Welcome to our dedicated page for Oncolytics Biotech news (Ticker: ONCY), a resource for investors and traders seeking the latest updates and insights on Oncolytics Biotech stock.
Oncolytics Biotech, Inc. (Nasdaq: ONCY) is a clinical-stage biotechnology company whose news flow centers on the development of pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Company updates frequently highlight clinical data in metastatic pancreatic cancer, metastatic breast cancer, and gastrointestinal tumors such as anal and colorectal cancers, where pelareorep is being evaluated in combination with chemotherapy and checkpoint inhibitors.
News releases from Oncolytics often cover clinical trial milestones, including results from the GOBLET study in squamous cell anal carcinoma and colorectal cancer, as well as alignment with the U.S. Food and Drug Administration on pivotal trial designs in first-line metastatic pancreatic ductal adenocarcinoma. Investors can also expect announcements about planned registration-directed studies, accelerated approval strategies in indications with no FDA-approved therapies, and translational findings such as tumor-specific T-cell responses in KRAS-mutant metastatic colorectal cancer.
Oncolytics’ news also addresses corporate and regulatory developments, including its proposal to change its jurisdiction of incorporation from Alberta, Canada, to the State of Nevada, its transition to domestic issuer status under SEC rules, and capital markets activities such as at-the-market equity programs. Additional updates describe expansions of the company’s Gastrointestinal Tumor Scientific Advisory Board and appointments of senior leaders in strategy, operations, and biostatistics to support late-stage clinical execution.
This ONCY news page aggregates these press releases and related coverage so readers can follow key developments in pelareorep’s clinical progress, regulatory interactions, intellectual property initiatives, and corporate strategy. It is a useful resource for tracking how new data, advisory board input, and structural changes may influence the company’s oncology pipeline over time.
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.
Oncolytics Biotech (NASDAQ: ONCY) has announced its voluntary delisting from the Toronto Stock Exchange (TSX), effective August 22, 2025. The company's shares will continue trading on the Nasdaq under the symbol "ONCY". This strategic decision comes as Oncolytics will cease to be a Foreign Private Issuer effective January 1, 2026.
The clinical-stage immunotherapy company, which develops pelareorep, made this decision based on several factors, including maintaining its Nasdaq listing, potential future U.S. re-domiciling plans, and cost efficiency considerations given its U.S. focus and shareholder base. Canadian shareholders will retain their ability to trade shares on Nasdaq through brokers with U.S.-registered affiliates.
Oncolytics Biotech (NASDAQ: ONCY), a clinical-stage immunotherapy company focused on pelareorep development, has scheduled its 2025 Annual General Meeting for August 8, 2025, at 10:00 a.m. ET. The meeting will be held virtually, with CEO Jared Kelly providing a corporate update and discussing strategic milestones for 2025 after the formal shareholder voting.
The company will also release its second quarter 2025 financial results before market opening on the same day. Shareholders can access detailed voting information through the Management Information Circular dated June 18, 2025, available on the company's website and in securities filings.
Oncolytics Biotech (NASDAQ: ONCY) has initiated FDA discussions for a potential registration-enabled pivotal study of pelareorep in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). The company plans to commence study activities by the end of 2025, focusing on a trial design that combines pelareorep with chemotherapy and potentially checkpoint inhibition.
The company aims to leverage its Fast Track and Orphan Drug designations in mPDAC, with overall survival as the primary endpoint. The strategy includes exploring an adaptive study design in collaboration with a third party, positioning Oncolytics for potential partnerships in GI oncology. Recent Key Opinion Leader feedback has validated pelareorep's ability to transform "cold" tumors into immunologically active ones, particularly in KRAS-mutated colorectal cancer.
Oncolytics Biotech (NASDAQ: ONCY) hosted a key opinion leader (KOL) webinar focusing on pelareorep's clinical data in pancreatic and gastrointestinal cancers. The event highlighted significant survival benefits demonstrated by pelareorep-based combinations in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) patients.
Key findings show that pelareorep combined with chemotherapy represents a promising treatment option for mPDAC patients. Translational data from multiple clinical trials validated pelareorep's mechanism of action, demonstrating tumor replication, chemokine expression stimulation, and correlation between tumor-infiltrating lymphocytes expansion and tumor size reduction.
Oncolytics Biotech (NASDAQ: ONCY), a clinical-stage immunotherapy oncology company, has successfully regained compliance with Nasdaq's minimum bid price requirement. The company received formal confirmation from Nasdaq's Listing Qualifications Department on July 22, 2025.
After falling below the required $1.00 minimum bid price in February 2025, ONCY has maintained a closing bid price at or above $1.00 for 10 consecutive business days from July 8 through July 21, 2025. The company is now fully compliant with all Nasdaq listing standards and will continue trading on the Nasdaq Capital Market.