Calidi Biotherapeutics Reports Fourth Quarter and Full-Year 2024 Financial Results and Recent Operational Highlights
Calidi Biotherapeutics (NYSE: CLDI) reported its Q4 and full-year 2024 financial results, highlighting significant progress across its three therapeutic platforms. The company demonstrated success in delivering gene therapy payload to tumors using its systemic antitumor virotherapy platform.
Key developments include: filing an IND for CLD-201 Phase 1 trial for multiple solid tumors in March 2025, advancing recruitment for a Phase 1 trial at Northwestern University for newly diagnosed high-grade glioma patients, and enrolling 14 patients in a City of Hope Phase 1 trial for recurrent high-grade glioma.
Financial results show a Q4 2024 net loss of $4.1 million ($0.27 per share), compared to $8.2 million in Q4 2023. Full-year 2024 net loss was $23.8 million ($2.97 per share). The company ended 2024 with $9.6 million in cash.
Calidi Biotherapeutics (NYSE: CLDI) ha riportato i risultati finanziari del quarto trimestre e dell'intero anno 2024, evidenziando progressi significativi nelle sue tre piattaforme terapeutiche. L'azienda ha dimostrato successo nella somministrazione di terapie geniche ai tumori utilizzando la sua piattaforma di viroterapia antitumorale sistemica.
Sviluppi chiave includono: la presentazione di un IND per la sperimentazione di fase 1 di CLD-201 per tumori solidi multipli a marzo 2025, l'avanzamento del reclutamento per una sperimentazione di fase 1 presso la Northwestern University per pazienti con glioma ad alto grado recentemente diagnosticati, e l'arruolamento di 14 pazienti in una sperimentazione di fase 1 presso la City of Hope per gliomi ricorrenti ad alto grado.
I risultati finanziari mostrano una perdita netta di $4,1 milioni ($0,27 per azione) nel quarto trimestre del 2024, rispetto a $8,2 milioni nel quarto trimestre del 2023. La perdita netta per l'intero anno 2024 è stata di $23,8 milioni ($2,97 per azione). L'azienda ha chiuso il 2024 con $9,6 milioni in cassa.
Calidi Biotherapeutics (NYSE: CLDI) informó sus resultados financieros del cuarto trimestre y del año completo 2024, destacando avances significativos en sus tres plataformas terapéuticas. La empresa demostró éxito en la entrega de terapia génica a tumores utilizando su plataforma de viroterapia antitumoral sistémica.
Los desarrollos clave incluyen: la presentación de un IND para el ensayo de fase 1 de CLD-201 para múltiples tumores sólidos en marzo de 2025, el avance en el reclutamiento para un ensayo de fase 1 en la Universidad Northwestern para pacientes con glioma de alto grado recién diagnosticados, y el reclutamiento de 14 pacientes en un ensayo de fase 1 en la City of Hope para gliomas recurrentes de alto grado.
Los resultados financieros muestran una pérdida neta de $4.1 millones ($0.27 por acción) en el cuarto trimestre de 2024, en comparación con $8.2 millones en el cuarto trimestre de 2023. La pérdida neta del año completo 2024 fue de $23.8 millones ($2.97 por acción). La empresa terminó 2024 con $9.6 millones en efectivo.
Calidi Biotherapeutics (NYSE: CLDI)는 2024년 4분기 및 전체 연도 재무 결과를 발표하며 세 가지 치료 플랫폼에서의 중요한 발전을 강조했습니다. 이 회사는 체계적인 항종양 바이로테라피 플랫폼을 사용하여 종양에 유전자 치료제를 전달하는 데 성공을 거두었습니다.
주요 개발 사항으로는: 2025년 3월에 다수의 고형 종양에 대한 CLD-201 1상 시험을 위한 IND 제출, 새로 진단된 고등급 교모세포종 환자를 위한 Northwestern University의 1상 시험 모집 진행, 그리고 재발성 고등급 교모세포종 환자를 위한 City of Hope의 1상 시험에 14명의 환자 등록이 포함됩니다.
재무 결과에 따르면 2024년 4분기 순손실은 $4.1 백만 ($0.27 주당)으로, 2023년 4분기의 $8.2 백만에 비해 감소했습니다. 2024년 전체 연도 순손실은 $23.8 백만 ($2.97 주당)으로 나타났습니다. 이 회사는 2024년을 $9.6 백만의 현금으로 마감했습니다.
Calidi Biotherapeutics (NYSE: CLDI) a annoncé ses résultats financiers du quatrième trimestre et de l'année complète 2024, mettant en évidence des progrès significatifs dans ses trois plateformes thérapeutiques. L'entreprise a réussi à délivrer des thérapies géniques aux tumeurs grâce à sa plateforme de virothérapie antitumorale systémique.
Les développements clés incluent : le dépôt d'un IND pour l'essai de phase 1 de CLD-201 pour plusieurs tumeurs solides en mars 2025, l'avancement du recrutement pour un essai de phase 1 à l'Université Northwestern pour des patients récemment diagnostiqués avec un gliome de haut grade, et l'inscription de 14 patients dans un essai de phase 1 à la City of Hope pour gliome récurrent de haut grade.
Les résultats financiers montrent une perte nette de $4,1 millions ($0,27 par action) au quatrième trimestre 2024, contre $8,2 millions au quatrième trimestre 2023. La perte nette pour l'année complète 2024 s'élevait à $23,8 millions ($2,97 par action). L'entreprise a terminé 2024 avec $9,6 millions en liquidités.
Calidi Biotherapeutics (NYSE: CLDI) hat seine finanziellen Ergebnisse für das vierte Quartal und das Gesamtjahr 2024 veröffentlicht und erhebliche Fortschritte in seinen drei therapeutischen Plattformen hervorgehoben. Das Unternehmen hat Erfolge bei der Bereitstellung von Gentherapien an Tumoren mit seiner systemischen antitumoralen Virotherapie-Plattform erzielt.
Wichtige Entwicklungen umfassen: die Einreichung eines IND für die CLD-201 Phase-1-Studie für mehrere solide Tumoren im März 2025, den Fortschritt bei der Rekrutierung für eine Phase-1-Studie an der Northwestern University für neu diagnostizierte Patienten mit hochgradigem Gliom sowie die Einschreibung von 14 Patienten in einer Phase-1-Studie der City of Hope für wiederkehrendes hochgradiges Gliom.
Die finanziellen Ergebnisse zeigen einen Nettoverlust von $4,1 Millionen ($0,27 pro Aktie) im vierten Quartal 2024, verglichen mit $8,2 Millionen im vierten Quartal 2023. Der Nettoverlust für das Gesamtjahr 2024 betrug $23,8 Millionen ($2,97 pro Aktie). Das Unternehmen schloss das Jahr 2024 mit $9,6 Millionen in bar ab.
- Successful demonstration of gene therapy payload delivery to tumors
- Filed IND for CLD-201 Phase 1 trial for multiple solid tumors
- Secured $12 million CIRM award for City of Hope trial
- Reduced net loss in Q4 2024 to $4.1M from $8.2M in Q4 2023
- Improved cash position to $9.6M from $1.9M year-over-year
- Continued net losses of $23.8M in 2024
- Declining R&D expenses from $13.0M to $8.9M year-over-year
- cash runway with $9.6M in cash reserves
Insights
Calidi's Q4/full-year results reveal a company making meaningful clinical progress while improving its financial position. Their multi-platform approach targeting aggressive cancers shows several positive developments:
Most notably, preclinical data demonstrated their systemic platform (CLD-400) can deliver gene therapy payloads to tumors with complete eradication in some models - a critical proof-of-concept for their mechanism of action. The IND filing for CLD-201 advances their solid tumor program into clinical testing, targeting breast cancer, head & neck carcinoma, and soft tissue sarcoma.
For their high-grade glioma program, two separate Phase 1 trials are progressing: Northwestern University's trial for newly diagnosed patients (led by renowned experts) and City of Hope's trial (with 14 patients enrolled) for recurrent disease supported by
Financially, Calidi reduced its quarterly net loss to
With multiple clinical catalysts in Q2-Q3 2025, including first patients dosed in two trials, Calidi is executing methodically across its pipeline while demonstrating fiscal discipline - notable progress for a small-cap oncology biotech.
Calidi's therapeutic approach represents intriguing science in the competitive oncolytic virus landscape. Their platform's demonstration of delivering gene therapy payloads to tumors via their "3KO" virus is technically significant, as this could potentially overcome delivery challenges that have efficacy in previous attempts at systemic administration.
The advancement of multiple clinical programs targeting distinct high-mortality cancers is methodical. Their high-grade glioma program (CLD-101) deserves particular attention given this indication's dismal prognosis and treatment options. The involvement of Dr. Roger Stupp (who pioneered the standard-of-care "Stupp protocol" for glioblastoma) lends credibility, as does the previous publication in The Lancet Oncology.
The CLD-201 IND filing for solid tumors demonstrates pipeline expansion beyond neurological cancers. Their target indications - breast cancer, head & neck squamous cell carcinoma, and soft tissue sarcoma - represent strategic choices where immunotherapy approaches have shown variable success and unmet needs remain substantial.
The
These advances represent incremental but tangible progress in a field where genuine innovation requires methodical clinical validation.
- Announced demonstrated ability to deliver transient gene therapy (payload) to tumors using systemic antitumor virotherapy platform
- Filed IND in March 2025 for CLD-201 company sponsored Phase 1 trial to treat multiple solid tumors
- Commencement of recruitment for Phase 1 trial in patients with newly diagnosed high-grade glioma at Northwestern University hospital
- 14 patients enrolled in Phase 1 trial conducted by City of Hope to treat recurrent high-grade glioma
SAN DIEGO, March 31, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today reported its fourth quarter and full-year 2024 operating and financial results and reviewed recent business highlights.
“Calidi continues to make great progress on all three of our platforms; our systemic asset CLD-400 proved it can deliver a gene therapy payload to targeted tumors, we filed an IND for our solid tumor asset CLD-201, and our CLD-101 program treating high-grade glioma is advancing in two Phase 1 trials,” said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics. “We think our multi-modal mechanism of action is a game changer in treating multiple deadly cancers, including metastatic cancer and lung cancer, solid tumors and high-grade glioma.”
Fourth Quarter 2024 and Recent Corporate Developments
- New data showed that a single dose of a tumor-selective triple knockout (“3KO”) RT virus genetically engineered to encode a specific immune-boosting payload (undisclosed) increased the antitumor immune response. These increased shifts in immune composition, driven by virotherapy encoding a payload, ultimately led to complete eradication of certain tested tumors in the preclinical model.
- In March 2025, Calidi filed an IND for a company sponsored, open label dose escalation trial of CLD-201 in adult patients with solid tumors, specifically with the indications of breast cancer, head & neck squamous cell carcinoma, and soft tissue sarcoma.
- In February 2025, Northwestern University hospital started recruiting for the CLD-101 Phase 1 clinical trial in patients with newly diagnosed high-grade glioma, an aggressive and often fatal form of brain cancer. This physician-led and NCI sponsored clinical trial, led by prominent experts Dr. Maciej Lesniak and Dr. Roger Stupp, builds on the promising results from a prior Phase 1 trial involving 12 patients treated with a single dose of CLD-101 published in the prestigious journal The Lancet Oncology.
- City of Hope and Calidi announced the 14th patient treated in a physician-sponsored Phase 1 trial assessing the safety and feasibility of a multi-dosing regimen to treat recurrent high-grade glioma. This program has secured
$12 million award from the California Institute for Regenerative Medicine (CIRM) to support this groundbreaking study.
Upcoming Anticipated Milestones
- Q2 2025: Payload and lead candidate information revealed on CLD-400 systemic platform
- Q2 2025: First patient dosed in CLD-101 Phase 1 trial in collaboration with Northwestern University for newly diagnosed high-grade glioma patients
- Q3 2025: First patient dosed in CLD-201 Phase 1 trial
Fourth Quarter 2024 Financial Results
The company reported a net loss attributable to common stockholders of
Research and development expenses were
General and administrative expenses were
Full Year 2024 Financial Results
The company reported a net loss attributable to common stockholders 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 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 (i) Form S-4 filed on August 2, 2023 and the corresponding prospectus filed on August 4, 2023, and (ii) on Form S-1 filed on April 15, 2024, and the Company’s periodic reports filed with the SEC on (i) Form 10-K filed on March 15, 2024, (ii) Form 10-Q filed on May 14, 2024, (iii) Form 10-Q filed on August 13, 2024, and (iv) Form 10-Q filed on November 12, 2024. These reports 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
CLDI@redchip.com
| CALIDI BIOTHERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except for par value data) | ||||||||
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash | $ | 9,591 | $ | 1,949 | ||||
| Prepaid expenses and other current assets | 636 | 2,354 | ||||||
| Total current assets | 10,227 | 4,303 | ||||||
| NONCURRENT ASSETS | ||||||||
| Machinery and equipment, net | 869 | 1,270 | ||||||
| Operating lease right-of-use assets, net | 2,934 | 4,073 | ||||||
| Other noncurrent assets | 152 | 373 | ||||||
| TOTAL ASSETS | $ | 14,182 | $ | 10,019 | ||||
| LIABILITIES AND EQUITY (DEFICIT) | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable | $ | 2,072 | $ | 2,796 | ||||
| Related party accounts payable | 2 | 81 | ||||||
| Accrued expenses and other current liabilities | 1,858 | 4,896 | ||||||
| Related party accrued expenses and other current liabilities | 480 | 536 | ||||||
| Term notes payable, net of discount, including accrued interest | 251 | 529 | ||||||
| Related party term notes payable, net of discount, including accrued interest | 2,702 | 278 | ||||||
| Related party bridge loan payable, including accrued interest | 223 | — | ||||||
| Related party other current liability | 638 | — | ||||||
| Finance lease liability, current | 66 | 81 | ||||||
| Operating lease right-of-use liability, current | 1,204 | 1,035 | ||||||
| Total current liabilities | 9,496 | 10,232 | ||||||
| NONCURRENT LIABILITIES | ||||||||
| Operating lease right-of-use liability, noncurrent | 1,845 | 3,037 | ||||||
| Finance lease liability, noncurrent | 145 | 216 | ||||||
| Promissory note | 600 | — | ||||||
| Related party term notes payable, net of discount, including accrued interest | — | 2,060 | ||||||
| Other noncurrent liabilities | — | 1,500 | ||||||
| Related party other noncurrent liabilities | — | 538 | ||||||
| Warrant liability | 119 | 623 | ||||||
| Related party warrant liability | 9 | 48 | ||||||
| TOTAL LIABILITIES | 12,214 | 18,254 | ||||||
| TOTAL EQUITY (DEFICIT) | 1,968 | (8,235 | ) | |||||
| TOTAL LIABILITIES AND EQUITY (DEFICIT) | $ | 14,182 | $ | 10,019 | ||||
| CALIDI BIOTHERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share data) | ||||||||
| Year Ended December 31, | ||||||||
| 2024 | 2023 | |||||||
| OPERATING EXPENSES | ||||||||
| Research and development | $ | (8,878 | ) | $ | (13,008 | ) | ||
| General and administrative | (12,898 | ) | (15,984 | ) | ||||
| Total operating expense | (21,776 | ) | (28,992 | ) | ||||
| Loss from operations | (21,776 | ) | (28,992 | ) | ||||
| OTHER INCOME (EXPENSES), NET | ||||||||
| Interest expense | (372 | ) | (329 | ) | ||||
| Interest expense – related party | (561 | ) | (740 | ) | ||||
| Series B convertible preferred stock financing costs – related party | — | (2,680 | ) | |||||
| Change in fair value of debt, other liabilities, and derivatives | 285 | (200 | ) | |||||
| Change in fair value of debt, other liabilities, and derivatives – related party | 39 | 1,378 | ||||||
| Grant income | 181 | 2,885 | ||||||
| Debt extinguishment | — | (139 | ) | |||||
| Debt extinguishment – related party | — | (332 | ) | |||||
| Other income (expense), net | 9 | (51 | ) | |||||
| Total other income (expenses), net | (419 | ) | (208 | ) | ||||
| LOSS BEFORE INCOME TAXES | (22,195 | ) | (29,200 | ) | ||||
| Income tax provision | (14 | ) | (16 | ) | ||||
| NET LOSS | $ | (22,209 | ) | $ | (29,216 | ) | ||
| Net loss attributable to noncontrolling interest | (66 | ) | — | |||||
| NET LOSS ATTRIBUTABLE TO CONTROLLING INTEREST | (22,143 | ) | (29,216 | ) | ||||
| Deemed dividend on warrants | (1,671 | ) | — | |||||
| NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | (23,814 | ) | (29,216 | ) | ||||
| Net loss per share; basic and diluted | $ | (2.97 | ) | $ | (17.33 | ) | ||
| Weighted average common shares outstanding; basic and diluted | 8,005 | 1,686 | ||||||
FAQ
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