ONCOLYTICS BIOTECH INC
ONCY evidence brief
What we can confirm
- BioSniper Score:
- 3.8 / 10
- Market Cap:
- $95.1M
- Lead Asset:
- pelareorep (Phase 2)
What it means
What to watch
Prepared research question
What matters most for ONCY—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · ONCY
Oncolytics Biotech Inc. (ONCY) is a clinical-stage immunotherapy company developing pelareorep, a systemically delivered oncolytic virus, with recent FDA alignment on pivotal trials in anal and colorectal cancer.
Key risk: Limited cash runway
BioSniper Score
Based on 3 of 6 signals
Limited data coverage
Financial data as of Jun 30, 2026.
Tracking 1 pipeline candidate · 2 clinical trials for ONCOLYTICS BIOTECH INC.
Oncolytics Biotech Inc. (ONCY) is a clinical-stage immunotherapy company developing pelareorep, a systemically delivered oncolytic virus, with recent FDA alignment on pivotal trials in anal and colorectal cancer.
- Cash & equivalents of $4.1M as of 2026-06-30 [sec].
- Net income of -$9.4M as of 2026-06-30 [sec].
- Shareholders' equity of -$6.2M as of 2026-06-30 [sec].
- Reached alignment with FDA on a pivotal study for pelareorep in anal cancer in April 2026 [news · published 2026-05-19].
- Received written FDA feedback on a potential registrational pathway for pelareorep in colorectal cancer via expansion of REO 033 trial in August 2026 [news · published 2026-08-27].
What works
- FDA alignment on a pivotal study for pelareorep in anal cancer provides a clear regulatory path forward [news · published 2026-05-19].
- Positive preclinical results show pelareorep activity is maintained in the presence of RAS inhibition, supporting combination potential [news · published 2026-09-10].
- A new U.S. patent protects commercial manufacturing of pelareorep into 2044, strengthening intellectual property [news · published 2026-06-16].
- All planned facilities for Part A of REO 033 trial have been activated with multiple participants admitted, indicating clinical progress [news · published 2026-09-28].
What to weigh
- Cash & equivalents of only $4.1M as of 2026-06-30 may limit operational runway without additional financing [sec].
- Net loss of -$9.4M as of 2026-06-30 reflects ongoing negative cash flow [sec].
- Shareholders' equity of -$6.2M as of 2026-06-30 indicates accumulated deficit and potential financial strain [sec].
- The company is winding down the GOBLET study to focus on registration, which may reduce pipeline diversity [news · published 2026-02-24].
From the filings
Quoted directly from source documents.
FDA alignment on pivotal study for pelareorep in anal cancer
“Oncolytics Biotech Inc. (NASDAQ: ONCY) announced it had reached alignment with the U.S. Food and Drug Administration (FDA) on a pivotal study for pelareorep”
News · May 19, 2026
Positive preclinical results combining pelareorep with pan-RAS inhibitor
“Preclinical results demonstrate pelareorep activity is maintained in the presence of RAS inhibition”
News · September 10, 2026
FDA written feedback on registrational pathway for CRC
“Oncolytics Biotech, Inc. (NASDAQ: ONCY) announced it had received written feedback from the FDA regarding the potential expansion of the ongoing REO 033 trial into a pivotal Part B study.”
News · August 27, 2026
New U.S. patent protecting commercial manufacturing of pelareorep into 2044
“Oncolytics Biotech® Secures New U.S. Patent Protecting Commercial Manufacturing of Pelareorep into 2044”
News · June 16, 2026
Catalyst timeline
- 2021-10-27 · Phase 2 start: A Phase 1 / 2 Multiple-indication Biomarker, Safety, and Efficacy Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab — This earlier-phase study provides foundational data for pelareorep combinations.
- 2026-04-30 · Phase 2 start: An Open-Label, Randomized, Multicentre, Phase 2 Study of FOLFIRI + Bevacizumab + Pelareorep vs. FOLFIRI + Bevacizumab for the Second-Line Treatment of Metastatic, RAS-mutated, Microsatellite-Stable (MSS) Colorectal Cancer — This randomized study is the core of the REO 033 trial and potential registration path.
Risks & what to watch (4)›
Key risks
- Limited cash runway — Cash & equivalents of $4.1M as of 2026-06-30 may be insufficient to fund operations without near-term financing [sec].
- Negative equity position — Shareholders' equity of -$6.2M as of 2026-06-30 indicates accumulated losses exceeding assets [sec].
- Dependence on regulatory milestones — Company is winding down GOBLET study and focusing on registration, making success contingent on FDA alignment [news · published 2026-02-24].
- Clinical trial execution risk — Part B of REO 033 trial is still in planning; any delays could impact registration timeline [news · published 2026-07-13].
What to watch
- Outcome of Type D meeting with FDA to discuss registrational pathway for REO 033 Part B [news · published 2026-07-13].
- Full preclinical dataset for pelareorep in combination with RAS-targeted approaches expected later in 2026 [news · published 2026-06-01].
- Enrollment progress and data from Part A of REO 033 trial [news · published 2026-09-28].
- Potential additional patent filings planned in 2026 to expand pelareorep intellectual property [news · published 2026-06-16].
Sources: Catalysts · News · Generated October 10, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 3 of 6 signals · derived from public data
Cash runway data unavailable
Net income -$9M
Lead: Phase 2
1 candidate
No upcoming catalysts tracked
No insider transactions in the last 180 days
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
59
Total value held
$3.3M
| Holder | Shares | Value |
|---|---|---|
| marshall wace, llp | 859,831 | $731K |
| renaissance technologies llc | 715,838 | $608K |
| sandbox financial partners, llc | 400,000 | $340K |
| seeds investor llc | 258,306 | $263K |
| tocqueville asset management l.p. | 149,000 | $126K |
| everhart financial group, inc. | 138,161 | $117K |
| xtx topco ltd | 109,758 | $93K |
| doliver advisors, lp | 100,000 | $85K |
| franklin resources inc | 69,842 | $71K |
| lpl financial llc | 78,901 | $67K |
Showing top 10 of 59 institutional holders of ONCOLYTICS BIOTECH INC. Open the full 13F history after sign-in.
Short Interest
as of Apr 20, 2026- % of float
- 5.4%
- Days to cover
- 8.1
- Shares short
- 6,184,650
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
ONCY short interestGovernance
Frequently asked questions
What is the AI investment thesis for ONCOLYTICS BIOTECH INC?
Oncolytics Biotech Inc. (ONCY) is a clinical-stage immunotherapy company developing pelareorep, a systemically delivered oncolytic virus, with recent FDA alignment on pivotal trials in anal and colorectal cancer.
What is ONCOLYTICS BIOTECH INC's lead drug candidate?
ONCOLYTICS BIOTECH INC's most advanced tracked candidate is pelareorep (Phase 2) for Ras-mutated Metastatic Colorectal Cancer; Anal Cancer Metastatic.
Who is the CEO of ONCOLYTICS BIOTECH INC?
Mr. Jared Kelly J.D., L.L.M. is the chief executive officer of ONCOLYTICS BIOTECH INC (ONCY).
Where is ONCOLYTICS BIOTECH INC headquartered?
ONCOLYTICS BIOTECH INC (ONCY) is headquartered in San Diego, CA, United States.
What therapeutic areas does ONCOLYTICS BIOTECH INC focus on?
ONCOLYTICS BIOTECH INC develops therapies across Oncology, Gastroenterology.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.