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

Oncolytics Biotech (Nasdaq: ONCY) reported initial preclinical data showing pelareorep combined with RAS inhibitor modalities achieved greater anti-tumor activity than either approach alone in a solid tumor model.

Rhea-AI Summary

Oncolytics Biotech (Nasdaq: ONCY) reported initial preclinical data showing pelareorep combined with RAS inhibitor modalities achieved greater anti-tumor activity than either approach alone in a solid tumor model.

The company plans further studies in pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer (CRC), with full results expected in late 2026.

Positive

• Preclinical combo shows greater anti-tumor activity than individual approaches
• Planned additional PDAC and CRC preclinical studies of pelareorep combinations
• Ongoing work includes KRAS G12C, pan-RAS and next-generation RAS agents
• Strategy targets RAS-mutated tumors with limited current treatment options
• Full initial preclinical dataset planned for presentation in late 2026

Negative

• Findings are early preclinical data, not clinical outcomes
• Full preclinical results not expected until fall or winter 2026

Argus Jun 1 session

+1.92% close to close Open Argus

Details

News Market Reaction – ONCY

On Jun 1, the day this news came out, ONCY closed 1.92% above the previous close.

Data tracked by StockTitan Argus for the Jun 1 session.

Market Context

This announcement adds preclinical support for pelareorep in combination with RAS-targeted approache...

Analysis

This announcement adds preclinical support for pelareorep in combination with RAS-targeted approaches in solid tumors, complementing recent clinical data in colorectal and anal cancers emphasizing durability and immune activation. Investors may track upcoming full datasets planned for 2026, funding disclosures showing limited cash of $5.5 million, and the company’s use of its effective $250,000,000 shelf and at-the-market programs as key factors shaping execution risk and development progress.

Key Figures

Quarterly net loss: $9.2 million Loss per share: $0.08 Prior-year net loss: $4.7 million +5 more

Quarterly net loss

$9.2 million

Three months ended March 31, 2026

Loss per share

$0.08

Three months ended March 31, 2026

Prior-year net loss

$4.7 million

Three months ended March 31, 2025

Cash and equivalents

$5.5 million

Balance as of March 31, 2026

Operating cash use

$7.3 million

Cash used in operating activities, Q1 2026

ATM net proceeds

$7.6 million

Raised via 7.4M shares through at-the-market offerings

ATM capacity

$75 million

New sales agreement allowing common stock issuances

Shelf registration size

$250,000,000

Form S-3 shelf filed March 31, 2026

Historical Context

5 past events · Latest: May 26

5 events

1. May 26

   Strategy commentary

   24h Move

   +0.1%

   CEO interview stressing pelareorep as immune‑priming backbone with strong survival signals.

2. May 22

   Conference data

   24h Move

   +2.5%

   ASCO 2026 translational data on pelareorep across gastrointestinal and breast tumors.

3. May 04

   Clinical data update

   24h Move

   +6.6%

   REO 022 colorectal cancer data showing long response duration and solid objective response rate.

4. Apr 27

   Regulatory alignment

   24h Move

   -6.0%

   FDA alignment on pivotal anal cancer study design targeting accelerated and full approval.

5. Apr 06

   Regulatory meeting plan

   24h Move

   -1.1%

   Planned Type C FDA meeting to discuss single‑arm registrational anal cancer pathway.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

immunotherapy, cytokines, tertiary lymphoid structures, tumor-infiltrating lymphocytes, +4 more

8 terms

immunotherapy medical

"Pelareorep is an investigational, systemically active immunotherapy that promotes..."

Treatment that uses or enhances the body’s immune system to detect and fight disease, most often cancers or chronic infections; think of it as training or arming the body’s own soldiers to find and destroy targets. It matters to investors because successful immunotherapies can lead to high-value drug approvals, recurring revenue from long-term treatments, and changes in competitive dynamics, while failures or safety issues in clinical trials can materially affect company valuations.

cytokines medical

"including the upregulation of key inflammatory cytokines resulting in the formation..."

Small proteins produced by immune and other cells that act as on/off signals or “text messages,” telling cells to ramp up, calm down, grow, or move during infection, injury, or disease. Investors watch cytokines because they are common drug targets and biomarkers—changes in cytokine activity can make a therapy work, cause serious side effects, or determine clinical trial and regulatory outcomes, all of which affect a company’s value.

tertiary lymphoid structures medical

"cytokines resulting in the formation of tertiary lymphoid structures and the expansion..."

Clusters of immune cells that form in non-lymph node tissues, acting like pop-up immune hubs where white blood cells gather, communicate and organize a local defense. They matter to investors because their presence or absence can change how a disease progresses and how well immunotherapies work, so they can serve as biomarkers or influence the commercial prospects and regulatory outlook of drugs and diagnostics.

tumor-infiltrating lymphocytes medical

"and the expansion of tumor-infiltrating lymphocytes."

Tumor-infiltrating lymphocytes are immune cells that have moved from the blood into a tumor and are actively interacting with cancer cells. For investors, they matter because their presence and activity can signal how well a patient’s immune system — or an immune-based drug — is likely to fight the tumor, and they are also the basis for a personalized cell therapy approach where these cells are grown and returned to the patient, affecting clinical trial outcomes and commercial potential.

pancreatic ductal adenocarcinoma medical

"additional studies in models of pancreatic ductal adenocarcinoma (“PDAC”) and colorectal..."

A fast-growing cancer that starts in the cells lining the pancreas’ small ducts; it is the most common and aggressive form of pancreatic cancer. It matters to investors because its severity and limited treatment options drive high unmet medical need, large potential markets for effective drugs or diagnostics, and strong sensitivity of company valuations to clinical trial results, regulatory approvals, or changes in treatment guidelines—similar to how fixing a main leak can prevent major damage in a building.

KRAS G12C inhibitors medical

"includes evaluations of pelareorep in combination with KRAS G12C inhibitors, pan-RAS..."

KRAS G12C inhibitors are a class of targeted cancer drugs designed to block the activity of a specific mutated form of the KRAS gene (called G12C) that drives tumor growth in some cancers. Think of the mutant KRAS as a jammed accelerator pedal that keeps a cell dividing; these drugs act like a mechanic fixing or locking that pedal so growth slows. Investors watch them because they can reshape treatment options, affect drug sales, and trigger regulatory approvals or setbacks that influence company value.

pan-RAS inhibitors medical

"combination with KRAS G12C inhibitors, pan-RAS inhibitors, and additional next-generation..."

Pan-RAS inhibitors are drugs designed to block the activity of the RAS family of proteins, which act like master switches that control cell growth and can drive many cancers when stuck in the “on” position. For investors, these medicines matter because they aim to treat a wide range of tumors driven by different RAS types, potentially expanding the addressable market and affecting the value and risk profile of companies developing them, while clinical trial success and safety remain key milestones.

RAS-mutated medical

"RAS pathway-targeting agents in RAS-mutated tumor models."

Ras-mutated describes a tumor that carries changes in one of the RAS family genes, which act like on/off switches for cell growth; these mutations make the switch stuck in the "on" position so cells grow uncontrollably. For investors, ras-mutated status matters because it determines which drugs or tests are likely to work, similar to knowing a car’s engine problem before choosing the right repair; that affects drug development, trial results, and market potential.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Early results from solid tumor model support additional studies in pancreatic and colorectal cancer models; full dataset planned for presentation later in 2026

SAN DIEGO, June 01, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech^® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage company developing pelareorep, today announced initial data from a preclinical study evaluating pelareorep in combination with RAS inhibitor modalities in a solid tumor model, which demonstrate evidence of greater anti-tumor activity in combination than with the individual approaches alone. Pelareorep is an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes.

Based on these findings, the Company is planning additional studies in models of pancreatic ductal adenocarcinoma (“PDAC”) and colorectal cancer (“CRC”) designed to further evaluate the combinations’ effects on immune activation, tumor response durability, and time-to-resistance. The ongoing work includes evaluations of pelareorep in combination with KRAS G12C inhibitors, pan-RAS inhibitors, and additional next-generation RAS pathway-targeting agents in RAS-mutated tumor models.

“We believe these initial findings further support pelareorep’s potential to serve as an immune-priming backbone for next-generation targeted therapies,” said Jared Kelly, Chief Executive Officer of Oncolytics. “RAS-mutated tumors, particularly pancreatic and colorectal cancers, remain among the most difficult cancers to treat due to intrinsic immune resistance and the emergence of therapeutic resistance over time. These preclinical results support further study of the combinations’ anti-tumor and immune effects, including in models designed to assess durability and time-to-resistance.”

Mr. Kelly continued, “Importantly, we believe this strategy may ultimately represent a potentially important area for further investigation in pancreatic cancer, where nearly all tumors harbor RAS pathway alterations and where patients continue to face extremely limited treatment options. The potential synergy observed in previous PDAC clinical studies and preclinical RAS-targeted modalities reinforces our belief that pelareorep may play an important role in future combination strategies designed to improve the durability of targeted therapies.”

Full results from the initial preclinical studies are expected to be presented in the fall or winter of 2026.

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 to “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 gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer. 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 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; the Company’s goals, strategies, and objectives; expectations around the design, milestones, anticipated timelines and expected outcomes for current and future studies, its belief in the clinical promise of pelareorep in anal, colorectal, pancreatic and other gastrointestinal cancers; the Company’s goals and expectations for its potential registrational development path for pelareorep in multiple gastrointestinal cancers; and plans for future disclosure of clinical trial results. 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 

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Oncolytics Biotech (ONCY) announce about pelareorep and RAS-targeted combinations on June 1, 2026?

Oncolytics Biotech announced initial preclinical data showing pelareorep plus RAS inhibitor modalities produced greater anti-tumor activity than either alone. According to Oncolytics, these results came from a solid tumor model and support continued evaluation of the combinations.

How might the pelareorep and RAS inhibitor data affect Oncolytics Biotech (ONCY) pancreatic cancer research?

The initial data are supporting further preclinical studies in pancreatic ductal adenocarcinoma models. According to Oncolytics, this strategy targets RAS-mutated pancreatic tumors, where nearly all cancers have RAS pathway alterations and treatment options remain extremely limited.

What cancers are being targeted in the new pelareorep RAS combination studies by Oncolytics Biotech (ONCY)?

The company plans additional preclinical studies in pancreatic ductal adenocarcinoma and colorectal cancer models. According to Oncolytics, these studies will examine immune activation, tumor response durability, and time-to-resistance in RAS-mutated tumor settings.

Which RAS-targeted agents are being evaluated with pelareorep in Oncolytics Biotech (ONCY) preclinical work?

Ongoing work includes pelareorep in combination with KRAS G12C inhibitors, pan-RAS inhibitors, and other next-generation RAS pathway-targeting agents. According to Oncolytics, these combinations are being tested in RAS-mutated solid tumor models.

When will investors see full results from Oncolytics Biotech (ONCY) pelareorep RAS preclinical studies?

Full results from the initial preclinical studies are expected in the fall or winter of 2026. According to Oncolytics, this future presentation will provide the complete dataset from the solid tumor combination experiments.

What is pelareorep and why is it important in Oncolytics Biotech (ONCY) RAS-targeted strategy?

Pelareorep is an investigational, systemically active immunotherapy that promotes potentially protective immune responses. According to Oncolytics, it may function as an immune-priming backbone for next-generation targeted therapies, including RAS-focused combinations in difficult-to-treat solid tumors.