Oncolytics Biotech Inc T.ONC

Alternate Symbol(s): ONCY

Healthcare Biotechnology

Oncolytics Biotech Inc. is a clinical-stage biotechnology company. The Company is focused on developing pelareorep, an intravenously delivered immunotherapeutic agent that activates the innate and adaptive immune systems and weakens tumor defense mechanisms. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype turning cold tumors hot through innate and adaptive immune responses to treat a variety of cancers. This improves the ability of the immune system to fight cancer, making tumors more susceptible to a broad range of oncology treatments. The Company’s primary focus is to advance its programs in hormone receptor-positive / human epidermal growth factor 2- negative (HR+/HER2-) metastatic breast cancer and advanced/metastatic pancreatic ductal adenocarcinoma to registration-enabling clinical studies. In addition, it is exploring opportunities for registrational programs in other gastrointestinal cancers through its GOBLET platform study.

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Oncolytics Biotech Inc > Accelerated Approval

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Post by Quentin30on Aug 01, 2024 5:01pm

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Post# 36159160

Accelerated Approval

Interesting, another Phase II (so smaller than a phase III), and then apply for accelerated approval..

So Noteable, the first time ONCY has specifically mentioned AA... that's a positive. The downside of course is how long it will take to get the data to run the study... Given that they haven't acknowledged submission of a CTA. I would expect ONCY to be in a position to apply for accelerated approval in mid 2026. If then approved late 2026/early 2027, they would be able to market Pela (with realtime Phase IV trial). Pity they only have cash till early 2025...

look out for dilution.

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