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Health & Biotech
It’s the quarterly season again as the ASX market announcements page becomes increasingly flooded with updates.
Here, we wrap up report highlights from three standout stocks in the ASX health sector.
DXB continued to make significant progress with its ACTION3 Phase 3 clinical trial in focal segmental glomerulosclerosis (FSGS) during the quarter, opening up several additional clinical sites globally.
The ACTION3 trial of DXB’s lead drug candidate DMX-200 in FSGS was currently recruiting across 17 of the 19 planned countries. DXB said recruitment remained on-track with blinded interim analysis for the first 144 patients currently expected around mid-CY25.
In September DXB announced the National Registry of Rare Kidney Diseases (RaDaR) had been engaged to enhance ACTION3 trial recruitment across the UK.
The company also announced in September that the first clinical site specialising in paediatric kidney disease was activated for its ACTION3 Trial.
To support the ACTION3 study moving into paediatric patients paediatric nephrologist Dr Howard Trachtman was appointed to the DXB medical advisory board.
Post quarter end DXB announced expert nephrologist and co-chair of the global medical collab PARASOL working group Dr Laura Mariani had also been appointed to its medical advisory board.
During the quarter the first patients were enrolled into the Open Label Extension study for DMX-200 after completing the ACTION3 Phase 3 clinical trial.
The OLE study allowed patients who have successfully completed the ACTION3 Phase 3 clinical trial, to optionally start or continue a two-year treatment of DMX-200 in an open label (unblinded) setting.
Net operating cash outflow for the September quarter was $4.08 million. The company received $530,000 upfront payment from Taiba and ~$1.16m in relation to the exercise of listed options.
Taiba acquired the exclusive rights to register and commercialise DMX-200 for the treatment of focal segmental glomerulosclerosis (FSGS) kidney disease in the United Arab Emirates (UAE), Saudi Arabia, Oman, Kuwait, Qatar, Bahrain and Iraq.
The company said it continued to receive strong partnering interest in DMX-200
DXB had a cash position of $19.2m at September 30, with a FY24 R&D tax incentive rebate of $7.9m anticipated in Q4 CY24.
PAR made substantial progress in its Phase 3 clinical trial preparations for the treatment of knee osteoarthritis (OA) with injectable pentosan polysulfate sodium (iPPS/Zilosul), an FDA-approved drug for treatment of diseases such as OA and Mucopolysaccharidosis (MPS) where inflammation plays a major pathogenic role.
In September PAR received a response from the FDA, which provided guidance on the progression of the Phase 3 OA program, enabling the company to refine and finalise the trial protocol.
The updated protocol was submitted to the FDA in October with PAR expecting the review period to conclude by November 29, enabling the initiation of pre-screening and enrolment activities at up to 10 Australian trial sites in Q1 2025.
PAR said a global clinical research organisation (CRO) selection was nearing completion, further preparing for Phase 3 enrolment in early 2025.
MD Paul Rennies said submission of its phase 3 protocol to the FDA was a significant milestone for PAR, representing the culmination of extensive work by our team and close collaboration with the FDA.
“We are confident that this progress, combined with the anticipated TGA response and our ongoing engagement with funding partners, positions us strongly as we move into this pivotal phase,” he said.
R&D expenditure for Q1 was $3.79m, down from $7.2m in the the previous quarter. Outflows of $4.72m, came under forecast guidance of $7m.
Major spending areas for the quarter included regulatory costs associated with key submissions to the US FDA with normalised accounts payable at the end of the quarter.
PAR is finalising its R&D incentive rebate and expects a refund for activities of between $5-6m, which will provide additional support for ongoing R&D activities.
The company forecasts cash outflow for Q2 FY25 to be under $7m, similar to the guidance for Q1, which it said aligned with strategic fiscal management practices, ensuring resource allocation towards critical costs related to the OA phase 3 program and operational efficiency.
On September 30, PAR’s cash and cash equivalents totalled $13.14m.
BB1 said during the quarter it made significant progress towards launch of its upcoming US FDA registration study for its smartphone-based AI app to aid in diagnosing autism, which is on-track to start before the calendar year end.
The digital healthcare company leverages smartphones, computer vision, AI and machine learning to diagnose neurodevelopmental conditions – including ADHD and autism.
BB1 said after a competitive selection process it was in the final stages of appointing a world-recognised CRO, with a track record of obtaining regulatory approvals for digital healthcare and medical devices, to co-ordinate its upcoming FDA registration trial.
Throughout the quarter, BB1 continued work on finalising the trial protocol, engaging with FDA as well as reaching out and interacting with future US based clinical sites.
During the past quarter the company announced two major clinical and future commercialisation partnerships with large European mental healthcare providers.
Together with Mental Care Group and INTER-PSY, BB1 has launched companion clinical studies in ADHD and autism, evaluating whether its technology can enhance diagnostic accuracy and efficiency in clinical settings.
BB1 said there was future commitment to commercialise the products with these partners in Europe upon successful outcomes.
Under the EU Medical Device Regulation (MDR) 2017/745, the diagnostic platform is classified as a class lla medical device and requires CE marking of conformity before it can be launched on the market. BB1 said conformity work had started.
In partnership with several research institutions, BB1 said it was currently conducting studies in autism, ADHD, frontotemporal Dementia, Alzheimer’s, Functional Neurological Disorders, and Spinocerebellar Ataxia with results expected next calendar year.
BB1’s cash balance was $5.41m at September 30.
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Health & Biotech
Health & Biotech
Health & Biotech
