Cytodyn

What Cytodyn does

CytoDyn Inc. (OTCQB: CYDY) is a publicly traded, clinical-stage biotechnology company founded in 2002 and headquartered in Vancouver, Washington. The company is focused exclusively on developing leronlimab, a first-in-class humanized IgG4 monoclonal antibody that targets the C-C chemokine receptor type 5 (CCR5). CCR5 is implicated in tumor metastasis, immune signaling, and infection, and leronlimab's mechanism — receptor antagonism — is designed to modulate the tumor microenvironment, enhance immune engagement, and potentially sensitize tumors to immune checkpoint inhibitors. CytoDyn's strategic emphasis has pivoted from its historical HIV application toward solid-tumor oncology, with primary development programs in metastatic triple-negative breast cancer (mTNBC) and metastatic colorectal cancer (mCRC), and exploratory programs in glioblastoma and Alzheimer's disease.

The company's clinical pipeline includes the Phase 2 CLOVER study in CCR5-positive, microsatellite-stable relapsed/refractory mCRC (enrollment completed with ~60 patients across 7 U.S. sites), an Expanded Access Program for mTNBC managed via WEP Clinical, and a Phase 2a SALIENT-AD study in collaboration with Weill Cornell Medicine evaluating leronlimab in early-stage Alzheimer's disease. Reported translational signals include 70% median ctDNA decline at week 2 in the first 19 mCRC patients dosed at City of Hope, 88% PD-L1 induction on circulating tumor cells in metastatic breast cancer patients at doses above 525 mg/week, and 17.9% (5/28) long-term survival beyond 60 months in a retrospective mTNBC pooled analysis.

CytoDyn is pre-revenue with no approved commercial products. Its revenue model, when and if leronlimab is approved, contemplates licensing/royalty economics and traditional pharmaceutical distribution; currently the company monetizes exclusively through equity financings. Headcount is 11-50 employees, capital is sourced from a $30 million Yorkville Advisors SEPA (November 2025) and a $17.5 million private placement (March 2026), with operations funded through 2027 following a renegotiation of a $57 million Chicago Ventures debt obligation at a reduced 5% interest rate. The company is governed by a Board including Tanya Durkee Urbach, Stephen M. Simes, Ryan Dunlap, Karen J. Brunke, and Lishomwa C. Ndhlovu, with Dr. Jacob Lalezari as CEO and Robert E. Hoffman as CFO.

Name

Cytodyn

Legal name

CytoDyn Inc.

Website

https://cytodyn.com

Company type

Public

Founded year

2002

Operating status

Operating

Headcount range

11–50 employees

Short description

CytoDyn is a clinical-stage biotechnology company developing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor, for solid-tumor oncology indications including metastatic triple-negative breast cancer and colorectal cancer, with exploratory programs in Alzheimer's disease.

Ownership category

akta.pro rank

Product category

Oncology Biopharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Monoclonal Antibody Therapeutics (mAbs) (HLAAAAAA)

akta.pro secondary industries

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC), Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB)

Keywords

• Monoclonal antibody therapeutics
• Clinical-stage biotechnology
• CCR5 receptor antagonism
• Solid-tumor oncology drugs
• Immunotherapy drug development

Headquarters

HQ city

Vancouver

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, Supply Chain, Others

Revenue model

1. Drug Development and Commercialization: CytoDyn is a clinical-stage biotechnology company with no current commercial revenue. The company is developing leronlimab as an investigational drug for multiple oncology indications. Revenue will depend on successful clinical development, regulatory approval, and eventual commercialization of leronlimab or potential partnerships/licensing agreements.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels6 records

Core offering

CytoDyn is a clinical-stage biotechnology company developing leronlimab, a first-in-class humanized IgG4 monoclonal antibody that targets the CCR5 receptor. The drug is being advanced across multiple solid-tumor oncology indications including metastatic triple-negative breast cancer (mTNBC), metastatic colorectal cancer (mCRC), and glioblastoma, with exploratory programs in Alzheimer's disease. The company operates through clinical trials and expanded access programs and has not yet received regulatory approval or commercialized any product.

Product overview

CytoDyn is a clinical-stage oncology company with a single core therapeutic product in development: leronlimab, a humanized monoclonal antibody targeting the CCR5 receptor. The company does not operate a platform-plus-modules or multi-product software architecture. Leronlimab is the sole drug candidate and is being advanced across multiple solid-tumor oncology indications (metastatic triple-negative breast cancer, metastatic colorectal cancer, glioblastoma) as well as exploratory programs in Alzheimer's disease and autoimmune conditions, either through proprietary clinical trials or collaborative partnerships for biomarker analysis and patient access programs.

Differentiator

Problem solved

Functional benefit

Products and services

• Leronlimab

Quantifiable outcome

• 70% median ctDNA decline at week 2 in mCRC patients (N=19)
• +4 more outcomes

Named customers3 records

Segments4 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

Five partnerships are on record, tiered core and supporting.

• Weill Cornell MedicinecoreStrategic or Co-development Partner · 11 June 2026Collaboration for Phase 2a SALIENT-AD study evaluating leronlimab in patients with early-stage, biomarker-confirmed Alzheimer's disease. The study will enroll approximately 10-20 patients over age 50 receiving weekly subcutaneous injections over a 12-week treatment period, with primary endpoint assessing brain inflammation and microglial activation using PET imaging.
• NateracoreStrategic or Co-development Partner · 4 June 2026Strategic collaboration to evaluate circulating tumor DNA (ctDNA) dynamics using Natera's Signatera personalized MRD assay in CytoDyn's CLOVER Phase 2 study for metastatic colorectal cancer. Natera will analyze clinical trial samples and provide real-world data analyses from its proprietary oncology database containing over 2 million plasma timepoints to generate insights into molecular response and disease progression.
• AI-Driven Drug Discovery Company (unnamed)supportingTechnology or Integration · 5 March 2026Joint development agreement with a third-party AI drug discovery company to develop longer-acting molecules derived from leronlimab.
• Creatv BiosupportingTechnology or Integration · 3 March 2026Collaboration using Creatv Bio's LifeTracDx liquid biopsy PD-L1 test as an exploratory biomarker in CytoDyn's Phase 2 clinical trial for relapsed/refractory metastatic colorectal cancer. The blood test monitors tumor response and immune microenvironment changes through biomarkers like PD-L1 expression.
• With Every Patient (WEP Clinical)supportingImplementation/ SI/ Consulting Partner · 27 January 2026Engaged as Clinical Research Organization (CRO) to manage CytoDyn's Expanded Access Program for patients with triple-negative breast cancer. WEP Clinical supports patient identification, site coordination, and regulatory compliance for the compassionate access program.

Scale indicators7 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Trillium Therapeutics: Developed anti-CCR5 (and SIRPα-CD47) antibodies for oncology; acquired by Pfizer in 2021. Most direct comparable on the CCR5 antibody mechanism that CytoDyn's leronlimab also pursues.
• MacroGenics: Clinical-stage biotech developing monoclonal antibodies for oncology (e.g., margetuximab, enoblituzumab), with a comparable single-platform mAb model, similar clinical-stage risk profile, and overlapping oncology indications.
• CytomX Therapeutics: Clinical-stage oncology biotech using antibody-based platforms (Probody) for solid tumors; comparable in being a clinical-stage mAb developer targeting difficult solid-tumor settings.

Emerging players

• Compugen: Clinical-stage immuno-oncology biotech using computational discovery to identify novel antibody targets; comparable in targeting tumor-microenvironment immune mechanisms with antibody therapeutics.
• BioXcel Therapeutics: Clinical-stage biotech developing therapeutics in oncology and neuroscience; comparable size, clinical-stage profile, and multi-indication approach akin to CytoDyn's oncology plus Alzheimer's strategy.
• Vigil Neuroscience: Clinical-stage biotech developing therapeutics targeting microglia-driven neuroinflammation in Alzheimer's disease; directly comparable to CytoDyn's leronlimab Alzheimer's program via the CCR5/microglia mechanism.

Broad incumbents

• ImmunoGen (now part of AbbVie): Developed antibody-based therapeutics for cancer (e.g., mirvetuximab, Elahere); exemplifies the clinical-stage-to-commercial oncology antibody path CytoDyn is pursuing with leronlimab.
• Bristol-Myers Squibb: Major oncology incumbent with checkpoint inhibitors (Opdivo, Yervoy) that CytoDyn's leronlimab could combine with; represents both a competitive threat and a potential strategic acquirer/partner.
• Merck & Co. Owns Keytruda, the dominant checkpoint inhibitor that CytoDyn seeks to combine with via PD-L1 upregulation; a primary competitor and a likely strategic suitor if leronlimab data are supportive.
• Takeda Pharmaceutical: Markets the small-molecule CCR5 antagonist maraviroc (Celsentri/Selzentry) for HIV and has explored CCR5 in oncology; relevant incumbent peer given the shared CCR5 mechanism.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/cytodyn-inc
• Xx.com/cytodyn

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds14 records

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 Cytodyn