Issued on behalf of Oncolytics Biotech Inc.

VANCOUVER, British Columbia, Jan. 08, 2026 (GLOBE NEWSWIRE) -- Equity-Insider.comNews Commentary – Biopharma M&A is entering a fever pitch, with precision oncology investments alone exploding to $138 billion as major players scramble to secure proven cancer therapies before their most profitable drugs lose protection^[1]. This looming $170 billion "patent cliff" has triggered a massive capital rotation into de-risked platforms that can reach patients and the market within the next 18 to 24 months^[2]. This urgent race for registration-ready assets is driving the 2026 investment case for Oncolytics Biotech Inc. (NASDAQ: ONCY), OS Therapies Inc. (NYSE-A: OSTX), SELLAS Life Sciences Group, Inc. (NASDAQ: SLS), Celcuity Inc. (NASDAQ: CELC), and RenovoRx, Inc. (NASDAQ: RNXT).

The stakes are high, as the global precision oncology market is now on a trajectory to hit $225.65 billion by 2032^[3]. With the FDA’s accelerated approval pathways delivering real-world survival gains in 65% of cases, investors are increasingly focusing on companies positioned at the edge of pivotal Phase 3 trials and registration milestones^[4]. For retail investors, this represents a high-velocity opportunity to own the companies building the next generation of life-saving medical infrastructure.

Clinical-stage biotech company Oncolytics Biotech Inc. (NASDAQ: ONCY) is fortifying its intellectual property position while advancing pelareorep, an investigational immunotherapy designed to activate the immune system against cancer.

In early Q3 2025, Oncolyticsfiled a Track 1 prioritized examination patent application with the United States Patent and Trademark Office focused on manufacturing-related innovations for pelareorep. If granted, this patent could extend protection to 2044, significantly lengthening pelareorep's commercial runway. The company received initial written feedback from the USPTO in Q4 2025 and expects a final action on this manufacturing patent application in Q3 2026.

Oncolytics plans to file additional patent applications covering novel therapeutic uses of pelareorep, which could provide IP protection beyond 2044. "Extending our intellectual property runway is a core pillar of our strategy," said Jared Kelly, Chief Executive Officer of Oncolytics. "As pelareorep continues to demonstrate meaningful clinical activity across gastrointestinal cancers, it is critical that we protect the innovation behind both how the therapy is manufactured and how it is used."

This strategic IP expansion comes as pelareorep delivers compelling clinical results across multiple gastrointestinal cancers. The company recently announced efficacy data showing pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer patients when combined with standard chemotherapy. This triples the historical 6-11% response rate for chemotherapy alone in this difficult-to-treat population, addressing a colorectal cancer market projected to reach $20 billion by 2033.

Equally compelling anal cancer results showed a 30% response rate in second-line squamous cell anal carcinoma, more than doubling 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 standard care, with two durable complete responses.

This clinical momentum has attracted elite academic validation. Oncolyticsexpanded its Gastrointestinal Tumor Scientific Advisory Board with three globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center. The company has also secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning it to launch the only immunotherapy registration trial currently planned for this disease.

CEO Jared Kelly and Chief Business Officer Andrew Aromando were both crucial contributors to their previous employer, Ambrx Biopharma's$2 billion acquisition by Johnson & Johnson.

CONTINUED… Read this and more news for Oncolytics Biotech at:   https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/

In other recent industry developments and happenings in the market include:

OS Therapies Inc. (NYSE-A: OSTX) outlined its outlook for first half 2026, with preparations underway for a Biologics License Application submission to the FDA by end of January 2026 for OST-HER2 in metastatic osteosarcoma under the Accelerated Approval Program, followed by Marketing Authorisation submissions to the U.K. MHRA and Europe's EMA by end of February and March 2026 respectively. The company expects to release biomarker data from its Phase 2b trial during the J.P. Morgan Healthcare Conference week and anticipates potential approvals in the U.K. in Q2 2026, U.S. in Q3 2026, and Europe in Q4 2026.

"OS Therapies is potentially at the cusp of improving the standard of care for patients with metastatic osteosarcoma," said Chairman and CEO Paul Romness. "2025 was a transformational year in which we announced promising OST-HER2 clinical trial results and had significant interactions with regulatory agencies in the U.S., U.K. and Europe regarding the path toward conditional marketing authorizations in 2026."

OST-HER2 has received Orphan Disease, Fast Track, and Rare Pediatric Disease designations, with the company eligible for a Priority Review Voucher valued at up to $160 million if approved before September 30, 2026. OS Therapies expects to file for a go-public transaction for its OS Animal Health subsidiary in early January 2026.

SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) provided an update on its pivotal Phase 3 REGAL trial evaluating galinpepimut-S in acute myeloid leukemia patients after second complete remission, announcing that 72 of the 80 events required to trigger final analysis had occurred as of December 26, 2025, with the company remaining fully blinded to all survival outcomes. The extended timeline beyond initial year-end expectations may reflect longer-than-anticipated patient survival times in this overall survival study.

"We appreciate the continued dedication of the patients, families, and investigators participating in the pivotal Phase 3 REGAL trial where survival times, fortunately for patients and caregivers, appear longer than expected," said Angelos Stergiou, MD, ScD h.c., CEO of SELLAS. "While the 80th event has not yet occurred, and we remain fully blinded, every passing month may increase the probability of a successful study."

SELLAS will announce the 80th event when it occurs, triggering the final analysis of this registration trial in a patient population with median overall survival of approximately eight months under the current standard of care, consisting of hypomethylating agents and BCL-2 inhibitors. GPS targets the WT1 protein and has received Orphan Disease and Fast Track designations from the FDA.

Celcuity Inc. (NASDAQ: CELC) recently presented updated results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial back in December at the 2025 San Antonio Breast Cancer Symposium, demonstrating compelling efficacy for gedatolisib combinations in hormone receptor positive, HER2-negative advanced breast cancer. For patients with time to progression on prior therapy exceeding 18 months, median PFS reached 12.4 months with gedatolisib triplet and 10.0 months with gedatolisib doublet versus 1.9 months for fulvestrant alone.

"The updated results provide further evidence of the potential for gedatolisib combined with fulvestrant with or without palbociclib to offer paradigm shifting results for patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer," said Igor Gorbatchevsky, Chief Medical Officer of Celcuity. "We are very excited that patients reported nearly two years of delay in definitive deterioration of their well-being."

For patients enrolled in the U.S., Canada, Western Europe and Asia Pacific, median PFS was 16.6 months with gedatolisib triplet versus 1.9 months for fulvestrant. The gedatolisib regimens demonstrated favorable safety profiles with effective stomatitis management, showing median resolution time of 12-14 days for Grade 2-3 events.

RenovoRx, Inc. (NASDAQ: RNXT) announced acceptance of a clinical data abstract at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium 2026, presenting pharmacokinetic and pharmacodynamic findings from its ongoing Phase III TIGeR-PaC trial comparing systemic drug levels of intra-arterial gemcitabine delivered via the RenovoCath device versus standard intravenous chemotherapy in locally advanced pancreatic cancer. The sub-study demonstrates decreased systemic drug levels with targeted delivery, providing scientific evidence for the reduced side effect profile observed with the TAMP therapy platform.

"This clinical data abstract further contributes to scientific basis for reported decreased clinical side effect profile with our approach to targeted drug-delivery via the TAMP therapy platform and IAG versus the standard of care, systemic intravenous therapy, which is demonstrated by decreased systemic drug levels compared to treatment delivered by systemic therapy," said Dr. Ramtin Agah, RenovoRx's Chief Medical Officer.

The presentation is scheduled for January 9, 2026 in San Francisco, with RenovoRx also commercializing its FDA-cleared RenovoCath device, having generated approximately $900,000 in revenues during the first nine months of 2025. The company received its first commercial purchase orders in December 2024, with several customers initiating repeat orders as RenovoRx expands to additional medical institutions, including high-volume National Cancer Institute-designated centers.

Source: https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/

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SOURCES CITED:

1. https://www.jpmorgan.com/insights/markets-and-economy/outlook/biopharma-medtech-deal-reports
2. https://www.cnbc.com/2026/01/07/big-pharma-race-to-snap-up-biotech-assets-as-170-billion-patent-cliff-looms.html
3. https://www.newstrail.com/precision-oncology-market-scope/
4. https://www.oncologynurseadvisor.com/news/fda-accelerated-approval-oncology-drugs-improved-patient-survival/