ASX Quarterly Health Wrap: Which companies are making progress in clinical trials?

It’s the quarterly season again as the ASX market announcements page becomes increasingly flooded with update lodgements.

To save you the trouble of trudging through it all, we’ve wrapped up highlights from some of the reports in the ASX health sector that caught our eye.

Optiscan (ASX:OIL)

Highlights:

Optiscan says its research and development projects continued to progress during March quarter
Second clinical device for intraoperative surgical use is nearing completion and planned for breast cancer surgery
Established a US Regional Office in Rochester Minnesota aimed to position Optiscan at the centre of the US medtech hub

OIL says during the March quarter it progressed well with its research and development projects outlined during its $16.7 million capital raise announced in July 2023.

The company’s second clinical device designed for intraoperative surgical use is nearing completion, which includes a new user interface and probes customised for open surgical applications.

This device is planned for use in open breast cancer surgery in the first instance, while the company explores other viable surgical use cases with potential clinical partners.

During the quarter, OIL says work progressed at an accelerated pace on developing its third clinical device designed specifically for diagnostic pathology use, as a digital replacement to the frozen section, opening up yet another use case for the company’s platform technology. Delivery of this device is expected in Q4 FY24.

OIL has also started development of its second generation Edge–AI–enabled flexible confocal endomicroscope for gastroenterology that can fit the biopsy channels of commonly used colonoscopes.

A successful CRC-P grant application will result in a $3m contribution from the Federal Government over the next three years to accelerate development of this product.

In addition to significant advancements in hardware development, OIL has progressed with its cloud-based telepathology platform with its beta phase progressing to schedule.

The company says real-time image streaming to the cloud, and storage, have been demonstrated by its partner Prolucid Technologies. OIL engineers have started work on updating its InVivage software to interface with the web portal.

OIL says the updated InVivage received safety certification in January 2024, and is ready for deployment in clinical trials awaiting advice from the US FDA on the most appropriate path to regulatory approval.

After the quarter end OIL announced due to complexity of the FDA regulatory pathway required for its combination (device/drug) suite of products including its future software as a medical device (SaMD), the company had appointed two US-based executives.

It also recruited Melbourne-based systems and firmware engineers to support its ambitious growth plans and established a US regional office at the Minnesota BioBusiness Center, which will serve as its clinical and regulatory hub.

OIL says good progress has been made in relation to alternatives to its topical fluorescein approach for oral imaging based on feedback and advice provided by the US FDA, and is currently in talks with suitable drug manufacturers.

The company says customer orders and production are progressing on schedule with orders of ~$300k shipped during the March quarter.

OIL also received an R&D tax incentive rebate of $672k during the quarter, enabling further investment in its multi-product portfolio development.

Paradigm Biopharmaceuticals (ASX:PAR)

Highlights:

Paradigm advances its Phase 3 trial into osteoarthritis in March quarter, with crucial US FDA meeting
Company’s PARA_MPSVI_001 Phase 2 trial meets primary endpoint of safety and tolerability of iPPS
Net cash outflow for the March quarter was $6.8m, which was less than the guided $8-11m

PAR says it has made strides during the quarter in advancing its Phase 3 trial in osteoarthritis (OA). In January PAR met with US FDA discuss outstanding requirements for the next stage of the Phase 3 clinical program.

PAR says its clinical and regulatory teams have filed the response to the Type D meeting with the FDA containing updated nonclinical and clinical data to the regulatory agency as well as the proposed clinical trial protocol using 2mg/kg twice weekly for the next stage of the trial.

The company says the response package was submitted through a request for review pathway, as directed, which doesn’t have strict Prescription Drug User Fee Act (PDUFA) Agency response timelines.

PAR says its OA clinical program has FDA granted fast-track designation and the feedback through this review pathway is typically received within three months.

During the quarter, PAR reported the top-line data from its PARA_MPSVI_001 Phase 2 trial of injectable pentosan polysulfate sodium (iPPS) to treat Mucopolysarcharidosis Type VI (MPS VI).

The multi-centre randomised trial conducted in Brazil successfully met the primary endpoint of safety and tolerability of iPPS and achieved positive results in several of the secondary outcomes.

PAR says R&D expenditure for the quarter of $13.1m was significantly reduced compared to the previous quarter of $27.06m.

The company says spend in Q3 FY24 related to continued study close-out costs, clinical research organisation costs, FDA meeting fees and consultant costs for the Type D meeting and a following response to the regulatory agency.

PAR also incurred spending relating to clinical trial product manufacturing in preparation of the next stage of the Phase 3 OA program.

The March quarter saw an increase in spend on patent and IP related cost due to annual renewals and fees for PAR’s extensive patent portfolio.

Net cash outflow for the quarter was $6.8m, inclusive of a $7.3m refund from the Federal Government’s R&D Tax Incentive refund claim for FY23, which is less than the guided $8-11m.

PAR’s cash balance as of March 31, 2024 was $26.2m.

Bioxyne (ASX:BXN)

Highlights:

Breath Life Sciences TGA GMP audit successfully completed and GMP manufacturing licence granted
Manufacturing activity forecasted to grow with multiple customers intending to place standing purchase orders over next 12 months
Capital raise post Q3 FY24 raised $1.45 million through issue of 145 million new shares at 1 cent/share

BXN received revenue of $1.7m for the March quarter and says it’s on target for $10m for FY2024.

The company says its wholly owned Breathe Life Sciences (BLS) subsidiary revenue for the quarter was constrained by late product deliveries from suppliers but this has improved during Q4 FY24.

BXN says the medicinal cannabis business is the key revenue driver with demand for prescribed cannabis dried flower and oral solution remaining high in Australia.

BLS was awarded a good manufacturing practice (GMP) licence to manufacture medical cannabis-based products, following a TGA audit during the quarter, along with Australia’s first GMP licence for psilocybin active pharmaceutical ingredients and MDMA (3,4-methylenedioxy-methamphetamine).

The company’s TGA GMP licence also covers final dose form capsules for supply to authorised prescribers and approved clinical trials.

After quarter end in April, BLS was granted an upgraded and amended wholesale licence for MDMA and psilocybin (schedule 8) finished products by the TGA.

The company started manufacturing under its GMP licence in mid-March 2024 and released four white label batch manufacturing runs prior before quarter end.

Since manufacturing activities started and before the end of the quarter BLS has secured $1.4 million worth of white label manufacturing purchase orders, from customers.

The company says manufacturing activity is forecasted to grow significantly with multiple customers intending to place standing purchase orders for manufactured products over the next 12 months with an estimated value to be in excess of $4.6m.

The company says investment in inventory has increased from $995k at June 30, 2023 to $2.1 million as at March 31, 2024. Net trade working capital including inventory at 31 March 2024 was $2m with cash in hand of $750k.