Oncolytics Biotech Inc Stock Price, News & Analysis

Oncolytics Biotech (NASDAQ: ONCY) reported updated data from the GOBLET study SCAC cohort showing pelareorep plus atezolizumab achieved a 30% objective response rate (6/20 evaluable patients) in second-line or later squamous cell anal carcinoma versus a 13.8% historical benchmark. The median duration of response was 15.5 months versus 9.5 months for the current standard. Two complete responses were durable (one >2 years, one 15 months) and an additional response is ongoing at 64 weeks. The company plans FDA discussions on a single-arm accelerated approval study in Q1 2026 with study launch potential in H1 2026.

Oncolytics Biotech (NASDAQ: ONCY) filed a Form F-4 registration statement including a preliminary management circular/prospectus and announced a Special Meeting of Shareholders to vote on a continuance from Alberta to British Columbia and a domestication from British Columbia to Nevada. The Domestication requires an affirmative vote of not less than two-thirds of votes cast and is expected to occur on January 1, 2026 or as soon as practicable thereafter.

The company said there are not expected to be material changes to operations or financial results, that it will continue SEC reporting and Nasdaq trading under ONCY, and that the move is intended to reduce regulatory burden and costs, aid capital raising, and reflect that most operations and shareholders are in the United States. Shareholders will also vote on a new incentive award plan.

Oncolytics Biotech (NASDAQ: ONCY) announced updates for its planned registration-directed clinical trial in first-line pancreatic ductal adenocarcinoma (PDAC). The company will meet with the FDA in mid-November 2025 to discuss study details.

The proposed trial features a three-arm design evaluating: 1) Gemcitabine + nab-paclitaxel (GnP) control, 2) GnP + pelareorep, and 3) GnP + pelareorep + checkpoint inhibitor. The study's primary endpoint is Overall Survival, with planned interim analysis for early efficacy assessment.

Previous post-hoc analysis showed pelareorep plus chemotherapy achieved 22% two-year survival rate compared to 9% with chemotherapy alone. The company aims to establish pelareorep as the first approved immunotherapy in first-line pancreatic cancer.

Oncolytics Biotech (NASDAQ:ONCY) reported progress updates on its GOBLET trial evaluating pelareorep for gastrointestinal cancers. In Cohort 4, studying second-line SCAC, the company achieved a 33% overall response rate in 12 patients, nearly tripling competitor results. Enrollment has reached 20 evaluable patients, with completion expected by end-2025.

For Cohort 5, investigating first-line mPDAC, enrollment is 40% complete, evaluating pelareorep with modified FOLFIRINOX with/without atezolizumab. The study is expanding to U.S. sites, including Northwestern University, pending protocol amendment approval.

Oncolytics Biotech (NASDAQ: ONCY) reported significant clinical and translational data from three metastatic colorectal cancer (mCRC) studies for its immunotherapy drug pelareorep. In the REO 022 trial, pelareorep combined with FOLFIRI and bevacizumab showed remarkable results in KRAS mutant patients, achieving 16.6 months median progression-free survival (versus 5.7 months standard) and 27.0 months median overall survival (versus 11.2 months standard).

The GOBLET study's 3L mCRC Cohort 3, combining pelareorep with atezolizumab and TAS-102, met its efficacy endpoint with improved survival rates. Translational data from REO 022 and REO 013 studies confirmed pelareorep's mechanism of action, demonstrating viral replication and immune activation in tumors. The company plans to advance regulatory discussions and develop an investigator-sponsored trial for KRAS mutant mCRC patients.

Oncolytics Biotech (NASDAQ: ONCY) has released updated safety data for its immunotherapy drug pelareorep, showcasing favorable results across multiple gastrointestinal cancers. The analysis encompasses over 1,200 total patients, including more than 300 gastrointestinal cancer patients across 8 clinical studies.

The data confirms pelareorep's consistent safety profile, with most adverse events being Grade 1 and 2, including fever, chills, fatigue, and gastrointestinal symptoms. The therapy has been tested in combination with various treatments, including modified FOLFIRINOX for metastatic pancreatic cancer, and in multiple tumor types such as colorectal and anal cancer.

Oncolytics Biotech (NASDAQ:ONCY), a clinical-stage immunotherapy company focused on developing pelareorep, has announced its participation in two upcoming investor conferences in September 2025. CEO Jared Kelly will engage with institutional investors at the H.C. Wainwright 27th Annual Global Investment Conference on September 9-10 and the Lake Street Capital Markets 9th Annual Best Ideas Growth Conference on September 11.

Both events will take place in New York City, with management conducting one-on-one meetings with investors. Interested parties can schedule meetings through conference representatives or by contacting the company directly.

Oncolytics Biotech (NASDAQ: ONCY) held its Annual General Meeting (AGM) on August 8, 2025, with 37.42% of outstanding shares represented. The company successfully elected eight directors to its board, with approval rates ranging from 80.45% to 91.64%. The highest approval was received by Jared Kelly (91.64%), while Jonathan Rigby received the lowest support (80.45%).

Shareholders also approved additional resolutions, including fixing the board size at eight members and appointing auditors. The meeting results demonstrate strong shareholder support for the company's governance structure.

Oncolytics Biotech (NASDAQ: ONCY) reported Q2 2025 financial results and outlined strategic plans for its immunotherapy drug pelareorep. The company reported a net loss of $6.2 million with $14.6 million in cash, projecting runway into Q1 2026.

Key developments include plans for a registration-enabling pivotal study in first-line metastatic pancreatic cancer (mPDAC), with start-up activities expected in Q4 2025. Clinical data showed impressive 21.9% two-year survival rate in mPDAC patients compared to 9.2% historical benchmark. The company appointed new CEO Jared Kelly and CBO Andrew Aromando, both experienced in successful biotech transactions.

Oncolytics demonstrated commitment to reducing dilution by terminating its At-the-Market and Equity Line of Credit facilities, and announced plans to delist from TSX while maintaining NASDAQ listing.