Ann: Firebrick Investor Update, page-15

Thanks to those who have posted comments and questions.
Let me pull together what is in the public domain to present the picture more clearly about where Firebrick is headed.

Our goal has always been to find a way to make Nasodine available so people will use it, and they will - especially doctors and other healthcare professionals; for them it's a "no-brainer" and our market research with Australian doctors has confirmed it. Our initial strategy was to pursue the common cold as our primary indication for regulatory approval, because anecdotally we know it works for the cold, if used early enough. We were also motivated by the fact that we had a granted patent for use in colds (so good commercial protection) and that the common cold is a huge market opportunity.

In our view, our first Phase 3 trial showed the product was sufficiently effective for approval in Australia, but we met extraordinary and unrelenting resistance from the regulator all the way through to an AAT appeal, which remains on foot. Regardless, based on EU regulatory advice, we needed to complete a second Phase 3 trial for approval in Europe and that was the main purpose of the 2023 Trial. Naturally, we expected that the second trial would also address any residual concerns by the local regulator.

As observed by @cdoyle, the second P3 trial has been invalidated, putting our plans for European approval for the common cold on hold. And as @RockstarJones noted, we have no immediate plans to repeat the trial, so where does that leave us? It is clear that we cannot take the risk on another expensive, 2-year-long, Phase 3 trial that (for whatever reason) might deliver unsupportive results. However, we have too much invested in the common cold to give up, so we are looking at alternative study designs that are less costly, faster, more controllable and not reliant on subjective and fuzzy outcomes, namely people's perceptions about symptoms and quality of life. We do not have any concrete plans yet, so I cannot say more, but the message is that the common cold is not a dead end for Nasodine from a regulatory perspective.

In the meantime, it may be alive and well from a market perspective. As announced today, we have a pretty exciting pathway forward which involves putting Nasodine on the market (in one or more countries, but not Australia), as a nasal antiseptic or nasal disinfectant. COVID has heightened people's concern and need to eliminate bugs in their noses. Nasodine is a perfect solution: It has been proven to be safe in multiple human trials, it has a two-year shelf life, and is manufacturing ready. Our existing patents should provide some protection for Nasodine's use as a nasal antiseptic/disinfectant, but we also have other intellectual property and product benefits that give us competitive advantages.

All going well, Nasodine can be on the market in at least one country in the first half of 2024, and it seems without any significant regulatory barriers. We are now all global and online, so access to Nasodine in one country should not limit its access to only that country. Once available as a nasal antiseptic/disinfectant, I believe consumers and doctors will use Nasodine for a range of indications, including treating/preventing the common cold and other respiratory illnesses. It may also be used in hospitals to eliminate nasal bacteria like MRSA that can cause post-surgical infections. I'm not promoting these uses, simply reporting what consumers and doctors have told us and what is already supported by the published literature. And when the next pandemic arrives, how useful will it be to have a product like Nasodine that clears viruses from the upper respiratory tract and can be used by every healthcare worker.

Personally I think 2024 is going a big year for Firebrick.

PM