Cytodyn
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.
- Company typePublic
- Founded2002
- HeadquartersVancouver, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
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.
Cytodyn firmographics
Firmographics- 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
Cytodyn industry classification
Industry- 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
Where Cytodyn is headquartered
LocationHeadquarters
- HQ city
- Vancouver
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Cytodyn business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Supply Chain, Others
Revenue model
- 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
Cytodyn product offering
Product offeringCore 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
Companies that use Cytodyn
Customer profileNamed customers3 records
Segments4 records
Ideal customer profiles2 records
Cytodyn technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Cytodyn partnerships and signals
Strategic signalPartnerships
Five partnerships are on record, tiered core and supporting.
- Weill Cornell MedicinecoreCollaboration 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 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)supportingJoint development agreement with a third-party AI drug discovery company to develop longer-acting molecules derived from leronlimab.
- Creatv BiosupportingCollaboration 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)supportingEngaged 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
Cytodyn competitors and assessment
Company assessmentDirect 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
Cytodyn social profiles
Digital presenceCytodyn financial estimates
Financial estimateRevenue estimate
Valuation estimate
Cytodyn leadership team
Management profileNumber of profiles
Profiles12 records
Cytodyn funding detail
Funding detailFunding overview
Funding rounds14 records
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Cytodyn 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 Cytodyn
What does Cytodyn do?
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.
Is Cytodyn a public or private company?
Cytodyn is a public company. It is classified as public and is currently operating.
When was Cytodyn founded?
Cytodyn was founded in 2002. It employs 11 to 50 people.
Where is Cytodyn based?
Cytodyn is headquartered in Vancouver, United States, in the North America region.
How does Cytodyn make money?
One revenue line is on record: drug Development and Commercialization.
Who are Cytodyn's main competitors?
Direct peers on record are Trillium Therapeutics, MacroGenics and CytomX Therapeutics. Emerging players are Compugen, BioXcel Therapeutics and Vigil Neuroscience. Broad incumbents are ImmunoGen (now part of AbbVie), Bristol-Myers Squibb, Merck & Co. and Takeda Pharmaceutical.
Does Cytodyn have an API?
No public API is recorded for Cytodyn.
What industry is Cytodyn in?
Cytodyn's product category is Oncology Biopharmaceuticals. Its primary akta.pro industry code is HLAAAAAA, Monoclonal Antibody Therapeutics (mAbs), with a secondary code of HLAIACAC, Neurology & CNS Specialty Pharmaceuticals. Its NAICS code is 325414 and its SIC code is 2836.