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New Alert: Oncolytics Biotech Inc. (Nasdaq: ONCY)
ONCY is our new NASDAQ biotech alert.
We were among the very first to bring ONCY to your attention in May.
Following our previous alert, ONCY rallied 29% in just 3 days.
Now, we believe ONCY could be on the verge of another breakout opportunity.
ONCY trades under 1.00 and has a chart setup that could be on the cusp of a big breakout higher, where momentum can build very quickly.
Importantly, since our previous alert, the company has announced several accomplishments that could be additional growth catalysts.
The company is in one of the hottest sectors today - biotech and immunotherapy - developing what could be a transformational approach to treating some of the deadliest cancers in the world.
ONCY is a NASDAQ listed “clinical-stage biotechnology company”.
ONCY is “developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent”.
It is “designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses”.
According to the company, “GI cancers are the largest unmet medical need in oncology”.
Colorectal cancer remains one of the largest oncology markets globally, with significant unmet need in later-line settings.
Pelareorep has been evaluated in "over 20 Oncolytics-sponsored studies and several externally sponsored studies, across multiple cancer indications, with over 1,200 patients treated, including over 300 patients with GI tumors."
“Pelareorep can extend survival while maintaining a favorable safety profile”.
“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.”
ONCY is “advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer.”
The Fast Track Designation enables more frequent meetings and communication with the FDA to ensure alignment on development plans and the collection of clinical data needed to support approval.
Furthermore, clinical programs with Fast Track Designation may be eligible for Accelerated Approval and Priority Review if relevant criteria are met.
For conditions where an available treatment exists, a candidate therapy regimen must show some advantage over the available treatment, such as superior effectiveness, to be granted Fast Track Designation.
ONCY is “actively pursuing strategic partnerships to accelerate development and maximize commercial impact.”
In the pharmaceutical world, ONCY has “teamed up with Roche Holding AG, Pfizer Inc., Merck Serono, Incyte Corporation, and Adlai Nortye to evaluate pelareorep in combination with therapeutic agents”.
ONCY has “also partnered with researchers from several institutions, including the Mayo Clinic, Duke University, the Rutgers Cancer Institute of New Jersey, the Ohio State University Comprehensive Cancer Center, the Keck School of Medicine of the University of Southern California, PrECOG, SOLTI, and AIO-Studien-gGmbH, to evaluate additional pelareorep-based combinations”.
ONCY has “137 patents issued worldwide” & “New patents expected to extend manufacturing protection to 2044 and method of use protection into 2046”.
Manufacturing is also a differentiator: pelareorep is a "non-genetically modified Reovirus" with "high yield and low cost of goods" - "made in Carlsbad, California from products generally sourced in the USA" - with no special handling requirements and an "easy to scale for large studies or commercial launch in multiple indications" profile.
Earlier this year, the company announced:
“Oncolytics Biotech® Receives FDA Fast Track Designation for Pelareorep in 2L KRAS-Mutant MSS Metastatic Colorectal Cancer”
Here are the highlights:
“Strong efficacy signals showing 33% ORR, 16.6-month PFS, and 27-month OS, improving on the SOC by 2-3X in a difficult-to-treat population”
“Company to launch controlled study in second-line KRAS-mutant MSS mCRC with interim data expected by the end of 2026”
“Pelareorep now has Fast Track Designation for two gastrointestinal cancers, solidifying its potential as an immunotherapeutic platform therapy in gastrointestinal cancers”
As the company further explained:
“The Fast Track Designation is supported by clinical data demonstrating a 33% objective response rate (“ORR”) for pelareorep-based therapy compared to approximately 10% ORR with standard-of-care (“SOC”) in this patient population.1-2 In addition, pelareorep combination therapy was associated with a median progression-free survival (“PFS”) of 16.6 months, compared to 5.7 months with SOC, and a median overall survival (“OS”) of 27 months, compared to 11.2 months with SOC.”
Sadly, as the company explains:
“KRAS-mutant MSS metastatic colorectal cancer represents one of the most challenging diseases in gastrointestinal oncology, as few effective treatment options exist following first-line progression, and available immune-based therapies provide little benefit.”
“There are an estimated 2 million new colorectal cancer cases each year globally, with an annual total addressable market of approximately $3-5 billion for the 2L KRAS-mutant MSS mCRC subgroup.”
Here are some of the company’s comments from this press release:
“This designation is an important validation of our focus on pelareorep’s potential as a platform immunotherapy for gastrointestinal cancers like colorectal cancer,” said Jared Kelly, Chief Executive Officer of Oncolytics. “Adding pelareorep to the standard-of-care in this underserved segment of colorectal cancer patients results in a doubling or tripling of critical clinical endpoints, including overall survival, progression-free survival, and objective response rate in a market that is estimated to be worth several billion dollars. Pelareorep offers the potential to help a meaningful number of patients, and I look forward to continuing to collaborate with the FDA to address this treatment gap as expeditiously as possible.”
In March, the company announced:
“Oncolytics Biotech® Launches Randomized Colorectal Cancer Study”
“Controlled study designed to confirm previous compelling efficacy with preliminary data expected by the end of 2026”
“Pelareorep-based treatment regimen recently granted Fast Track Designation in 2L KRAS-mutant MSS metastatic colorectal cancer, confirming its potential in this large indication”
Here are the comments from this press release:
“The potential to improve clinical outcomes compared to the standard-of-care in the second-line setting would have the potential to benefit patients around the world who are affected by colorectal cancer,” said Dr. Van Morris, Associate Professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston, TX, and member of the Oncolytics Biotech Gastrointestinal Scientific Advisory Board. “An immunotherapy with the potential to improve outcomes would improve treatment options in colorectal cancer and would be highly welcomed, especially as we are seeing more and more younger patients being diagnosed with colorectal cancer.”
In April, the company announced:
“Oncolytics Biotech® Announces Type C FDA Meeting to Discuss Single-arm Registrational Pathway for Pelareorep in Anal Cancer”
Here are the company’s comments from this press release:
“We believe this upcoming FDA meeting is a critical step in advancing pelareorep toward a potential registration pathway in anal cancer,” said Jared Kelly, Chief Executive Officer of Oncolytics. “Our goal is to align with the FDA on the statistical analysis plan and sample size for a potential pivotal single-arm study in second-line and later SCAC. In a setting with limited approved therapies, we believe the strength and durability of our data support this approach, and recent regulatory discussions in oncolytic virus development underscore the importance of demonstrating clear, durable clinical benefit with checkpoint inhibition. With few late-line options and no confounding checkpoint inhibitor data, SCAC offers a clearer efficacy signal and a potentially more efficient path to approval for pelareorep.”
As the company further explains:
“SCAC is a rare cancer with limited treatment options in the second-line and later setting, and outcomes remain poor following progression on first-line treatment.”
“The World Health Organization estimates that there are approximately 54,000 cases of anal cancer globally each year, and the anal cancer market is expected to double to $2.3 billion from 2025 to 2035.”
In May, the company announced:
“Oncolytics Biotech® Reports Durable Responses in Second-Line RAS-Mutant MSS Colorectal Cancer”
Here are the highlights:
“2L KRAS-Mutant MSS mCRC Demonstrates ~3–4x Improvement in Duration of Response vs. Historical 4–6 Month Benchmark”
“Company Engaged with FDA to Support Potential Accelerated Approval Pathway in 2L RAS-Mutant MSS mCRC”
Importantly:
“Pelareorep-based combination therapy demonstrated a 19.5-month median duration of response in second-line (“2L”) KRAS-mutant MSS mCRC patients in the REO 022 study, compared to historical benchmarks of approximately 4–6 months in this setting.1 Additional data from this study include an objective response rate of 33% for patients receiving pelareorep, bevacizumab, and FOLFIRI, tripling the 6-11% for the standard of care.”
Here are the company’s comments:
“We believe these data demonstrate a compelling durability signal for pelareorep in colorectal cancer,” said Jared Kelly, Chief Executive Officer of Oncolytics. “A 19.5-month median duration of response in second-line patients—representing a three- to four-fold improvement over historical expectations—highlights pelareorep’s potential to deliver sustained benefit in a population with few effective options. We believe these results support a path toward accelerated approval in second-line RAS-mutant MSS metastatic colorectal cancer, and we are actively engaging with the FDA to align on a regulatory strategy leveraging our ongoing randomized study.”
On May 22, the company announced:
“Oncolytics Biotech® to Present Data at ASCO 2026 Reinforcing Pelareorep’s Potential Across Gastrointestinal Tumors”
Here are some of the company’s comments from this press release:
"These findings demonstrate that pelareorep works by expanding preexisting tumor-reactive immune cells rather than introducing new antigens," said Dr. Richard Vile, Ph.D., Professor of Immunology at the Mayo Clinic and Oncolytics Scientific Advisory Board Member. "This further underscores Oncolytics' continued commitment to define the mechanisms by which pelareorep engages the immune system and illustrates the progress being made in developing a differentiated immunotherapy to improve treatment options for difficult-to-treat cancers."
"KRAS-mutant tumors remain among the most challenging to treat with immunotherapy," said Jared Kelly, Chief Executive Officer of Oncolytics. "These data reflect important progress in bridging translational and clinical data and help us better understand how immune responses are activated by pelareorep. When we can point to translational and mechanistic data as the reason for clinical efficacy, it gives us confidence that our development plans are more likely to succeed."
In addition, over the past few weeks, the company announced several accomplishments.
On June 1, 2026, the company announced:
“Oncolytics Biotech® Announces Positive Initial Preclinical Findings Supporting Further Evaluation of Pelareorep in Combination with RAS-Targeted Approaches”
As the company explains:
“Based on these findings, the Company is planning additional studies in models of pancreatic ductal adenocarcinoma ("PDAC") and colorectal cancer ("CRC") designed to further evaluate the combinations' effects on immune activation, tumor response durability, and time-to-resistance. The ongoing work includes evaluations of pelareorep in combination with KRAS G12C inhibitors, pan-RAS inhibitors, and additional next-generation RAS pathway-targeting agents in RAS-mutated tumor models.”
Here are some of the company’s comments:
"We believe these initial findings further support pelareorep's potential to serve as an immune-priming backbone for next-generation targeted therapies," said Jared Kelly, Chief Executive Officer of Oncolytics. "RAS-mutated tumors, particularly pancreatic and colorectal cancers, remain among the most difficult cancers to treat due to intrinsic immune resistance and the emergence of therapeutic resistance over time. These preclinical results support further study of the combinations' anti-tumor and immune effects, including in models designed to assess durability and time-to-resistance."
Mr. Kelly continued, "Importantly, we believe this strategy may ultimately represent a potentially important area for further investigation in pancreatic cancer, where nearly all tumors harbor RAS pathway alterations and where patients continue to face extremely limited treatment options. The potential synergy observed in previous PDAC clinical studies and preclinical RAS-targeted modalities reinforces our belief that pelareorep may play an important role in future combination strategies designed to improve the durability of targeted therapies."
On June 2, 2026, the company announced:
“Oncolytics Biotech® Announces Appointment of Steve Glover to Board of Directors and Promotion of John McAdory to Chief Operating Officer”
“Mr. Glover brings significant public company leadership and transaction experience to Oncolytics, including serving as Chairman of Ambrx Biopharma during its acquisition by Johnson & Johnson in a transaction valued at approximately $2 billion.”
“Additionally, Mr. McAdory has been promoted to Chief Operating Officer. As COO, he will oversee the Company's clinical operations and development activities, preclinical research and development efforts, and will play a key role in strategic partnerships and broader business development initiatives. Mr. McAdory joined Oncolytics earlier this year after serving as VP of Clinical Operations at CG Oncology.”
Here are some of the comments from this press release:
"We are thrilled to welcome Steve to our Board at a transformational time for Oncolytics," said Jared Kelly, Chief Executive Officer of Oncolytics. "Steve has extensive experience helping build and position innovative biotechnology companies for strategic growth and value creation, including through the successful sale of Ambrx to Johnson & Johnson. His experience across corporate strategy, financing, and strategic transactions will be invaluable as we continue to advance pelareorep and expand our immunotherapy platform strategy."
Mr. Kelly continued, "I am also very excited to announce John's promotion to Chief Operating Officer. Since joining Oncolytics, John has already had a meaningful impact on our operational execution and clinical development strategy. His background helping advance innovative oncology programs at CG Oncology and his strong operational leadership make him ideally suited to help drive our next phase of growth as we advance our registration-enabling studies, expand our preclinical pipeline, and pursue strategic partnership opportunities."
In addition:
"I am excited to join the Board of Oncolytics during this important period of clinical and corporate momentum," said Mr. Glover. "I believe pelareorep has the potential to become an important immunotherapy backbone across multiple solid tumor indications, and I look forward to working with the management team and Board to help maximize the platform's value."
"I appreciate the confidence the Board and leadership team have placed in me," said John McAdory, Chief Operating Officer of Oncolytics. "I believe Oncolytics is uniquely positioned with compelling clinical and translational data, particularly in gastrointestinal cancers, and I look forward to helping accelerate and execute on the Company's developmental, operational, and strategic objectives."
Last week, the company announced:
“Oncolytics Biotech® Secures New U.S. Patent Protecting Commercial Manufacturing of Pelareorep into 2044”
Here are the highlights from this press release:
“Intellectual property update confirms pelareorep's unique manufacturing process and scalability”
“Previously filed method-of-use patent application expected to provide protection into 2046”
“Additional patent filings planned in 2026 to further expand the pelareorep intellectual property estate”
Here are some of the company’s comments from this press release:
"Building a strong intellectual property estate around pelareorep is an important part of our strategy as we advance the program toward potential registration and commercialization," said Jared Kelly, Chief Executive Officer of Oncolytics. "This newly issued patent strengthens our protection around the manufacturing of pelareorep and supports our ability to produce the product at commercial scale. Combined with our previously filed method-of-use patent application and additional planned filings, we continue to build a durable patent portfolio designed to support the long-term value of pelareorep. Checking this box represents another important milestone as we execute on our strategy and move pelareorep into its next phase of development."
We believe ONCY could be positioned for high growth.
Make sure to do your own due diligence.
Sources: Presentation, PR1, PR2, PR3, PR4, PR5, PR6, PR7, PR8, PR9, PR10, PR11, PR12, PR13, PR14, Website, Chart
Happy Trading!
SmallCapStocks Team
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