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New Alert: Oncolytics Biotech Inc. (Nasdaq: ONCY)
ONCY is our brand new NASDAQ biotech alert.
This is a hidden gem that most investors have not yet found.
It 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 has a chart setup that could be on the cusp of a big breakout opportunity.
ONCY trades under 1.00 and momentum can build very quickly.
Importantly, over the past few months, the company has announced multiple accomplishments that could be significant growth catalysts.
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.
ONCY has announced multiple accomplishments recently.
In February 2026, 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.”
Earlier this month, 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.”
Most recently, on Friday, the company announced:
“Oncolytics Biotech® to Present Data at ASCO 2026 Reinforcing Pelareorep’s Potential Across Gastrointestinal Tumors”
“SAN DIEGO, May 22, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage company developing pelareorep, today announced translational data from the GOBLET and AWARE-1 trials will be presented at the 2026 American Society of Clinical Oncology (“ASCO”) Annual Meeting at McCormick Place, Chicago, Illinois, from May 29-June 2, 2026. Pelareorep is an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes.”
We believe ONCY could be positioned for significant upside.
Make sure to do your own due diligence.
Happy Trading!
SmallCapStocks Team
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