Indonesia Phase 3 Dosing underway (25/9/25)

A standard news flow item for Biotech’s, dosing underway in the Phase 3 Indonesian trial of R327G for Diabetic Foot Infections, Claytons market sensitive. Five sites now activated (not sure out of how many planned), with initial readouts expected Q1 2026 after 100 of the 310 targeted patients included in the trial have been treated.

I am a bit confused on the date reference, as a 30 June year end reporting company Q1 2026 is now (Sep25), I think they mean the March 2026 quarter end with a view to the first commercial sales possibly falling into CY26. It could be either, the trial was expected to take 12 months – readouts are very quick on efficacy for the treatment and it’s a relatively small trial, and there are a lot of DFI patients in Indonesia (20.9m live with diabetes), so recruitment is not an issue.

Per the below program pipeline, this is just the DFI for the Indonesia (ASEAN) market, not the broader, more complex and likely longer Phase 3 for ASSSI to be held in Australia, which will include DFI but also other wounds and burns.

More than 1 in 10 adults in Indonesia have diabetes and 60% of all diabetic foot ulcers (DFU) develop infections. The incidence of DFU in Indonesia is reportedly 7.3%, and globally 6.3%. So that suggests 1.5m incidences of DFU each year in Indonesia which would suggest around 915k become infected.

Indonesian’s or their health system are unlikely to pay a lot for the treatment and the company hasn’t provided any commercial guidance on this market, but circa 1m patients each year that could use the treatment is a healthy market even with modest penetration at low values and margins for an ASX company with a market cap around $100m, ignoring the rest of ASEAN or the ABSSSI program.

RCE should have enough capital to get to the end of 2026 and to market in Indonesia if all goes to plan. They will need additional capital to get to markets beyond that in the ASEAN region and also to complete clinical approval and bring the ABSSSI to market in Australia and the US.

So they will be looking for a strong share price lift early next calendar year to raise on and pumping the commercial prospects in Indonesia plus start of the ABSSSI trials in Australia to do that. Hopefully that’s the way it plays out and they are well capitalised to go all the way without high levels of dilution.

Disc: I own RL+SM

China Patent (27/5/25)

Yesterday Recce announced the acceptance of their China Patent in what I would qualify as questionably market sensitive announcement.

Today the price has spiked 20% and buyers are overwhelming sellers with a high volume of trade for the stock. Why today and not yesterday is my question, but I suspect the answer is that it has nothing to do with the announcement.

The price is now back around the pre capital raise announcement price and for some reason we have a lot of interested investors… They must have been close to getting a speeding ticket and if they send another market sensitive announcement out later this week (a real one) they will have some questions to answer.

It’s good to see the price rise, just odd to happen all of a sudden.

Disc: I own RL+SM

USAMRIID Cooperative Research & Development Agreement (28/4/25)

Todays announcement indicates a deepening relationship with US Defence agencies adding this agreement with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) to the US DoD Burns treatment program.

The USAMRIID program is supported and funded by the Defence Threat Reduction Agency (DTRA) and will test Recce’s synthetic anti-infective RECCE® 327 (R327) against a panel of biodefence pathogens in USAMRIID’s established in vitro (in lab) infection models. Then in vitro (in animal) in the US DoD laboratory equipped to safely study highly hazardous pathogens requiring maximum containment at Biosafety Level 4.

No cost or revenue is mentioned, presumably RCE will provide the compound (R327) for free which is inexpensive and if the DoD is paying for the research then it’s a good deal with an opportunity for expanded use at next to no cost.

The announcement also provides a bit more credibility for R327, additional US agency support shows that external groups who have looked deeply at the science see good potential.

This also supports their current capital raise at 28c, the 1-6 entitlement opened on 22 April and closes 5 May. I hope the price stays above 28c to help support the raise, but I will be following and make a call to invest around the close date.

Disc: I own RL+SM

RCE halted trade yesterday pending the release of the results of it's Phase 2 ABSSSI clinical trial.

Given there is no release this morning it looks like Monday for the announcement, which based on the 21 January update on the trial completing dosing, should be fine.

With the results we should get a bit more information on next steps (ie Phase 3 plans), the company needs a share price boost because they will need to raise more money at some point to get through Phase 3 in both Australia and Indonesia. They should be able to get some financing via Endpoints Capital to bring forward some R&D rebates, but that will not be enough.

Alternatively, with Phase 2 results in the bag, they are getting very attractive for Big Pharma. So a collaboration/partnership on development is the alternative funding path through the clinic and to commercialisation. The companies current market cap is chump change for any suitable buyers, so this is a real avenue of exit (sale) or monetisation (collaboration) of the IP.

Disc: I own RL+SM