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ASX clarifies criteria for early-stage technology, biotechnology and medical technology listings

Key points

ASX has updated Guidance Note 1 to clarify the factors it will consider when assessing the suitability for admission of early-stage technology, biotechnology and medical technology listing applicants.

The revised guidance outlines the qualitative factors ASX will assess, including the entity's background, stage of development, revenue and commercialisation, IP ownership, and investment history.

For biotechnology and medical technology listing applicants that are yet to generate revenue, ASX will focus on the status of their clinical trialsIn Compliance Update No. 05/25, ASX has announced changes to Guidance Note 1 Applying for Admission - ASX Listings.

The revised guidance, which came into effect on 30 May 2025, is aimed at providing greater clarity for early-stage technology, biotechnology and medical technology companies around the factors ASX considers when assessing their suitability for listing. Greater clarity for early-stage listing applicantsASX has indicated that it will take a more rigorous approach to assessing early-stage listing applicants, particularly those in the technology and life sciences sectors.

Over the last 18 months, ASX has been informally communicating the key factors it considers when assessing these applicants through briefings, conferences and informal commentary. These factors are now formally set out in Guidance Note 1.While the core admission requirements remain unchanged, ASX has emphasised that it will assess early-stage technology, biotechnology and medical technology listing applicants through a more qualitative lens, including consideration of the following factors:

Background of the entity

The business has been developed and grown by its promoters over a period of time.The business was recently acquired by its promoters and there is no continuity of key personnel.

DevelopmentMaterial cash has been spent over several years developing the business.There has been little or no cash spent on development.

Revenue and commercialisation
There is a market for the product and commercialisation opportunities, as evidenced by:revenue of $1 million or more in the last 12 months; or binding agreements for sales of $1 million or more in the next 12 months.

No revenue or binding agreements to generate revenue.

Ownership of intellectual propertyIntellectual property righgranted or applied for in each relevant jurisdiction and target market.

No intellectual property rights granted or applied for in each relevant jurisdiction and target market.

Investment history
The entity has conducted material seed raisings from independent parties.

Funds raised in seed raisings have been at prices demonstrating a decreasing level of risk.Funds raised in seed raisings directly contribute to the advancement of the technology and business. The entity has conducted no material seed raisings. Seed raisings have been conducted at nominal prices. Seed raisings have been conducted without subsequent and meaningful development of the technology and business. These factors are not new in substance but are now clearly set out in the guidance.

This should help advisers better prepare early-stage technology, biotechnology and medical technology listing applicants for the admissions process and manage expectations around the timing and the likelihood of success. ASX has also provided additional guidance for biotechnology and medical technology listing applicants that are yet to generate revenue. In these cases, ASX will place particular focus on the status of any planned or required clinical trials. It will consider whether clinical trials have been completed, commenced, or will be ready to commence promptly after listing, and, if the trials will be commenced after listing, whether the applicant has ethics approval, contracts, protocols and medical arrangements in place to conduct trials promptly after listing.

If clinical trials are not required, ASX will expect evidence from the relevant regulatory authority confirming that trials are not necessary for commercialisation. In all cases, applicants must be able to demonstrate a clear path to commercialisation and appropriate use of funds raised through the IPO.

Implications for listing applicants

The changes signal a continued focus by ASX on the quality and readiness of early-stage technology, biotechnology and medical technology companies seeking to list, and a clear intention to discourage speculative or premature IPOs. While the formal listing criteria remain unchanged, applicants and their advisers should expect more robust scrutiny and be prepared to address the qualitative suitability factors now outlined in the guidance.

This article was written by David Naoum, Partner and Lachlan Pearce, HWL Ebsworth.