It’s quarterly season again as the ASX market announcements page becomes increasingly inundated with updates.

Here, we round up report highlights from three standout stocks in the ASX healthcare sector.

• DXB opens additional sites for its ACTION 3 phase 3 clinical trial in focal segmental glomerulosclerosis during the quarter
• The National Register of Rare Kidney Diseases is committed to improving recruitment to ACTION3 trials in the UK
• The first clinical site specialized in pediatric kidney disease activated for the ACTION3 study

DXB continued to make significant progress with its Phase 3 ACTION3 clinical trial in focal segmental glomerulosclerosis (FSGS) during the quarter, opening several additional clinical sites globally.

The ACTION3 trial of DXB’s lead drug candidate DMX-200 in FSGS was currently recruiting in 17 of the 19 planned countries. DXB said recruitment remained on track, with an interim blinded analysis of the first 144 patients currently expected in mid-CY25.

In September DXB announced The National Rare Kidney Disease Register (RaDaR) has been engaged to improve recruitment to the ACTION3 trials in the UK.

The company also announced in September that the first clinical site specialized in pediatric kidney diseases has been activated for its ACTION3 process.

To support the ACTION3 trial moving to pediatric patients, pediatric nephrologist Dr. Howard Trachtman, has been appointed to the DXB Medical Advisory Board.

DXB announced after the end of the quarter Expert nephrologist and co-chair of the PARASOL global medical collaboration working group, Dr. Laura Mariani was also appointed to its medical advisory board.

During the quarter, the first patients were enrolled in the Open Label Extension study for DMX-200 following the completion of the Phase 3 ACTION3 clinical trial.

The OLE trial allowed patients who successfully completed the Phase 3 ACTION3 clinical trial to start or optionally continue two years of DMX-200 treatment in an open-label (unblinded) setting.

Net operating cash flow for the September quarter was $4.08 million. The Company received an upfront payment of $530,000 from Taiba and ~$1.16 million in connection with the exercise of listed options.

Taiba acquired the exclusive rights to register and market 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 partnership interest for the DMX-200

DXB had a cash position of $19.2 million as of September 30, with a FY24 R&D tax incentive reduction of $7.9 million anticipated in Q4 CY24.

• Final Protocol for Paradigm’s Phase 3 Study of iPPS/Zilosul for the Treatment of Knee OA Submitted to FDA
• Global CRO selection nearing completion, further preparing for phase 3 enrollment in early 2025
• Net outflows of $4.72 million were below guidance of $7 million, and cash outflows for Q2 are also forecast to be below $7 million

PAR has 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 the treatment of diseases such as OA and Mucopolysaccharidosis (MPS) in inflammation. plays a major pathogenic role.

In September, PAR received a response from the FDA that provided guidance on the progress of the Phase 3 OA program, allowing the company to refine and finalize the trial protocol.

The updated protocol was submitted to the FDA in October and PAR expects the review period to be completed by 29 November, allowing pre-screening and enrollment activities to commence at up to 10 Australian study sites in Q1 2025.

PAR said a global clinical research organization (CRO) selection is nearing completion, further preparing for Phase 3 enrollment in early 2025.

MD Paul Rennies said the 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 TGA’s anticipatory response and our ongoing engagement with our funding partners, positions us strongly as we move into this pivotal phase,” he said.

Research and development expenses for Q1 were $3.79 million, down from $7.2 million in the prior quarter. Exits of $4.72 million were estimated by $7 million.

Major expense areas for the quarter included regulatory costs associated with key submissions to the US FDA with normalized accounts payable at the end of the quarter.

PAR is finalizing its R&D incentive reduction and expects an activity reimbursement of between $5 million and $6 million, which will provide additional support for ongoing R&D activities.

The company expects Q2 FY25 cash flow to be below $7 million, similar to Q1 guidance, which it said is aligned with strategic fiscal management practices, ensuring resources are allocated to critical costs related to the OA phase 3 program and operational efficiency.

As of September 30, PAR’s cash and cash equivalents totaled $13.14 million.

• Progress on Blinklab’s FDA registration study, which is on track to begin this calendar year
• Strategic partnerships signed with outpatient mental health providers in Europe for autism and ADHD
• Regulatory work has begun to obtain ISO/CE mark certifications in Europe to support future commercial launch

BB1 said during the quarter that it has made significant progress toward launching its upcoming US FDA registration trial for its smartphone-based AI app to help diagnose autism, which is on track to begin before the end of the calendar year.

The digital healthcare company uses smartphones, computer vision, artificial intelligence and machine learning to diagnose neurodevelopmental conditions – including ADHD and autism.

BB1 said, following a competitive selection process, that it is in the final stages of appointing a globally recognized CRO with a track record of obtaining regulatory approvals for digital healthcare and medical devices to coordinate its future process of FDA registration.

Throughout the quarter, BB1 continued to work on finalizing the trial protocol, engaging with the FDA, as well as contacting and engaging with prospective US clinical sites.

During the last quarter, the company announced two major clinical and future commercial partnerships with large mental health providers in Europe.

Together with Mental Care Group and INTER-PSY, BB1 has launched companion clinical trials in ADHD and autism, evaluating whether its technology can improve diagnostic accuracy and efficiency in clinical settings.

BB1 said there is a future commitment to commercialize the products with these partners in Europe following successful results.

According to the EU Medical Device Regulation (MDR) 2017/745, the diagnostic platform is classified as a class lla medical device and requires the CE marking of conformity before it can be placed on the market. BB1 said compliance work has begun.

In partnership with several research institutions, BB1 said it is 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 $5.41 million as of September 30.

At Stockhead, we tell it like it is. Although Dimerix, Blinklab and Paradigm are Stockhead advertisers, they did not sponsor this article.

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