What Orna Therapeutics does

Orna Therapeutics is a clinical-stage biotechnology company that develops engineered circular RNA (oRNA®) therapeutics paired with proprietary lipid nanoparticle (LNP) delivery systems for the treatment of cancer, autoimmune diseases, genetic disorders, and infectious disease. The company's core platform replaces linear mRNA with self-circularized RNA constructs that exhibit greater stability, longer half-life, simplified manufacturing, lower immunogenicity, and higher protein expression via engineered IRES elements. Orna's technology stack is anchored by four interlocking modules: the oRNA® circular RNA platform, non-hepatic LNP formulations, the panCAR™ in vivo CAR delivery platform (which generates CAR-T, CAR-NK, and CAR-Mac cells simultaneously without lymphodepletion or ex vivo manufacturing), and the STEM™ LNP platform for in vivo gene editing in bone marrow. Discovery is supported by the FoRCE™ high-throughput screening platform for oRNA variant optimization.

Orna's lead clinical candidate, ORN-252, is an anti-CD19 in vivo CAR-T therapy targeting B cell-driven autoimmune diseases such as lupus, rheumatoid arthritis, and myasthenia gravis; the company described the program as clinical-trial-ready with an IND/CTA submission planned for 2025 and first-in-human studies anticipated in 2026. Additional pipeline programs include an anti-CD19/anti-BCMA in vivo CAR for B cell malignancies, an in vivo gene editing program for sickle cell disease and beta-thalassemia (through a Vertex collaboration), and an infectious disease vaccine program (through a Merck collaboration). As of the latest available data, Orna had no commercial products and no publicly disclosed product pricing.

Orna has operated a partnership-driven business model rather than building an internal commercial sales force, monetizing its platform through large licensing and collaboration agreements with major pharmaceutical partners (Merck up to $3.75 billion, Vertex up to $4.35 billion, and Simnova Biotherapeutics for the China market). The company raised a $221 million Series B in August 2022 at an implied valuation above $1.5 billion and acquired ReNAgade Therapeutics in May 2024 to add LNP delivery capability in-house. On February 9, 2026, Eli Lilly and Company announced a definitive agreement to acquire Orna for up to $2.4 billion in cash (upfront plus milestone payments), following which Orna operates as a wholly owned subsidiary of Eli Lilly; commercialization of ORN-252 and the broader oRNA platform is expected to occur through Lilly's enterprise infrastructure.

Name

Orna Therapeutics

Legal name

Orna Therapeutics, Inc.

Website

https://ornatx.com

Company type

Private

Founded year

2019

Operating status

Acquired

Headcount range

101–250 employees

Short description

Orna Therapeutics is a clinical-stage biotechnology company developing engineered circular RNA (oRNA®) therapeutics and proprietary non-hepatic LNP delivery for autoimmune, oncology, genetic, and infectious diseases, now operating as a wholly owned subsidiary of Eli Lilly and Company.

Ownership category

akta.pro rank

Product category

RNA Therapeutics

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Pharmaceutical Preparation Manufacturing (325412)

SIC

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

akta.pro primary industry

RNA Therapeutics Platforms & Design (sequence design, target ID/validation, AI/bioinformatics) (HLAAADAG)

akta.pro secondary industries

RNA Delivery Technologies (LNPs, polymers, conjugates incl. GalNAc, peptides, exosomes) (HLAAADAD), mRNA Therapeutics (vaccines, protein replacement, immuno-oncology) (HLAAADAA), RNA Chemistry & Oligonucleotide Engineering (backbones, modifications, stereochemistry) (HLAAADAE)

Keywords

• Circular RNA therapeutics
• Lipid nanoparticle delivery
• In vivo cell therapy
• Gene editing delivery
• RNA therapeutic platform

Headquarters

HQ city

Cambridge

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Technology licensing and milestone payments: Pre-commercial revenue generated through collaboration agreements with major pharmaceutical partners, including upfront payments, research funding, and milestone-based payments tied to development and commercialization achievements. Example: Vertex collaboration valued up to $4.35B; Merck collaboration valued up to $3.75B with $150M upfront and up to $3.5B in milestones.
2. Venture capital financing: Pre-revenue startup funding via equity rounds, including a $221 million Series B financing in August 2022 led by BioImpact Capital at a Series B valuation over $1.5 billion.
3. Strategic acquisition value (Eli Lilly): Company acquired by Eli Lilly in February 2026 for up to $2.4 billion in cash (upfront plus milestone payments), transitioning the business into a wholly owned subsidiary model with future value captured through Lilly's commercialization of ORN-252 and the oRNA platform.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels3 records

Core offering

Orna Therapeutics develops engineered circular RNA (oRNA®) therapeutics paired with proprietary lipid nanoparticle (LNP) delivery systems for in vivo cell engineering and gene editing. The platform enables off-the-shelf, redosable treatments for oncology, autoimmune diseases, infectious disease, and genetic blood disorders, with lead candidate ORN-252 (anti-CD19 in vivo CAR-T for B cell-driven autoimmune diseases) and partnered programs with Merck (vaccines), Vertex (gene editing for sickle cell disease and beta-thalassemia), and Simnova (oncology/China market).

Product overview

Orna Therapeutics offers a unified circular RNA therapeutics platform composed of multiple interlocking modules: the core oRNA® (engineered circular RNA) technology, novel LNP delivery solutions, the panCAR™ in vivo CAR delivery platform, the STEM™ bone marrow delivery platform, and the FoRCE™ high-throughput screening platform. The pipeline products — led by ORN-252 (anti-CD19 in vivo CAR-T for B cell-driven autoimmune diseases) and the anti-CD19 / anti-BCMA in vivo CAR program for B cell malignancies (partnered with Simnova) — are built directly on this oRNA® + LNP platform stack. Additional partnered programs include a gene editing collaboration with Vertex for sickle cell disease and beta thalassemia, and an infectious disease vaccine collaboration with Merck. Since February 2026, Orna has operated as a wholly owned subsidiary of Eli Lilly and Company.

Differentiator

Problem solved

Functional benefit

Brands

• oRNA®: Engineered circular RNA platform developed by Orna, used as the foundation of Orna's therapeutic programs.
• panCAR™
• FoRCE™ (Formulated oRNA Cell-based Evaluation)
• SiTu Editing in the Marrow (STEM)™
• OROBOROS

Products and services

• oRNA® (engineered circular RNA) Orna's proprietary engineered circular RNA platform formed by self-circularization from a linear RNA precursor. oRNA offers simplified production (no caps, tails, or modified nucleotides), simple purification with lower immune reaction risk, longer RNA half-life, increased protein expression via IRES function discoveries, larger cargo capacity, and easier formulation into lipid nanoparticles. Sold/licensed to pharma partners as a standalone platform technology.
• panCAR™ in vivo CAR delivery platform In vivo CAR delivery platform combining oRNA® technology with proprietary LNPs to modify immune cells within a patient without lymphodepletion. Generates CAR-T, CAR-NK, and CAR-Mac cells at once in an off-the-shelf, easily redosable format for oncology and autoimmune indications. Licensed as a standalone platform.
• STEM™ (SiTu Editing in the Marrow) LNP delivery platform targeting stem cells in the bone marrow using passive targeting, enabling potential treatment of certain genetic diseases such as sickle cell disease and beta-thalassemia directly in the bone marrow without requiring ex vivo cell extraction. Licensed as a standalone platform.
• FoRCE™ (Formulated oRNA Cell-based Evaluation) High-throughput screening platform that evaluates thousands of oRNA variants in LNPs across multiple cell types to identify optimal sequences with ideal performance; adapts viral expression elements into oRNA constructs to increase potency by orders of magnitude.
• ORN-252 Orna's lead clinical-trial-ready in vivo CAR-T cell therapy targeting CD19, using circular RNA paired with lipid nanoparticles to treat B cell-driven autoimmune diseases such as lupus and rheumatoid arthritis. Demonstrated robust B cell depletion in non-human primate models; Phase 1 clinical trial application anticipated in 2025-2026.
• Anti-CD19 / Anti-BCMA in vivo CAR program (B cell malignancies) Pipeline program targeting B cell malignancies (lymphoma, multiple myeloma, leukemia) using an anti-CD19 / anti-BCMA in vivo CAR approach with panCAR™ delivery, partnered with Simnova Biotherapeutics for CAR proteins, rapid early clinical assessment, and China market access.
• Gene editing program (sickle cell disease and beta-thalassemia) Collaboration with Vertex Pharmaceuticals leveraging Orna's differentiated LNP delivery solutions and STEM™ bone marrow-targeted platform to support Vertex's efforts in developing next-generation gene editing therapies for sickle cell disease and beta-thalassemia.
• Infectious disease vaccine program Collaboration with Merck leveraging the potency and durability of Orna's oRNA® platform coupled with novel LNP delivery insights to develop next-generation vaccine candidates using protective antigens and other strategies, targeting undisclosed antigens with potential application to multiple pathogens.

Quantifiable outcome

• Robust B cell depletion demonstrated in non-human primate models supporting in vivo panCAR approach
• +3 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Four partnerships are on record, tiered flagship partnership and core partnership.

• Eli Lilly and Companyflagship partnershipStrategic or Co-development Partner · 9 February 2026Eli Lilly acquired Orna Therapeutics for up to $2.4 billion in cash (including upfront and milestone-based payments); the deal provides Lilly with Orna's oRNA platform and lead asset ORN-252 (clinical-trial-ready anti-CD19 in vivo CAR-T for B cell-driven autoimmune diseases). Transaction announced February 9, 2026, expected to close in first half of 2026. Orna now operates as a wholly owned subsidiary of Eli Lilly.
• Vertex Pharmaceuticalsflagship partnershipStrategic or Co-development Partner · 1 January 2025Vertex collaboration (valued up to $4.35 billion) leverages Orna's differentiated LNP delivery solutions to enhance Vertex's efforts in developing next-generation gene editing therapies. Pipeline focuses on sickle cell disease and beta-thalassemia through Orna's STEM™ (SiTu Editing in the Marrow) bone marrow-targeted LNP delivery platform. Pre-existing collaboration that was anticipated to raise antitrust considerations following Lilly's acquisition.
• Simnova Biotherapeuticscore partnershipStrategic or Co-development Partner · 1 May 2024Partnership provides access to CAR proteins, rapid early clinical assessment, and the China market for multiple potential oncology therapies. Targets anti-CD19 / anti-BCMA in vivo CAR for B cell malignancies using Orna's panCAR™ platform. Originated in 2024 alongside Orna's acquisition of ReNAgade Therapeutics.
• Merck & Co.flagship partnershipStrategic or Co-development Partner · 1 August 2022Orna is collaborating with Merck to develop the next generation of vaccine candidates by leveraging the potency and durability of the oRNA® platform with novel LNP delivery insights. The 2022 BioImpact Capital-announced collaboration covering vaccines and cancer treatments was valued up to $3.75 billion with $150 million upfront and up to $3.5 billion in milestones; pipeline page lists 'Infectious disease & others / Protective antigens & other strategies' as the Merck collaboration track.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Laronde Therapeutics (now Sail Biomedicines): Pioneer in engineered circular RNA therapeutics (eRNA) and a founding competitor in the same modality category as Orna's oRNA® platform, with comparable long-duration, redosable protein expression strategy.
• Beam Therapeutics: In vivo and ex vivo base editing therapeutics targeting sickle cell disease, beta-thalassemia, and other genetic diseases — directly comparable to Orna's STEM™-enabled in vivo gene editing programs and to the partnered Vertex program.
• Verve Therapeutics: In vivo base editing for cardiovascular and other genetic diseases using LNP delivery; shares Orna's focus on in vivo delivery (LNP-based) for genetic diseases and competes for the same non-hepatic LNP targeting advances.
• Cabaletta Bio: Clinical-stage CAR-T developer focused on B cell-driven autoimmune diseases (lupus, myositis, etc.) using CD19-directed cell therapy; directly competes with ORN-252 for the same autoimmune patient population and physician audience.

Emerging players

• Strand Therapeutics: Develops self-replicating and circular RNA-based programmable therapeutics for oncology and other diseases; shares Orna's focus on next-generation RNA constructs and programmable gene expression.

Broad incumbents

• Moderna: Leader in linear mRNA therapeutics and LNP delivery, with deep resources targeting vaccines, oncology, rare diseases, and autoimmune indications — the modality incumbent against which oRNA® competes for share.
• Alnylam Pharmaceuticals: Established RNA-based therapeutics company (siRNA platform) with deep CMC and LNP manufacturing expertise; Orna's CTO Siva Sakhamuri was previously VP of Manufacturing at Alnylam, and both companies target genetically defined diseases.
• Vertex Pharmaceuticals: Flagship Orna collaboration partner (up to $4.35B) and a major player in sickle cell disease/beta-thalassemia via Casgevy (ex vivo gene editing); a comparable counterparty in the gene-editing therapeutic space and potential competitive threat post-Lilly acquisition.
• Intellia Therapeutics: In vivo CRISPR/Cas9 gene editing platform using LNP delivery for genetic diseases and oncology; directly comparable to Orna's STEM™ platform and in vivo editing ambitions.
• BioNTech: Global mRNA therapeutics leader with extensive vaccine, oncology, and cell therapy pipelines, plus LNP delivery expertise; the European incumbent against which circular RNA platforms will compete for share.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/orna_tx
• LinkedInlinkedin.com/company/ornatx

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Subsidiaries1 record

Funding overview

Funding rounds3 records

Investors10 records

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M&A1 record

Investments

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

Frequently asked questions about Orna Therapeutics