Opthea (OPT: $0.85) is currently conducting two Phase III studies with its ophthalmic drug candidate, OPT-302, for the treatment of wet AMD. Those trials are seeking to recruit just under 2,000 people. With completion of recruitment approaching, that major milestone will trigger a countdown to the pending results a little over 12 months later, which should see considerable interest build in the stock.

Arguably the most significant event for the Australian biotech sector is approaching with a decision expected from the FDA on the approval of trofinetide, developed by Neuren Pharmaceuticals (NEU: $7.16), on 12 March.

EBR Systems (EBR: $0.60) is a relatively new biotech on the ASX, having listed in November 2021 at $1.08 per share, raising $110 million. It is developing the world's first and only wireless electronic heart pacing system for the left ventricular, called WiSE. It is being trialled with commercially available right ventricle pacers (both with leads and wireless) to offer a novel cardiac resynchronisation therapy (CRT).

Cogstate (CGS: $1.18) came close to being acquired in the recent weeks with discussions with an interested group beginning in December and negotiations ending last week.

Aortic heart valve company Anteris Technologies (AVR: $21.71) has completed a $35 million capital raise, conducted at $24 per share. Investors also received a free two-year option to buy an additional share at $29.

Aroa Biosurgery (ARX: $1.15) delivered another consistent quarter of growth. Net cash receipts were up 88% over the PCP to NZ$17 million for the quarter, and up 83% over the PCP for the last nine months to NZ$42 million.

Insecticide development company Bio-Gene Technology (BGT: $0.096) has signed a development and product access deal with Israeli group STK Bio-Ag Technologies.

Going into to 2023, Pharmaxis will have two Phase II study results to report. One is with PXS-6302 in the treatment of scars, and the second is with PXS-5505 for the treatment of myelofibrosis.

Wound healing products company Aroa Biosurgery (ARX: $1.10) is proving to be a very predictable performer, meeting or exceeding its sales forecasts.

For the first half of its 2023 financial year (ending 30 September) the company achieved a 44% growth in sales to NZ$29 million. The company is forecasting to be EBITDA neutral by the end of March next year.

Last year novel antibody company Adalta (1AD: $0.044) announced that it would be moving to develop an inhaled formulation of its lead drug candidate, AD-214. This followed preclinical studies that showed high accumulation of the compound in the liver, although no liver toxicity was observed in patients in the Phase I study.

Dimerix (DXB: $0.17) has completed recruitment of the first part of its Phase III study in the kidney disease FSGS (focal segmental glomerulosclerosis) with 72 patients. It will now move into the second part where an additional 72 patients will be treated for 35 weeks with placebo or active drug.

The Phase III trial data on the emerging Alzheimer's disease drug lecanemab has been published in the New England Journal of Medicine and was presented at the recent Alzheimer's disease conference, CTAD, held in San Francisco, by Dr Sharen Cohen. Dr Cohen was an investigator on the Phase III Eisai/Biogen Alzheimer's disease study and co-authored the paper that was published.

The data is of interest to Cogstate (CGS: $1.80) and investors as Cogstate's core business is in conducting Alzheimer's disease studies, and its blue sky is the use of its cognitive diagnostic tool, licensed by Eisai, to help identify patients should an effective drug treatment for Alzheimer's disease become available.

Anteris Technologies (AVR: $23.20) is developing an aortic heart valve, called DurAVR THV. The device is implanted via a catheter rather than through open chest surgery and has delivered some impressive results compared to other valves implanted through the same process or through surgery.

Last month the company announced that it had reached agreement with the FDA on an early feasibility study to follow on from its first feasibility study in 13 patients. The early feasibility study will recruit 15 patients who will be implanted across seven implant centres in the US. It is only expected to take a few weeks to fully recruit.

Novel antibody company Patrys (PAB: $0.021) held its AGM this week. The presentation by its CEO James Campbell is worth reading closely.

Imricor Medical Systems (IMR: $0.275) achieved consumable revenue of just US$115,000 for the quarter, down 15% on the previous corresponding period. However, it has increased the number of active sites by three to nine sites.

Pharmaxis (PXS: $0.066) has two drug candidates in clinical development, both based on its lysyl oxidase inhibition platform that seeks to reduce or stop collagen crosslinking that is crucial to the fibrosis process. The drug candidates are PXS-5505, being trialled in a Phase II study in myelofibrosis, and a second investigator-led study in liver cancer due to commence this year; as well as PXS-6302, which is being investigated as a treatment for existing and new scars. The trial in existing scars has reached the 75% recruitment mark.

Aroa Biosurgery (ARX: $0.86) continues to outperform. Revenue for its first half (ending 30 September) was up 44% on the PCP to NZ$29 million. Surprisingly it has also delivered a positive EBITDA for the half year, ahead of expectations. Aroa is forecasting to be EBITDA neutral for the full year.

Cogstate (CGS: $1.77) has achieved another very strong quarter of sales contracts totalling US$17.9 million after US$1.1 million in contract cancellations. Its net cashflow was just US$0.2 million.