Invion’s Cash Tightrope: Can New Funding Sustain Its Ambitious Cancer Programs?

Regulatory Breakthrough with FDA Orphan Drug Designation

Invion Limited (ASX, IVX) marked a significant milestone in the September quarter by securing Orphan Drug Designation (ODD) from the US Food and Drug Administration for its lead candidate, INV043, targeting anal cancer. This designation not only validates the promise of Invion’s Photosoft™ technology platform but also unlocks seven years of market exclusivity in the US, potential tax credits, and a streamlined clinical development pathway. The FDA’s decision was supported by compelling preclinical data from the Peter MacCallum Cancer Centre, demonstrating that INV043 combined with immune checkpoint inhibitors achieved tumor control rates around 80%, a substantial improvement over immune therapy alone.

Strengthening the Balance Sheet to Fuel Clinical Progress

To support its advancing clinical programs, Invion successfully raised approximately $1 million through a Loyalty Entitlement Offer, complemented by a $782,000 convertible note issue backed by specialist biotech funds. These capital injections provide the company with enhanced financial flexibility to continue patient screening in its Phase I/II non-melanoma skin cancer trial and to prepare for the upcoming anogenital cancer trial in collaboration with Peter Mac. The convertible notes are structured to convert into ordinary shares upon signing an expanded global licensing agreement with RMW Cho Group, a deal currently under negotiation.

Expanding Horizons, Animal Health Collaboration

Beyond human oncology, Invion has entered a new collaboration with Protect Animal Health Inc., a leading Taiwanese animal therapeutics company. Protect will fund and conduct studies evaluating Photosoft compounds for treating cancers in companion animals, tapping into a growing pet cancer therapeutics market projected to reach over US$12 billion by 2034. This partnership could accelerate commercialisation pathways and potentially lead to co-development agreements, highlighting the versatility of Invion’s technology across species.

Clinical Trials and Industry Engagement

Invion continues to advance its clinical pipeline with ongoing patient screening in Queensland for the non-melanoma skin cancer trial and collaborative trial design work for anogenital cancers. The company also maintains active research partnerships in South Korea, supplying additional doses of INV043 for testing. Engagement with the biotech community remains strong, with Invion’s CEO Prof Thian Chew participating in expert panels and presenting at key industry conferences, reinforcing the company’s profile in personalised cancer therapies.

Financial Position and Outlook

At quarter-end, Invion held $537,000 in cash reserves, excluding the recent convertible note proceeds. Operating costs increased due to R&D activities, while administration expenses were managed down from the previous quarter. The company acknowledges the need to carefully manage its cash runway but remains confident in its ability to continue operations and meet business objectives, supported by recent capital raises and strategic partnerships.