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Oncolytics Biotech Inc.

ONCY
OvervaluedBiotech · Clinical
FDA catalysts, PDUFA dates & pipeline intelligence
$0.54
▼ -0.05 · -7.69%

Financials

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52W LOW $0.5452W HIGH $1.32
Volume
1.12 M
Value Traded
637.71 K
Short % Float
8.75%
-13.72%Week
-31.52%1 Month
-38.65%3 Month
-41.46%6 Month
-73.55%5 Year
-98.38%All Time

Cash Data

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Key Stats

Market Cap
69.42 M
EPS (TTM)
-0.35
P/E Ratio
-
Ent. Value
65.30 M
Total Shares
127.51 M
Float Shares
98.81 M
Insiders
1.55%
Institutions
3.95%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
Phase 2 data readout
pelareorep
Metastatic breast cancer · randomized Phase 2 programs (pelareorep combinations)
Fast Track
Phase 2Oncolytic VirusesOncology
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

ONCY Catalyst Timeline

Dated clinical, regulatory and corporate events for Oncolytics Biotech Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for Oncolytics Biotech Inc.

976Total events
8Upcoming
151Tier-1 (high impact)
2008 to 2027Coverage

Upcoming catalysts 2

T2Enrollment Complete
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Pelareorep
T2Timing Guidance
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Pelareorep

Event history 50

▲Enrollment UpdatePelareorepTrial
Nearly all planned Part A REO 033 sites activated; multiple patients enrolled
second-line RAS-mutant, microsatellite-stable (MSS) metastatic colorectal cancer (mCRC)source ↗
▲PublicationPelareorepPresentation
PNAS publication of preclinical data showing pelareorep converts immunologically cold liver cancer microenvironment to hot
hepatocellular carcinomasource ↗
▲Preclinical PoCPelareorepPreclinical
Preclinical data show pelareorep increased PD-L1, ICOSL and CD8+ T cell density in liver cancer models
hepatocellular carcinomasource ↗
▲Preclinical PoCPelareorepPreclinical
Positive preclinical results of pelareorep plus pan-RAS inhibitor in RAS-driven colorectal cancer model
RAS-driven colorectal cancersource ↗
▲FDA Feedback ReceivedPelareorepFDA Meeting
FDA provided written feedback on pivotal Part B expansion design
second-line RAS-mutant MSS metastatic colorectal cancersource ↗
▲Fast Track DesignationPelareorepDesignation
FDA grants Fast Track designation for pelareorep in second-line and later anal cancer
inoperable, locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on or were intolerant to one or more prior lines of systemic therapysource ↗
▲Enrollment UpdatePelareorepTrial
More than 20 patients pre-identified across participating centers
RAS-mutant MSS metastatic colorectal cancersource ↗
◆Patent GrantedPelareorepIP / Competition
Expected final action on Track 1 manufacturing patent application
◆Trial InitiationPelareorepTrial
Potential single-arm pivotal study launch in 2L SCAC
second-line unresectable squamous cell carcinoma of the anal canalsource ↗
▲Enrollment MilestonePelareorepTrial
Half of planned clinical sites activated by end of July 2026
RAS-mutant MSS metastatic colorectal cancersource ↗
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Past FDA Catalysts and PDUFA Decisions

How ONCY actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2026-05-30pelareorep Phase 1/2 data readout Phase 1/2
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

D33 / 100
Pipeline Score
$20M
Pipeline Value
Overvalued
Valuation Signal
3
Drugs Scored
0.3x
rNPV / MCap
Top 60%
Micro Cap
(rank 395 of 658)
Percentile Rank
Oncolytics Biotech Inc. faces pipeline headwinds (33/100), with $1.5B risk-adjusted pipeline value, led by REOLYSIN in Metastatic Breast Cancer (Phase 2), across $79B in total addressable markets, but cash runway is a concern.
Showing 1 of 3 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
REOLYSIN Monoclonal antibodyCompletedNCT00753038Carcinoma, Squamous Cell of the Head and NeckPhase 3 COMPLETED 181May 1, 2013
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Clinical Trial Results

Readouts, endpoints and source filings for every ONCY program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
pelareorep
Fast TrackAcceleratedOrphan
unresectable metastatic squamous cell carcinoma of the anal canal2026-04-27median duration of response of 15.5 months versus 9.5 months; 12-month survival of 82% versus 45.7%Read MoreOncolytics Aligns with FDA on Planned Pivotal Anal Cancer StudyRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
Kelly JaredDirector, Officer (Chief Executive Officer)Buy 5,050 114,050 held$0.96 03/12/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
No hedge fund reported a 13F position in ONCY for Q2 2026.
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Every 13F position with quarter over quarter share flow and average entry price.
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Shares held by hedge funds each quarter, and who bought or sold.

ONCY Institutional Ownership Trends

Options Data

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Option Chain Statistics

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Real-Time Option Chain

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LastVolOILastVolOI
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Calls vs Puts by Expiry

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Competitive positioning

How ONCY ranks across every disease it competes in

Competitive Position is a premium feature
See how ONCY ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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ONCY News

-ONCY
Sep 29, 2026
ONCYGeneral

Oncolytics Biotech® Announces Publication Demonstrating Pelareorep Creates Immune Responses in Liver Cancer That Make Tumors Susceptible to Immunotherapy

Oncolytics Biotech announced the publication of data demonstrating that pelareorep can transform the immunologically inactive microenvironment of liver cancer into an active one, making it more susceptible to immunotherapy. The findings suggest that pelareorep enhances the efficacy of existing cancer treatments, although liver cancer is not a current focus for the company. The publication highlights significant immune response changes, including increased CD8+ T cell infiltration.

Read more →
-ONCY
Sep 28, 2026
ONCYPhases

Oncolytics Biotech® Reports Accelerating Enrollment in Randomized REO 033 RAS-Mutant, MSS Colorectal Cancer Study

Oncolytics Biotech has reported significant progress in its REO 033 study for RAS-mutant, MSS colorectal cancer, with nearly all clinical sites activated and patients enrolled. The company anticipates providing an interim update by year-end 2026, focusing on the efficacy of pelareorep combined with standard treatments. The FDA has aligned with Oncolytics on a potential path for accelerated approval based on positive clinical outcomes.

Read more →
-ONCY
Sep 10, 2026
ONCYPhases

Oncolytics Biotech® Announces Positive Preclinical Results Combining Pelareorep with a Pan-RAS Inhibitor in Colorectal Cancer

Oncolytics Biotech announced positive preclinical results for pelareorep in combination with a pan-RAS inhibitor in colorectal cancer. The study showed that both therapies reduced tumor growth, with the combination yielding the best results. These findings suggest that pelareorep could enhance the effectiveness of RAS-targeted therapies and help delay resistance. Further evaluations are planned to optimize dosing and assess the therapy's impact on tumor response.

Read more →
-ONCY
Aug 18, 2026
ONCYFDA Updates

Oncolytics Biotech® Aligns with FDA on Registrational Path for Second-Line RAS-Mutant MSS Colorectal Cancer

Oncolytics Biotech has received positive feedback from the FDA regarding its REO 033 study for second-line RAS-mutant MSS colorectal cancer. The FDA's guidance supports a potential pivotal Part B expansion based on initial clinical data. The company aims for accelerated approval using objective response rates and progression-free survival metrics. Oncolytics plans to initiate Part B activities following positive interim results from Part A.

Read more →
-ONCY
Jul 20, 2026
ONCYFDA Updates

Oncolytics Biotech® Receives Fast Track Designation for Pelareorep in Second-Line and Later Anal Cancer

Oncolytics Biotech has received Fast Track designation from the FDA for pelareorep, aimed at treating patients with advanced squamous cell carcinoma of the anal canal. This designation allows for expedited development and review, addressing a significant unmet medical need in a market estimated at $1 billion. The company has demonstrated promising clinical results, including a 30% objective response rate in prior studies.

Read more →
-ONCY
Jul 13, 2026
ONCYFDA Updates

Oncolytics Biotech® Reports FDA Regulatory Milestone and Strong Clinical Progress in Randomized RAS-Mutant MSS Colorectal Cancer Trial

Oncolytics Biotech has reported significant progress in its REO 033 trial for RAS-mutant MSS colorectal cancer, with half of the planned clinical sites set to activate this month. The company plans to hold a Type D meeting with the FDA to discuss a potential registrational pathway for the trial. The study aims to validate previous encouraging results and has received Fast Track designation from the FDA.

Read more →
-ONCY
Jun 16, 2026
ONCYGeneral
▲ +11.7%on this news

Oncolytics Biotech® Secures New U.S. Patent Protecting Commercial Manufacturing of Pelareorep into 2044

Oncolytics Biotech has secured a new U.S. patent protecting the manufacturing process of its investigational immunotherapy, pelareorep, until 2044. This patent enhances the company's intellectual property portfolio and supports the commercial production of pelareorep. Additionally, a method-of-use patent application is under review, potentially extending protection to 2046. Oncolytics plans further patent filings to broaden its intellectual property estate.

Read more →
-ONCY
Jun 2, 2026
ONCYGeneral
▼ -12.5%on this news

Oncolytics Biotech® Announces Appointment of Steve Glover to Board of Directors and Promotion of John McAdory to Chief Operating Officer

Oncolytics Biotech has appointed Steve Glover to its Board of Directors and promoted John McAdory to Chief Operating Officer. Glover brings extensive experience from his previous role at Ambrx Biopharma, while McAdory will oversee clinical operations and development. The company is focused on advancing its investigational immunotherapy, pelareorep, which shows promise in treating various cancers.

Read more →
-ONCY
Jun 1, 2026
ONCYPhases

Oncolytics Biotech Announces Positive Initial Preclinical Findings Supporting Further Evaluation of Pelareorep in Combination with RAS-Targeted Approaches

Oncolytics Biotech has announced positive initial preclinical findings regarding pelareorep, showing enhanced anti-tumor activity when combined with RAS inhibitors. The company plans to continue research on these combinations, particularly in pancreatic ductal adenocarcinoma and colorectal cancer models. CEO Jared Kelly highlighted the potential of pelareorep to improve treatment efficacy against RAS-mutated tumors that are notoriously challenging to treat due to immune resistance. Full results are expected to be released later in 2026.

Read more →
-ONCY
May 22, 2026
ONCYConferences/Events

Oncolytics Biotech® to Present Data at ASCO 2026 Reinforcing Pelareorep’s Potential Across Gastrointestinal Tumors

Oncolytics Biotech announced that it will present data on pelareorep at the 2026 ASCO Annual Meeting. The data from the GOBLET and AWARE-1 trials indicate that pelareorep enhances immune responses in gastrointestinal tumors. The findings suggest that pelareorep may effectively expand tumor-reactive immune cells, potentially improving treatment options for challenging cancers.

Read more →
-ONCY
May 4, 2026
ONCYFDA Updates
▲ +6.6%on this news

Oncolytics Biotech® Reports Durable Responses in Second-Line RAS-Mutant MSS Colorectal Cancer

Oncolytics Biotech has reported promising results for its investigational therapy, pelareorep, in patients with second-line RAS-mutant MSS metastatic colorectal cancer. The therapy demonstrated a median duration of response of 19.5 months, significantly exceeding historical benchmarks. The company is engaging with the FDA to explore an accelerated approval pathway based on these findings.

Read more →
-ONCY
Apr 27, 2026
ONCYPhases
▼ -6%on this news

Oncolytics Aligns with FDA on Planned Pivotal Anal Cancer Study

Oncolytics Biotech has announced alignment with the FDA on a pivotal clinical study for pelareorep, aimed at treating unresectable metastatic squamous cell carcinoma of the anal canal. The study will focus on patients with no FDA-approved therapies and aims to support both accelerated and full approval. The company plans to incorporate FDA feedback into the final protocol, emphasizing the need for new treatment options in this area.

Read more →
-ONCY
Apr 6, 2026
ONCYFDA Updates

Oncolytics Biotech® Announces Type C FDA Meeting to Discuss Single-arm Registrational Pathway for Pelareorep in Anal Cancer

Oncolytics Biotech has announced a Type C meeting with the FDA to discuss a registrational pathway for pelareorep in anal cancer. The focus will be on initiating a pivotal study evaluating pelareorep in combination with a checkpoint inhibitor for patients with squamous cell anal carcinoma. Encouraging clinical activity has been observed, with a notable objective response rate in previous studies.

Read more →
-ONCY
Apr 1, 2026
ONCYGeneral
▲ +9.6%on this newsshared move

Oncolytics Biotech® Completes Domicile Change to the United States

Oncolytics Biotech has successfully changed its jurisdiction of incorporation from Alberta, Canada, to Nevada, USA. This transition, approved by shareholders, is expected to enhance operational efficiency and access to U.S. capital markets. The company will maintain its Calgary office while establishing a new headquarters in San Diego. The change reflects Oncolytics' status as a U.S. domestic issuer.

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-ONCY
Mar 19, 2026
ONCYConferences/Events

Oncolytics Biotech to Present New Mechanistic and Translational Data Supporting Pelareorep as an Immune-Priming Backbone at AACR 2026

Oncolytics Biotech Inc. announced that two abstracts related to its investigational immunotherapy pelareorep were accepted for presentation at the AACR Annual Meeting 2026. Pelareorep has shown promising results in activating immune responses in various cancers, particularly those driven by RAS mutations. Key data indicate that pelareorep could significantly enhance the effectiveness of immunotherapy and targeted therapies. The company aims to advance its clinical programs to address significant unmet needs in oncology, including pancreatic cancer.

Read more →
-ONCY
Mar 2, 2026
ONCYPhases
▼ -9.7%on this news

Oncolytics Biotech® Launches Randomized Colorectal Cancer Study

Oncolytics Biotech has launched a Phase 2 study, REO 033, for metastatic colorectal cancer using pelareorep. The trial will compare the efficacy of pelareorep combined with standard treatments against a control arm. Preliminary data is expected by the end of 2026, following promising results from earlier studies.

Read more →
-ONCY
Feb 26, 2026
ONCYGeneral

Immuno-Oncology Investments Accelerate as Pipeline Catalysts Multiply in 2026

Oncolytics Biotech is advancing its registrational programs in anal and colorectal cancer, with promising data from the GOBLET study. The company plans to meet with the FDA to align on study design for approval. The immuno-oncology market is projected to grow significantly, with Oncolytics positioned to capitalize on this expansion through its innovative therapies.

Read more →
-ONCY
Feb 24, 2026
ONCYPhases
▲ +6.6%on this newsshared move

Oncolytics Biotech® to Prioritize Registration-Focused Programs in Anal and Colorectal Cancer

Oncolytics Biotech has concluded enrollment in the GOBLET study and will now prioritize registration-focused programs in squamous cell anal cancer and metastatic colorectal cancer. The company believes it has sufficient data to pursue regulatory approval efficiently. A meeting with the FDA is planned for mid-April to discuss the design of a registrational study.

Read more →
-ONCY
Feb 5, 2026
ONCYFDA Updates
▼ -7%on this news

Oncolytics Biotech® Receives FDA Fast Track Designation for Pelareorep in 2L KRAS-Mutant MSS Metastatic Colorectal Cancer

Oncolytics Biotech has received FDA Fast Track Designation for pelareorep in combination with bevacizumab and FOLFIRI for treating KRAS-mutant MSS metastatic colorectal cancer. Clinical data shows a 33% objective response rate and improved survival metrics compared to standard-of-care. The company plans to initiate a controlled study with interim data expected by the end of 2026.

Read more →
-ONCY
Feb 5, 2026
ONCYFDA Updates
▼ -7%on this news

The $71 Billion Cancer Shift: Why The FDA Is Speeding Up

Oncolytics Biotech has received Fast Track Designation from the FDA for its cancer treatment pelareorep, which demonstrates significant survival benefits in KRAS-mutant colorectal cancer patients. The treatment achieved a 33% response rate and improved median survival to 27 months compared to 11.2 months with standard chemotherapy. The company plans to launch a controlled study to further evaluate pelareorep's efficacy.

Read more →

About Oncolytics Biotech Inc.

San Diego, CA 29 employees oncolyticsbiotech.com
HeadquartersSUITE 325, 4350 EXECUTIVE DRIVE, SAN DIEGO, CA, 92121
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