ASX Queries INOVIQ’s Bold Cancer Treatment Claims Amid Early Research Stage

• INOVIQ confirms 88% cancer cell death in lab-based in vitro studies
• Study conducted in-house with ongoing validation at Peter MacCallum Cancer Institute
• Company justifies use of 'treatment' and forward-looking statements despite early research stage
• Detailed statistical analysis supports significance of results
• INOVIQ affirms compliance with ASX continuous disclosure requirements

Background and Announcement Context

INOVIQ Limited (ASX, IIQ), a biotechnology company focused on cancer therapeutics, recently announced that its novel CAR-NK-EV platform achieved an 88% kill rate of breast and lung cancer cells in laboratory studies. The announcement, made on 18 June 2025, highlighted the potential of engineered immune cell-derived exosomes as a new treatment avenue for solid tumours.

However, the Australian Securities Exchange (ASX) raised questions regarding the announcement's headline, the level of detail provided about the study, and the basis for forward-looking statements. INOVIQ has now submitted a detailed response addressing these concerns.

Clarifying the Study and Its Significance

INOVIQ emphasized that the 88% cancer cell death figure was derived from in vitro studies; laboratory experiments on cultured cancer cell lines; specifically triple-negative breast cancer (TNBC) and non-small-cell lung cancer (NSCLC) cells. The company clarified that the term 'treatment' is appropriate within this context, as the study employed a treatment, control design, a standard and regulatory-mandated approach in preclinical research.

The studies were conducted in-house at INOVIQ’s Notting Hill laboratories, complementing ongoing research at the Peter MacCallum Cancer Institute. The company explained that the in vitro experiments used a real-time xCELLigence assay to measure cytotoxic effects, with statistically significant reductions in cell viability confirmed through rigorous analysis.

Forward-Looking Statements and Regulatory Compliance

INOVIQ defended its forward-looking statements about the potential advantages of its CAR-NK-EV therapy, such as being 'off-the-shelf,' faster to produce, safer, and potentially more effective than current CAR-T therapies. The company cited scientific literature supporting these claims and clarified that such statements were appropriately qualified as speculative projections.

Importantly, INOVIQ confirmed full compliance with ASX Listing Rules, including continuous disclosure obligations. The company stated that all material information related to the study results was disclosed and that the announcement was not misleading by omission. The Board reviewed and approved the response to ASX queries.

Implications for Investors and the Market

This exchange underscores the challenges biotech companies face in balancing early-stage scientific communication with regulatory transparency. While the in vitro results are promising, they remain preliminary and require further validation in clinical settings. Investors should interpret the findings as an encouraging step rather than definitive proof of clinical efficacy.

INOVIQ’s clarification helps set a more measured tone around its research progress, potentially stabilizing market reactions following the initial announcement. The company’s commitment to regulatory compliance and detailed disclosure may bolster investor confidence as it advances its therapeutic platform.

Bottom Line?

INOVIQ’s detailed response reinforces transparency but reminds investors that lab success is just the first step in a long clinical journey.

Questions in the middle?

• When will INOVIQ release results from in vivo or clinical trials to validate these in vitro findings?
• How might the market react if subsequent studies fail to replicate the high efficacy reported?
• What are the regulatory hurdles and timelines for advancing CAR-NK-EV therapies toward approval?