Latest news with #Pelareorep
Cision Canada
3 hours ago
- Business
- Cision Canada
Biotech Underdogs Line Up for Pivotal Shots at Game-Changing Cancer Treatments
Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, B.C., /CNW/ -- Equity Insider News Commentary – The average age of cancer patients is getting younger, as experts are urgently examining the rise of early-onset incidence across several different cancer types. According to the Cancer Discovery study from the National Cancer Institute (NCI), the largest increases were seen in female breast, colorectal, kidney, uterine, and pancreatic cancers. Biotechs in the oncology space are responding with optimistic new treatments with potential milestones in the near future that may shift the tide in the sector, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Celcuity Inc. (NASDAQ: CELC), Evaxion A/S (NASDAQ: EVAX), Lyell Immunopharma, Inc. (NASDAQ: LYEL), and Agenus Inc. (NASDAQ: AGEN). Globally, the cancer‑drug sector is projected to surpass US$900billion in sales by 2034, according to Vision Research Reports. Next‑generation therapeutics (those powered by precision and personalized medicine) are pegged by Precedence Research to hit US$175.2billion during that same time period, growing at a 7.35% CAGR. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has officially entered the most critical phase of its journey yet—pursuing a potential registration-enabled trial in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), for its flagship asset, pelareorep. The company announced it has begun formal discussions with the U.S. Food and Drug Administration (FDA) aimed at finalizing a pivotal study design, with trial start-up activities expected to begin before the end of 2025. For investors and potential partners, this marks a clear shift from promising data to regulatory execution in one of the deadliest solid tumors in medicine. "We expect to move quickly and decisively down a clear regulatory path," said Jared Kelly, CEO of Oncolytics. "This is about execution and focus. Our goal is to win on survival—and this pivotal study is how we do it. We believe this program not only creates significant value for shareholders but also positions Oncolytics as a highly attractive partner for pharma companies seeking to break open the immunotherapy landscape in mPDAC and other GI tumors." The move comes as Oncolytics sharpens its focus on pelareorep, a systemically delivered oncolytic virus designed to convert so-called "cold" tumors—those that are typically invisible to the immune system—into "hot" tumors that can respond to immunotherapy. Pelareorep has been studied across over 1,100 patients and has demonstrated promising results in difficult cancers like mPDAC and HR+/HER2- breast cancer, particularly when used in combination with chemotherapy and immune checkpoint inhibitors. In first-line pancreatic cancer, pelareorep-based regimens have shown a notable 21.9% two-year overall survival rate, compared to a 9.2% historical benchmark. In a separate study pairing pelareorep with chemotherapy and a checkpoint inhibitor, researchers recorded a 62% objective response rate—remarkable given that checkpoint inhibitors are not currently approved for use in this indication. This robust efficacy signal, along with impressive translational data, helped lay the groundwork for this regulatory step. "This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME – all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep." Earlier this month, Oncolytics hosted a key opinion leader event featuring gastrointestinal cancer experts who reviewed survival outcomes, biomarker validation, and the drug's potential role in combination therapy. That expert panel helped reinforce the view that pelareorep's mechanism—activating innate and adaptive immune responses in patients—is both biologically sound and commercially relevant. Oncolytics' execution-focused strategy is being led by Jared Kelly and Andrew Aromando, who both played key roles in Ambrx Biopharma's US$2 billion acquisition by Johnson & Johnson. Kelly was appointed CEO earlier this year, while Aromando recently joined as Chief Business Officer. Together, along with Oncolytics' already-established team, they're guiding the company into late-stage development with a sharp focus on capital efficiency and strategic alignment. Regulatory designations are already in place to accelerate development. Pelareorep holds Fast Track and Orphan Drug designations for pancreatic cancer (and Fast Track for HR+/HER2‑ mBC breast cancer) from the FDA, meaning the agency has already recognized both the drug's potential and the serious unmet need in this patient population. These statuses not only streamline review processes but also increase the attractiveness of the program to potential pharmaceutical partners. For context, pancreatic cancer is one of the deadliest common cancers, with a five-year survival rate of less than 14%. Most patients are diagnosed at a metastatic stage, and current treatment options provide limited benefit. Unlike other cancers where immunotherapies like checkpoint inhibitors have transformed care, mPDAC remains largely resistant to those approaches—making the promise of pelareorep especially notable. What distinguishes pelareorep is its dual capability: it acts as both a viral therapy that replicates in cancer cells and a biological agent that activates the body's own immune response. Tumor samples have shown increased PD-L1 expression, heightened interferon signaling, and infiltration of tumor-killing T cells—all hallmark indicators that the immune system is being mobilized against cancer. These features are seen as essential for the next generation of immuno-oncology approaches. With this latest milestone, Oncolytics is entering a phase where the outcomes of FDA interaction will shape not only clinical plans but also potential commercial partnerships. If the agency accepts the company's proposed trial framework and endpoints—centered around overall survival—the resulting study could become the definitive test for pelareorep's market potential in mPDAC. More details on the trial design and timing are expected once FDA feedback is received, but the goal is clear: initiate the pivotal trial start-up activities before the end of 2025 and establish pelareorep as a cornerstone immunotherapy in one of the most underserved cancer settings. In the meantime, the company remains active in its ongoing breast cancer program and is continuing to explore pelareorep's potential in other gastrointestinal cancers, including KRAS-mutated colorectal cancer. However, first-line pancreatic cancer has now emerged as the lead strategic focus. The transition from early-stage promise to registration-stage planning marks a decisive evolution in the Oncolytics story. With data in hand, regulatory engagement underway, and a seasoned leadership team at the helm, Oncolytics is advancing into its most consequential chapter yet. In other recent industry developments and happenings in the market include: Celcuity Inc. (NASDAQ: CELC) recently announced that its Phase 3 VIKTORIA-1 trial met both progression-free survival (PFS) primary endpoints in patients with HR+/HER2- breast cancer without PIK3CA mutations. Gedatolisib-based combinations showed significant PFS improvements compared to standard therapies, including a 7.3-month gain for the triplet arm (9.3 vs. 2.0 months for fulvestrant monotherapy) and a 5.4-month gain for the doublet (7.4 vs. 2.0 months for fulvestrant monotherapy). "The efficacy improvement relative to the control that each of the gedatolisib regimens demonstrated was historic for this patient population," said Brian Sullivan, Chairman, CEO and co-founder of Celcuity. "We are excited about the potential opportunity to provide a breakthrough therapeutic option for patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer." The company plans to discuss a potential NDA submission with the FDA following a full data presentation later this year. Lyell Immunopharma, Inc. (NASDAQ: LYEL) announced impressive new data from its LYL314 trial in relapsed/refractory large B-cell lymphoma, showing an 88% overall response rate and 72% complete response rate in the 3L+ setting. Over 70% of complete responders remained disease-free at 6 months. "Based on these robust data, and our recent End-of-Phase 1 meeting with the FDA, we have initiated PiNACLE, a single-arm pivotal trial of LYL314 in patients with large B-cell lymphoma in the third- or later-line setting and remain on track to initiate a pivotal trial to evaluate LYL314 in the second-line setting by the beginning of 2026," said Lynn Seely, MD, President and CEO of Lyell. The pivotal PiNACLE trial is now underway to support potential approval of this next-generation dual-targeting CAR T therapy. Later this year in October, Evaxion A/S (NASDAQ: EVAX) shared it will be presenting two-year data at ESMO 2025 from its Phase 2 trial of EVX-01, an AI-designed personalized cancer vaccine, showing durable responses in advanced melanoma. Results included a 69% overall response rate and a strong correlation between AI predictions and immune activity. The study supports EVX-01's role as a first-line immunotherapy candidate when paired with checkpoint inhibitors like pembrolizumab. "We are delighted to have the two-year data from the EVX-01 phase 2 trial accepted for presentation at the ESMO Congress 2025," said Birgitte Rønø, CSO and interim CEO of Evaxion. "As one of the most important and prestigious medical oncology conferences in the world, the congress will be a great place for us to present the data to a large audience, including potential partners." Also at ESMO 2025, Agenus Inc. (NASDAQ: AGEN) will present survival data from its botensilimab/balstilimab program, including an oral session highlighting survival plateaus across five refractory tumor types. With over 1,200 patients treated, the agents are showing promising results in historically cold tumors like mCRC and non-melanoma skin cancer. These data continue to support botensilimab as a backbone immunotherapy candidate for solid tumors. CONTACT: Equity Insider [email protected] (604) 265-2873 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. Equity Insider is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of 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 MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. 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, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. 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The Market Online
7 hours ago
- Business
- The Market Online
Oncolytics Biotech sparks FDA discussions for potential pivotal pancreatic cancer trial
Oncolytics Biotech (TSX:ONC) has initiated regulatory discussions with the U.S. Food and Drug Administration (FDA) to advance pelareorep, its lead immunotherapeutic candidate The FDA discussions will focus on finalizing a clinical trial design that leverages pelareorep's demonstrated synergy with chemotherapy—with or without checkpoint inhibitors—and will use overall survival as the primary endpoint The company expects to move quickly and decisively down a clear regulatory path Oncolytics Biotech stock (TSX:ONC) opened trading at C$1.47 A clinical-stage immunotherapy company announced that it has initiated regulatory discussions with the U.S. Food and Drug Administration (FDA) to advance its lead immunotherapeutic candidate. Oncolytics Biotech (TSX:ONC) wants to move pelareorep into a potential registration-enabled pivotal study for first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). Assuming productive engagement with the FDA, Oncolytics anticipates beginning study start-up activities before the end of 2025. This milestone underscores the company's confidence in pelareorep's differentiated mechanism of action and its promising survival signal in one of the most aggressive and underserved solid tumors. This content has been prepared as part of a partnership with Oncolytics Biotech Inc. and is intended for informational purposes only. The FDA discussions will focus on finalizing a clinical trial design that leverages pelareorep's demonstrated synergy with chemotherapy—with or without checkpoint inhibitors—and will use overall survival as the primary endpoint. Among the trial design options under consideration is an adaptive study model, potentially in collaboration with a third-party partner. The announcement follows a recent event hosted by Oncolytics, where leading experts highlighted pelareorep's potential not only in mPDAC but also in other gastrointestinal cancers, including KRAS-mutated colorectal cancer. The event reinforced the urgent need for innovative immunotherapies in pancreatic cancer, a field that has seen limited progress in recent decades. 'We expect to move quickly and decisively down a clear regulatory path,' Jared Kelly, Chief Oncolytics' CEO said in a media statement. 'This is about execution and focus. Our goal is to win on survival—and this pivotal study is how we do it. We believe this program not only creates significant value for shareholders but also positions Oncolytics as a highly attractive partner for pharma companies seeking to break open the immunotherapy landscape in mPDAC and other GI tumors.' Pelareorep has already received both fast track and orphan drug designations from the FDA for mPDAC, and translational data continue to support its immunologic activity. These regulatory advantages, combined with compelling clinical data, position Oncolytics as an attractive partner for companies seeking to expand their GI oncology pipelines. Oncolytics Biotech is a clinical-stage biotechnology company developing immunotherapies against breast, anal and pancreatic cancer. Oncolytics Biotech stock (TSX:ONC) opened 0.66 per cent lower trading at C$1.47, but it has climbed 20.38 per cent since the year began and is up 4.76 per cent since this time last year. Join the discussion: Find out what the Bullboards are saying about Oncolytics Biotech and check out Stockhouse's stock forums and message boards. Stockhouse does not provide investment advice or recommendations. All investment decisions should be made based on your own research and consultation with a registered investment professional. The issuer is solely responsible for the accuracy of the information contained herein. For full disclaimer information, please click here .
Yahoo
6 days ago
- Business
- Yahoo
Key Opinion Leader Event Highlights Pelareorep's Compelling Pancreatic and Gastrointestinal Data And Future Potential
SAN DIEGO and CALGARY, AB, July 23, 2025 /CNW/ -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, hosted a key opinion leader (KOL) webinar featuring leading physicians in the fields of oncology and immunotherapy discussing pelareorep's robust clinical data and how it fits in the evolving treatment landscape for pancreatic and gastrointestinal (GI) cancers. The KOLs provided individual presentations and then participated in a roundtable Q&A discussion. A replay of the full conversation can be found by clicking here. A selection of key takeaways includes: The meaningful survival benefit demonstrated by pelareorep-based treatment combinations in first-line (1L) metastatic pancreatic ductal adenocarcinoma (mPDAC) patients across randomized and single-arm clinical studies necessitates evaluating pelareorep in a registration-enabling study in 1L mPDAC. Immunotherapies have not yet been approved to treat mPDAC patients, illustrating an unmet need, which provides an opportunity for an immunologically active agent like pelareorep to deliver an impactful clinical benefit in this challenging indication. The combination of pelareorep and chemotherapy would be an appealing treatment option for 1L mPDAC patients, even with the presence of RAS inhibitors in the treatment paradigm. Translational data from multiple mPDAC and colorectal cancer clinical trials validate pelareorep's mechanism of action, showing that it replicates in tumors, stimulates chemokine expression, and induces the expansion of tumor-infiltrating lymphocytes (TILs), which correlates with a reduction in tumor size. "I want to thank our esteemed panel of oncologists for their meaningful contributions to our KOL event," said Jared Kelly, Chief Executive Officer of Oncolytics. "Their insights underscore a critical and timely message: pelareorep is a compelling immunotherapy platform that is well situated for combination strategies and a highly differentiated asset for pharma partners looking to expand or establish leadership in GI oncology. We are committed to moving forward aggressively toward registrational development while engaging with partners who share our vision of transforming outcomes in these difficult-to-treat cancers." About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For more about Oncolytics, please visit: or follow the company on social media on LinkedIn and on X @oncolytics. This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our commitment to moving forward aggressively toward registrational development while engaging with partners who share our vision of transforming outcomes in these difficult-to-treat cancers; our plans to advance pelareorep into registration enabling studies in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Company Contact Jon PattonDirector of IR & Communicationjpatton@ Investor Relations for Oncolytics Mike MoyerLifeSci Advisors+1-617-308-4306mmoyer@ Media Contact for Oncolytics Owen BlaschakLifeSci Communicationsoblaschak@ Logo - View original content to download multimedia: SOURCE Oncolytics Biotech® Inc. View original content to download multimedia: Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Cision Canada
6 days ago
- Business
- Cision Canada
Key Opinion Leader Event Highlights Pelareorep's Compelling Pancreatic and Gastrointestinal Data And Future Potential
SAN DIEGO and CALGARY, AB, July 23, 2025 /CNW/ -- Oncolytics Biotech ® Inc. (Nasdaq: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, hosted a key opinion leader (KOL) webinar featuring leading physicians in the fields of oncology and immunotherapy discussing pelareorep's robust clinical data and how it fits in the evolving treatment landscape for pancreatic and gastrointestinal (GI) cancers. The KOLs provided individual presentations and then participated in a roundtable Q&A discussion. A replay of the full conversation can be found by clicking here. A selection of key takeaways includes: The meaningful survival benefit demonstrated by pelareorep-based treatment combinations in first-line (1L) metastatic pancreatic ductal adenocarcinoma (mPDAC) patients across randomized and single-arm clinical studies necessitates evaluating pelareorep in a registration-enabling study in 1L mPDAC. Immunotherapies have not yet been approved to treat mPDAC patients, illustrating an unmet need, which provides an opportunity for an immunologically active agent like pelareorep to deliver an impactful clinical benefit in this challenging indication. The combination of pelareorep and chemotherapy would be an appealing treatment option for 1L mPDAC patients, even with the presence of RAS inhibitors in the treatment paradigm. Translational data from multiple mPDAC and colorectal cancer clinical trials validate pelareorep's mechanism of action, showing that it replicates in tumors, stimulates chemokine expression, and induces the expansion of tumor-infiltrating lymphocytes (TILs), which correlates with a reduction in tumor size. "I want to thank our esteemed panel of oncologists for their meaningful contributions to our KOL event," said Jared Kelly, Chief Executive Officer of Oncolytics. "Their insights underscore a critical and timely message: pelareorep is a compelling immunotherapy platform that is well situated for combination strategies and a highly differentiated asset for pharma partners looking to expand or establish leadership in GI oncology. We are committed to moving forward aggressively toward registrational development while engaging with partners who share our vision of transforming outcomes in these difficult-to-treat cancers." About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For more about Oncolytics, please visit: or follow the company on social media on LinkedIn and on X @ oncolytics. This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our commitment to moving forward aggressively toward registrational development while engaging with partners who share our vision of transforming outcomes in these difficult-to-treat cancers; our plans to advance pelareorep into registration enabling studies in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Company Contact Jon Patton Director of IR & Communication [email protected] Investor Relations for Oncolytics Mike Moyer LifeSci Advisors +1-617-308-4306 [email protected] Media Contact for Oncolytics
Cision Canada
22-07-2025
- Business
- Cision Canada
Oncolytics Biotech® Regains Compliance with Nasdaq Trading Rules
SAN DIEGO and CALGARY, AB, July 22, 2025 /CNW/ -- Oncolytics Biotech ® Inc. (Nasdaq: ONCY) (TSX: ONC) ("Oncolytics" or the "Company"), a leading clinical-stage company specializing in immunotherapy for oncology, received a formal letter (the "Compliance Notice") from the Listing Qualifications Department of The Nasdaq Stock Market LLC ("Nasdaq") dated July 22, 2025 informing the Company that it has regained compliance with the minimum bid price requirement under Listing Rule 5550(a)(2) (the "Minimum Bid Price Requirement"). The Company is now in compliance with all Nasdaq listing standards, and its common shares will continue to trade on the Nasdaq Capital Market under the ticker "ONCY." As previously announced, the Company was notified by Nasdaq on February 13, 2025, that the Company's common shares failed to maintain a minimum bid price of US$1.00 over the previous 30 consecutive business days as required by the Minimum Bid Price Requirement. According to the Compliance Notice, the Company regained compliance with the Minimum Bid Price Requirement because the closing bid price of the Company's common shares has been at or above $1.00 per share for 10 consecutive business days, from July 8, 2025, through July 21, 2025, and the matter is now closed. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype – turning "cold" tumors "hot" – through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For more about Oncolytics, please visit: or follow the company on social media on LinkedIn and on X @ oncolytics. Investor Relations for Oncolytics Mike Moyer LifeSci Advisors +1-617-308-4306 [email protected]
