Calidi Biotherapeutics
Calidi Biotherapeutics is a clinical-stage biotechnology company developing stem cell-protected and systemically delivered oncolytic virus immunotherapies (SuperNova and RedTail platforms) for solid tumor cancers, including glioma, soft tissue sarcoma, and lung cancer.
- Company typePublic
- Founded2015
- HeadquartersSan Diego, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What Calidi Biotherapeutics does
Calidi Biotherapeutics is a clinical-stage biotechnology company developing oncolytic virus-based immunotherapies for solid tumor cancers, headquartered in San Diego with a research subsidiary (StemVac GmbH) in Bernried, Germany. The company operates two proprietary technology platforms: the SuperNova platform, which uses adipose-derived mesenchymal stem cells to shield oncolytic vaccinia viruses from complement and innate immune clearance, and the RedTail platform, which employs a tumor-specific, replicating enveloped vaccinia virus expressing CD55 to enable systemic administration and localized delivery of therapeutic genetic payloads such as IL-15 superagonist and bispecific T-cell engagers. The clinical pipeline includes CLD-101 (NeuroNova, neural stem cell-delivered oncolytic virus for high-grade glioma, in Phase 1 with City of Hope and Northwestern University), CLD-201 (SuperNova for soft tissue sarcoma, FDA Fast Track designated with cleared IND), CLD-401 (RedTail lead candidate for NSCLC and head & neck cancer, in IND-enabling studies with positive FDA pre-IND feedback), and CLD-501 (in-situ TROP-2 T-cell engager, preclinical). The company became publicly traded on NYSE American (CLDI) in September 2023 via a SPAC merger with First Light Acquisition Group.
The business model is pre-revenue and dependent on capital markets: Calidi funds operations through dilutive public equity raises, warrant exercises, and non-dilutive grants (notably $15.1M from the California Institute for Regenerative Medicine). Future revenue is expected from licensing proprietary platforms to pharmaceutical partners, royalties from the exclusive veterinary worldwide license of SuperNova-1 to VetStem Biopharma, and ultimately commercialization of FDA-approved oncology therapeutics. As of March 2026, the company held $6.6M in cash against a $20.06M FY2025 net loss and has disclosed substantial doubt about its ability to continue as a going concern without additional financing.
Calidi Biotherapeutics firmographics
Firmographics- Name
- Calidi Biotherapeutics
- Legal name
- Calidi Biotherapeutics, Inc.
- Website
- https://calidibio.com
- Company type
- Public
- Founded year
- 2015
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Calidi Biotherapeutics is a clinical-stage biotechnology company developing stem cell-protected and systemically delivered oncolytic virus immunotherapies (SuperNova and RedTail platforms) for solid tumor cancers, including glioma, soft tissue sarcoma, and lung cancer.
- Ownership category
- akta.pro rank
Calidi Biotherapeutics industry classification
Industry- Product category
- Oncology Biopharmaceuticals
- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (3254)
- SIC
- Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)
- akta.pro primary industry
- Oncology Gene Therapies (incl. oncolytic vectors & gene-modified approaches) (HLAAACAF)
- akta.pro secondary industries
- Oncology & Hematology Pharmaceuticals (HLAIAAAC), Oncology Specialty Pharmaceuticals (HLAIACAA)
Keywords
Where Calidi Biotherapeutics is headquartered
LocationHeadquarters
- HQ city
- San Diego
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
Calidi Biotherapeutics business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain
Revenue model
- Drug Development and Commercialization: Pre-revenue clinical stage company. Future revenue expected from FDA-approved oncology therapeutics. Currently conducting Phase 1 clinical trials and IND-enabling studies.
- Partnerships and Licensing: Revenue potential from licensing proprietary technology platforms, collaborative partnerships with pharmaceutical companies, and downstream royalties from veterinary applications.
- Veterinary License (VetStem): Exclusive veterinary worldwide license for SuperNova-1 (SNV1) with VetStem Biopharma. Receives development milestone payments and downstream royalties.
Go-to-market motion2 records
Distribution channels1 record
Marketing channels5 records
Calidi Biotherapeutics product offering
Product offeringCore offering
Calidi Biotherapeutics is a clinical-stage biotechnology company developing oncolytic virus-based immunotherapies delivered through proprietary stem cell and enveloped virotherapy platforms for the treatment of solid tumors. Its product candidates include CLD-101 (NeuroNova) for high-grade glioma, CLD-201 (SuperNova) for soft tissue sarcoma, CLD-401 (RedTail lead) for lung and head/neck cancers, and CLD-501 (in-situ T-cell engager) for solid tumors. The company is currently pre-revenue and monetizes through licensing agreements (e.g., VetStem) and expects future revenue from FDA-approved oncology therapeutics and platform licensing.
Product overview
Calidi Biotherapeutics is a clinical-stage biotechnology company developing a portfolio of oncolytic virus-based immunotherapies for cancer treatment. The company operates two core technology platforms: the SuperNova (stem cell-delivered oncolytic virus) platform and the RedTail (systemic enveloped virotherapy) platform. The product portfolio includes multiple clinical-stage candidates: CLD-101 (NeuroNova) for high-grade glioma in Phase 1 trials, CLD-201 (SuperNova) for soft tissue sarcoma with FDA Fast Track designation and IND clearance, and CLD-401 (RedTail lead candidate) in IND-enabling studies for lung and head/neck cancers. The company also has CLD-501 (T-cell engager) in preclinical development. All programs leverage the company's proprietary cell-based delivery technology to overcome the challenge of effective oncolytic virus delivery to tumor sites.
Differentiator
Problem solved
Functional benefit
Brands
- SuperNova: First-in-class stem-cell loaded viral therapy platform for cancer treatment
- RedTail
- NeuroNova
- StemVac
Products and services
- CLD-101 (NeuroNova) Neural stem cells engineered to carry an oncolytic virus for the treatment of high-grade glioma and brain cancer. Currently in Phase 1 clinical trials in collaboration with City of Hope and Northwestern University.
- CLD-201 (SuperNova) First-in-class stem-cell loaded viral therapy using adipose-derived mesenchymal stem cells to deliver and potentiate vaccinia virus for the treatment of soft tissue sarcoma and other solid tumors. Granted FDA Fast Track designation.
- CLD-401 Lead RedTail platform candidate; an IL-15 superagonist gene medicine delivered via systemic enveloped virotherapy designed to selectively target tumors and express IL-15 superagonist to activate T-cells and NK-cells. Targeting non-small cell lung cancer, head and neck cancer, and other tumors with high unmet medical need; in IND-enabling studies.
- CLD-501 In-situ T-cell engager candidate targeting TROP-2 for solid tumors, developed using the RedTail platform to enable tumor-specific, localized expression of therapeutic payloads within solid tumor microenvironments. Additional T-cell engager targets in development include EGFR, EpCAM, and Nectin-4.
- RedTail Platform (RTNova) Dual-programmable virotherapy platform for systemic tumor targeting and localized gene delivery. Uses tumor-specific replicating enveloped vaccinia virus expressing CD55 to enable complement and neutralizing antibody resistance for systemic administration and delivery of therapeutic payloads.
- SuperNova Platform (SNV1) Stem cell-based delivery platform using adipose-derived mesenchymal stem cells to protect and potentiate oncolytic vaccinia virus for the treatment of solid tumors. Shields viruses from complement inactivation and innate immune clearance.
Quantifiable outcome
- FDA Fast Track Designation received for CLD-201 (SuperNova) for soft tissue sarcoma
- +3 more outcomes
Companies that use Calidi Biotherapeutics
Customer profileNamed customers2 records
Segments2 records
Ideal customer profiles3 records
Calidi Biotherapeutics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature6 records
Calidi Biotherapeutics partnerships and signals
Strategic signalPartnerships
Eight partnerships are on record, tiered core and minor.
- Avance ClinicalcorePartnership to facilitate Australian regulatory approval and accelerate initiation of CLD-401 clinical trials. Australian CRO with expertise in oncology trials.
- Matica BiocoreStrategic partnership for GMP manufacturing and analytical services for CLD-401 at Matica's Texas facility. Supports IND submission for oncolytic virus therapy targeting metastatic tumors.
- SIGA TechnologiesminorCollaboration to advance RTNova virotherapy for lung cancer and metastatic solid tumors. SIGA is a commercial-stage pharmaceutical company focused on antivirals.
- Northwestern UniversitycoreAgreement for exclusive commercial rights to Northwestern's IND for treatment of malignant glioma. FDA cleared IND application for CLD-101 clinical trial in high-grade glioma.
- GenScript ProBiominorPartnership for distribution of SuperNova-1 technology. GenScript ProBio provides contract development and manufacturing services.
- VetStem BiopharmaminorExclusive veterinary worldwide license for development and commercialization of SuperNova-1 (SNV1) for treatment of cancer in animals. Receives development milestone payments and downstream royalties.
- National Institutes of Health (NIH)minorCollaborative study with NIH's Department of Transfusion Medicine to study the impact of different stem cell carriers on therapeutic potential of oncolytic viruses.
- City of HopecoreExclusive license agreement for novel oncolytic virotherapy technology with City of Hope and University of Chicago. City of Hope also conducting Phase 1 clinical trial for CLD-101 in recurrent high-grade glioma.
Scale indicators11 records
Recent moves7 records
Expansion highlights6 records
Calidi Biotherapeutics competitors and assessment
Company assessmentDirect peers
- Replimune Group: Replimune is a publicly traded clinical-stage biotech developing a pipeline of oncolytic immunotherapies (RP1, RP2, RP3) for solid tumors. It is the closest direct competitor to Calidi, with a comparable systemic virotherapy platform and similar cancer indications (melanoma, squamous cell carcinoma, and others).
- Genelux Corporation: Genelux is a clinical-stage biotechnology company developing oncolytic virus therapies (Olvi-Vec, GL-ONC1) for solid tumors. It is a direct peer given its focus on systemically and locally delivered oncolytic vaccinia-based immunotherapies.
- Targovax: Targovax is a clinical-stage immuno-oncology company developing oncolytic virus-based therapies (ONCOS-102) and RAS mutation-targeted treatments. Direct peer as a competitor in the systemic oncolytic virotherapy space.
- Oncorus: Oncorus is a clinical-stage biotech developing intratumorally and systemically administered oncolytic herpes virus immunotherapies for solid tumors. Direct peer in the systemic oncolytic virotherapy category.
Emerging players
- CG Oncology: CG Oncology is a clinical-stage biotech developing oncolytic virus immunotherapy (cretostimogene) for bladder cancer. Comparable as a peer in the oncolytic virus immunotherapy category targeting solid tumors.
- Adagene: Adagene is a clinical-stage biopharmaceutical company developing novel antibody-based cancer immunotherapies using dynamic precision design. Comparable as a peer in the next-generation immuno-oncology space with a similar clinical-stage profile.
Broad incumbents
- ImmunityBio: ImmunityBio is a publicly traded clinical-stage company developing cell-based and immunotherapeutic platforms (including Anktiva/N-803, an IL-15 superagonist) for cancer and infectious disease. Comparable given overlap with Calidi's IL-15 superagonist approach (CLD-401) and broader cell-based immunotherapy focus.
- Precigen: Precigen (formerly Intrexon/Ziopharm) is a clinical-stage biotech developing gene and cell therapies with oncology applications (PRGN-3005 UltraCAR-T, PRGN-2009 off-the-shelf AdenoVerse immunotherapy). Comparable as a peer in gene-based oncology platforms.
- Sorrento Therapeutics: Sorrento Therapeutics is a clinical-stage biopharmaceutical company developing immuno-oncology therapies including oncolytic virus platforms (Seprehvec) and cellular therapies. Comparable given its diversified immunotherapy portfolio including virotherapy.
Others
- LumaBridge (Cancer Insight): LumaBridge is an oncology-focused clinical research organization (CRO) founded by Dr. George Peoples (a Calidi board member). Relevant as a contract clinical development services peer that supports similar early-stage oncology immunotherapy trials.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat4 records
Key risks6 records
Key highlights6 records
Customer concentration
Calidi Biotherapeutics social profiles
Digital presenceCalidi Biotherapeutics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Calidi Biotherapeutics leadership team
Management profileNumber of profiles
Profiles13 records
Calidi Biotherapeutics subsidiaries and ownership
Company hierarchySubsidiaries2 records
Calidi Biotherapeutics funding detail
Funding detailFunding overview
Funding rounds18 records
Investors4 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Calidi Biotherapeutics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Calidi Biotherapeutics
What does Calidi Biotherapeutics do?
Calidi Biotherapeutics is a clinical-stage biotechnology company developing oncolytic virus-based immunotherapies delivered through proprietary stem cell and enveloped virotherapy platforms for the treatment of solid tumors. Its product candidates include CLD-101 (NeuroNova) for high-grade glioma, CLD-201 (SuperNova) for soft tissue sarcoma, CLD-401 (RedTail lead) for lung and head/neck cancers, and CLD-501 (in-situ T-cell engager) for solid tumors. The company is currently pre-revenue and monetizes through licensing agreements (e.g., VetStem) and expects future revenue from FDA-approved oncology therapeutics and platform licensing.
Is Calidi Biotherapeutics a public or private company?
Calidi Biotherapeutics is a public company. It is classified as public and is currently operating.
When was Calidi Biotherapeutics founded?
Calidi Biotherapeutics was founded in 2015. It employs 11 to 50 people.
Where is Calidi Biotherapeutics based?
Calidi Biotherapeutics is headquartered in San Diego, United States, in the North America region.
How does Calidi Biotherapeutics make money?
Three revenue lines are on record. Drug Development and Commercialization is the primary driver. The others are partnerships and Licensing and veterinary License (VetStem).
Who are Calidi Biotherapeutics's main competitors?
Direct peers on record are Replimune Group, Genelux Corporation, Targovax and Oncorus. Emerging players are CG Oncology and Adagene. Broad incumbents are ImmunityBio, Precigen and Sorrento Therapeutics. LumaBridge (Cancer Insight) is listed as an others.
Does Calidi Biotherapeutics have an API?
No public API is recorded for Calidi Biotherapeutics.
What industry is Calidi Biotherapeutics in?
Calidi Biotherapeutics's product category is Oncology Biopharmaceuticals. Its primary akta.pro industry code is HLAAACAF, Oncology Gene Therapies (incl. oncolytic vectors & gene-modified approaches), with a secondary code of HLAIAAAC, Oncology & Hematology Pharmaceuticals. Its NAICS code is 325414 and its SIC code is 2836.