Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER — Baystreet.ca News Commentary — The global precision oncology market is on pace to reach $303 billion in 2035[1], a figure that reflects more than steady growth, signaling a structural shift in where serious medical capital is heading. That momentum is getting a further push from the FDA's accelerating pace of oncology designations in early 2026[2], with breakthrough and fast-track designations flowing to targeted therapies across pancreatic, colorectal, lung, and breast cancers. Against that backdrop, companies like Oncolytics Biotech (NASDAQ: ONCY), IceCure Medical (NASDAQ: ICCM), Pulse Biosciences (NASDAQ: PLSE), Actuate Therapeutics (NASDAQ: ACTU), and SOPHiA GENETICS (NASDAQ: SOPH) are each advancing niche, data-driven plays directly in the path of this capital migration.
Institutions are positioning for the deals that follow, and the setup looks increasingly clear: Goldman Sachs is forecasting a record-breaking year for biopharma M&A in 2026[3], with oncology commanding the largest share of targeted transactions. The reason is structural, as next-generation cancer diagnostics are scaling fast[4], with AI-driven genomic profiling platforms emerging as the primary value anchor for the 2026 investment cycle, turning raw tumor biology into the kind of durable, data-backed clinical evidence that acquirers are willing to pay a premium to own.
Oncolytics Biotech (NASDAQ: ONCY) is presenting new mechanistic and translational data at the American Association for Cancer Research (AACR) Annual Meeting in San Diego this April, data that adds scientific depth to the company's push into some of cancer's hardest-to-treat corners.
The two abstracts, drawn from the AWARE-1 breast cancer study and the GOBLET gastrointestinal cancer trial, both center on the same question: can pelareorep, the company's lead drug, make tumors more vulnerable to immunotherapy? The short answer, based on these findings, appears to be yes. In AWARE-1, biopsies showed pelareorep triggering the formation of tertiary lymphoid structures, essentially localized immune hubs that help the body mount a sustained attack on cancer cells.
Tumors that would otherwise stay "cold" and invisible to the immune system showed signs of becoming "hot." In GOBLET Cohort 1, patients with pancreatic cancer who showed early immune activation after four weeks on a pelareorep-based regimen lived longer without their disease progressing than those who did not, 7.5 months compared to 5.6 months. That same treatment combination previously posted a 62% objective response rate in first-line pancreatic cancer patients, more than double what chemotherapy alone has historically produced.
The data matter because they help explain the results Oncolytics has already reported in colorectal cancer, where the backdrop is equally encouraging. The company recently launched REO 033, a randomized Phase 2 trial testing pelareorep alongside bevacizumab and FOLFIRI in second-line RAS-mutated, microsatellite-stable metastatic colorectal cancer, a patient group with very few good treatment options today.
The trial builds on earlier results from REO 022, where the same drug combination produced 27 months of overall survival, 11.2 months of progression-free survival, and a 33% objective response rate, against 16.6 months, 5.7 months, and roughly 10% for the standard of care. The FDA took notice, granting the regimen Fast Track Designation earlier this year. The second-line KRAS-mutant colorectal cancer market is estimated at $3 to $5 billion annually. REO 033 expects to open its first site next month, with preliminary data targeted for year-end 2026.
Oncolytics is a clinical-stage biotechnology company that has spent years building a scientific case for pelareorep across multiple tumor types. Across anal cancer, pancreatic cancer, and now colorectal cancer, the drug is accumulating a consistent body of evidence as something that may make other gastrointestinal cancer treatments work better. That kind of backbone role, if confirmed in larger trials, could position Oncolytics as a meaningful partner in the broader immuno-oncology landscape, where combination strategies are increasingly where the field is heading.
CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
In other industry developments:
IceCure Medical (NASDAQ: ICCM) received FDA approval for its post-marketing ChoICE Trial study design for ProSense® cryoablation in the local treatment of low-risk breast cancer, building on the device's October 2025 FDA marketing authorization. The study is designed to enroll approximately 400 patients across 30 clinical sites in the U.S. within 36 months, with enrollment expected to commence in the second half of 2026.
"We believe the combination of FDA marketing authorization, this FDA-approved post-market study with 30 clinical sites across the country, supportive American Society of Breast Surgeons guidelines, an established reimbursement code, and strong physician engagement positions us to meaningfully expand access to ProSense® as a minimally invasive treatment option for eligible breast cancer patients across the U.S.," stated Eyal Shamir, CEO of IceCure.
Participating clinical sites will treat enrolled patients while also serving as active commercial sites, supporting the company's broader commercial expansion of ProSense®. Study procedures are eligible for reimbursement under an established Centers for Medicaid and Medicare Services CPT Category III code, providing approximately $4,000 for the facility fee alone, a framework IceCure believes may support claims for study procedures with additional pathways potentially developing over time.
Actuate Therapeutics (NASDAQ: ACTU) launched a strategic research initiative to evaluate combinations of its clinical-stage GSK-3β inhibitor elraglusib with emerging RAS-targeted therapies, targeting resistance mechanisms that continue to limit durable responses in RAS-driven cancers. The program includes in-vitro and in-vivo studies across tumor models of RAS resistance, with initial data expected in Q2 2026 and additional preclinical results anticipated in the second half of 2026.
The combination strategy is designed to simultaneously suppress downstream survival signaling through GSK-3β inhibition while blocking proliferative signaling via RAS inhibition, potentially enhancing antigen presentation and T cell activation in immunologically resistant RAS-mutant tumors such as pancreatic cancer. Actuate is advancing elraglusib in a Phase 2 trial in metastatic pancreatic cancer, where the drug has now been administered to more than 500 patients across its development program.
Pulse Biosciences (NASDAQ: PLSE) announced first patient enrollments in its multi-center first-in-human feasibility study of the nPulse Vybrance Percutaneous Electrode System for treatment of T1N0M0 papillary thyroid microcarcinoma in collaboration with UT MD Anderson Cancer Center and Sarasota Memorial. The study targets the most common and slow-growing form of thyroid cancer using the company's proprietary nanosecond Pulsed Field Ablation technology, which non-thermally ablates tissue while sparing critical anatomical structures, including nerves and vessels.
"We believe the nonthermal mechanism of action of nsPFA positions our nPulse technology as a potential treatment option for both benign and malignant thyroid tumors," said Paul LaViolette, Co-Chairman and CEO of Pulse Biosciences. "Commencing these first-in-human feasibility cases in collaboration with world-class institutions like UT MD Anderson and Sarasota Memorial is an important initial step and is consistent with our mission to rigorously generate data and demonstrate the potential to improve patient outcomes and provide clinicians with more precise, tissue-sparing tools for minimally invasive treatment applications."
Pulse Biosciences separately reported 100% procedural success at 6 months and 96% at one year in its atrial fibrillation (AF) catheter feasibility study, with FDA approval received in Q4 2025 to commence a pivotal IDE study for paroxysmal AF. The company generated $264 thousand in revenue in Q4 2025 from its controlled commercial launch and continues enrollment in the PRECISE-BTN benign thyroid nodule study targeting 100 patients.
SOPHiA GENETICS (NASDAQ: SOPH) reported fourth quarter and full year 2025 results with Q4 revenue of $21.7 million, representing 22% year-over-year growth, and full-year revenue of $77.3 million, up 19% year-over-year on the strength of 391,000-plus analyses performed on its SOPHiA DDM™ platform. The company signed a record 124 new customers in 2025 and expanded its footprint with two major U.S. integrated health systems expected to contribute approximately 60,000 analyses annually.
"We finished 2025 strong, with Q4 revenue growing 22% and full-year revenue increasing 19% year-over-year, as our growth momentum continues to accelerate," said Jurgi Camblong, CEO and co-founder of SOPHiA GENETICS. "Exceptional new business momentum, including the recent signing of two major integrated health systems in the U.S., which are expected to add 60,000 analyses annually, as well as a record 124 new customers signed in 2025, positions us well for 2026 and beyond."
SOPHiA GENETICS reaffirmed 2026 guidance of $92 million to $94 million in full-year revenue, representing approximately 20% to 22% growth over 2025, while targeting an adjusted EBITDA loss of $29 million to $32 million compared to $41.5 million in 2025. The company expects to approach adjusted EBITDA breakeven by year-end 2026 and cross into positive adjusted EBITDA in the second half of 2027.
Article Source: usanewsgroup.com
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SOURCES CITED:
1. https://www.researchnester.com/reports/precision-oncology-market/5663
2. https://www.targetedonc.com/view/fda-oncology-update-january-2026-new-horizons-in-precision-medicine
3. https://www.pharmavoice.com/news/deal-merger-acquisition-pharma-2026-drug/807450/
4. https://www.globenewswire.com/news-release/2026/01/29/3228890/28124/en/Next-Generation-Cancer-Diagnostics-Research-Report-2026-Global-Market-Size-Trends-Competitive-Analysis-Opportunities-and-Forecasts-2021-2025-2026-2031.html
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