Tim Angeles

PharmAust (ASX:PAS) says patient recruitment at the next dosing level for its Monepantel (MPL) drug for Motor Neurone Disease (MND) has commenced, after review by the Trial Safety Committee.

PharmAust says MPL was found to be well tolerated by all MND patients and there were no reported safety issues or SAEs, and four new patients are undergoing screening.

It says MPL has the potential to reduce the rate of degeneration and loss of motor neurons in the brainstem and if successful, could receive orphan drug designation by the US FDA for MND.

PharmAust says the Phase 1/2 study is being funded by FightMND and is supported by PharmAust's subsidiary, Epichem.

Island Pharmaceuticals Limited has received feedback from the FDA on their Investigational New Drug application for their ISLA-101 Phase 2a clinical trial.

As part of the feedback, amendments to the protocol may be required and the FDA has placed the IND on Clinical Hold.

Island Pharmaceuticals is a mid-clinical stage antiviral drug development company and their lead asset is ISLA-101, a drug being repurposed for the prevention and treatment of dengue fever.

They are close to commencing a Phase 2a clinical trial in dengue-infected subjects.

Pilbara Minerals (ASX:PLS) has announced its December 2022 quarterly activities report, saying strong sales and improved pricing outcomes support an $851.1M increase in cash balance to $2.226B.

Pilbara Minerals says it produced 162,151 dry metic tonnes (dmt) of spodumene concentrate, up 10% quarter on quarter.

It also says it shipped 148,627 dmt of spodumene concentrate, up 8% quarter on quarter.

Pilbara Minerals also highlighted the average realised spodumene concentrate sales price was US$5,668/dmt on SC4.4 basis (CIF China), up 33% quarter on quarter.

The company's Board also approved pre-FID P1000 Expansion Project funding of $38.3M to maintain project schedule, with FID scheduled for the March quarter 2023.

Neurotech International (ASX: NTI) has been granted a pre-IND meeting by the US Food and Drug Administration (FDA) to discuss their chemistry/manufacture/control package, non-clinical requirements and proposed clinical developmental program for NTI164 in Autism Spectrum Disorder (ASD).

The company has conducted a Phase I/II clinical trial in ASD, which has demonstrated excellent safety and efficacy results.

It plans to commence a Phase II/III clinical trial in Q4 CY2022, and to conduct additional Phase I/II trials in PANDAS/PANS and cerebral palsy during CY2023.

NTI164 is a proprietary drug formulation derived from a unique cannabis strain with low THC and a combination of cannabinoids.

Pre-clinical studies have demonstrated anti-proliferative, anti-oxidative, anti-inflammatory and neuro-protective effects.

It is being developed as a therapeutic drug product for a range of neurological disorders in children.

Following the announcement, shares of Neurotech were up 5.97%.

Nanosonics (ASX:NAN), a leader in infection prevention solutions, has provided an update on its H1 FY23 results and outlook statements.

Preliminary results show profit before tax of approximately $11.4 million, 35% higher than the prior corresponding period.

Total revenue is expected to be approximately $81.6 million, a 27% increase in constant currency.

Operating expenses are expected to be approximately $54.5 million for the half year.

Global total installed base is expected to have grown to approximately 31,120.

Nanosonics has adjusted its targets for FY23 to total revenue growth of 36% to 41%, gross margin of 77% to 79%, and operating expenses to grow between 22% and 27%.

Further details will be released on 23 February 2023.

Following the announcement, shares of Nanosonics (ASX:NAN) were up 12.24%.

Bellevue Gold (ASX:BGL) has announced that its Mining Proposal and Mine Closure Plan for the Bellevue Gold Project have been approved by the Department of Mines, Industry Regulation and Safety under the Mining Act 1978 (WA).

Construction and underground development are on track and on budget for first gold in the second half of this calendar year.

The progress of Bellevue Plant construction includes CIL tanks advancing ahead of schedule, 1,500m3 of concrete out of 2,250m3 completed, and structural steel to commence erection before the end of January 2023.