<div id="readability-page-1"><div><div> Issued on behalf of Oncolytics Biotech Inc. VANCOUVER – Baystreet.ca News Commentary – The FDA issued multiple breakthrough approvals for oncology drugs in November 2025, marking a transformative month for cancer treatment with pivotal regulatory decisions across lung, breast, blood, and gastrointestinal cancers[1]. Market analysts project global oncology spending to reach $668.26 billion by 2034, driven by companies transitioning from open-ended clinical exploration to defined, registration-enabling pathways that provide investors with clear timelines and binary outcomes[2]. These regulatory advancements position Oncolytics Biotech Inc. (NASDAQ: ONCY), MAIA Biotechnology, Inc. (NYSE-American: MAIA), Nuvation Bio Inc. (NYSE: NUVB), OS Therapies Inc. (NYSE-American: OSTX), and Zentalis Pharmaceuticals, Inc. (NASDAQ: ZNTL) at the vanguard of drug development. Industry forecasts show the anticancer drug market growing at a robust 9.5% compound annual growth rate through 2032, as precision oncology and immunotherapy combinations become standard approaches across major tumor types[3]. The shift toward registration-directed development programs accelerated throughout late 2025, as biotechnology companies secured regulatory alignment that enables expedited pathways and provides shareholders with transparent roadmaps to potential commercial approval[4]. Oncolytics Biotech Inc. (NASDAQ: ONCY) has announced promising efficacy and translational data supporting pelareorep in KRAS-mutant metastatic colorectal cancer, achieving a 33% objective response rate in second-line patients with microsatellite-stable disease who received pelareorep, Avastin, and FOLFIRI. This represents triple the historical response rate of 6-11% for Avastin plus FOLFIRI in this setting. The data strengthen pelareorep's potential across gastrointestinal tumors, building on recent anal cancer results showing a 30% response rate in second-line squamous cell anal carcinoma, more than double the 13.8% benchmark for the only FDA-approved immunotherapy in this setting. The median duration of response reached 15.5 months compared to 9.5 months for current standard care, with two durable complete responses among responders. Translational analysis revealed that pelareorep treatment led to notable increases in KRAS-mutant-specific T-cell populations, providing mechanistic support for the clinical activity observed in this genetically defined patient population. These findings position pelareorep as a precision immunotherapy capable of providing a meaningful clinical benefit over the current standard of care. &#34; Colorectal cancer is the core of our emerging GI tumor platform strategy for pelareorep, with a projected total addressable market of $20 billion by 2033,&#34; said Jared Kelly, CEO of Oncolytics Biotech. &#34;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.&#34; The company plans to sponsor a controlled study in second-line KRAS-mutant MSS colorectal cancer following consultation with key opinion leaders and regulatory authorities, providing analytical rigor to support potential regulatory submissions. This will enable Oncolytics to have control over the data generated from this study and update relevant stakeholders at their discretion, including investors and potential partners. &#34;These results are extremely encouraging,” said Dr. Sanjay Goel, Professor of Medicine at Rutgers Cancer Institute of New Jersey. “Achieving a 33% ORR in KRAS-mutant MSS colorectal cancer is highly unusual in this setting and warrants immediate further study.&#34; The company recently established a Gastrointestinal Tumor Scientific Advisory Board to guide registration strategy across pancreatic, colorectal, and anal cancers. Inaugural members include Dr. Goel, Dr. Deva Mahalingam from Northwestern University, and Dr. Dirk Arnold, principal investigator of the GOBLET study. Oncolytics has also secured FDA alignment on its pivotal Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning the company to launch the only immunotherapy registration trial currently planned for this disease. Pelareorep holds both Fast Track and Orphan Drug designations from the FDA for pancreatic cancer. CEO Jared Kelly and Chief Business Officer Andrew Aromando were both crucial contributors to Ambrx Biopharma's $2 billion acquisition by Johnson &amp; Johnson, demonstrating proven ability to advance assets through value-creating transactions. CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/ In other recent industry developments and happenings in the market include: MAIA Biotechnology, Inc. (NYSE-American: MAIA) has highlighted the ongoing momentum of its ateganosine clinical program at SITC 2025, with 12 patients enrolled in the Phase 2 THIO-101 expansion trial to date across sites in Hungary, Poland, Turkey and Taiwan. The company has begun screening patients in its Phase 3 THIO-104 trial, which has received FDA Fast Track designation for ateganosine in the treatment of NSCLC. &#34;In this population, third-line NSCLC patients resistant to chemo and immunotherapy, current treatments show overall survival of around 6 months, and based on the 17.8 months OS observed in THIO-101 to date, we believe that our Phase 3 trial could lead to an early commercial approval of ateganosine by the FDA,&#34; said Vlad Vitoc, M.D., CEO of MAIA Biotechnology. &#34;It's only a matter of successful execution to bring our novel NSCLC treatment to this large patient population with significant unmet medical need.&#34; As of September 17, 2025, a patient who began therapy in March 2023 has shown survival of 30 months. MAIA's telomere-targeting agent ateganosine has demonstrated the ability to activate both innate and adaptive immune responses, with enrollment momentum expected to continue in the near term. Nuvation Bio Inc. (NYSE: NUVB) announced publication of positive Phase 2 results for safusidenib in grade 2 IDH1-mutant gliomas published in Neuro-Oncology, demonstrating a 44.4% objective response rate with 87.9% of patients progression-free at 24 months. The study evaluated 27 chemotherapy and radiotherapy-naïve patients with IDH1-mutant grade 2 gliomas, with median progression-free survival not yet reached at a median follow-up of 28 months. &#34;The results published in the journal of Neuro-Oncology demonstrate safusidenib's impressive response rate and prolonged progression-free survival that suggest the possibility to delay chemoradiation, potentially improving quality of life for patients,&#34; said David Hung, MD, Founder, President and CEO of Nuvation Bio. &#34;While the published results reflect the March 10, 2023 data cut-off, as of September 15, 2025, 12 patients remained on treatment with safusidenib, further supporting the durability of responses.&#34; The company is progressing the G203 study in high-grade IDH1-mutant gliomas, with a protocol amendment on track to finalize the study as a global Phase 3 to support potential regulatory approvals. The primary endpoint is progression-free survival as assessed by Blinded Independent Central Review, which the FDA agreed could support full approval in this setting. OS Therapies Inc. (NYSE American: OSTX) achieved full alignment with the United Kingdom Medicines and Healthcare Products Regulatory Agency on all key points surrounding non-clinical, CMC, and post-market authorization confirmatory study design for its Phase 2b clinical trial of OST-HER2 in the prevention or delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma. The world leader in listeria-based cancer immunotherapies advanced the correlation of upregulated immune response biomarkers as a key pre-specified surrogate clinical efficacy endpoint, with pending biomarker analysis awaiting alignment with the U.S. Food &amp; Drug Administration at its December 11, 2025 Type C Meeting. &#34;We were pleased with the insightful feedback from our colleagues at UK MHRA during yesterday's pre-MAA meeting,&#34; said Paul Romness, CEO of OS Therapies. &#34;Their perspective will be very helpful as we finalize preparations for our upcoming Type C Meeting with US FDA on Thursday.&#34; The company reiterated its end of January 2026 timeline for conditional Marketing Authorisation Application submission to MHRA, positioning OST-HER2—which has received Rare Pediatric Disease Designation, Fast-Track, and Orphan Drug designations. OS Therapies reported positive Phase 2b data demonstrating statistically significant benefit in the 12-month event-free survival primary endpoint, and if approved, would become eligible to receive a Priority Review Voucher. Zentalis Pharmaceuticals, Inc. (NASDAQ: ZNTL) advanced its DENALI Phase 2 trial evaluating azenosertib in Cyclin E1-positive platinum-resistant ovarian cancer, maintaining expectations for topline data by year-end 2026 with potential to support an accelerated approval submission to the FDA. The company reported $280.7 million in cash, cash equivalents and marketable securities as of September 30, 2025, providing operational runway into late 2027. &#34;We are pleased with our continued disciplined execution of the DENALI clinical trial this quarter, supporting late-stage development of azenosertib as a potential treatment for Cyclin E1-positive platinum-resistant ovarian cancer, and positioning us for an anticipated topline data readout by year end 2026,&#34; said Julie Eastland, CEO of Zentalis. &#34;With $280.7 million in cash providing runway into late 2027, we maintain a robust financial foundation to deliver on our azenosertib objectives.&#34; The DENALI trial continues enrollment in Part 2a, evaluating two dose levels (400mg and 300mg once-daily 5:2 dosing) with up to 30 patients each, followed by Part 2b enrolling approximately 70 patients at the selected dose. Zentalis also completed enrollment in its TETON Phase 2 trial in uterine serous carcinoma, with results planned for publication in the first half of 2026. Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/ CONTACT: Baystreet.ca [email protected] (250) 999-4849 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. Baystreet.ca is a wholly-owned subsidiary of Baystreet.ca Media Corp. (“BAY”) BAY has been not been paid a fee for Oncolytics Biotech Inc. advertising and/or digital media, but the owner(s) of BAY also own Market IQ Media Group, Inc., which has been paid a fee from the company directly. There may be 3rd parties who may have shares Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of BAY own shares of Oncolytics Biotech Inc. which were purchased in the open market. BAY and all of it’s respective employees, owners and affiliates reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time thereafter without any further notice. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material disseminated by BAY has been approved by the above mentioned company; this is a paid advertisement, and we own shares of the mentioned company that we will sell, and we also reserve the right to buy shares of the company in the open market, or through other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCES CITED: 1. https://www.targetedonc.com/view/november-2025-key-fda-highlights-in-oncology 2. https://www.globenewswire.com/news-release/2025/12/02/3198196/0/en/Oncology-Market-Size-Worth-USD-668-26-Billion-by-2034.html 3. https://www.globenewswire.com/news-release/2025/12/03/3198632/0/en/Future-of-Anticancer-Drug-Market-2025-2032-Emerging-Oncology-Therapies-Market-Opportunities-and-Global-Competitive-Strategies-AnalystView-Market-Insights.html 4. https://www.curetoday.com/view/every-fda-oncology-approval-from-november-2025 </div></div></div>

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The FDA's breakthrough approvals in November 2025 have accelerated cancer drug development, benefiting companies like Oncolytics Biotech Inc. and others. Oncolytics' pelareorep shows promising results in KRAS-mutant colorectal cancer, achieving a 33% response rate. The company plans further studies and has FDA alignment for a Phase 3 trial in pancreatic cancer. MAIA Biotechnology's ateganosine program also progresses, with potential early FDA approval for NSCLC treatment.

Pivotal Cancer Trials Gain Momentum as Regulatory Clarity Emerges