Opthea (OPT: $1.25) has gained access of up to US$260 million ($371 million) to reach top-line results of two Phase III trials with its drug candidate OPT-302. The top-line results are now due in mid 2024. The funds will also be used for pre-commercialisation activities.

It's the largest capital raise for the sector (excluding raises conducted by CSL, Cochlear and ResMed), for non-asset purchases.

For the six and 12 months to 30 June this year, medical device company Anteris Technologies (AVR: $24.60) has been the best performing stock, with a share price gain of 122% over the last six months and 310% over the financial year.

Pharmaxis (PXS: $0.077) has executed a deal for the license and sale of its Orbital drug inhalation device with Aptar Pharma for US$5 million.

Neuren Pharmaceuticals (NEU: $5.45) has some very clear objectives set for the next 17 months. The most significant of these is gaining US approval of its lead drug candidate, trofinetide, which is being commercialised in North America under license from Neuren by Acadia Pharmaceuticals for the treatment of Rett syndrome in children and adults.

Acadia filed trofinetide for approval last month. The next stage is notice from the FDA that the application is in order and has been accepted (in September), which will trigger a US$10 million payment to Neuren from Acadia.

Imricor Medical Systems (IMR: $0.29) is pioneering MRI-guided cardiac ablation, rather than ablation procedures conducted using x-ray fluoroscopy imaging. It is the only company in the world that sells MRI-compatible consumable devices used for cardiac ablation.

Cardiac ablation is a minimally invasive procedure whereby electrical abnormalities in the heart, which cause abnormal heart rhythms, are corrected by heating or freezing cardiac tissue inside the heart via a catheter. The issue with using x-ray to help guide the procedures is that the heart is almost invisible to x-rays.

Wound healing products company Aroa Biosurgery (ARX: $0.86) continues to deliver consistent and strong top-line growth. Cash receipts in the June quarter were NZ$13.9 million (up 162% over the PCP). Net cash outflow was NZ$1.3 million from operations and investment in equipment, down from NZ$3.7 million in the PCP and down from NZ$6.5 million in the previous quarter.

Wound healing products company Aroa Biosurgery (ARX: $0.86) continues to deliver consistent and strong top-line growth. Cash receipts in the June quarter were NZ$13.9 million (up 162% over the PCP). Net cash outflow was NZ$1.3 million from operations and investment in equipment, down from NZ$3.7 million in the PCP and down from NZ$6.5 million in the previous quarter.

The strong performance in the June quarter included a large shipment of product to the company's distributor, TelaBio, in the March quarter. The company is maintaining its revenue guidance of NZ$51 - NZ$55 million for this financial year (which ends 31 March 2023).

Cogstate (CGS: $1.83) has delivered a stunning year result for FY2022 with sales (contracts signed) of US$82.5 million. Revenue (unaudited), which trails the signing of contracts in a growth phase, was US$45 million, up 38% to the previous corresponding period (PCP).

Patrys (PAB: $0.023) has received some delays over the last two years to making its novel antibody drug candidate, PAT-DX1. However the path to clinical studies now appears in sight with a successful manufacturing run exceeding previous product yield expectations.

Imugene (IMU: $0.225) has released final overall survival data from its Phase Ib/II HER-Vaxx study in 36 patients with advanced gastric cancer with tumours that overexpressed the HER2 receptor.

Radiopharm Theranostics (RAD: $0.16) has in-licensed an additional targeting agent from Case Western Reserve University (CWRU) in the US.

The peptide licensed targets a fragment of a receptor found only on tumour cells and not in healthy tissue, called PTPµ. The peptide has been found, in preclinical studies, to recognise not only the main tumour but also small tumour metastases.

Imricor Medical Systems (IMR: $0.115) listed on the ASX in 2019 at $0.83 per share raising $13 million. The company was formed in 2006 in the US and is pioneering cardiac ablation treated specifically through the guidance of MRI. Traditional ablation procedures are conducted using fluoroscopy and x-ray imaging.

There are multiple advantages in using MRI to help guide the procedure, most notably the better imaging quality that can be achieved compared to x-ray. This results in arguably better ablation outcomes, less repeat procedures and shorter treatment periods. Efficacy of the ablation procedures involves inserting an ablation catheter through the veins or arteries to correct irregular electrical signals in the heart. Other safety benefits for patients and surgeons come from not using x-ray images.

Antibody development company Patrys (PAB: $0.021) has announced the publication of some new and important data around its rare portfolio of compounds.

CEO of Radiopharm Theranostics (RAD: $0.185), Riccardo Canevari, believes that the next big platform in oncology, following immunotherapy and cell therapies, will be radiopharmaceuticals.

Canevari highlighted the said the approval of Lutathera (in 2018) from Novartis (where Canevari was working at the time), for the treatment of neuroendocrine tumours and the more recent approval this year of Pluvicto (also from Novartis) as key events for the sector. Lutathera achieved a stunning efficacy result in its pivotal trial achieving a hazard ratio of 0.21, meaning a 79% risk reductio of disease progression or death. For Pluvicto, reaching primary and secondary endpoints in prostate cancer was a game changer.

By 2027 the sales of biologics are predicted to surpass the aggregate sales of small molecule drugs, with US$120 billion more sales and making up 55% of all drug sales. This is a positive aspect for Patrys (PAB: $0.022), an antibody therapeutics company, according to CEO James Campbell. However, small molecule drug sales are still expected to increase by around 50% over this period driven by CNS therapy product sales.

During the pandemic, Dimerix (DXB: $0.17) was very pleased to have been able to complete two Phase II kidney disease studies. The company has now moved to a Phase III program in FSGS (kidney disease) involving 75 sites spread across 12 countries, including in the US where the company recently gained FDA approval (IND) to commence its study there as well. The first patient was treated in this study this week.

Dimerix CEO Nina Webster said that sclerotic kidney disease is a progressive three mechanism cycle that results in an acceleration of the disease as it progresses to end stage kidney failure. The drugs currently on the market all focus on the first mechanism of this disease by reducing hypertension across the bloodstream.

CAR-T therapies currently remain predominantly for use in oncology according to Chimeric Therapeutics CEO and Bioshares Biotech Summit keynote speaker Jennifer Chow.

Cancer therapies commenced largely in the 1940's with chemotherapy, which could be described as bombing the patient with broad acting drugs. This was followed by targeted therapies in the 1990's such as monoclonal antibodies. In the last decade, the major advances have been in immunotherapies, such as checkpoint therapies. These targeted therapies started to improve short-term survival, and then the immunotherapies were found to improve long-term survival.

During the pandemic, Cogstate CEO Brad O'Connor said the whole pharmaceutical industry saw the demand for remote assessments in clinical trials increase, with the company's digital cognitive assessments well set up for decentralized studies.

Cognitive assessment company Cogstate has signed US$73.6 million of new sales contracts, up 105% on the PCP. This is a record for the company.

Another nuclear imaging and therapy company, Radiopharm Theranostics (RAD: $0.245), listed on the ASX in November last year raising $50 million at $0.60 per share.

Radiopharm has four imaging studies underway withy three therapeutic trials and an additional imaging study expected to commence by year's end. At a briefing this week, CEO Riccardo Canevari said that he expected the radiopharmaceutical market to grow very fast after the recent approval of Pluvicto, with other pharmaceutical companies waiting to enter the radiopharmaceutical sector. The three major pharmaceutical companies active in this sector are Novartis, Bayer and AstraZeneca.