Calidi Biotherapeutics Reports Fourth Quarter and Full-Year 2023 Operating and Financial Results
- Calidi Biotherapeutics Inc. awarded $5.3 million grant from CIRM for developing ovarian cancer treatment with NeuroNova
- Introduction of RTNova platform targeting diverse tumors to advance cancer treatment
- Appointment of new members to Scientific and Medical Advisory Board and Board of Directors
- Issuance of new U.S. patent covering SuperNova technology platform for enhanced treatment
- Anticipated milestones include clinical updates and patient dosing for various trials in 2024
- Increased net loss reported for Q4 2023 and full-year 2023 compared to the previous year
- Significant rise in research and development expenses in 2023
- General and administrative expenses also increased in 2023
- cash reserves as of December 31, 2023, compared to the previous year
Insights
The recent funding received by Calidi Biotherapeutics from the California Institute for Regenerative Medicine (CIRM) signals a strong vote of confidence in the company's technology, particularly in the field of oncolytic virotherapy. This niche area of cancer treatment has been gaining traction and Calidi's focus on developing treatments for metastatic ovarian cancer and high-grade glioma positions it within a significant market segment with unmet medical needs. The $5.3 million award earmarked for preclinical and clinical trial design advances is a critical step in bringing these innovative therapies closer to market.
Calidi's reported net loss for the fourth quarter and full-year 2023, while not uncommon for clinical-stage biotech companies, does raise questions about the company's runway and its ability to sustain operations without additional capital infusion. The increased R&D expenses reflect the company's investment in its pipeline but also put pressure on its financial resources. Investors should monitor the company's capital-raising efforts and the outcomes of its upcoming clinical trials to assess the potential for future value creation.
The issuance of a new U.S. patent covering the SuperNova technology platform suggests a strategic emphasis on building a robust intellectual property portfolio, which is vital for competitive advantage in the biotech industry. However, the practical implications of this patent for revenue generation remain to be seen, as the clinical trial for the platform is not expected to commence until the second half of 2024.
Calidi Biotherapeutics' financial results for the fourth quarter and the full year of 2023 indicate a significant increase in both R&D and G&A expenses, which is reflective of the company's growth phase and strategic investments in its product pipeline. However, the net loss widening year-over-year, coupled with a relatively modest cash position, suggests the need for careful financial management and possibly additional capital raises in the near future.
The increase in share count, as implied by the lower loss per share despite a higher net loss, may suggest that the company has been issuing more shares to raise funds, which can lead to dilution for existing shareholders. The cash reserves, while improved from the previous year, still indicate a limited runway, necessitating a close watch on the company's burn rate and funding strategies.
Investors should consider the risks associated with the biotechnology sector, where long development timelines and regulatory hurdles can impact the stock's performance. The anticipation of clinical trial updates can drive volatility in the stock price and positive results could provide catalysts for value appreciation. Conversely, any setbacks in the trials could have a detrimental effect on investor sentiment.
The strategic collaboration with City of Hope and the investment from CIRM in Calidi Biotherapeutics underscores the potential of oncolytic virotherapy as a promising avenue in cancer treatment. The focus on metastatic ovarian cancer and high-grade glioma, both of which are cancers with high mortality rates and limited effective treatments, suggests that Calidi is targeting areas of significant unmet medical need, which could translate to substantial clinical impact if their therapies prove to be effective.
The development of the RTNova systemic delivery approach reflects an innovative step in making oncolytic virotherapy more accessible and potentially more effective for patients with advanced solid tumors. The ability to shield the viral payload from the immune system is a key challenge in this field and Calidi's preclinical success with the SuperNova platform could represent a major advancement, though the true test will come with clinical trial results.
Given the complexity of oncolytic virotherapy, the upcoming interim clinical updates will be important in evaluating the efficacy and safety profile of Calidi's treatments. The long-term impact on the oncology treatment landscape will depend on these clinical outcomes, as well as the company's ability to navigate the regulatory pathway and eventually bring these treatments to market.
-
City of Hope, a leader in cancer research and treatment, was awarded
$5.3 million - Announced novel systemic enveloped oncolytic virotherapy platform, RTNova, designed to target diverse tumor types
- Strengthened team with the appointment of three new members to Scientific and Medical Advisory Board and one member to Board of Directors
-
Issued new
U.S. patent covering novel SuperNova (CLD-201) technology platform
“Calidi continues to make great progress across our development programs while continuing to innovate and expand our industry-leading position in cell-based immunotherapies,” said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics. “We anticipate reporting an interim clinical update from our Phase 1 trial evaluating CLD-101 in high-grade glioma patients in collaboration with City of Hope in the second quarter of this year assuming we are successful in raising additional capital, and we were thrilled to recently strengthen our collaboration with City of Hope to evaluate CLD-101 for the treatment of ovarian cancer with the support of CIRM. In addition, we were proud to recently unveil our potentially paradigm-shifting advance in the treatment of advanced solid tumors, including lung cancer and metastatic disease, that required a systemic application, through our RTNova systemic delivery approach.”
Fourth Quarter 2023 and Recent Corporate Developments
-
City of Hope, a leader in cancer research and treatment, was awarded
$5.3 million - Publicly announced novel systemic enveloped oncolytic virotherapy program, RTNova (CLD-400), targeting advanced solid tumors, including advanced metastatic disease. The new program builds upon Calidi’s experience using stem cells to protect oncolytic viruses from inactivation by the patient’s immune system allowing for easier administration, increased cost-effectiveness, and the ability to reach a broad patient population.
- Appointed Antonio Chiocca, M.D., Ph.D., David T. Curiel, M.D., Ph.D., and Burt L. Nabors, M.D., to the company’s Scientific and Medical Advisory Board. These physician scientists bring a deep expertise in oncology, hailing from top cancer research institutions and facilities.
- Announced the appointment of David LaPré to the company’s Board of Directors. Mr. LaPré brings significant experience in technical operations strategy and execution in the pharmaceutical industry.
- Received patent covering novel SuperNova technology platform (CLD-201) composed of adipose-derived mesenchymal stem cells loaded with oncolytic vaccinia virus. This patent strengthens the company’s robust intellectual property portfolio as Calidi plans to initiate a clinical trial in the second half of 2024. Calidi has shown preclinically the potential of SuperNova to shield the viral payload from the immune system allowing for its delivery to tumor sites.
Upcoming Anticipated Milestones
- 1H 2024: Interim clinical update from CLD-101 Phase 1 trial in collaboration with City of Hope for recurrent high-grade glioma patients
- 1H 2024: First patient dosed in CLD-101 Phase 1 trial in collaboration with Northwestern University for newly diagnosed high-grade glioma patients
- 2H 2024: First patient dosed in CLD-201 Phase 1 trial
Fourth Quarter 2023 Financial Results
The company reported a net loss of
Research and development expenses were
General and administrative expenses were
Full Year 2023 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, and on Form 10-K filed on March 15, 2024.
CALIDI BIOTHERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except for par value data) (Unaudited) |
||||||||
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|
|
|
|||||
|
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December 31, |
||||||
|
|
2023 |
|
2022 |
||||
|
|
|
|
|
||||
ASSETS |
|
|
|
|
|
|
||
CURRENT ASSETS |
|
|
|
|
|
|
||
Cash |
|
$ |
1,949 |
|
|
$ |
372 |
|
Prepaid expenses and other current assets |
|
|
2,354 |
|
|
|
414 |
|
Total current assets |
|
|
4,303 |
|
|
|
786 |
|
NONCURRENT ASSETS |
|
|
|
|
|
|
||
Machinery and equipment, net |
|
|
1,270 |
|
|
|
887 |
|
Operating lease right-of-use assets, net |
|
|
4,073 |
|
|
|
199 |
|
Forward purchase agreement derivative asset |
|
|
230 |
|
|
|
— |
|
Other noncurrent assets |
|
|
143 |
|
|
|
725 |
|
TOTAL ASSETS |
|
$ |
10,019 |
|
|
$ |
2,597 |
|
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT |
|
|
|
|
|
|
||
CURRENT LIABILITIES |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
2,796 |
|
|
$ |
2,124 |
|
Related party accounts payable |
|
|
81 |
|
|
|
147 |
|
Accrued expenses and other current liabilities |
|
|
4,896 |
|
|
|
5,142 |
|
Related party accrued expenses and other current liabilities |
|
|
536 |
|
|
|
205 |
|
Legal settlement liability |
|
|
— |
|
|
|
640 |
|
Loans payable, net of issuance costs |
|
|
— |
|
|
|
1,000 |
|
Term notes payable, net of discount, including accrued interest |
|
|
529 |
|
|
|
507 |
|
Related party term notes payable, net of discount, including accrued interest |
|
|
278 |
|
|
|
1,962 |
|
Related party convertible notes payable, including accrued interest |
|
|
— |
|
|
|
804 |
|
Related party contingently convertible notes payable, including contingently issuable warrants, at fair value |
|
|
— |
|
|
|
1,152 |
|
Simple agreements for future equity (SAFE), at fair value |
|
|
— |
|
|
|
24,575 |
|
Related party SAFE, at fair value |
|
|
— |
|
|
|
4,615 |
|
Finance lease liability, current |
|
|
81 |
|
|
|
72 |
|
Operating lease right-of-use liability, current |
|
|
1,035 |
|
|
|
44 |
|
Total current liabilities |
|
|
10,232 |
|
|
|
42,989 |
|
NONCURRENT LIABILITIES |
|
|
|
|
|
|
||
Operating lease right-of-use liability, noncurrent |
|
|
3,037 |
|
|
|
305 |
|
Finance lease liability, noncurrent |
|
|
216 |
|
|
|
142 |
|
Related party term notes payable, net of discount, including accrued interest |
|
|
2,060 |
|
|
|
— |
|
Other noncurrent liabilities |
|
|
2,038 |
|
|
|
— |
|
Related party warrant liability |
|
|
48 |
|
|
|
— |
|
Warrant liability |
|
|
623 |
|
|
|
— |
|
TOTAL LIABILITIES |
|
|
18,254 |
|
|
|
43,436 |
|
CONVERTIBLE PREFERRED STOCK |
|
|
— |
|
|
|
9,601 |
|
STOCKHOLDERS’ DEFICIT |
|
(8,235 |
) |
|
|
(50,440 |
) |
|
TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT |
$ |
10,019 |
|
|
$ |
2,597 |
|
|
CALIDI BIOTHERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share data) (Unaudited) |
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|
|
Year Ended December 31, |
||||||
|
|
2023 |
|
2022 |
||||
REVENUE |
|
|
|
|
||||
Service revenues |
|
$ |
— |
|
|
$ |
45 |
|
Total revenue |
|
|
— |
|
|
|
45 |
|
OPERATING EXPENSES |
|
|
|
|
|
|
||
Cost of revenues |
|
|
— |
|
|
|
(14 |
) |
Research and development |
|
|
(13,008 |
) |
|
|
(7,257 |
) |
General and administrative |
|
|
(15,984 |
) |
|
|
(15,902 |
) |
Total operating expense |
|
|
(28,992 |
) |
|
|
(23,173 |
) |
Loss from operations |
|
|
(28,992 |
) |
|
|
(23,128 |
) |
OTHER INCOME (EXPENSES), NET |
|
|
|
|
|
|
||
Interest expense |
|
|
(329 |
) |
|
|
(42 |
) |
Interest expense – related party |
|
|
(740 |
) |
|
|
(116 |
) |
Series B convertible preferred stock financing costs – related party |
|
|
(2,680 |
) |
|
|
— |
|
Change in fair value of debt, other liabilities, and derivatives |
|
|
(200 |
) |
|
|
(1,887 |
) |
Change in fair value of debt, other liabilities, and derivatives – related party |
|
|
1,378 |
|
|
|
(238 |
) |
Grant income |
|
|
2,885 |
|
|
|
— |
|
Debt extinguishment |
|
|
(139 |
) |
|
|
— |
|
Debt extinguishment – related party |
|
|
(332 |
) |
|
|
— |
|
Other income (expense), net |
|
|
(51 |
) |
|
|
(5 |
) |
Total other income (expenses), net |
|
|
(208 |
) |
|
|
(2,288 |
) |
LOSS BEFORE INCOME TAXES |
|
|
(29,200 |
) |
|
|
(25,416 |
) |
Income tax provision |
|
|
(16 |
) |
|
|
(11 |
) |
NET LOSS |
|
$ |
(29,216 |
) |
|
$ |
(25,427 |
) |
Net loss per share; basic and diluted |
|
$ |
(1.73 |
) |
|
$ |
(2.99 |
) |
Weighted average common shares outstanding; basic and diluted |
|
|
16,887 |
|
|
|
8,505 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240315064932/en/
For Investors:
Stephen Jasper
Gilmartin Group
stephen@gilmartinir.com
For Media:
Stephen Thesing
ir@calidibio.com
Source: Calidi Biotherapeutics, Inc.
FAQ
What grant did Calidi Biotherapeutics Inc. receive and from whom?
What is the new platform introduced by Calidi for cancer treatment?
Who were the new members appointed to Calidi's Scientific and Medical Advisory Board?
What does the new U.S. patent cover for Calidi?
What financial results were reported by Calidi for Q4 2023?
How much cash reserves did Calidi have as of December 31, 2023?
