Oncolytics Biotech

What Oncolytics Biotech does

Oncolytics Biotech Inc. is a clinical-stage biopharmaceutical company developing pelareorep, a first-in-class, intravenously delivered double-stranded RNA (dsRNA) immunotherapeutic agent for gastrointestinal cancers. Pelareorep selectively infects tumor cells with RAS pathway mutations, replicates to produce dsRNA, lyses tumor cells, and initiates innate and adaptive immune responses — converting immunologically cold tumors to hot tumors via PD-L1 upregulation, chemokine/cytokine release, and tertiary lymphoid structure formation. The platform has been evaluated in over 1,300 patients with a favorable safety profile and is being advanced in three lead GI indications: metastatic pancreatic ductal adenocarcinoma (mPDAC), KRAS-mutant microsatellite-stable metastatic colorectal cancer (mCRC), and unresectable squamous cell anal carcinoma (SCAC). The company has FDA Fast Track Designation in mCRC and has secured FDA alignment on pivotal trial designs for first-line mPDAC (November 2025) and second-line SCAC (April 2026).

The company is publicly listed on NASDAQ (ONCY) and TSX (ONC), completed its reincorporation from Alberta, Canada to Nevada, USA on March 31, 2026, and now operates from San Diego. Because pelareorep is investigational and not yet approved, Oncolytics generates no product revenue; the business model is R&D-driven with future value contingent on FDA approval and either independent commercialization or — more likely given leadership pedigree — a partnership, licensing, or sale transaction with a large pharmaceutical partner (existing relationships include Roche, Pfizer, Merck KGaA, and Incyte for checkpoint-inhibitor supply and combination development). Capital formation has been primarily through equity (~$35M raised in 2023–2025) and non-dilutive grants ($5M PanCAN Therapeutic Accelerator Award, 2023). Recent strategic priorities include registrational-trial execution, capital-efficient pipeline focus (GOBLET Cohort 5 in pancreatic cancer was discontinued in February 2026), and IP extension (new U.S. manufacturing patent granted June 2026, protection into 2044).

Name

Oncolytics Biotech

Legal name

Oncolytics Biotech Inc.

Website

https://oncolyticsbiotech.com

Company type

Public

Founded year

1999

Operating status

Operating

Headcount range

11–50 employees

Short description

Oncolytics Biotech is a clinical-stage biopharmaceutical company developing pelareorep, a first-in-class double-stranded RNA immunotherapy, for gastrointestinal cancers including pancreatic, colorectal, and anal cancers, with no commercial product revenue.

Ownership category

akta.pro rank

Product category

Oncolytic Virus Immunotherapy

NAICS

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

SIC

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

akta.pro primary industry

Oncology Gene Therapies (incl. oncolytic vectors & gene-modified approaches) (HLAAACAF)

akta.pro secondary industries

Oncology Specialty Pharmaceuticals (HLAIACAA), Medical Oncology (HLAKAFAB), Gastrointestinal Oncology (HLAKAFAK)

Keywords

• Oncolytic virus immunotherapy
• Immuno-oncology therapeutics
• Gastrointestinal cancer treatment
• Viral immunotherapy platform
• Biopharmaceutical drug development

Headquarters

HQ city

Calgary

HQ country

Canada

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Drug Development and Commercialization: Oncolytics Biotech is a clinical-stage biopharmaceutical company developing pelareorep as an investigational immunotherapy for gastrointestinal cancers. The company does not currently have commercialized products and has no revenue from product sales. All revenue potential is tied to successful clinical development and eventual FDA approval and commercialization of pelareorep.
2. Partnership and Licensing Deals: The company may generate revenue through strategic partnerships with large pharmaceutical companies, including co-development agreements, milestone payments, and potential licensing arrangements for pelareorep in various cancer indications.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels5 records

Core offering

Oncolytics Biotech is a clinical-stage biopharmaceutical company developing pelareorep, a first-in-class double-stranded RNA (dsRNA) immunotherapeutic agent, as a platform immunotherapy for gastrointestinal cancers including metastatic pancreatic ductal adenocarcinoma (mPDAC), metastatic colorectal cancer (mCRC), and unresectable squamous cell anal carcinoma (SCAC). The drug is delivered intravenously and works by generating, recruiting, and training immune cells to recognize and kill cancer while remodeling the tumor microenvironment.

Product overview

Oncolytics Biotech is a clinical-stage biopharmaceutical company developing a single core product, pelareorep, as a first-in-class double-stranded RNA (dsRNA) immunotherapeutic agent. Pelareorep functions as a platform immunotherapy designed for the treatment of gastrointestinal (GI) tumors, with clinical programs targeting metastatic pancreatic ductal adenocarcinoma (mPDAC), metastatic colorectal cancer (mCRC), and unresectable squamous cell anal carcinoma (SCAC). The company's development strategy focuses on advancing pelareorep through multiple clinical trials including the GOBLET study, AWARE-1 trial, and REO 022/033 studies, evaluating the drug in combination with chemotherapy, checkpoint inhibitors (atezolizumab, pembrolizumab), and targeted therapies.

Differentiator

Problem solved

Functional benefit

Products and services

• Pelareorep

Quantifiable outcome

• 62% objective response rate in first-line mPDAC with pelareorep combination therapy versus historical chemotherapy rates
• +6 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Twelve partnerships are on record, tiered core and minor.

• Roche Holding AGcoreStrategic or Co-development Partner · 5 March 2024Co-development partnership with Roche for pelareorep in combination with atezolizumab (checkpoint inhibitor) in gastrointestinal cancers. Roche logo appears on pipeline page indicating ongoing collaboration. AIO-Studien-gGmbH manages GOBLET trial in partnership with Roche.
• Pfizer Inc.coreStrategic or Co-development PartnerPartnership with Pfizer to evaluate pelareorep in combination with therapeutic agents. Multiple sources confirm co-development agreements with Pfizer for combination therapy development.
• Merck KGaAcoreStrategic or Co-development PartnerPartnership with Merck KGaA (known as Merck Serono in some regions) for co-development of pelareorep in combination therapies for cancer treatment.
• Incyte CorporationminorStrategic or Co-development PartnerCollaboration with Incyte to evaluate pelareorep in combination with therapeutic agents for cancer treatment.
• Adlai NortyeminorStrategic or Co-development PartnerPartnership with Adlai Nortye for evaluation of pelareorep in combination with therapeutic agents.
• Mayo CliniccoreStrategic or Co-development PartnerAcademic partnership with Mayo Clinic researchers including Professor Richard Vile (Co-Director of Gene and Virus Therapy program and Director of Mayo's Immuno-oncology program) for evaluation of pelareorep-based combinations.
• Rutgers Cancer Institute of New JerseycoreStrategic or Co-development PartnerPartnership with Rutgers Cancer Institute for clinical trials with Dr. Sanjay Goel serving as Lead Investigator for REO 033 Phase 2 trial and member of Scientific Advisory Board.
• AIO-Studien-gGmbHcoreStrategic or Co-development PartnerAcademic research organization managing the GOBLET Phase 1/2 study at 17 centers in Germany, evaluating pelareorep in multiple gastrointestinal cancers.
• SOLTIminorStrategic or Co-development PartnerAcademic research partnership for evaluation of pelareorep-based combinations in clinical trials.
• PrECOGminorStrategic or Co-development PartnerPartnership with PrECOG for evaluation of pelareorep in clinical trials.
• Memorial Sloan Kettering Cancer CentercoreStrategic or Co-development PartnerScientific Advisory Board members Dr. Eileen O'Reilly (Winthrop Rockefeller Endowed Chair of Medical Oncology) and Dr. Neil Segal (Research Director of GI Oncology) from MSK.
• MD Anderson Cancer CentercoreStrategic or Co-development PartnerScientific Advisory Board member Dr. Van Morris (Associate Professor in GI Medical Oncology) from MD Anderson Cancer Center.

Scale indicators10 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Replimune: Clinical-stage biotech developing oncolytic virus immunotherapies (RP1, RP2, RP3) for solid tumors. Most directly comparable to Oncolytics as a pure-play oncolytic virus company pursuing registration-enabling trials in GI and skin cancers.
• CG Oncology: Late-stage oncolytic virus immunotherapy company with nadofaragene firadenovec for bladder cancer. Recently IPO'd and progressing toward BLA submission, offering a direct comp on valuation, registration path, and oncolytic virus commercial model.
• Candel Therapeutics: Clinical-stage biotech developing oncolytic virus immunotherapies (CAN-2409) for prostate cancer and glioblastoma. Direct peer in oncolytic virus modality with late-stage trials and similar regulatory strategy.
• Istari Oncology: Clinical-stage biotech developing PVSRIPO, an oncolytic virus immunotherapy for glioblastoma and other solid tumors. Comparable as an oncolytic virus platform with registration-stage ambitions.
• Genelux Corporation: Clinical-stage biotech developing Olvi-Vec, a next-generation oncolytic virus for ovarian cancer and other solid tumors. Directly comparable in modality, scale, and development stage.

Emerging players

• Turnstone Biologics: Clinical-stage biotech developing oncolytic virus immunotherapies combined with cell therapy for solid tumors. Emerging player with overlapping modality but earlier-stage pipeline.
• SillaJen: Korean biotech developing Pexa-Vec, a oncolytic vaccinia virus for hepatocellular carcinoma and other solid tumors. Comparable as an oncolytic virus company with global development ambitions.

Broad incumbents

• Amgen: Approved Imlygic (talimogene laherparepvec/T-Vec), the first FDA-approved oncolytic virus immunotherapy for melanoma. Broad incumbent that validated the oncolytic virus category and provides commercial benchmark for pelareorep's potential market entry.
• Merck & Co. Major oncology player with Keytruda checkpoint inhibitor franchise that pelareorep is being combined with in clinical trials. Serves as both a partner (separate from Merck KGaA) and a key competitive benchmark in GI cancer immunotherapy.
• Pfizer: Major oncology player and active partner of Oncolytics for pelareorep combination development. Represents the strategic commercial partner profile and potential acquirer, given its track record of acquiring clinical-stage oncology assets (e.g., Trillium Therapeutics for $2.2B).

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/oncolytics-biotech
• Xx.com/Oncolytics
• Facebookfacebook.com/Oncolytics.Biotech.Inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

Funding overview

Funding rounds8 records

Investors2 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 Oncolytics Biotech