Oncolytics Biotech® Announces Updated Clinical Data from GOBLET Cohort 4 Demonstrating Activity of Pelareorep Plus Atezolizumab in Third-Line Anal Cancer

Rhea-AI Summary

Oncolytics Biotech (NASDAQ: ONCY) announced updated GOBLET Cohort 4 data in third-line metastatic squamous cell anal carcinoma on Jan 12, 2026. As of the data cut, 4 of 14 evaluable patients (≈29% ORR) achieved objective responses including 2 complete responses and 2 partial responses. Median duration of response is ~17 months (67 weeks). The company notes historical third-line ORRs are ≈10% or less and there are no FDA-approved therapies for third-line anal cancer. Oncolytics plans a Type C meeting with the FDA in Q1 2026 and says reproducible ORR/DOR in a registration study could support accelerated approval.

Positive

• ORR ≈29% in third-line SCAC (4 of 14 evaluable)
• 2 complete responses observed in heavily pretreated patients
• Median DOR ~17 months (67 weeks) indicating durability
• Planned FDA Type C meeting in Q1 2026 to discuss registration

Negative

• Small evaluable cohort: only 14 third-line patients
• Registration and accelerated approval depend on reproducing these results in a larger trial

News Market Reaction

+2.47% 3.2x vol

2 alerts

+2.47% News Effect

+$3M Valuation Impact

$108M Market Cap

3.2x Rel. Volume

On the day this news was published, ONCY gained 2.47%, reflecting a moderate positive market reaction. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $3M to the company's valuation, bringing the market cap to $108M at that time. Trading volume was very high at 3.2x the daily average, suggesting strong buying interest.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Third-line ORR: 4/14 patients (~29%) Third-line DOR: ≈17 months (67 weeks) Historical ORR: ≈10% or less +5 more

8 metrics

Third-line ORR 4/14 patients (~29%) GOBLET Cohort 4 third-line metastatic SCAC

Third-line DOR ≈17 months (67 weeks) Median duration of response in GOBLET Cohort 4

Historical ORR ≈10% or less Historical third-line SCAC objective response rate

Complete responses 2 patients Third-line SCAC cohort responses with pelareorep+atezolizumab

Partial responses 2 patients Third-line SCAC cohort responses with pelareorep+atezolizumab

Second-line ORR 30% Pelareorep+atezolizumab in second-line anal cancer

Standard-of-care ORR 13.8% FDA-approved standard-of-care in second-line anal cancer

Second-line DOR 15.5 vs 9.5 months Pelareorep+atezolizumab vs current standard-of-care DOR

Market Reality Check

Price: $1.05 Vol: Volume 646,315 vs 20-day ...

normal vol

$1.05 Last Close

Volume Volume 646,315 vs 20-day avg 536,131 (relative volume 1.21x) ahead of the update. normal

Technical Shares at $0.97, trading above 200-day MA of $0.91 and 35.9% below the $1.51 52-week high.

Peers on Argus

ONCY was down 2.41% pre-news while oncology peers like ACTU and others in Biotec...

1 Down

ONCY was down 2.41% pre-news while oncology peers like ACTU and others in Biotechnology also showed single-day declines, but only ACTU appeared in the momentum scanner (-4.89%). Moves look more company-specific than a broad sector rotation.

Common Catalyst Several GI/oncology names have clinical and corporate updates today (e.g., ACTU Phase 2 pancreatic data), but there is no clear unified catalyst driving the whole peer group.

Historical Context

5 past events · Latest: Jan 08 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 08	IP strategy update	Positive	+3.2%	Track 1 patent path that may extend pelareorep protection to 2044.
Jan 07	Advisory board expansion	Positive	-0.4%	Added GI oncology experts and highlighted aggregated efficacy signals.
Dec 16	mCRC efficacy data	Positive	+12.7%	KRAS-mutant mCRC data with 33% ORR and >2x survival vs historical.
Dec 09	Redomiciling plan	Neutral	+1.3%	Rescheduled meeting and outlined plan to move jurisdiction to Nevada.
Nov 20	Meeting postponement	Negative	+0.9%	Delayed special meeting due to SEC delays from government shutdown.

Pattern Detected

ONCY has often shown positive reactions to strong clinical and IP news, while governance or structural updates have produced mixed or diverging price responses.

Recent Company History

Over the last few months, ONCY has highlighted advancing pelareorep across multiple GI tumors and corporate restructuring. On Dec 16, 2025, promising KRAS-mutant mCRC efficacy data coincided with a 12.68% gain. Updated anal cancer GOBLET data on Oct 28, 2025 saw a modest 0.83% move. Corporate actions around redomiciling to Nevada (Nov 20, Dec 9) and IP strategy updates (Jan 8, 2026) produced relatively small, mixed reactions, suggesting the strongest sensitivity has been to clear efficacy signals.

Market Pulse Summary

This announcement details updated GOBLET Cohort 4 results, with pelareorep plus atezolizumab achievi...

Analysis

This announcement details updated GOBLET Cohort 4 results, with pelareorep plus atezolizumab achieving ~29% ORR and a median DOR of ~17 months in third-line SCAC, versus historical ORR of about 10% or less. It builds on prior GOBLET and mCRC data that previously moved the stock. Investors may watch for the planned FDA Type C meeting in Q1 2026 and clarity on a potential registration path in this setting with no approved therapies.

Key Terms

objective response rate, median duration of response, complete responses, partial responses, +3 more

7 terms

objective response rate medical

"four of 14 evaluable third-line patients ... achieved objective responses, resulting in an objective response rate"

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.

median duration of response medical

"The median duration of response (“DOR”) is approximately 17 months (67 weeks)"

Median duration of response is the midpoint time that a beneficial effect from a treatment lasts among patients who showed a measurable improvement; half of responders saw the effect stop sooner, half later. Investors care because it shows how durable a therapy’s benefit is — like the typical lifespan of a product’s performance — which affects expected clinical value, market demand, pricing power and reimbursement prospects.

complete responses medical

"These responses included two complete responses and two partial responses."

Complete responses are instances in clinical testing where a treatment makes all detectable signs of a disease disappear according to the trial’s measurements and criteria. For investors, multiple complete responses show strong effectiveness signals—like repeatedly removing every visible stain in a laundry test—which can increase the odds of regulatory approval, drive future sales expectations, and materially affect a company’s valuation.

partial responses medical

"These responses included two complete responses and two partial responses."

A partial response is when a treatment produces a clear, measurable improvement in a disease—such as reduced tumor size or better lab markers—but does not eliminate the condition entirely. For investors, partial responses signal that a drug or therapy is biologically active and may provide clinical benefit, yet they also indicate remaining unmet need, which affects the size of the potential market, pricing power, regulatory likelihood, and prospects for further development.

squamous cell anal carcinoma medical

"GOBLET Cohort 4 in patients with third-line metastatic squamous cell anal carcinoma"

A type of cancer that starts in the flat, skin-like cells lining the anal canal; it forms a tumor that can remain localized or spread to nearby tissue and lymph nodes. Investors watch it because its diagnosis, treatment options, and approval of new drugs or procedures affect demand for medical services, drugmakers’ revenues, clinical trial outcomes, regulatory reviews, and healthcare costs—similar to how a fault in one part of a system can create cascading repair and replacement markets.

third-line medical

"patients with third-line metastatic squamous cell anal carcinoma"

Third-line describes a treatment or intervention used after the first and second standard options have failed, been not tolerated, or are unsuitable; it is the backup plan doctors turn to later in a patient's care. For investors, third-line status signals a smaller, harder-to-reach market and higher clinical and regulatory risk, but it can also mean less competition and the potential for premium pricing if the option proves effective—think of it as the specialty tool brought out when the basic tools don't work.

accelerated approval regulatory

"sufficient to support accelerated approval in this indication, consistent with regulatory precedent"

Accelerated approval is a process that allows new medical treatments to be approved more quickly than usual if they address serious or life-threatening conditions and show promising early results. For investors, it signals that a treatment may reach the market sooner, potentially boosting a company's prospects, but it also involves some uncertainty since full evidence of effectiveness is still being gathered.

AI-generated analysis. Not financial advice.

Compared to the historical benchmark, pelareorep-atezolizumab nearly tripled ORR 

Combination achieved encouraging median DOR of almost 17 months

Data establishes clear path in indication with no approved therapy

SAN DIEGO, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech^® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced updated clinical data from GOBLET Cohort 4 in patients with third-line metastatic squamous cell anal carcinoma (“SCAC”), a setting with no U.S. Food and Drug Administration (“FDA”)-approved treatment options. Previous analysis from this cohort has focused on second-line or later SCAC patients.

Updated GOBLET Cohort 4 Third-Line Anal Cancer Data

As of the current data cut, four of 14 evaluable third-line patients receiving pelareorep and atezolizumab achieved objective responses, resulting in an objective response rate (“ORR”) of approximately 29%. These responses included two complete responses and two partial responses. The median duration of response (“DOR”) is approximately 17 months (67 weeks), indicating both depth and durability of clinical benefit in a heavily pretreated population.

Patients enrolled in this cohort had progressed following multiple prior systemic therapies and represent a highly refractory disease population. In historical third-line SCAC studies, objective response rates are typically approximately 10% or less, with limited durability.^{1, 2} There are currently no FDA-approved therapies for patients with third-line anal cancer.

The observed response rate and emerging durability in GOBLET Cohort 4 compare favorably with historical outcomes and highlight the potential clinical relevance of pelareorep plus atezolizumab in this setting of significant unmet medical need.

“As we continue to analyze the Goblet data, we are finding important trends that are helping to shape our clinical development strategy,” said Jared Kelly, Chief Executive Officer of Oncolytics. “When you isolate to anal cancer patients with two prior lines of treatment and see a strong signal like this, it points the arrow in a direct line to a registration study in an indication where there are no FDA-approved therapies. We already had good data here, but looking closer, it becomes clearer that we can make an immediate impact on patients’ lives who have no options.”

In the second-line setting, pelareorep and atezolizumab achieved a 30% ORR, more than doubling the 13.8% ORR that was approved by the FDA for the current standard of care therapy. Additionally, the median duration of response is 15.5 months for pelareorep and atezolizumab compared to 9.5 months (link to the PR).

Planned Registration Strategy and Accelerated Approval Pathway

If the objective response rate and duration of response observed in GOBLET Cohort 4 are reproduced in the planned registration study, Oncolytics believes the resulting dataset would be sufficient to support accelerated approval in this indication, consistent with regulatory precedent in rare cancers with no available therapies. After initial encouraging feedback from KOLS and the FDA, Oncolytics is planning to have a Type C meeting with the FDA in Q1 2026 to discuss and receive guidance on this development plan.

References

1. Marabelle et al. Pembrolizumab for previously treated advanced anal squamous cell carcinoma: results from the non-randomised, multicohort, multicentre, phase 2 KEYNOTE-158 study. Lancet Gastroenterol Hepatol. 2022 May;7(5):446-454. doi: 10.1016/S2468-1253(21)00382-4.
2. Benson et al. Anal Carcinoma, Version 2.2023, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2023 Jun;21(6):653-677. doi: 10.6004/jnccn.2023.0030.

About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses.

The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic pancreatic and breast cancers, of which both development programs have received Fast Track designation from the FDA, and other gastrointestinal tumors. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics.

Forward-looking statements
This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; expectations regarding the Company’s proposed design of potential registration studies, including plans to advance pelareorep plus atezolizumab into a registration-directed clinical study in second-line and later SCAC and potential meetings with the FDA; expectations relating to outcomes of ongoing and future studies, in addition to anticipated accelerated FDA approvals; the Company’s goals, strategies and objectives; and its belief in the clinical promise of pelareorep in metastatic anal and other gastrointestinal cancers. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.

Company Contact
Jon Patton
Director of IR & Communication
jpatton@oncolytics.ca

Investor Relations for Oncolytics
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mmoyer@lifesciadvisors.com

Media Contact for Oncolytics
Owen Blaschak
LifeSci Communications
oblaschak@lifescicomms.com

FAQ

What objective response rate did Oncolytics report for third-line anal cancer (ONCY) in GOBLET Cohort 4?

Oncolytics reported an objective response rate of approximately 29% (4 of 14 evaluable patients).

How durable were the responses to pelareorep plus atezolizumab in the ONCY GOBLET Cohort 4 update?

The median duration of response was reported as ~17 months (67 weeks).

Did Oncolytics report complete responses in the third-line ONCY GOBLET Cohort 4 data?

Yes. The company reported 2 complete responses among the 4 objective responders.

How do the GOBLET Cohort 4 third-line ONCY results compare with historical third-line SCAC outcomes?

The reported ~29% ORR compares favorably to historical third-line ORRs of ≈10% or less.

Will Oncolytics (ONCY) seek accelerated approval for pelareorep plus atezolizumab in third-line anal cancer?

Oncolytics plans a Type C meeting with the FDA in Q1 2026 and says a reproduced ORR/DOR in a registration study could support accelerated approval.

How many third-line patients were evaluable in the GOBLET Cohort 4 ONCY update?

There were 14 evaluable third-line patients in the updated dataset.