Oncolytics Biotech reports Q2 highlights, management team updates, and financial results.

• Oncolytics Biotech reported Q2 2025 financial results and highlights • Company engaged with regulators on plans for a registration-enabling study • New management team members bring expertise in clinical programs and biotech transactions • Translational data further elucidate pelareorep's mechanism of action • Company terminated At-the-Market and Equity Line of Credit facilities • Commitment to limiting dilution • Focus on digital data for clinical programs and transactions.

Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported its second-quarter 2025 financial results and highlighted significant developments in its clinical programs and management team. The company announced that it has engaged with regulators to discuss plans for a registration-enabling study for its lead drug candidate, pelareorep, in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). Additionally, the company has terminated its At-the-Market financing facility and Equity Line of Credit to limit dilutive financing and maximize shareholder value.

Financial Highlights

As of June 30, 2025, Oncolytics reported $14.6 million in cash and cash equivalents, projecting a cash runway through key milestones and into the first quarter of 2026. The net loss for the second quarter of 2025 was $6.2 million, compared to a net loss of $7.3 million for the second quarter of 2024. Research and development expenses for the second quarter of 2025 were $2.8 million, compared to $4.6 million for the second quarter of 2024. General and administrative expenses for the second quarter of 2025 were $2.9 million, compared to $3.4 million for the second quarter of 2024.

Clinical Program Highlights

The company presented translational data further demonstrating pelareorep's mechanism of action at the American Society of Clinical Oncology Annual Meeting. Pelareorep expands reovirus-specific T cells, increases cytokines and chemokines, and increases tumor-infiltrating lymphocytes (TILs) in the blood. The company also highlighted survival data in mPDAC and breast cancer, showing meaningful survival benefits for patients treated with pelareorep-based regimens compared to either control arms or historical data.

Management Team Changes

Oncolytics appointed Jared Kelly as the new Chief Executive Officer and Andrew Aromando as the Chief Business Officer. Both executives bring extensive experience in advancing clinical programs and navigating successful biotech transactions. They were instrumental in guiding the sale of Ambrx Biopharma to Johnson & Johnson.

Strategic Decision to Pursue Registration-Enabling Pivotal Study

The company is pursuing a registration-enabling pivotal study for pelareorep in first-line mPDAC. Discussions with regulators are underway to finalize the approval pathway for pelareorep in this indication. If discussions proceed as expected, start-up activities for the study are expected to commence as early as Q4 2025.

Commitment to Limiting Dilution

Oncolytics has terminated its At-the-Market financing facility with Cantor Fitzgerald and Equity Line of Credit with Alumni Capital. The company believes it has sufficient capital to reach critical regulatory and clinical milestones this fall and pursue strategic opportunities without the need for near-term dilutive financings.

Reference List

[1] https://www.marketscreener.com/news/oncolytics-biotech-reports-second-quarter-financial-results-and-details-clinical-program-plans-for-ce7c5edddb8af723