Calidi Biotherapeutics Reports First Quarter 2024 Operating and Financial Results
Calidi Biotherapeutics (NYSE American: CLDI), a clinical-stage biotech firm, reported its Q1 2024 financial results and business developments. Key highlights include three upcoming posters at the 2024 ASCO Annual Meeting, featuring an update from the ongoing Phase 1 trial of CLD-101 for recurrent high-grade glioma.
Calidi also presented new data on its immunotherapies at the AACR Annual Meeting and unveiled the RTNova systemic delivery platform targeting multiple tumor types. The company completed a $6.1 million public offering, strengthening its balance sheet amid ongoing capital-raising efforts and cost-cutting measures to advance its pipeline.
Financially, Calidi reported a net loss of $7.2 million ($0.20 per share) for Q1 2024, a slight increase from $6.5 million ($0.75 per share) in Q1 2023. R&D expenses increased marginally to $2.7 million, while G&A expenses grew to $4.0 million from $2.8 million. The company ended Q1 2024 with $1.2 million in cash and $0.2 million in restricted cash.
- Completion of a $6.1 million public offering to strengthen the balance sheet.
- Upcoming poster presentations at the 2024 ASCO Annual Meeting, including updates on Phase 1 trial for CLD-101.
- New data presented at AACR Annual Meeting supporting the first-in-class use of stem cells in antitumor virotherapies.
- Unveiling of RTNova systemic platform for targeting multiple tumor types, demonstrating preclinical resilience and diverse applicability.
- Net loss increased to $7.2 million in Q1 2024 from $6.5 million in Q1 2023.
- R&D expenses increased slightly to $2.7 million, indicating rising costs.
- G&A expenses rose significantly to $4.0 million from $2.8 million, contributing to higher operational costs.
- Cash reserves decreased to $1.2 million by the end of Q1 2024 from $1.9 million at the end of 2023, highlighting potential liquidity concerns.
Insights
From a financial perspective, Calidi Biotherapeutics Inc.'s latest results reveal a mixed outlook. The company's net loss increased to
However, the successful capital raise of
For retail investors, the key takeaway is that while Calidi is making progress on its R&D and clinical fronts, the financial health remains under pressure. The balance between raising new funds and managing operational expenses will be critical in the short term.
Calidi Biotherapeutics’ advancements in their novel immunotherapies, particularly the RTNova systemic platform, are noteworthy. The platform’s capacity to resist inactivation by human serum and target multiple types of tumors marks a significant step forward in the field of virotherapies. This could potentially expand the range of cancers that can be treated, offering a broader patient population access to effective therapies.
Moreover, the upcoming data presentations at prestigious conferences like ASCO and AACR indicate robust ongoing research and development efforts. The Phase 1 trial updates and preclinical data will be critical in validating the therapeutic potential of their pipeline, which includes innovative stem cell-based delivery mechanisms.
These scientific and clinical strides are promising; however, they are still in early stages. Investors should be prepared for the inherent uncertainties and potential delays typical in clinical trials.
In terms of market positioning, Calidi Biotherapeutics is leveraging its novel technologies to carve out a niche in the immunotherapy space. The emphasis on systemic delivery platforms that target diverse tumor types could differentiate Calidi from other players in the oncology market. This innovation, if clinically validated, can open vast commercial opportunities.
However, the company’s current focus on raising additional capital and implementing cost-cutting measures signals financial stress, which might affect investor confidence. The successful capital raise of
For investors, it’s important to monitor upcoming clinical data releases and how effectively the company manages its capital and operational strategies. Long-term potential hinges on these factors.
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
“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
Research and development expenses were
General and administrative expenses were
The company had approximately
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
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) |
||||||||
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|
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|
|
March 31,
|
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December 31,
|
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|
|
|
|
|
||||
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) |
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Three Months Ended March 31, |
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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
Source: Calidi Biotherapeutics, Inc.
FAQ
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