ASX biotechs with big catalysts in 2024: Part 2

Avita Medical is expecting to have its RECELL Go marketing application approved by US FDA in May 2024
AI-focused medtech company Artrya expects its predicate 510(K) application to be approved in late June
Paradigm Pharmaceuticals will seek TGA provisional approval next year to market iPPS in Australia for knee osteorthritis

 

Several ASX biotech companies have catalysts in 2024 in what is shaping up to be a big year for the sector.  Here’s part 2 of our series on the ASX biotechs with upcoming catalysts in 2024.

 

Aroa Biosurgery (ASX:ARX) and Avita Medical – AVH

Soft tissue repair companies ARX and AVH are due to report key financial results early into 2024.

Morgans healthcare and life sciences expert Scott Power says ARX is expecting a strong H2 FY24 result.

Its H1 FY24 result released at the end of November was in line with expectations and importantly reconfirmed FY24 guidance, albeit with the help of a lower exchange rate.

Power says ARX’s Myriad family of products continue to be the major growth driver up 80% and accounting for 33% of product sales, which Morgans forecast this increase to 35% of sales for FY24.

“We are expecting a strong second half from Aroa and evidence of that will be available when they report their third quarter results at the end of January,” he  says.

Power says AVH will report their full FY23 results in February together with providing calendar 2023 guidance.

“We expect both will be well received by the market and we should sales grow almost 40%,” Power says.

Furthermore, he says RECELL GO, which is AVH’s introduction of an automated workflow to its manually operated RECELL, is expected to have its marketing application approved by the US FDA in May 2024.

In October announced the FDA requested additional information regarding its marketing application for its latest RECELL GO, resulting in a delay of four to six months in processing its premarket approval (PMA) supplement application for the device.

 

Artrya (ASX:AYA)

AYA CEO Mathew Regan told Stockhead the AI-focused medtech company, which works alongside clinicians to improve diagnosis of coronary heart disease and develop a holistic overview of at risk patients, has several catalysts coming up in 2024.

“For us 2024 will be a pivotal year with some key catalysts,” he says.

AYA has a predicate 510(K) application underway for its Salix Coronary Anatomy (SCA) platform with the US FDA.  SCA is a CCTA image analysis solution to enable physicians to identify and analyse the extent and type of arterial plaque.

“We are expecting at this stage a clearance from the FDA by late June,” Regan says.

He says AYA will then follow up with a de novo application for novel medical devices for its more AI-focused solutions.

In November AYA announced a partnership with Northeast Georgia Health Ventures (NGHV) to validate the SCA platform into its workflow and hospital network, while the product goes through the 510(K) clearance process.

The two companies will also develop specific use cases for AYA’s software products across the five hospitals under the network to validate the detection of coronary artery disease.

Post-FDA pre-market clearances, NGHV will work with AYA to roll out and expand its point-of-care SCA solution to clinicians and patients to help the 100,000 heart disease patients each year in the US state of Georgia.

AYA says the market opportunity in the US for its product is driven by the scale of heart disease, which kills one person every 34 seconds globally.

“We expect once we clear FDA with the help of organisations like NGHV we’ll be able to move into a revenue situation in the US within calendar year 2024,” Regan says.

He says the TGA has approved an Australian version of its Salix product which features more AI and has several pilots underway.  AYA is forecasting to move to revenue positive for the product in Australia in FY24.

“It is commercial ready now and we are hoping our pilots for the product turn into a commercial reality,” he says.

“There are other jurisdictions which we may be able to access with our Australian product as well and we also have approvals in Europe and elsewhere.

“Our key focus for 2024 will be commercialising in Australia, broadening our market access into other jurisdictions, revenues in 2024 and solidifying our FDA clearance and move to generate revenue in the US with strategic partners like Northeast Georgia.”

 

Paradigm Biopharmaceuticals (ASX:PAR)

Primarily focused on development of injectable pentosan polysulfate sodium (iPPS/Zilosul) for treatment of diseases such as osteoarthritis (OA) and Mucopolysaccharidosis (MPS) where inflammation plays a major pathogenic role PAR has several catalysts in 2024.

PAR will seek TGA provisional approval next year to market its lead drug iPPS in Australia for knee OA, providing potential significant revenues prior to the completion of its global pivotal Phase 3 study.

The provisional approval process involves PAR submitting a determination application to the regulatory body, which then has 30 days to accept if the company has acceptable data to proceed to the final stage of a full dossier submission.

The determination application is expected to occur early in Q1 2024. If the TGA grant PAR provisional approval it would be likely in 2025 following full dossier submission).

PAR will also have the US FDA review clinical trial protocol to proceed to the next stage of  its Phase 3 trial for knee OA in Q1 2024.

The company says following agreement with the FDA, it will start recruitment and enrolment of ~ 600 subjects needed for the final stage of the trial.

PAR currently has 120 clinical trial sites across seven countries on standby to recommence enrolment of subjects and expects the first subject in the next stage of its phase 3, to be randomised in Q2 2024.

And after open and active discussions with commercial partners to license iPPS for either OA or MPS in 2023 PAR is expecting to conclude one or more regional licensing deals in H1 2024, which the company says would be a significant catalyst for the share price and commercial validation of its product and clinical program.

 

PharmAust (ASX:PAA)

Clinical-stage biotech PAA has several catalysts coming up in 2024.  The company recently announced it had wrapped up the Phase 1 MEND study of the drug monepantel (MPL) in patients with motor neurone disease (MND/ALS).

PAA is due to release top line results from the study in Q1 2024 and has applied for an orphan drug designation (ODD) with the US FDA, which incentivises development of drugs or biological products to treat rare diseases by offering market exclusivity for several years and tax credits.

All patients from the Phase  1 trial have also been invited to move to a 12-month open-label trial, which the company hopes to kick off in Q1 Cy24.    The company will use data from the Phase 1 study to open an Investigational New Drug Application (IND) with the FDA to commence a Phase 2 study in H1 CY24.

Furthermore,  PAA plans to use data from its Phase 2 veterinary clinical study of MPL treatment for canine B-Cell lymphoma to file an investigational new animal drug with the US FDA, paving the way to advance into a field study in the US early next year in about 60 dogs, lasting for about 12-months.

 

The ARX, AVH, AYA,PAR & PAA share price today:

 

 

At Stockhead we tell it like it is. While Aroa Biosurgery, Paradigm Biopharmaceuticals and PharmAust are  Stockhead advertisers, they did not sponsor this article.

The views, information, or opinions expressed in the interviews in this article are solely those of the interviewees and do not represent the views of Stockhead. Stockhead does not provide, endorse or otherwise assume responsibility for any financial product advice contained in this article.

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