Now Tracking: New Biotech Profile (Nasdaq: ONCY) Powers Its Way To The Top Of Our Watchlist

Did you catch our most recent Nasdaq profile? It was a doozy.

Any content you receive is for information purposes only. Always conduct your own research. *Disseminated on Behalf of Oncolytics Biotech Inc. Now Tracking: New Biotech Profile (Nasdaq: ONCY) Powers Its Way To The Top Of Our Watchlist *Click Here To Get Our Alerts Faster Via SMS* February 3rd Dear Reader, Did you catch our most recent Nasdaq profile? It was a doozy. From Monday's close of $.609, it rocketed to a high of $.944 Tuesday. That surge resulted in a mind-blowing move of approx. 55% short term. A solid way to start the week, but our attention has turned quickly... A leading force in cancer research is reshaping how the immune system is harnessed to fight disease. This organization’s innovative platform integrates viral therapy and immunology to target difficult-to-treat cancers, offering a fresh perspective on what’s possible beyond conventional treatments. With promising clinical progress and growing recognition in the oncology community, its approach could redefine standards of care. And with an average analyst target projecting triple-digit potential upside, this Nasdaq idea is topping our watchlist Wednesday: Oncolytics Biotech Inc. (Nasdaq: ONCY) 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. And based on 5 key potential catalysts on our radar, (Nasdaq: ONCY) has hit the top of our watchlist. Take a look: #1. An Average Of 7 Analyst Targets Suggest Major Upside Potential (Triple-Digit!). #2. Updated Clinical Data Acts As Attention-Grabbing Information. #3. An IP And Patent Update Highlights The Potential Of Future Commercialization Efforts. #4. Promising Efficacy And Translational Data Fly Off The Page (Multi-Bn Dollar Colorectal Cancer Market). #5. Two Recent Hires Stack The Team With Serious Experience. But more on those in a second... Complete Company Breakdown - Oncolytics Biotech Inc. (Nasdaq: ONCY) Oncolytics Biotech Inc. is driven to improve the lives of people with cancer by giving them what matters most: more quality time. To achieve this, the company is developing pelareorep, a unique immunotherapy designed to awaken the immune system and unlock its antitumor potential. Pelareorep is delivered intravenously and is systemically active, setting it apart from similar immunotherapies that require direct injection into the tumor. It has the ability to turn immunologically “cold” tumors that are resistant to therapeutic intervention “hot” by replicating in cancer cells, expanding tumor-infiltrating lymphocyte (TIL) clones in the blood, and upregulating interferons, CXCL9/10/11, and PD-L1. Pelareorep has the potential to benefit patients with cancer across a variety of indications and can be used as a single agent or combined with other standard-of-care therapies, including chemotherapy and checkpoint inhibitors, to enhance its tumor-fighting capabilities. The Expansive Potential of Pelareorep Pelareorep is a first-in-class, nonpathogenic, oncolytic virus that can be delivered intravenously and works by generating, recruiting, and training immune cells to recognize and kill cancer while remodeling the tumor microenvironment to enable immune cell access.  In addition to its demonstrated single-agent activity, pelareorep can also work in synergy with chemotherapy, immune checkpoint inhibitors (ICIs), CAR T-cell therapy, proteasome inhibitors, bispecific antibodies, and CDK4/6 and PARP inhibitors to enhance its antitumor potential and meaningfully extend patient remissions. Pelareorep specifically targets cancer cells and induces a cascade of inflammatory responses that activate the innate and adaptive immune system to destroy the tumor while sparing normal tissue. Pelareorep’s unique ability to introduce double-stranded RNA, a powerful immune stimulant, directly into cancer cells results in PD-L1 upregulation and cytokine and chemokine production, inducing enhanced infiltration and T-cell activation. Because pelareorep replicates only in tumor cells, it is well-tolerated by patients. Pelareorep Treatment Intravenous pela evades neutralization by associating with mononuclear cells in the blood and is delivered to the tumor. Cold Tumor Pela selectively infects and replicates in tumor cells with RAS pathway mutations. Pela replication produces dsRNA in tumor cells. Hot Tumor Pela infection kills some tumor cells by cell lysis and initiates an inflammatory response, through activation of chemokines and cytokines creating a “hot” tumor. Tumor Under Attack The pela-initiated inflammatory response results in activation and expansion of TIL clones that can attack and kill the tumor. ----- Pipeline The cancer-fighting potential of pelareorep has generated partnerships with leading academic institutions and pharmaceutical industry collaborators. Given the validity of the mechanism of action and the efficacy observed thus far, the Company anticipates that its benefits will extend across multiple indications, including breast, gastrointestinal (GI), and hematologic malignancies. Grab Source And More Here: ONCY Website. ONCY Presentation. ----- And as we mentioned previously, (Nasdaq: ONCY) has several potential catalysts putting it on our radar. Take a look: #1. ONCY Potential Catalyst - An Average Of 7 Analyst Targets Suggest Major Upside Potential (Triple-Digit!). Check out what MarketBeat is reporting: As of Tuesday's close, ONCY had 7 analyst targets pointing to a significant amount of upside potential. In fact, with an average target of $6.25, ONCY could have over 500% potential upside from its closing valuation on Tuesday the 3rd. MarketBeat reports further that Patrick R. Trucchio of H.C. Wainwright has given ONCY a $10 target representing a potential upside over 1,000% from Tuesday's close. Could (Nasdaq: ONCY) be undervalued from current chart levels? ----- #2. ONCY Potential Catalyst - Updated Clinical Data Acts As Attention-Grabbing Information. Oncolytics Biotech® Announces Updated Clinical Data from GOBLET Cohort 4 Demonstrating Activity of Pelareorep Plus Atezolizumab in Third-Line Anal Cancer 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. 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). ... Read the full article here. ----- #3. ONCY Potential Catalyst - An IP And Patent Update Highlights The Potential Of Future Commercialization Efforts. Oncolytics Biotech® Provides Update on Intellectual Property Strategy and Patent Filings Track 1 manufacturing patent application and additional planned filings to potentially extend patent coverage beyond 2044 SAN DIEGO, January 08, 2026--(BUSINESS WIRE)--Oncolytics Biotech® Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, today provided an update on the status of its intellectual property ("IP") portfolio and ongoing efforts to extend patent protection for pelareorep as part of the company’s long-term value creation and development strategy. In early Q3 2025, Oncolytics filed a Track 1 prioritized examination patent application with the United States Patent and Trademark Office ("USPTO") focused on manufacturing-related innovations for pelareorep. If granted, this patent application could result in granted claims with a potential term extending to 2044, significantly lengthening the commercial runway for pelareorep. The company received initial written feedback from the USPTO in Q4 2025. Based on the Track 1 timeline, Oncolytics expects a final action in Q3 2026 regarding this manufacturing patent application. In addition, Oncolytics plans to file one or more additional patent applications relating to the manufacture and method-of-use covering novel therapeutic uses of pelareorep. If allowed, this could provide potential IP protection beyond 2044. "Extending our intellectual property runway is a core pillar of our strategy," said Jared Kelly, Chief Executive Officer of Oncolytics. "As pelareorep continues to demonstrate meaningful clinical activity across gastrointestinal cancers, it is critical that we protect the innovation behind both how the therapy is manufactured and how it is used. These efforts are designed to give pelareorep the best possible chance to impact patients’ lives—particularly those with very limited treatment options—while also increasing long-term value for our shareholders." Oncolytics stated that it expects to continue pursuing additional IP opp's in 2026 as part of a comprehensive approach to supporting late-stage development, potential regulatory approvals, and future commercialization of pelareorep. Read the full article here. ----- #4. ONCY Potential Catalyst - Promising Efficacy And Translational Data Fly Off The Page (Multi-Bn Dollar Colorectal Cancer Market). Oncolytics Biotech® Announces Promising Efficacy and Translational Data Supporting Pelareorep in KRAS-Mutant Metastatic Colorectal Cancer 33% ORR achieved in second-line KRAS-mutant MSS colorectal cancer—triple historical response rates for Avastin + FOLFIRI of 6-11% Translational analysis shows pelareorep enhances KRAS-mutant–specific T-cell activity, providing mechanistic support for clinical responses Data strengthen pelareorep’s potential to transform a multi–Bn dollar underserved colorectal cancer market SAN DIEGO, December 16, 2025--(BUSINESS WIRE)--Oncolytics Biotech® Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, today announced clinical and translational findings supporting the development of pelareorep in second-line metastatic colorectal cancer ("mCRC"), specifically in patients with KRAS-mutant, microsatellite-stable ("MSS") disease. This represents one of the most difficult-to-treat and least responsive subgroups within colorectal cancer. In a previously completed clinical study evaluating pelareorep in combination with standard-of-care therapy, 33% of KRAS-mutant MSS patients achieved an objective response, compared to the well-established historical objective response rate ("ORR") of approximately 6–11% for Avastin® (bevacizumab) + FOLFIRI in second-line mCRC. In that same study, patients receiving the pelareorep, bevacizumab, and FOLFIRI treatment regimen more than doubled progression-free survival and overall survival compared to those receiving bevacizumab and FOLFIRI (click here for the PR). In addition to the clinical activity, a separate translational analysis of paired tumor biopsies revealed that treatment with pelareorep led to a notable increase in KRAS-mutant–specific T-cell populations, indicating that pelareorep may directly enhance anti-tumor immune recognition in this genetically defined subgroup. These findings provide strong biological support for pursuing pelareorep as a precision immunotherapy capable of addressing a patient population that rarely benefits from checkpoint inhibitors or other immunotherapies. A complete analysis of the translational data will be presented at an upcoming medical meeting. "Colorectal cancer is the core of our emerging GI tumor platform strategy for pelareorep, with a projected total addressable market of $20Bn by 2033," said Jared Kelly, Chief Executive Officer of Oncolytics Biotech. "Pelareorep has clearly demonstrated the potential to become a transformational new treatment option in this underserved setting. With translational data supporting its unique activation of KRAS-specific T cells, pelareorep has delivered a 33 percent response rate in KRAS-mutant, MSS colorectal cancer." ... Read the full article here. ----- #5. ONCY Potential Catalyst - Two Recent Hires Stack The Team With Serious Experience. Oncolytics Biotech® Appoints John McAdory as EVP of Strategy and Operations and Yujun Wu to Lead Biostatistics Appointments strengthen late-stage clinical execution and statistical leadership as the Company advances multiple registration-directed programs in gastrointestinal cancers SAN DIEGO, Jan. 14, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced the appointment of John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics. These appointments are expected to enhance the Company’s operational, clinical, and regulatory capabilities as Oncolytics advances registration-directed development programs in pancreatic, colorectal, and anal cancers. Mr. McAdory will oversee clinical development execution, operational strategy, and regulatory readiness across the Company’s portfolio. He brings extensive experience leading late-stage oncology programs, particularly in the oncolytic vi-rus space. Most recently, Mr. McAdory served as Vice President, Clinical Operations at CG Oncology, Inc. (Nasdaq: CGON), a late-stage biotechnology company developing an intratumoral oncolytic virus. Over his career, he has managed large, registration-directed clinical trials involving hundreds of patients across multiple tumor types and supported global regulatory interactions. “John’s background running complex, late-stage oncology trials makes him exceptionally well-suited to lead Oncolytics’ next phase of execution,” said Jared Kelly, Chief Executive Officer of Oncolytics. “As we progress toward pivotal and registration-enabling studies in anal, pancreatic, and colorectal cancers, his experience will be critical to ensuring disciplined execution, speed, and regulatory alignment.” Mr. Wu joins Oncolytics to lead Biostatistics, bringing deep expertise in statistical strategy, regulatory interactions, and late-stage trial design. Most recently, he served as Head of Biostatistics at Morphic Therapeutic, where he supported multiple clinical programs through late-stage development and played a key role during the company’s acquisition by Eli Lilly and Company. Previously, Mr. Wu led statistical strategy and regulatory execution for multiple Phase 3 and registration oncology programs at Takeda, Pharmaceutical Company Limited (NYSE: TAK), leveraging innovative trial designs to accelerate late-stage development and global regulatory approvals. “Yujun’s experience designing and supporting late-stage studies and interacting with regulators significantly strengthens our internal capabilities," added Mr. Kelly. “As we pursue accelerated approval strategies and pivotal trials, high-quality statistical leadership is essential, and Yujun brings that expertise at a critical time for the Company.” ... Read the full article here. ----- (Nasdaq: ONCY) Recap - 5 Potential Catalysts Hits Our Radar #1. An Average Of 7 Analyst Targets Suggest Major Upside Potential (Triple-Digit!). #2. Updated Clinical Data Acts As Attention-Grabbing Information. #3. An IP And Patent Update Highlights The Potential Of Future Commercialization Efforts. #4. Promising Efficacy And Translational Data Fly Off The Page (Multi-Bn Dollar Colorectal Cancer Market). #5. Two Recent Hires Stack The Team With Serious Experience. ----- We're initiating coverage on Oncolytics Biotech Inc. (Nasdaq: ONCY). Be on the lookout for updates coming your way soon. Talk shortly. Sincerely, FierceAnalyst | Jaks Swift Editorial Writer (Always Remember The St-ock Prices Could Be Significantly Lower Now From The Dates I Provided.) *FierceInvestor (FierceInvestor . com) is owned by SWN Media LLC, a limited liability company. Data is provided from third-party sources and FierceInvestor ("FI") is not responsible for its accuracy. Make sure to always do your own research and due diligence on any day and swing profile I bring to your attention. We do not provide personalized fin-ancial advice, are not finan-cial advisors, and our opinions are not suitable for all in-vest-ors. Pursuant to an agreement between SWN Media LLC and TD Media LLC, SWN Media LLC has been hired for a period beginning on 02/03/2026 and ending on 02/04/2026 to publicly disseminate information about (ONCY:US) via digital communications. Under this agreement, TD Media LLC has paid SWN Media LLC twenty thousand USD ("Funds"). These Funds were part of the ninety thousand USD funds that TD Media LLC received from Oncolytics Biotech Inc., the issuer of (ONCY:US). Neither SWN Media LLC, TD Media LLC and their member own shares of (ONCY:US). Please see important disclosure information here: https://fierceinvestor.com/disclosure/oncy-wayo3/#details

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