Oncolytics Biotech® to Engage FDA for Potential Registration-Enabled Study in First-Line Pancreatic Cancer with Goal to Launch Trial Activities by Year-End
SAN DIEGO and CALGARY, AB, July 29, 2025 /CNW/ -- Oncolytics Biotech ® Inc. (Nasdaq: ONCY) (TSX: ONC) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, today announced it has initiated regulatory discussions with the U.S. Food and Drug Administration (FDA) for a potential registration-enabled pivotal study in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). Assuming discussions with the FDA go as expected, the Company expects to commence study start-up activities before the end of 2025.
This milestone reflects Oncolytics' conviction in pelareorep's differentiated mechanism of action and its encouraging survival signal in one of the most lethal and underserved solid tumors. The FDA interaction will focus on finalizing a clinical trial design that leverages pelareorep's demonstrated synergy with chemotherapy with or without checkpoint inhibition, and overall survival as the primary endpoint. Among the potential options, Oncolytics will consider proposing an adaptive study in collaboration with a third party.
"We expect to move quickly and decisively down a clear regulatory path," said Jared Kelly, Chief Executive Officer 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."
Oncolytics' recent Key Opinion Leader event reinforced the clinical promise of pelareorep in mPDAC and other gastrointestinal (GI) cancers, including KRAS-mutated colorectal cancer, and validated its ability to transform "cold" tumors into immunologically active ones. Experts emphasized the scarcity of innovation in pancreatic cancer and the urgent demand for new immunotherapies that can deliver a survival benefit in this setting.
With Fast Track and Orphan Drug designations in mPDAC and translational data supporting pelareorep's immunologic activity, the Company believes it is well-positioned to engage potential partners seeking to bolster their GI oncology pipelines. The upcoming regulatory discussions and planned trial initiation represent major catalysts for strategic collaboration and long-term value creation.
Additional information on the study design, timelines, and next steps will be provided following regulatory feedback.
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 early-phase studies in pancreatic and colorectal cancer. It induces anti-cancer immune responses by converting immunologically "cold" tumors "hot" through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and checkpoint inhibitors in metastatic breast and pancreatic cancers, both of which have received Fast Track designation from the FDA. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @ oncolytics.
Forward-looking statements
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 plans for a potential registration-enabled pivotal study in first-line mPDAC and the anticipated potential timing of commencement of start-up activities and enrollment in a study, the focus of our discussions with the FDA in respect of the study; the anticipated trial design; our plans to move quickly and decisively down a clear regulatory path; our goals, strategies and objectives; our belief in the clinical promise of pelareorep in mPDAC and other gastrointestinal cancers; our belief that we are well-positioned to engage potential partners seeking to bolster their GI oncology pipelines; and our active pursuit of strategic partnerships. 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. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, and market dynamics. Please refer to Oncolytics' public filings with securities regulators in the U.S. and Canada for more information. The company assumes no obligation to update forward-looking statements, except as required by 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
Owen Blaschak
LifeSci Communications
[email protected]
SOURCE Oncolytics Biotech® Inc.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Globe and Mail
3 hours ago
- Globe and Mail
3 Unstoppable Stocks to Buy in August
Key Points Investors have multiple reasons to like AbbVie stock. Eli Lilly remains a top stock to buy and hold. Vertex Pharmaceuticals is moving quickly to expand its markets beyond cystic fibrosis. 10 stocks we like better than AbbVie › The "it" factor. Some stocks have it. Other stocks don't. But the ones that do can be virtually unstoppable. Three Motley Fool contributors believe they've found such unstoppable stocks with the "it" factor to buy in August -- and they're all in the healthcare sector. Here's why they picked AbbVie (NYSE: ABBV), Eli Lilly (NYSE: LLY), and Vertex Pharmaceuticals (NASDAQ: VRTX). There are many reasons to buy this stock Prosper Junior Bakiny (AbbVie): It's been a little over two years since AbbVie lost patent exclusivity for its best-selling drug, autoimmune disease medicine Humira. That didn't stop AbbVie, though; it just slowed it down momentarily. The company rebounded nicely and has since returned to top-line growth. AbbVie now owns another one of the top-10 selling therapies in the world, Skyrizi, which targets several immunology conditions. Skyrizi's sales have been growing at an incredibly rapid rate. Together with Rinvoq, AbbVie's immunology lineup has successfully filled the gap left by Humira. That's an important reason to consider the stock: AbbVie's ability to overcome a significant patent cliff speaks volumes about its innovative abilities. Beyond that, AbbVie's lineup is deep. It features older products that continue to make meaningful contributions to its financial results, such as its Botox franchise, and newer products that can help drive top-line growth for a while, like migraine treatment Qulipta. AbbVie's pipeline also looks deep. The company should be able to record consistent clinical and regulatory wins. Lastly, we can't mention AbbVie without pointing out its incredible dividend track record. The company is part of the exclusive group of Dividend Kings, boasting an active streak of 53 consecutive payout increases, which includes the time it spent as a division of its former parent company, Abbott Laboratories. AbbVie's forward yield of 3.5% is much higher than the S&P 500 's average of 1.3%, and its cash payout ratio looks reasonable at 61.8%. In addition to an excellent underlying business, a strong lineup, and a solid pipeline, AbbVie is an outstanding stock for income-seeking investors. Investing in this company could yield superior returns over the long term. Eli Lilly is a top growth stock to own for years David Jagielski (Eli Lilly): A stock that looks unstoppable right now is Eli Lilly. While many investors will focus on its highly successful GLP-1 drugs, Zepbound and Mounjaro, as the main reasons to invest in the business, there's much more behind the company, and why it's a top growth stock. Eli Lilly has a promising Alzheimer's treatment, Kisunla, which regulators approved for use last year. It's still in the early innings of its growth and according to analysts, it could generate up to $5 billion in annual revenue at its peak. Meanwhile, Eli Lilly is still focusing on developing more life-changing treatments for patients. It's planning to invest $4.5 billion into a research and manufacturing facility, which it calls Lilly Medicine Foundry. By utilizing new manufacturing methods to ensure high efficiency, the new center can help the company scale and bring new products to market faster. The company also has vast resources at its disposal, which can help it invest in research and development and potentially acquire promising businesses along the way. In the trailing 12 months, Eli Lilly has generated $11.1 billion in profit on sales totaling $49 billion. The company's terrific margins, strong growth prospects, and commitment to producing new treatments are why this pharmaceutical stock can be among the best investments you can put in your portfolio right now. A big biotech innovator that's targeting new markets Keith Speights (Vertex Pharmaceuticals): To truly be unstoppable, a company can't have competition that could, well, stop it. Vertex Pharmaceuticals has this covered with its cystic fibrosis (CF) franchise. No other drugmaker has approved therapies that treat the underlying cause of CF. The number of companies with experimental CF therapies in late-stage clinical testing that could compete with Vertex totals... zero. Actually, Vertex's biggest rival in treating CF is itself. The company's newest CF therapy, Alyftrek, offers a more convenient once-per-day dosing than its current top-seller, Kaftrio/Trikafta. However, CF isn't the main reason why I like Vertex. My primary interests lie with other indications the biotech innovator is targeting. For example, Vertex won U.S. regulatory approval for Journavx earlier this year. It's the first new class of pain medication in over 20 years. Journavx is safe and effective, with none of the side effects and addictive potential associated with opioids -- because it isn't an opioid. The company's pipeline features promising late-stage programs that could further expand Vertex's market opportunity. Inaxaplin targets APOL1-mediated kidney disease, which affects around 250,000 patients worldwide. Povetacicept holds the potential to treat multiple kidney diseases, with IgA nephropathy first on the list with a patient population of over 1 million. Zimislecel could cure severe type 1 diabetes. At first glance, Vertex might seem to be priced at a premium, with its shares trading at 26.3 times forward earnings. However, the company's growth prospects are so strong that its valuation is attractive. Vertex's price-to-earnings-to-growth (PEG) ratio, based on analysts' five-year earnings growth estimates, is a super-low 0.58. Should you invest $1,000 in AbbVie right now? Before you buy stock in AbbVie, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and AbbVie wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $625,254!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $1,090,257!* Now, it's worth noting Stock Advisor's total average return is 1,036% — a market-crushing outperformance compared to 181% for the S&P 500. Don't miss out on the latest top 10 list, available when you join Stock Advisor. See the 10 stocks » *Stock Advisor returns as of July 29, 2025 David Jagielski has no position in any of the stocks mentioned. Keith Speights has positions in AbbVie and Vertex Pharmaceuticals. Prosper Junior Bakiny has positions in Eli Lilly and Vertex Pharmaceuticals. The Motley Fool has positions in and recommends AbbVie, Abbott Laboratories, and Vertex Pharmaceuticals. The Motley Fool has a disclosure policy.
Globe and Mail
6 hours ago
- Globe and Mail
3 Dividend Stocks to Hold for the Next 20 Years
Key Points General Mills is offering a historically high yield backed by a powerful and diversified food business. PepsiCo is a Dividend King with a high yield and iconic global brands. Hershey makes an affordable luxury that people will be willing to pay up for. 10 stocks we like better than PepsiCo › Remember one thing when you consider consumer staples makers: You "need" the products they sell. That's particularly true when it comes to food-focused consumer staples companies like General Mills (NYSE: GIS), PepsiCo (NASDAQ: PEP), and Hershey (NYSE: HSY). Here's why each one of these dividend stocks is worth buying and holding for 20 years, or more, right now. 1. General Mills is shifting with the times General Mills makes food products like cereal, snack bars, pet food, and baking products. It owns a collection of brand names that you likely know well, including Blue Buffalo and Cheerios. The brands and products it sells are staples in grocery stores and in consumer cupboards. It's highly unlikely that General Mills will suddenly go out of business anytime soon. That said, right now the company is facing some headwinds. Consumer buying habits are shifting, and some buyers are pulling back on spending. That has left General Mills' financial results weak. Sales and earnings fell year over year in the fourth quarter of fiscal 2025. The company's fiscal 2026 outlook was a bit weak, too. But management is doing what it can to adjust, including changing formulations to match current trends, adjusting its brand and product portfolio, and trying to keep a lid on costs. These are the right moves and, in time, they will likely lead to General Mills getting back on track. It always has in the past. While General Mills' stock is out of favor, you can buy it at an attractive 4.8% yield. That's near the highest levels in the company's history. If you like income and think long term, General Mills should probably be on your buy list today. 2. PepsiCo has industry-leading brands General Mills is a good company with industry-leading brands, but PepsiCo's brands stand out even more. It's the No. 2 beverage company and the No. 1 salty snack maker. It also makes packaged food products that compete with companies like General Mills. The problem for PepsiCo is that customer tastes are shifting, and it is out of step with its customers. The company is working on the issue -- it recently bought a Mexican-American food business and a probiotic beverage company. Both are more in line with current trends. Sure, PepsiCo's recent financial results aren't that great, and they lag those of its closest peers. It's OK -- that happens even to well-run businesses. PepsiCo didn't achieve Dividend King status by accident, and it has muddled through hard times before. It's highly likely that it will do so again. In the meantime, you can collect a historically high 3.9% dividend yield. If the dividend history here is any guide, you'll end up a long-term winner if you're willing to step in while the rest of Wall Street is selling. 3. Hershey's cocoa problem makes it hard to love Hershey is the most difficult story to appreciate here for two reasons. First, while it makes food, the most important product it sells is chocolate. That's not a necessity, even though people love the affordable indulgence. Second, the biggest headwind for the business is a shocking rise in the price of cocoa, a key ingredient in chocolate. Cocoa comes from trees, so it could take some time before high prices lead to changes in the industry. That's why investors have sold Hershey stock hard, leading to a historically high 2.9% dividend yield. Just how bad is it? Despite increasing prices and the expectation of sales growth in 2025, Hershey is projecting rising costs to lead to a roughly mid-30% drop in earnings in 2025. And given the nature of cocoa, the pain could linger for a bit. There's a good reason why investors are negative on the stock. But if you can stomach some near-term uncertainty, the long-term picture is likely to be continued and growing demand for the affordable luxuries that Hershey sells. You need and want what they make It is hard to suggest that chocolate, soda, or cereal are life necessities. You can certainly eat and drink other things. But these consumer staples giants have long delivered the food items that people want to buy. That will be just as true in one year as it is in 10 years or 20 years. The headwinds they face today aren't likely to change anything about the nature of these businesses, even if the companies do need to adjust to better align with current trends. The truth is that they've all done that many times before. Given the historically high yields on offer from General Mills, PepsiCo, and Hershey, buying and holding for decades is probably a good call for even the most conservative dividend investors today. Should you invest $1,000 in PepsiCo right now? Before you buy stock in PepsiCo, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and PepsiCo wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $625,254!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $1,090,257!* Now, it's worth noting Stock Advisor's total average return is 1,036% — a market-crushing outperformance compared to 181% for the S&P 500. Don't miss out on the latest top 10 list, available when you join Stock Advisor. See the 10 stocks » *Stock Advisor returns as of July 29, 2025
Globe and Mail
6 hours ago
- Globe and Mail
Here's How Alphabet Can Become the World's Second $4 Trillion Company
Key Points The company generates the most profits among its big tech peers. Investors are worried about the legacy search business. But Alphabet has proven that it's here to stay. 10 stocks we like better than Alphabet › Nvidia made history by becoming the world's first $4 trillion company, and no other company has achieved this feat. Currently, Microsoft and Apple are in second and third place but have a bit of work to do with their $3.8 trillion and $3.2 trillion market caps, respectively. However, there's a dark horse that could beat those two to the $4 trillion threshold: Alphabet (NASDAQ: GOOG)(NASDAQ: GOOGL), the world's fifth-largest company by market cap with a valuation of $2.5 trillion. That's a long way away from $4 trillion and significantly behind Microsoft and Apple. But there's one factor that Alphabet has going for it that gives it a solid argument for reaching $4 trillion before any of the companies ahead of it. Alphabet's second quarter was dominant Alphabet is likely better known by the businesses that it owns: Google, YouTube, Waymo, and the Android operating system. It has a dominant empire in various niches, but its most important is Google Search. In the second quarter, Google Search generated $54 billion of the company's revenue of $96 billion. That's a large chunk of its total, so it needs to continue having this division perform well to succeed as a whole. However, there are some early warning signs that have investors concerned. The most significant technologies in generative artificial intelligence (AI) have the potential to transform how people use the internet. Currently, the vast majority of people seek information using Google Search. That could change if generative AI becomes more widely adopted by the masses. The market broadly assumes that it will replace Google, but that seems far from reality. One area where Google has bridged the gap is with AI search overviews, which give users a generative AI-powered summary of their search results. Management discussed the popularity of this feature during its second-quarter conference call and provided a couple of key insights for investors. First, AI overviews now have over 2 billion users in 40 different languages, showcasing its widespread appeal. Another huge revelation for investors is that it sees the same monetization as regular search results, so it's not harming Google's business at all by heavily investing in this technology. This showed up in Alphabet's results, as Google Search revenue rose 12% year over year. That's an acceleration from the 10% year-over-year growth in the first quarter. This isn't a sign of a dying business; it's a sign of one that's growing. As a result, there's no reason for Alphabet to trade at a significant discount to its big-tech peers, since it's growing just as fast (if not faster) than most of them. Its peers fetch a much higher premium The four companies ahead of Alphabet in market cap are Nvidia, Microsoft, Apple, and Amazon. Compared to these four, Alphabet trades at a huge discount. GOOGL PE Ratio data by YCharts; PE = price to earnings. However, over the past 12 months, Alphabet has produced the most net income of any of these companies. GOOGL Net Income (TTM) data by YCharts; TTM = trailing 12 months. Alphabet actually produces the most profit of any company that trades on U.S. exchanges, and if it received the same multiple as its peers, it would be the largest company in the world (in some cases). Company Trailing P/E Alphabet's Valuation at That Premium Nvidia 56.0 $6.47 Trillion Microsoft 39.7 $4.59 Trillion Apple 33.3 $3.85 Trillion Amazon 37.7 $4.36 Trillion Data source: YCharts. So, if the company were to receive the same respect as its peers, it would already be the world's largest company. Whether you think most of the big tech stocks are overvalued or if you think Alphabet is undervalued, it doesn't matter. It has some of the best chances of beating the market over the next few years due to its low valuation and impressive growth, considering its size. I think it's a top stock to buy now, and it makes even more sense if you're concerned that the market in general is getting too expensive. Should you invest $1,000 in Alphabet right now? Before you buy stock in Alphabet, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Alphabet wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $625,254!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $1,090,257!* Now, it's worth noting Stock Advisor's total average return is 1,036% — a market-crushing outperformance compared to 181% for the S&P 500. Don't miss out on the latest top 10 list, available when you join Stock Advisor. See the 10 stocks » *Stock Advisor returns as of July 29, 2025 Keithen Drury has positions in Alphabet, Amazon, and Nvidia. The Motley Fool has positions in and recommends Alphabet, Amazon, Apple, Microsoft, and Nvidia. The Motley Fool recommends the following options: long January 2026 $395 calls on Microsoft and short January 2026 $405 calls on Microsoft. The Motley Fool has a disclosure policy.
