Oncolytics Biotech Reports Q2 2024 Financials and Highlights

Oncolytics Biotech® Inc., a prominent clinical-stage company focusing on immunotherapy for oncology, has announced significant operational milestones and financial results for the second quarter, ending June 30, 2024. These achievements highlight the company's strategic advancements in developing its leading therapeutic agent, pelareorep, for breast and pancreatic cancers.

During the second quarter, Oncolytics Biotech received constructive feedback from the FDA's Type C meeting, which supports the planned registration-enabling study for pelareorep in HR+/HER2- metastatic breast cancer (mBC). The FDA endorsed progression-free survival as the study's primary endpoint and overall survival as a secondary endpoint. The study will include patients who have failed hormonal therapy and received no more than one line of antibody-drug conjugate (ADC) therapy. The control arm will use paclitaxel monotherapy, while the test arm will combine pelareorep with paclitaxel. This combination has already demonstrated significant patient benefits in previous studies.

Additionally, Oncolytics Biotech dosed the first patient in the new GOBLET study's pancreatic cancer cohort, which is supported by funding from the Pancreatic Cancer Action Network (PanCAN). This fifth cohort will assess the combination of pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab in newly diagnosed pancreatic ductal adenocarcinoma (PDAC) patients. Earlier data revealed that pelareorep, when combined with other chemotherapy regimens, notably enhanced tumor response rates. This combination has earned Fast Track Designation from the FDA and will be examined in an adaptive registration-enabling trial through collaboration with the Global Coalition for Adaptive Research (GCAR).

Oncolytics Biotech also announced a preliminary collaboration with GCAR to include pelareorep in an adaptive registration-enabling pancreatic cancer trial. This collaboration aims to generate registration-enabling data for the treatment of first-line metastatic PDAC, evaluating a regimen of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab. This innovative trial design allows for the evaluation of multiple investigational therapies, potentially accelerating the study timeline and reducing costs compared to traditional trial designs.

In the second quarter of 2024, Oncolytics Biotech reported a cash position of $24.9 million, ensuring sufficient funds to meet key milestones into 2025. The net loss for the quarter was $7.3 million, slightly lower than the $7.4 million loss reported in the same period in 2023. Research and development expenses increased to $4.6 million due to higher clinical trial costs and share-based compensation, while general and administrative expenses remained consistent at $3.4 million.

Oncolytics Biotech anticipates several milestones in the coming months. These include reporting overall survival results from the BRACELET-1 trial in HR+/HER2- mBC in the second half of 2024, finalizing the master protocol for the adaptive registration-enabling trial in PDAC with GCAR, and providing a safety run-in update for the GOBLET mFOLFIRINOX cohort in the first half of 2025.

The company's Chair of the Board, Wayne Pisano, has taken on the role of Interim CEO during Dr. Matt Coffey's medical leave of absence. Pisano brings over 30 years of pharmaceutical industry experience to his leadership role, underscoring the company's commitment to advancing its strategic objectives.

In summary, Oncolytics Biotech continues to make significant progress in developing pelareorep as a promising therapeutic agent for breast and pancreatic cancers. With robust clinical data, strategic collaborations, and a solid financial footing, the company is well-positioned to achieve its upcoming milestones and advance its mission to improve cancer treatment outcomes.

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