Calidi Biotherapeutics Reports Second Quarter 2025 Financial Results and Recent Operational Highlights
Calidi Biotherapeutics (NYSE American: CLDI), a clinical-stage biotech company, reported its Q2 2025 financial results and operational highlights. The company presented promising preclinical data for CLD-401 at ASCO, demonstrating enhanced biological efficacy in delivering IL-15 superagonist to metastatic tumors. Additionally, CLD-201 received FDA Fast Track Designation for soft tissue sarcoma treatment.
Financially, Calidi raised $4.6 million through a warrant inducement offering, bringing total 2025 gross proceeds to $15.7 million. The company reported a net loss of $5.7 million ($1.99 per share) in Q2 2025, compared to $7.4 million in Q2 2024. Cash position stood at $5.3 million as of June 30, 2025.
Calidi Biotherapeutics (NYSE American: CLDI), una società biotech in fase clinica, ha pubblicato i risultati finanziari e gli aggiornamenti operativi del 2° trimestre 2025. L'azienda ha presentato dati preclinici promettenti su CLD-401 all'ASCO, che mostrano una maggiore efficacia biologica nella somministrazione del superagonista di IL-15 ai tumori metastatici. Inoltre, CLD-201 ha ricevuto la Designazione Fast Track dalla FDA per il trattamento del sarcoma dei tessuti molli.
Sul fronte finanziario, Calidi ha raccolto $4.6 million tramite un'offerta di inducimento di warrant, portando i proventi lordi totali del 2025 a $15.7 million. La società ha registrato una perdita netta di $5.7 million ($1.99 per azione) nel 2° trimestre 2025, rispetto a $7.4 million nel 2° trimestre 2024. La posizione di cassa era di $5.3 million al 30 giugno 2025.
Calidi Biotherapeutics (NYSE American: CLDI), una biotecnológica en fase clínica, informó sus resultados financieros y avances operativos del 2.º trimestre de 2025. La compañía presentó datos preclínicos prometedores de CLD-401 en ASCO, que demuestran una mayor eficacia biológica al administrar un superagonista de IL-15 a tumores metastásicos. Además, CLD-201 obtuvo la Designación Fast Track de la FDA para el tratamiento del sarcoma de tejidos blandos.
En el aspecto financiero, Calidi recaudó $4.6 million mediante una oferta de inducimiento de warrants, elevando los ingresos brutos totales de 2025 a $15.7 million. La compañía registró una pérdida neta de $5.7 million ($1.99 por acción) en el 2.º trimestre de 2025, frente a $7.4 million en el 2.º trimestre de 2024. La posición de efectivo era de $5.3 million al 30 de junio de 2025.
Calidi Biotherapeutics (NYSE American: CLDI), 임상 단계의 바이오테크 기업이 2025년 2분기 재무 실적 및 운영 하이라이트를 발표했습니다. 회사는 ASCO에서 CLD-401의 전임상 데이터를 공개했으며, 전이성 종양에 IL-15 슈퍼아고니스트를 전달할 때 생물학적 효능이 향상됨을 보였습니다. 또한 CLD-201은 연부 조직 육종 치료를 위해 FDA로부터 패스트트랙 지정(Fast Track Designation)을 받았습니다.
재무 측면에서 Calidi는 워런트 유도(offering)를 통해 $4.6 million을 조달하여 2025년 총 총수입을 $15.7 million으로 늘렸습니다. 회사는 2025년 2분기에 $5.7 million의 순손실(주당 $1.99)을 보고했으며, 이는 2024년 2분기의 $7.4 million과 비교됩니다. 2025년 6월 30일 기준 현금 잔액은 $5.3 million입니다.
Calidi Biotherapeutics (NYSE American: CLDI), une société biotechnologique en phase clinique, a publié ses résultats financiers et faits marquants opérationnels du 2e trimestre 2025. La société a présenté des données précliniques prometteuses sur CLD-401 lors de l'ASCO, montrant une efficacité biologique accrue dans l'administration d'un superagoniste IL-15 aux tumeurs métastatiques. De plus, CLD-201 a obtenu la désignation Fast Track de la FDA pour le traitement des sarcomes des tissus mous.
Sur le plan financier, Calidi a levé $4.6 million via une offre d'incitation de warrants, portant le produit brut total 2025 à $15.7 million. La société a enregistré une perte nette de $5.7 million ($1.99 par action) au 2e trimestre 2025, contre $7.4 million au 2e trimestre 2024. La trésorerie s'élevait à $5.3 million au 30 juin 2025.
Calidi Biotherapeutics (NYSE American: CLDI), ein Biotech-Unternehmen in der klinischen Phase, veröffentlichte seine Finanzzahlen und operativen Highlights für das 2. Quartal 2025. Das Unternehmen präsentierte auf der ASCO vielversprechende präklinische Daten zu CLD-401, die eine verbesserte biologische Wirksamkeit bei der Abgabe eines IL-15-Superagonisten an metastasierende Tumoren zeigen. Zudem erhielt CLD-201 die Fast Track Designation der FDA für die Behandlung von Weichteilsarkomen.
Finanziell sammelte Calidi $4.6 million durch ein Warrants-Inducement-Angebot und erhöhte damit die Bruttoerlöse für 2025 auf $15.7 million. Das Unternehmen verzeichnete im 2. Quartal 2025 einen Nettogewinn von - stattdessen einen Nettoverlust von $5.7 million ($1.99 pro Aktie), gegenüber $7.4 million im 2. Quartal 2024. Die Liquiditätsposition belief sich zum 30. Juni 2025 auf $5.3 million.
- Received FDA Fast Track Designation for CLD-201 for soft tissue sarcoma treatment
- Successfully raised $4.6M through warrant inducement offering, totaling $15.7M in 2025
- Reduced net loss to $5.7M in Q2 2025 from $7.4M in Q2 2024
- Demonstrated enhanced biological efficacy of CLD-401 in preclinical studies
- Cash position decreased to $5.3M from $9.6M in December 2024
- R&D expenses increased to $2.6M from $2.2M year-over-year
- IND filing for CLD-401 not expected until end of 2026
Insights
Calidi secured FDA Fast Track for CLD-201, presented promising CLD-401 data, raised $4.6M, while reducing quarterly losses by 23% year-over-year.
Calidi Biotherapeutics' Q2 results demonstrate meaningful scientific advancement coupled with improved financial discipline. The company secured FDA Fast Track Designation for CLD-201, their stem cell-loaded oncolytic viral therapy for soft tissue sarcoma - a significant regulatory milestone that could accelerate approval timelines and validates their platform approach.
The preclinical data presented at ASCO for CLD-401 shows two critical advantages: the CD55 membrane expression that reduces immune clearance (solving a major challenge for systemic delivery of oncolytic viruses) and successful IL-15 superagonist delivery to metastatic sites. This suggests their RedTail platform may overcome the historical limitations of oncolytic virus therapies.
Financially, Calidi has shown improved capital efficiency with a 23% reduction in quarterly net loss (
The
- Presented preclinical data at the American Society of Clinical Oncology (ASCO) on CLD-401 demonstrating biological efficacy IL-15 superagonist delivery to metastatic tumor sites and reduced immune clearance through engineered CD55 membrane expression; IND filing expected by the end of 2026
- Received FDA Fast Track Designation for CLD-201, a first-in-class stem-cell loaded intratumoral viral therapy for the treatment of patients with soft tissue sarcoma
- Raised
$4.6 million gross proceeds through a warrant inducement offering with existing investors that further strengthens the company’s balance sheet and extends its runway
SAN DIEGO, Aug. 08, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, today reported its second quarter 2025 operating and financial results and reviewed recent business highlights.
“We are extremely excited about the progress at Calidi,” said Eric Poma, PhD, CEO of Calidi Biotherapeutics. “We believe our RedTail platform, with its ability to protect virus from immune clearance and induce tumor lysis and the delivery of potent therapeutic genetic medicines to metastatic sites through systemic administration, will be a substantial breakthrough in the field of oncolytic viruses and tumor-targeted gene therapies. We look forward to leveraging our scientific, operational and capital markets experience to continue building on Calidi’s strong platforms.”
Second Quarter 2025 and Recent Corporate Developments
- Presented new preclinical data surrounding CLD-401, the first lead compound from Calidi’s proprietary RedTail platform, at the American Society for Clinical Oncology (ASCO) on May 30th in Chicago, IL., demonstrating enhanced biological efficacy in syngeneic tumor models through the delivery of IL15 superagonist to metastatic tumors sites after systemic administration. Calidi also demonstrated the engineered expression of CD55 on the enveloped virus, allowing the virus to avoid immune clearance and enabling systemic administration. The systemic administration of the CD55-expressing enveloped virus allows Calidi to target metastatic disease patients with high unmet need.
- Raised
$4.6 million in gross proceeds from a warrant inducement offering with existing investors despite a challenging financing environment for the biotech industry, increasing the total gross proceeds raised in all offerings in 2025 to$15.7 million . - Granted Fast Track Designation to CLD-201 by the U.S. Food and Drug Administration (FDA) for the treatment of patients with soft tissue sarcoma. CLD-201 is a first-in-class stem cell loaded intratumoral oncolytic viral therapy that has demonstrated significant advantages over current intratumoral oncolytic viral approaches. An IND for a Phase 1 study was successfully opened for CLD-201 in Q1-2025.
Second Quarter 2025 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 pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease. The company's proprietary Redtail platform features an engineered enveloped oncolytic virus designed for systemic delivery and targeting of metastatic sites. This advanced enveloped technology is intended to shield the virus from immune clearance, allowing virotherapy to effectively reach tumor sites, induce tumor lysis, and deliver potent gene therapies to metastatic locations.
The lead candidate from the Redtail platform, currently in IND-enabling studies, targets non-small cell lung cancer, ovarian cancer, and other tumor types with high unmet medical need. Additionally, Calidi is developing protected virotherapies, in clinical-stage, for intratumoral and localized administration, focusing on a subset of injectable cancer indications.
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 key milestones, including certain pre-clinical data, 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 annual report filed with the SEC on Form 10-K on March 31, 2025, as 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) | ||||||||
| June 30, 2025 | December 31, 2024 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash | $ | 5,279 | $ | 9,591 | ||||
| Prepaid expenses and other current assets | 770 | 636 | ||||||
| Total current assets | 6,049 | 10,227 | ||||||
| NONCURRENT ASSETS | ||||||||
| Machinery and equipment, net | 929 | 869 | ||||||
| Operating lease right-of-use assets, net | 2,333 | 2,934 | ||||||
| Other noncurrent assets | 40 | 152 | ||||||
| TOTAL ASSETS | $ | 9,351 | $ | 14,182 | ||||
| LIABILITIES AND TOTAL EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable | $ | 1,215 | $ | 2,072 | ||||
| Related party accounts payable | 12 | 2 | ||||||
| Accrued expenses and other current liabilities | 1,493 | 1,858 | ||||||
| Related party accrued expenses and other current liabilities | 441 | 480 | ||||||
| Term notes payable, net of discount, including accrued interest | — | 251 | ||||||
| Related party term notes payable, net of discount, including accrued interest | 775 | 2,702 | ||||||
| Related party bridge loan payable, including accrued interest | — | 223 | ||||||
| Related party other current liability | — | 638 | ||||||
| Finance lease liability, current | 113 | 66 | ||||||
| Operating lease right-of-use liability, current | 1,304 | 1,204 | ||||||
| Total current liabilities | 5,353 | 9,496 | ||||||
| NONCURRENT LIABILITIES | ||||||||
| Operating lease right-of-use liability, noncurrent | 993 | 1,845 | ||||||
| Finance lease liability, noncurrent | 226 | 145 | ||||||
| Promissory note | 600 | 600 | ||||||
| Warrant liability | 96 | 119 | ||||||
| Related party warrant liability | 7 | 9 | ||||||
| TOTAL LIABILITIES | 7,275 | 12,214 | ||||||
| TOTAL EQUITY | 2,076 | 1,968 | ||||||
| TOTAL LIABILITIES AND TOTAL EQUITY | $ | 9,351 | $ | 14,182 | ||||
| CALIDI BIOTHERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share data) | ||||||||
| Three Months Ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| (Unaudited) | ||||||||
| OPERATING EXPENSES | ||||||||
| Research and development | $ | (2,593 | ) | $ | (2,167 | ) | ||
| General and administrative | (3,071 | ) | (3,605 | ) | ||||
| Total operating expense | (5,664 | ) | (5,772 | ) | ||||
| Loss from operations | (5,664 | ) | (5,772 | ) | ||||
| OTHER INCOME (EXPENSES), NET | ||||||||
| Interest expense | (29 | ) | (108 | ) | ||||
| Interest expense – related party | (23 | ) | (165 | ) | ||||
| Change in fair value of other liabilities and derivatives | (18 | ) | 86 | |||||
| Change in fair value of other liabilities and derivatives – related party | (1 | ) | 9 | |||||
| Grant income | — | 181 | ||||||
| Other expense, net | (22 | ) | 10 | |||||
| Total other income (expenses), net | (93 | ) | 13 | |||||
| LOSS BEFORE INCOME TAXES | $ | (5,757 | ) | $ | (5,759 | ) | ||
| Income tax provision | (4 | ) | (8 | ) | ||||
| NET LOSS | $ | (5,761 | ) | $ | (5,767 | ) | ||
| Net loss attributable to noncontrolling interest | (46 | ) | — | |||||
| NET LOSS ATTRIBUTABLE TO CONTROLLING INTEREST | (5,715 | ) | (5,767 | ) | ||||
| Deemed dividend on warrants | — | (1,671 | ) | |||||
| NET LOSS ATTRIBUTABLE TO COMMONvSTOCKHOLDERS | (5,715 | ) | (7,438 | ) | ||||
| Net loss per share; basic and diluted | $ | (1.99 | ) | $ | (16.75 | ) | ||
| Weighted average common shares outstanding; basic and diluted | 2,877 | 444 | ||||||
FAQ
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What is CLD-201 and what designation did it receive from the FDA?
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