Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER – Baystreet.ca News Commentary – The global oncology market is charging toward a massive $668 billion valuation by 2034[1], fueled by a structural shift where institutional capital is abandoning discovery-stage speculation to hunt for execution-ready platforms. This regulatory velocity is hitting hyperdrive, with the FDA's accelerated approval pathway delivering significant survival gains and transforming registration-directed security into the ultimate value catalyst for 2026[2]. This convergence of massive scale and regulatory clarity has created a "Precision Sanctuary" for high-conviction clinical leaders, positioning Oncolytics Biotech Inc. (NASDAQ: ONCY), GeoVax Labs (NASDAQ: GOVX), Foghorn Therapeutics (NASDAQ: FHTX), ORIC Pharmaceuticals (NASDAQ: ORIC), and SELLAS Life Sciences Group (NASDAQ: SLS) at the center of the cycle.
Professional buyside investors are calling 2026 a pivotal year for value creation as sector fundamentals strengthen and old policy risks finally fade into the background[3]. The urgency is being driven by an explicit "Big Pharma" arms race: a looming $170 billion patent cliff is forcing industry giants to snap up late-stage biotech assets at any cost[4]. In this environment, having a disciplined, registration-anchored trial isn't just a milestone—it's the mandatory baseline for capturing asymmetric upside in the 2026 oncology cycle.
Oncolytics Biotech Inc. (NASDAQ: ONCY) is strengthening its operational and clinical leadership as it advances pelareorep toward multiple registration-directed programs in gastrointestinal cancers.
The company recently announced the appointments of John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics, bringing deep expertise in late-stage oncology trial execution and regulatory strategy. McAdory joins from CG Oncology, where he served as Vice President of Clinical Operations leading late-stage development programs for oncolytic virus therapies. Wu arrives from Morphic Therapeutic, where he headed Biostatistics through the company's acquisition by Eli Lilly, and previously led statistical strategy for multiple Phase 3 oncology programs at Takeda. Both executives bring direct experience navigating complex registration trials and global regulatory interactions.
"John's background running complex, late-stage oncology trials makes him exceptionally well-suited to lead Oncolytics' next phase of execution," said Jared Kelly, CEO of Oncolytics Biotech. "As we progress toward pivotal and registration-enabling studies in anal, pancreatic, and colorectal cancers, his experience will be critical to ensuring disciplined execution, speed, and regulatory alignment."
These appointments complete a transformative executive team buildout following Kelly's promotion to CEO last year and the addition of Chief Business Officer Andrew Aromando. They were both crucial contributors to Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson. Oncolytics also recently expanded its Scientific Advisory Board with globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, positioning the company for accelerated clinical development across multiple indications.
The company recently announced breakthrough 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 patient population.
The company is also advancing pelareorep toward potential accelerated approval in anal cancer after reporting third-line data that achieved a 29% objective response rate, nearly tripling historical benchmarks in a setting with no FDA-approved treatment options. The median duration of response reached approximately 17 months.
Second-line or later results were equally compelling, with pelareorep achieving a 30% response rate, more than doubling the 13.8% benchmark for the only FDA-approved immunotherapy in this setting. The median duration of response of 15.5 months compared to 9.5 months for standard care demonstrates pelareorep's ability to deliver durable clinical benefit in patients with limited treatment options.
Oncolytics 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. This regulatory milestone clears the path for initiating a pivotal study in one of oncology's most challenging therapeutic areas.
CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
In other recent industry developments and happenings in the market include:
GeoVax Labs (NASDAQ: GOVX) highlighted 2026 as a pivotal year for progress following the J.P. Morgan Healthcare Conference Week in San Francisco, where the Company outlined multiple late-stage clinical, regulatory, and manufacturing milestones across its diversified portfolio. In oncology, GeoVax continues to advance Gedeptin, its gene-directed enzyme prodrug therapy, following encouraging safety and tumor-response signals from prior clinical studies, with key 2026 inflection points including publication of results from the recently completed Gedeptin trial and initiation of a Phase 2 study evaluating Gedeptin in combination with an immune checkpoint inhibitor as a potential first-line therapy for head and neck cancer by year-end.
"GeoVax enters 2026 with increasing clarity on execution, prioritization, and value creation," said David Dodd, Chairman and CEO of GeoVax. "With GEO-MVA representing an expedited path to potential commercialization, alongside multiple clinical data readouts relative to GEO-CM04S1, our multi-antigen COVID-19 vaccine and, the anticipated initiation of the Phase 2 Gedeptin trial, we believe that this year will provide a meaningful convergence of regulatory, clinical, and manufacturing catalysts for the Company."
GeoVax continues to pursue a partnership-oriented development strategy for Gedeptin, designed to advance the program efficiently while preserving long-term upside, with updates on preclinical evaluations of Gedeptin in combination with immune checkpoint inhibitors informing potential expansion into additional solid tumor indications. The Company is also progressing updates on preclinical evaluations of Gedeptin in combination with immune checkpoint inhibitors, informing potential expansion into additional solid tumor indications beyond head and neck cancer.
Foghorn Therapeutics (NASDAQ: FHTX) highlighted its January equity financing of $50 million with BVF Partners, Deerfield Management, founding investor Flagship Pioneering and a leading biotech mutual fund in a transaction priced at a 30% premium to the closing stock price. The Company's Phase 1 dose-escalation trial of FHD-909 in SMARCA4-mutant cancers is advancing as planned with a focus on non-small cell lung cancer, where prognosis is poor and worsens with each additional line of therapy, while the selective CBP degrader program with potential in ER+ breast cancer is on track to be IND-ready in 2026 and the selective EP300 degrader program shows preclinical superior anti-tumor efficacy and tolerability over dual CBP/EP300.
"We are pleased to have raised $50 million in an equity financing, priced at a 30% premium to the closing stock price on January 9, 2026," said Adrian Gottschalk, President and CEO of Foghorn. "We continue to execute across our first-in-class pipeline focused on developing new treatment options for cancers with significant unmet need."
ORIC Pharmaceuticals (NASDAQ: ORIC) reported operational highlights showcasing significant progress across its oncology pipeline with $413 million in cash expected to fund operations into 2H 2028. The company advanced rinzimetostat in prostate cancer, with 55% of patients achieving PSA50 response and 20% achieving PSA90 response, while enozertinib demonstrated a 67% response rate in first-line EGFR exon 20 NSCLC and 100% intracranial response rate.
"2025 was a transformative and highly productive year for ORIC, marked by meaningful progress across our pipeline, including data that further strengthened our conviction in the potential best-in-class profiles of rinzimetostat in prostate cancer and enozertinib in lung cancer," said Jacob M. Chacko, M.D., CEO of ORIC Pharmaceuticals. "We also bolstered our leadership team and substantially extended our cash runway into 2H 2028 in anticipation of these programs advancing towards registrational studies and, ultimately, commercialization."
The company plans to initiate its first global Phase 3 registrational trial in metastatic castration-resistant prostate cancer in 1H 2026. ORIC Pharmaceuticals raised $244 million from top-tier healthcare specialist funds and expects multiple clinical data readouts across both programs throughout 2026.
SELLAS Life Sciences Group (NASDAQ: SLS) entered an agreement with IMPACT-AML to expand its SLS009 clinical program into Europe through the prestigious EU Mission Cancer framework. The collaboration enables capital-efficient expansion into frontline acute myeloid leukemia with broader patient enrollment across European clinical sites, with U.S. enrollment planned for Q1 2026 and European enrollment anticipated in Q2 2026.
"This is a highly meaningful milestone for SELLAS and for the SLS009 program," said Angelos Stergiou, M.D., Sc.D., CEO of SELLAS. "Gaining access to the IMPACT-AML framework represents strong external validation of SLS009 and reflects the growing recognition of SLS009's potential in addressing critical unmet needs in AML. Importantly, this collaboration allows us to efficiently expand our clinical program into Europe by leveraging an established infrastructure, significantly improving capital efficiency while supporting broader and faster patient enrollment as we advance the program into frontline AML."
The study will enroll approximately 40 patients evaluating SLS009 combined with azacitidine and venetoclax in newly diagnosed AML patients with high-risk features. SELLAS Life Sciences is developing SLS009 as a potentially first-in-class differentiated CDK9 inhibitor demonstrating high response rates in AML patients with unfavorable prognostic factors.
Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
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SOURCES:
1. https://finance.yahoo.com/news/oncology-market-size-worth-usd-152700666.html
2. https://www.oncologynurseadvisor.com/news/fda-accelerated-approval-oncology-drugs-improved-patient-survival/
3. https://www.biocentury.com/article/658098/biotech-s-bull-is-back-and-investors-think-it-can-stick
4. https://www.cnbc.com/2026/01/07/big-pharma-race-to-snap-up-biotech-assets-as-170-billion-patent-cliff-looms.html
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