What Cullinan Oncology does

Cullinan Therapeutics (NASDAQ: CGEM, formerly Cullinan Oncology) is a Cambridge, Massachusetts-based clinical-stage biopharmaceutical company developing differentiated bispecific T cell engagers and targeted small molecules for cancer and autoimmune diseases. The pipeline comprises four clinical-stage assets: CLN-978, a CD19xCD3 TCE with a novel 65 kDa dual-scFv plus HSA-binding domain for subcutaneous B cell depletion in rheumatoid arthritis, systemic lupus erythematosus, and Sjögren's disease; velinotamig, an asymmetric BCMAxCD3 TCE for autoimmune cytopenias and SLE; CLN-049, an FLT3xCD3 TCE for relapsed/refractory AML and MDS that demonstrated a 31% complete response rate at the highest dose at ASH 2025; and zipalertinib, an oral next-generation irreversible EGFR exon 20 insertion tyrosine kinase inhibitor co-developed with Taiho Oncology that received FDA Breakthrough Therapy Designation in January 2022 and has an accepted NDA with a PDUFA target action date of February 27, 2027.

The company's core technology platform centers on T cell engagers that redirect cytotoxic T cells via CD3 binding to disease-driving cells expressing defined antigens (CD19, BCMA, FLT3), combined with a targeted small molecule approach for genetically defined cancer subsets. Cullinan uses a "thriller or killer" early discovery filter to advance only the most promising differentiated molecules, supported by translational research capabilities and a global clinical investigator network across oncology and rheumatology.

The business model is pre-revenue with no approved products; future revenue is expected to come from product sales upon regulatory approval, beginning with zipalertinib through Taiho Oncology's U.S. commercial channel, and potentially through partnerships or out-licensing for pipeline assets such as velinotamig (where Genrix Bio is independently developing the China program). The company maintains approximately $439M in preliminary year-end cash providing runway into 2029 and is led by CEO Nadim Ahmed, formerly President of Hematology at Bristol Myers Squibb.

Name

Cullinan Oncology

Legal name

Cullinan Therapeutics, Inc.

Website

https://cullinantherapeutics.com

Company type

Public

Founded year

2016

Operating status

Operating

Headcount range

101–250 employees

Short description

Cullinan Therapeutics (NASDAQ: CGEM) is a clinical-stage biopharmaceutical company developing bispecific T cell engagers (CLN-978, velinotamig, CLN-049) and the EGFR TKI zipalertinib for cancer and autoimmune diseases. Its pipeline targets patients with EGFR ex20ins NSCLC, AML, MDS, RA, SLE, and Sjögren's disease.

Ownership category

akta.pro rank

Product category

Clinical-stage Biopharmaceuticals (Oncology and Immunology Therapeutics)

NAICS

Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Specialty Care Pharmaceuticals (HLAIAAAB)

akta.pro secondary industry

Rare Oncology & Hematologic Malignancy Therapies (HLAIAIAC)

Keywords

• Bispecific antibody therapeutics
• T cell engagers
• Clinical-stage biopharmaceuticals
• Oncology drug development
• Autoimmune disease therapeutics

Headquarters

HQ city

Cambridge

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Product Revenue (Future): As a clinical-stage biopharmaceutical company, Cullinan does not yet have approved products generating revenue. The company is advancing a pipeline of bispecific antibodies and small molecules through clinical development toward regulatory approval and commercialization, at which point revenue would be generated through product sales.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels4 records

Core offering

Cullinan Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of differentiated bispecific T cell engagers (CLN-978, velinotamig, CLN-049) and the small-molecule EGFR inhibitor zipalertinib. Its assets target high-unmet-need populations including autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, Sjögren's disease) and cancers (EGFR ex20ins NSCLC, relapsed/refractory AML, MDS), with zipalertinib advancing toward a Feb 27, 2027 PDUFA action date.

Product overview

Cullinan Therapeutics is a clinical-stage biotech company developing a pipeline of differentiated biological therapeutics in autoimmune diseases and cancer. The company's product portfolio consists of four investigational bispecific antibodies: CLN-978 (CD19xCD3 TCE) and Velinotamig (BCMAxCD3 TCE) targeting autoimmune diseases; Zipalertinib (EGFR TKI) for NSCLC; and CLN-049 (FLT3xCD3 TCE) for AML/MDS. All products are investigational and have not been approved by health authorities.

Differentiator

Problem solved

Functional benefit

Products and services

• CLN-978 Novel CD19xCD3 bispecific T cell engager (TCE) being developed for autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, and Sjögren's disease. CLN-978 triggers redirected lysis of CD19-expressing target cells, is engineered for high affinity binding to CD19 to efficiently target B cells (including those with very low CD19 expression), and is designed for subcutaneous, off-the-shelf administration via a 65 kDa dual-scFv plus HSA-binding architecture.
• Velinotamig BCMAxCD3 bispecific T cell engager designed to simultaneously bind BCMA and CD3, redirecting cytotoxic T cells to target BCMA-expressing cells. Engineered with high affinity for BCMA and lower affinity for CD3 to recruit and activate T cells while minimizing non-specific activation and potential toxicity mediated by CD3 engagement; developed for autoimmune cytopenias and systemic lupus erythematosus.
• Zipalertinib Orally available, next-generation, irreversible EGFR tyrosine kinase inhibitor being developed in collaboration with Taiho Oncology and Taiho Pharmaceutical for the treatment of non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations. Designed to inhibit EGFR ex20ins variants while sparing wild-type EGFR.
• CLN-049 Investigational FLT3xCD3 bispecific T cell engager designed to simultaneously bind the extracellular domain of FLT3 on AML cells and the CD3 epsilon T cell receptor subunit on T cells. FLT3 (wildtype or mutant) is detected on AML cells in more than 80% of patients, making it a broadly applicable target. Being developed for relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome.

Quantifiable outcome

• CLN-049 showed 31% complete response rate at the highest dose in relapsed/refractory AML patients in Phase 1 study, with favorable safety profile (December 2025 ASH data).
• +2 more outcomes

Named customers1 record

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Two partnerships are on record, tiered core.

• Taiho Oncology / Taiho Pharmaceutical Co., Ltd.coreStrategic or Co-development PartnerZipalertinib is being developed by Taiho Oncology and its parent company Taiho Pharmaceutical in collaboration with Cullinan Therapeutics for the U.S. market. Taiho holds the NDA accepted by the FDA with PDUFA target action date of February 27, 2027. Taiho sponsors the REZILIENT2 and REZILIENT3 trials, while Cullinan co-develops the U.S. program.
• Genrix BiocoreStrategic or Co-development PartnerGenrix Bio is independently enrolling a Phase 1/2a study in China in patients with treatment-refractory autoimmune diseases, starting with moderate to severe SLE and expanding into other indications for velinotamig (BCMAxCD3 bispecific T cell engager), while Cullinan plans to initiate its own Phase 1/2a study in Q1 2027.

Scale indicators8 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Immunocore Holdings: Clinical-stage biotech with the ImmTAC platform — bispecific T cell engagers that redirect T cells to tumor targets (e.g., tebentafusp). Closest analog to Cullinan's TCE biology and oncology+autoimmune pivot.
• MacroGenics: DART and TRIDENT bispecific T cell engager platform company targeting hematologic and solid tumors (e.g., enoblituzumab, vobramitamab). Direct competitor in the CD3-bispecific antibody space.
• Genmab: Developer of the DuoBody bispecific antibody platform and creator of Epkinly (epcoritamab, CD20xCD3) — the closest commercial-stage BCMA/CD19 TCE competitor to velinotamig and CLN-978.

Broad incumbents

• Regeneron Pharmaceuticals: Develops linvoseltamab (BCMAxCD3) and broader oncology bispecific platform through VelocImmune antibodies. Competes head-on with velinotamig and CLN-049 while bringing far greater development and commercial resources.
• Bristol Myers Squibb: Sells Reblozyl (luspatercept) in MDS and is a major oncology+autoimmune incumbent. Cullinan's CEO and CMO alumni originated from BMS's hematology franchise, and BMS is the dominant autoimmune competitor (Sotyktu, Zeposia, oral lupus).
• AstraZeneca: Holds Tagrisso (osimertinib) and the EGFR-mutated NSCLC franchise that defines the competitive context for zipalertinib, and is expanding in autoimmune via Alexion. Mid-tier overlap across the Cullinan pipeline.
• AbbVie: ImmunoSet franchise leaders Skyrizi and Rinvoq and the dominant player in rheumatology. CLN-978 in RA, SLE, and Sjögren's would compete directly with AbbVie's anchored autoimmune portfolio.
• Pfizer: Large oncology pipeline including the legacy Array EGFR franchise and Elrexfio (elranatamab, BCMAxCD3) — direct competitive overlap with both zipalertinib and velinotamig.

Emerging players

• Zymeworks: Clinical-stage bispecific antibody platform (Azymetric, Zanidatamab) focused on oncology. Compares as a smaller-scale, platform-anchored TCE/biologic peer in early-to-mid clinical development.
• Disc Medicine: Clinical-stage hematology biotech addressing rare blood disorders. Cullinan's CEO Nadim Ahmed sits on Disc Medicine's board, and the company is comparable as a small-cap public hematology/rare-disease biotech.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/cullinantx

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries3 records

Funding overview

Funding rounds1 record

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Cullinan Oncology