Novellus

What Novellus does

Novellus, now doing business as Ernexa Therapeutics and publicly traded on NASDAQ under ticker ERNA, is a clinical-stage biotechnology company developing engineered allogeneic cell therapies based on a proprietary induced pluripotent stem cell (iPSC) platform. The company's core technology engineers iPSCs and differentiates them into induced mesenchymal stem cells (iMSCs), which exploit the natural tumor- and inflammation-homing properties of MSCs to deliver therapeutic cytokine payloads directly to disease sites. Its lead candidate, ERNA-101, secretes IL-7 and IL-15 cytokines to convert immunologically "cold" tumors into immune-responsive ones, with an initial indication in platinum-resistant ovarian cancer. A second candidate, ERNA-201, delivers IL-10 to inflamed tissue to reset the immune system, with an initial indication in rheumatoid arthritis. Both candidates are preclinical, with ERNA-101 advancing toward an IND submission in Q3 2026 and a planned first-in-human Phase 1 study in Q4 2026. The platform also includes B2M-knockout gene editing to reduce alloreactivity and an IL-12-engineered iPSC-derived macrophage program. Scientific foundation draws from Dr. Michael Andreeff's research at MD Anderson Cancer Center.

Ernexa is headquartered in Cambridge, Massachusetts with an additional office in San Diego, and operates with 11-50 employees under CEO Sanjeev Luther and CSO Robert H. Pierce, MD. The company is pre-commercial and generates no product revenue; its economics will depend on eventual commercialization of cell therapy products or partnership-based monetization. The company completed a $10.5 million public offering of common stock and warrants in February 2026 and executed a 1-for-25 reverse stock split effective May 4, 2026 to maintain Nasdaq listing compliance. It also reduced general and administrative expenses by approximately 61% year-over-year in 2025, signaling tight capital discipline heading into the clinical phase. Historical financing includes a $57 million private round in September 2020 from Cormorant Asset Management, HBM Healthcare Investments, Novartis Venture Fund, OrbiMed, Pontifax (lead), and Wellington Management.

The company's go-to-market motion is sales-led and partnership-oriented, targeting pharmaceutical partners for co-development of combination regimens with ERNA-101 alongside checkpoint inhibitors, CAR-T cells, bispecific T-cell engagers, and tumor-infiltrating lymphocytes. Geographic expansion is signaled through selection into the JETRO Japan Entry Acceleration Program (JEAP) in January 2026, with planned partnership exploration in Japan. Investor communications are conducted through a dedicated investor relations portal, GlobeNewswire press release distribution, virtual investor events, and scientific conference presentations at AACR, ASGCT, and ISSCR. Pre-commercial cell therapy distribution will initially flow through clinical trial sites at leading oncology centers, then through traditional pharmaceutical channels upon regulatory approval.

Name

Novellus

Legal name

Ernexa Therapeutics

Website

https://novellustx.com

Company type

Public

Founded year

2014

Operating status

Operating

Headcount range

11–50 employees

Short description

Novellus (now Ernexa Therapeutics) is a clinical-stage biotechnology company developing engineered allogeneic iPSC-derived mesenchymal stem cell therapies for advanced cancer and autoimmune disease, with lead candidate ERNA-101 advancing toward Phase 1 trials in platinum-resistant ovarian cancer.

Ownership category

akta.pro rank

Product category

Engineered Cell Therapy

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Stem Cell Therapies (MSC/iPSC/HSC-derived) (HLAAABAE)

akta.pro secondary industries

Cell Therapy Developers (Allogeneic/Off-the-shelf) (HLAAABAB), Regenerative Immunology & Inflammation Modulation (pro-regenerative biologics) (HLAAAGAL), Cell Therapy Enabling Technologies (gene editing, cell engineering, delivery methods) (HLAAABAL)

Keywords

• Engineered cell therapy
• Allogeneic iPSC therapy
• Cancer immunotherapy
• Autoimmune disease therapy
• Mesenchymal stem cells

Headquarters

HQ city

Cambridge

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Cell Therapy Product Revenue: Pre-commercial stage biotechnology company developing novel cell therapies (ERNA-101 for ovarian cancer, ERNA-201 for autoimmune disease) that will be commercialized upon regulatory approval. Revenue will come from product sales upon successful clinical development and regulatory clearance.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Novellus (Ernexa Therapeutics) engineers induced pluripotent stem cells (iPSCs) and differentiates them into induced mesenchymal stem cells (iMSCs) that home to tumors or sites of inflammation and deliver therapeutic cytokine payloads. Its lead candidate ERNA-101 secretes IL-7/IL-15 to activate T cells and NK cells in the tumor microenvironment for platinum-resistant ovarian cancer, while ERNA-201 delivers IL-10 to suppress inflammation for autoimmune diseases such as rheumatoid arthritis. The allogeneic, off-the-shelf approach eliminates the need for patient-specific cell harvesting.

Product overview

Ernexa Therapeutics is developing a portfolio of off-the-shelf, synthetic cell therapies based on its proprietary iMSC (induced mesenchymal stem cell) platform. The platform engineers induced pluripotent stem cells (iPSCs) into synthetic iMSCs that can home to sites of disease (tumors or inflammation) and deliver therapeutic cytokine payloads. The core product portfolio includes: (1) ERNA-101, the lead oncology candidate delivering IL-7/IL-15 cytokines for treatment of platinum-resistant ovarian cancer, currently advancing toward IND submission (Q3 2026) and first-in-human trials (Q4 2026); and (2) ERNA-201, an anti-inflammatory candidate delivering IL-10 for autoimmune diseases starting with rheumatoid arthritis. Both products leverage the same iMSC platform technology but target different therapeutic endpoints through different cytokine payloads.

Differentiator

Problem solved

Functional benefit

Products and services

• ERNA-101 Lead cell therapy candidate: engineered allogeneic induced mesenchymal stem cells (iMSCs) derived from iPSCs, designed to home to tumors and deliver an IL-7/IL-15 fusion cytokine directly into the tumor microenvironment to activate T cells and NK cells. Initial indication is platinum-resistant ovarian cancer; preclinical data showed complete tumor elimination and 100% survival when combined with PD-1 blockade.
• ERNA-201 Cell therapy candidate: engineered iMSCs designed to deliver IL-10 anti-inflammatory cytokine directly to sites of inflammation, converting inflammatory macrophages into an anti-inflammatory state to reset the immune system. Initial indication is rheumatoid arthritis, with potential expansion to broader autoimmune diseases.
• iMSC Platform Proprietary allogeneic platform technology: engineering induced pluripotent stem cells (iPSCs) and differentiating them into synthetic induced mesenchymal stem cells (iMSCs) that leverage MSC natural tumor- and inflammation-homing biology to deliver therapeutic cytokine payloads precisely where needed.

Quantifiable outcome

• Complete tumor clearance and 100% long-term survival in preclinical ovarian cancer models when ERNA-101 combined with PD-1 blockade
• +4 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Three partnerships are on record, tiered core.

• Japan External Trade Organization (JETRO)coreStrategic or Co-development Partner · 27 January 2026Selected as one of ten companies globally for the Japan Entry Acceleration Program (JEAP), JETRO's first acceleration program for overseas startups. Program provides expert-led mentoring, market-entry guidance on Japan's regulatory, clinical and commercial landscape, and engagement opportunities with Japanese R&D organizations including CDMOs and CROs for potential collaborations in development, manufacturing, and clinical execution.
• The University of Texas MD Anderson Cancer CentercoreStrategic or Co-development PartnerFoundational research by Dr. Michael Andreeff from MD Anderson demonstrated that engineered mesenchymal stem cells can successfully home to tumor sites, deliver immunostimulatory molecules, and reduce tumor burden in preclinical ovarian cancer models. This work forms the scientific foundation for Ernexa's iMSC platform and ERNA-101 program.
• Potential Big-Pharma CollaboratorscoreStrategic or Co-development PartnerErnexa is evaluating potential co-development partnerships with major pharmaceutical companies for ERNA-101 in combination with immunotherapies including CAR-T, bispecific T-cell engagers, checkpoint inhibitors, and tumor-infiltrating lymphocytes. The company also anticipates potential Phase 2 co-development partnership opportunities in 2H 2027.

Scale indicators8 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Fate Therapeutics: Clinical-stage iPSC-derived cell therapy company developing off-the-shelf NK and T-cell cancer therapies. Most directly comparable to Ernexa as both are built on iPSC platforms for allogeneic cancer cell therapy, though Fate has greater scale and more advanced clinical assets.
• Century Therapeutics: Allogeneic iPSC-derived cell therapy developer focused on hematologic and solid tumor malignancies using engineered NK and T cells. Comparable to Ernexa in iPSC platform origin and allogeneic off-the-shelf delivery, with broader multi-modality engineering.
• Mesoblast: Commercial-stage cell therapy company developing mesenchymal stem cell (MSC)-based therapies for inflammatory and immunologic diseases, including acute graft-versus-host disease. Comparable MSC platform addressing autoimmune/inflammatory indications paralleling Ernexa's ERNA-201.
• Nkarta: Clinical-stage allogeneic NK cell therapy company for cancer using engineered NK cells with chimeric antigen receptors. Comparable allogeneic off-the-shelf approach for solid tumors and hematologic malignancies, though NK rather than MSC chassis.
• Pluristem Therapeutics: Cell therapy company using placenta-derived mesenchymal-like adherent stromal cells (PLX cells) for inflammatory and ischemic diseases. Comparable MSC-derived allogeneic cell therapy platform with off-the-shelf delivery, though earlier-stage placental rather than iPSC source.
• Athersys: Clinical-stage cell therapy company developing MultiStem (multipotent adult progenitor cells) for inflammatory and autoimmune conditions including ARDS and ischemic stroke. Comparable allogeneic cell therapy targeting inflammatory diseases with similar indications to ERNA-201.
• Atara Biotherapeutics: Allogeneic T-cell and NK cell therapy company developing off-the-shelf cellular immunotherapies, notably tabelecleucel for post-transplant lymphoproliferative disease and autoimmune applications. Comparable allogeneic cell therapy approach across oncology and autoimmune indications.

Broad incumbents

• Crispr Therapeutics: Clinical-stage gene-editing company with partnered programs (Casgevy with Vertex) and allogeneic CAR-T cell therapy pipeline. Comparable gene-editing capability (Ernexa uses B2M-KO) and cell therapy approach, but at substantially greater scale and with approved products.

Emerging players

• Vor Biopharma: Clinical-stage cell therapy and gene editing company engineering hematopoietic stem cells (HSCs) for cancer. Comparable gene-editing modality and allogeneic cell therapy approach, focused on hematologic malignancies.
• Caribou Biosciences: Clinical-stage allogeneic CAR-T cell therapy company using CRISPR gene editing platform. Comparable gene-edited allogeneic cell therapy approach, though with CAR-T rather than MSC chassis.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/novellus-inc
• Xx.com/NovellusInc

Revenue estimate

Valuation estimate

Number of profiles

Profiles18 records

Funding overview

Funding rounds2 records

Investors6 records

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M&A

Investments

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

Frequently asked questions about Novellus