ONCOLYTICS BIOTECH INC SEC Filings

Oncolytics Biotech Inc. announced leadership changes, appointing John McAdory as Chief Operating Officer and adding Steve Glover to its Board of Directors. McAdory, age 49, previously led clinical operations roles at CG Oncology, SillaJen, UCB, and Amgen, and will oversee clinical, preclinical, and development activities as well as strategic partnerships.

Glover, age 66, becomes the ninth director and received an option to purchase 96,000 common shares, vesting in three equal annual installments of 32,000 shares starting one year after June 1, 2026. He brings more than 35 years of biopharma leadership, including chairing Ambrx Biopharma through its approximately $2 billion acquisition by Johnson & Johnson and co-founding Coherus BioSciences. The company emphasizes these appointments as supporting advancement of pelareorep, its investigational immunotherapy platform.

Oncolytics Biotech Inc. filed an 8-K after issuing a press release about early preclinical results for its immunotherapy pelareorep used with RAS inhibitor modalities in a solid tumor model. The combination showed greater anti-tumor activity than either approach alone, supporting further evaluation.

The company plans additional preclinical studies in pancreatic ductal adenocarcinoma and colorectal cancer models, including combinations with KRAS G12C and pan-RAS inhibitors and other next-generation RAS-pathway agents. Full results from these initial studies are expected to be presented in the fall or winter of 2026.

Oncolytics Biotech Inc. is highlighting new translational data on its investigational immunotherapy pelareorep at the 2026 American Society of Clinical Oncology Annual Meeting. The data come from the GOBLET phase 1/2 gastrointestinal cancer trial and the AWARE-1 window-of-opportunity breast cancer study.

Across studies, pelareorep treatment was associated with a multi-step immune activation process: antiviral signaling in tumors, expansion of virus-specific T cells, and subsequent activation of tumor‑specific T cells linked to tumor regression signals. In pancreatic cancer, expansion of pre‑existing tumor‑infiltrating lymphocyte clones in blood correlated with reductions in tumor volume, including mutant KRAS‑specific T‑cell responses.

In breast cancer, serial biopsies showed increased antiviral and immune gene expression, toll‑like receptor 3 activation, CXCL13 induction, and tertiary lymphoid structure formation. AWARE‑1 reported that combining pelareorep, letrozole, and atezolizumab led to 60% of patients achieving at least a 30% increase in CelTIL score, a measure associated with favorable outcomes.

Oncolytics Biotech Inc. reported a larger quarterly loss and highlighted funding risk as it advances its cancer pipeline. For the three months ended March 31, 2026, net loss widened to $9.2 million, or $0.08 per share, from $4.7 million a year earlier as research and development and general and administrative expenses both roughly doubled.

Cash and cash equivalents were $5.5 million, and operating activities used $7.3 million of cash. Management stated that existing cash, even with access to equity distribution arrangements, is not sufficient to fund planned operations for at least twelve months, raising substantial doubt about the company’s ability to continue as a going concern unless additional financing is secured.

To bolster liquidity, the company raised net proceeds of $7.6 million by selling 7.4 million common shares through at-the-market offerings and later entered a new sales agreement allowing issuances of up to $75 million. Oncolytics continues to focus on pelareorep, its immunotherapy candidate, including a new randomized Phase 2 colorectal cancer trial and Fast Track Designation in RAS‑mutated metastatic colorectal cancer.

Oncolytics Biotech Inc. reported new clinical data from its REO 022 study in second-line RAS-mutant, microsatellite-stable metastatic colorectal cancer. Pelareorep-based combination therapy achieved a 19.5‑month median duration of response, compared with historical benchmarks of about 4–6 months in this setting.

The regimen of pelareorep, bevacizumab, and FOLFIRI showed a 33% objective response rate, versus 6–11% reported for standard care. The company is enrolling a randomized Phase 2 trial in this population and is actively engaged with the FDA to discuss a potential accelerated approval pathway based on response durability and time‑to‑event endpoints.

Oncolytics Biotech Inc. reported that a recent Type C meeting with the U.S. Food and Drug Administration resulted in alignment on the design of a pivotal randomized controlled study of pelareorep in patients with unresectable metastatic squamous cell carcinoma of the anal canal.

The planned single pivotal trial is expected to enroll patients whose disease has progressed after standard chemotherapy and checkpoint inhibitor treatment, a setting with no FDA-approved therapies. The study is being structured so accelerated approval and full approval could be pursued at different points using multiple endpoints.

Oncolytics highlighted prior data in second-line and later anal cancer, where pelareorep plus a checkpoint inhibitor showed a median response duration of 15.5 months versus 9.5 months and 12‑month survival of 82% versus 45.7% compared with current standard care. Pelareorep is also being developed in colorectal and pancreatic cancers, where it has FDA Fast Track designation.

Oncolytics Biotech Inc. entered into an Open Market Sale Agreement with Jefferies LLC to sell shares of common stock with an aggregate offering price of up to $75.0 million through an at-the-market program.

Sales will be made from time to time under the company’s effective Form S-3 shelf registration, with Jefferies acting as agent or principal and earning a commission of up to 3.0% of gross proceeds. The company plans to use any net cash raised to fund clinical development of pelareorep, related research and development, operating costs, working capital and general corporate purposes.

Oncolytics Biotech Inc. has filed a prospectus supplement to offer up to $75,000,000 of common stock through an at-the-market sales agreement with Jefferies LLC. Sales may occur from time to time at market prices; Jefferies may act as agent or principal and may earn commissions up to 3.0%.

The company states net proceeds will be used to fund clinical development of pelareorep, R&D, operating costs and general corporate purposes. The prospectus cites 108,021,271 shares outstanding as of December 31, 2025 and presents a pro forma example (sale of 78,125,000 shares at $0.96) producing up to 186,146,271 shares outstanding.

Oncolytics Biotech Inc. has scheduled a Type C meeting with the U.S. FDA on April 16, 2026 to discuss a potential single-arm registrational study of pelareorep plus a checkpoint inhibitor in second-line and later squamous cell anal carcinoma (SCAC).

The company plans to propose a pivotal trial enrolling approximately 60–70 patients, using objective response rate as the primary endpoint to support potential full approval. In Cohort 4 of the GOBLET study, pelareorep plus a checkpoint inhibitor achieved an approximately 30% objective response rate and a median duration of response of 17 months in late-line SCAC, compared with real-world response rates of about 10–14% and a median duration of response of roughly 9.5 months.

Oncolytics highlights SCAC as a rare cancer with limited second-line and later treatment options and notes external estimates of about 54,000 anal cancer cases globally each year, with the anal cancer market projected to reach $2.3 billion by 2035.