SAN DIEGO, Jan. 09, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today provided additional context regarding its previously announced proposal to change the Company’s jurisdiction of incorporation from Alberta, Canada, to the State of Nevada in the United States. The Company believes it is important to clearly communicate the strategic and operational reasons underlying this proposal as Oncolyt ...

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Core Viewpoint - Oncolytics Biotech Inc. has filed an amended registration statement on Form F-4 with the SEC, which includes a management circular/prospectus and other relevant documents related to various proposals [1] Group 1 - The registration statement has been declared effective by the SEC [1]

Core Insights - The market is experiencing inefficiencies, with certain subsectors lagging behind despite overall momentum in the S&P 500 [1] - Specific undervalued companies have been identified, particularly in late-stage biotech and defense infrastructure, which are poised for growth due to improved fundamentals [2] Oncolytics Biotech - Oncolytics Biotech has developed pelareorep, a treatment that converts "cold" tumors into "hot" ones, enhancing the effectiveness of existing cancer therapies [3] - The company is addressing a significant patent cliff in the pharmaceutical industry, with over $250 billion in annual sales at risk, making its solutions attractive to Big Pharma [4] - A pivotal Phase 3 trial for pancreatic cancer is set to begin, with a focus on overall survival as the primary endpoint [4] - Previous Phase 2 data indicated a near-doubling of median overall survival compared to historical controls, leading to partnerships with major pharmaceutical companies [5] - The current market capitalization is below $150 million, significantly undervalued compared to comparable oncology assets [6] Avant Technologies - Avant Technologies is addressing the critical issue of data security in pharmaceutical AI by creating private compute grids for biotech firms [7][8] - The company has shifted its business model to focus on partnerships with biotech firms that require secure computational resources for cell-based therapies [9] - Avant is misclassified as a generic microcap tech stock, while it actually provides specialized infrastructure for data-sensitive sectors [11] VisionWave Holdings - VisionWave Holdings develops AI-powered detection systems for autonomous drone swarms, addressing the evolving needs of modern defense networks [12] - The company recently launched Argus, a space-enabled counter-drone system that utilizes satellite-based sensors for enhanced threat detection [14] - VisionWave is positioned to benefit from the Pentagon's increased focus on counter-drone technology and autonomous systems [15] - The current market valuation does not reflect the company's technological capabilities, which are expected to improve as their systems move from development to deployment [16] GoldHaven Resources - GoldHaven Resources is advancing a high-grade gold project in Brazil, capitalizing on increasing demand for gold amid geopolitical tensions and inflation [17][18] - The company is drilling high-priority targets, with the potential to define significant resources in a prolific gold belt [19] - GoldHaven is trading at a discount compared to peers, with the market pricing in exploration risks without recognizing its jurisdictional advantages [20] VentriPoint Diagnostics - VentriPoint Diagnostics offers a cost-effective solution for cardiac imaging by transforming standard 2D ultrasound images into 3D reconstructions [21][22] - The company's VMS+ software allows hospitals to upgrade existing ultrasound machines, avoiding the high costs associated with MRI installations [23] - VentriPoint is positioned to benefit from the shift in healthcare systems towards software-driven efficiency, with a significant addressable market for cardiac imaging software [26]

Oncolytics Biotech Inc. (ONCY) has been on a downward spiral lately with significant selling pressure. After declining 8.8% over the past four weeks, the stock looks well positioned for a trend reversal as it is now in oversold territory and there is strong agreement among Wall Street analysts that the company will report better earnings than they predicted earlier.We use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whether a stock is oversold. This is a mo ...

Core Insights - Oncolytics Biotech Inc. (ONCY) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive shift in earnings estimates which is a significant factor influencing stock prices [1][3][10] Earnings Estimates and Stock Performance - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6] - For Oncolytics Biotech, the Zacks Consensus Estimate for earnings has increased by 13.1% over the past three months, reflecting a positive outlook for the company's earnings [8] Investment Implications - The upgrade to Zacks Rank 2 positions Oncolytics Biotech in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10] - Rising earnings estimates indicate an improvement in the company's underlying business, which is expected to drive the stock price higher [5][10]

Core Insights - The combination of pelareorep and atezolizumab achieved a 30% objective response rate (ORR) in patients with second-line or later squamous cell anal carcinoma (SCAC), significantly higher than the historical benchmark of 13.8% for the only FDA-approved treatment [1][2] - The median duration of response for this combination therapy was 15.5 months, compared to 9.5 months for the current standard of care [3] - Oncolytics Biotech plans to discuss a single-arm accelerated approval study with the FDA in Q1 2026 [1][6] Efficacy Results - Among 20 evaluable patients, six achieved a response, resulting in a 30% ORR, which is more than double the historical benchmark [2] - Two durable complete responses were observed, with one lasting over two years and another lasting 15 months; an additional patient has an ongoing response at 64 weeks [3] - The results indicate the potential for pelareorep to provide durable immunologic tumor control in gastrointestinal tumors without chemotherapy [4] Company Strategy - The SCAC cohort is part of the broader GOBLET study, which evaluates pelareorep in combination with checkpoint inhibitors and standard therapies across multiple gastrointestinal cancer indications [5] - Oncolytics intends to engage with the FDA regarding a potential single-arm study for accelerated approval in SCAC, with a possible launch in the first half of 2026 [6] - The GOBLET study includes multiple treatment groups targeting various gastrointestinal cancers, assessing both efficacy and safety [7][8] Company Background - Oncolytics Biotech is a clinical-stage biotechnology company focused on developing pelareorep, an investigational immunotherapeutic agent designed to activate immune responses against cancer [10] - The company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in various cancer types, including pancreatic and breast cancers [11]

Core Insights - Oncolytics Biotech Inc. is advancing its clinical trial for pelareorep in first-line pancreatic ductal adenocarcinoma (PDAC) and is scheduled to meet with the FDA in mid-November 2025 to discuss study details [1][4] Proposed Registration Study Design - The study design is based on a post-hoc pooled clinical analysis showing a 22% two-year survival rate for patients receiving pelareorep with chemotherapy, compared to 9% for those on chemotherapy alone [3] - The trial will utilize a three-arm design: 1. Gemcitabine + nab-paclitaxel (GnP) control arm 2. GnP + pelareorep 3. GnP + pelareorep + checkpoint inhibitor (CPI) - The primary endpoint is Overall Survival (OS), with statistical rigor to detect significance between investigational arms and the control arm [8] Company Overview - Oncolytics is a clinical-stage biotechnology company focused on developing pelareorep, an investigational immunotherapeutic agent designed to activate immune responses against cancer [5] - The company is also pursuing strategic partnerships to enhance development and commercial impact, with Fast Track designation from the FDA for its programs in metastatic pancreatic and breast cancers [6]

Core Insights - Oncolytics Biotech Inc. is advancing its clinical-stage immunotherapy, pelareorep, with updates on enrollment, U.S. site expansion, and data readouts from the GOBLET trial focused on gastrointestinal cancers [1][2][6] Enrollment Progress - The GOBLET trial is evaluating pelareorep's efficacy in gastrointestinal cancers, with a specific focus on Cohort 4 (SCAC) and Cohort 5 (mPDAC) [2][4] - Enrollment in Cohort 4 is currently at 20 evaluable patients, with completion expected by the end of 2025 [2] - Cohort 5 is approximately 40% enrolled, with full enrollment anticipated by the end of 2026 [4][5] Efficacy Data - In Cohort 4, pelareorep combined with atezolizumab showed a 33% overall response rate (ORR) in 12 patients, significantly higher than the 11% ORR achieved by retifanlimab [2] - In Cohort 5, pelareorep combined with chemotherapy achieved a 62% ORR in 13 evaluable patients [4] U.S. Site Expansion - The company has submitted a protocol amendment to open U.S. clinical sites for the GOBLET study, with Northwestern University expected to participate [6][7] - This expansion aims to provide novel immunotherapy strategies to U.S. patients with pancreatic cancer [7] Future Updates - An efficacy update for Cohort 4 is expected in Q4 2025, while an interim efficacy update for Cohort 5 is anticipated in Q1 2026 [3][5] Company Overview - Oncolytics is developing pelareorep, an intravenously delivered double-stranded RNA immunotherapeutic agent, which has shown promise in various cancer studies [8] - The company is pursuing strategic partnerships to enhance development and commercial impact [9]

Core Insights - Oncolytics Biotech Inc. has reported that pelareorep demonstrates a significant survival benefit in KRAS mutant metastatic colorectal cancer (mCRC), with median progression-free survival (PFS) of 16.6 months compared to 5.7 months for the current standard of care, and median overall survival (OS) of 27.0 months versus 11.2 months [6]. Group 1: Clinical Efficacy - In the REO 022 trial, pelareorep combined with FOLFIRI and bevacizumab showed promising results in platinum refractory 2L mCRC KRAS mutant patients [2]. - The GOBLET study's 3L mCRC Cohort 3 demonstrated that pelareorep combined with atezolizumab and TAS-102 met its predefined efficacy endpoint, achieving durable disease control and survival rates exceeding historical benchmarks [2]. Group 2: Mechanism of Action - Studies including REO 022 and REO 013 confirmed pelareorep's mechanism of action, showing viral replication and immune activation in mCRC tumors, including dendritic cell maturation and CD8+ T cell activation [3]. - The findings indicate that pelareorep can modify mCRC tumors to become immune responsive, making them more amenable to checkpoint inhibition [3]. Group 3: Future Development Plans - The company plans to initiate an investigator-sponsored trial to further explore pelareorep's potential in KRAS mutant mCRC, leveraging the robust immune activation and survival benefits observed in previous studies [4]. - Oncolytics aims to define a regulatory pathway for pelareorep and engage with leading investigators to establish a clear path to registration in mCRC, including the design of a confirmatory study [4].