, current |
1,075 |
1,035 |
||||||
|
Total current liabilities |
14,953 |
10,232 |
||||||
|
NON-CURRENT LIABILITIES |
||||||||
|
Operating lease right-of-use liabilities, non-current |
2,756 |
3,037 |
||||||
|
Financial lease liabilities, non-current |
197 |
216 |
||||||
|
Convertible notes payable, including accrued interest |
3,375 |
– |
||||||
|
Warranty liability |
647 |
623 |
||||||
|
Related Party Warranty Liability |
50 |
48 |
||||||
|
Notes payable to related parties, net of discount, including accrued interest |
– |
2,060 |
||||||
|
Other non-current liabilities |
– |
2,038 |
||||||
|
TOTAL RESPONSIBILITIES |
21,978 |
18,254 |
||||||
|
SHAREHOLDER DEFICIT |
(14,573 |
) |
(8,235 |
) |
||||
|
TOTAL LIABILITIES AND SHAREHOLDER DEFICIT |
$ |
7,405 |
$ |
10,019 |
||||
|
CALIDI BIOTHERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except data per share) (Unaudited) |
||||||||
|
Three months ending March 31, |
||||||||
|
2024 |
2023 |
|||||||
|
OPERATIONAL EXPENSES |
||||||||
|
Research and Development |
$ |
(2,743 |
) |
$ |
(2,622 |
) |
||
|
General and administrative |
(4,009 |
) |
(2,792 |
) |
||||
|
Total operating expense |
(6,752 |
) |
(5,414 |
) |
||||
|
Loss of operations |
(6,752 |
) |
(5,414 |
) |
||||
|
OTHER REVENUE (EXPENSES), NET |
||||||||
|
Interest Expenses |
(98 |
) |
(67 |
) |
||||
|
Interest expense – related party |
(155 |
) |
(150 |
) |
||||
|
Interest Expenses |
(157 |
) |
(150 |
) |
||||
|
Change in the fair value of debt, other liabilities and derivatives |
(198 |
) |
(1,026 |
) |
||||
|
Change in the fair value of debts, other liabilities and derivatives – related party |
(1 |
) |
(487 |
) |
||||
|
Change in the fair value of debt, other liabilities and derivatives |
(1 |
) |
(487 |
) |
||||
|
Income granted |
– |
691 |
||||||
|
Other expenses, net |
(17 |
) |
(5 |
) |
||||
|
Total other expenses, net |
(469 |
) |
(1,044 |
) |
||||
|
LOSS BEFORE INCOME TAX |
(7,221 |
) |
(6,458 |
) |
||||
|
Provision for income tax |
(4 |
) |
(4 |
) |
||||
|
NET LOSS |
$ |
(7,225 |
) |
$ |
(6,462 |
) |
||
|
Net loss per share; basic and diluted |
$ |
(0.20 |
) |
$ |
(0.75 |
) |
||
|
Weighted average of common shares outstanding; basic and diluted |
35,552 |
8,655 |
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Contacts
For Investors:
Stephen Jasper
Gilmartin Group
stephen@gilmartinir.com
For media:
Stephen Thesing
ir@calidibio.com