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December 19th, 2022

Lecanemab Data Presented; Positive News for Cogstate

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.

December 18th, 2022

Anteris Technologies to Progress Heart Valve to Early Feasibility Study

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.

November 24th, 2022

Patrys AGM Highlights

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

November 4th, 2022

Imricor Medical Systems to Focus on Dedicated MRI Labs

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.

November 4th, 2022

Pharmaxis Releases Initial Data in Myelofibrosis

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.

November 4th, 2022

Aroa Biosurgery - Revenue Up 44%

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.

November 4th, 2022

Cogstate Signs US$17.9 Million of Contracts in September Quarter

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.

October 18th, 2022

Dimerix – Recruitment Accelerating in Phase III Study

Dimerix (DXB: $0.165) has reached around 40% recruitment into the first part of its Phase III focal segmental glomerulosclerosis (FSGS) study (as of mid September). The global study is seeking to recruit 286 patients for final analysis across 70 sites. The interim readout will be on 72 patients measuring proteinurea after 35 weeks of treatment.

October 18th, 2022

Antisense Therapeutics Revises Clinical Program in DMD

With a deterioration in capital markets, Antisense Therapeutics (ANP: $0.86) has adjusted its clinical program in Duchenne's Muscular Dystrophy with its lead drug candidate ATL1102. The company had previously intended to conduct a potentially pivotal Phase IIb/III study in 114 patients. That has now been changed to a Phase IIb program that will seek to enroll 45 subjects.

October 5th, 2022

Pharmaxis - Encouraging Early Data from Scar Removal Study

Pharmaxis (PXS: $0.081) has released some data on the first eight patients treated with its drug candidate, PXS-6302, to remove existing scars. The first eight patients were all treated with PXS-6302 whilst the next 42 being recruited are blinded between placebo or active arms.

October 5th, 2022

Anteris Technologies - Aortic Valve Outperforms Surgical and TAVR Competitors

Aortic heart valve company Anteris Technologies (AVR: $23.10) had multiple presentations at the major US conference TCT (Transcatheter Cardiovascular Therapeutics) held in Boston last month. The event has around 11,000 specialists in the field attending and was founded by Dr Martin Leon, who has joined the Anteris Medical Advisory Board earlier this year.

October 5th, 2022

Eisai Delivers Positive Phase III Alzheimer's Data

Cogstate's (CGS: $2.09) partner, Eisai Co Ltd, has for the first time in this disease area, delivered unequivocally positive data for its Alzheimer's disease treatment, lecanamab.

Eisai will now seek to file the therapy for full approval with the FDA by the end of March. Eisai will use Cogstate's electronic cognitive test battery to help identify potential patients for treatment, under a US$45 million deal signed in 2020 between the two companies.

September 19th, 2022

Pharmaxis: Can PXS-6302 'Un-scar the Scar'?

Pharmaxis (PXS: $0.084) is using its lysyl oxidase platform to develop a topical application for the removal of scars. Results are due around year's end and may be a driver for this stock over coming months.

September 19th, 2022

ResApp Health Sold to Pfizer for $180 Million

ResApp Heath has been acquired by Pfizer at a fully diluted value of $180 million, or $0.208 per share. The company was acquired via a Scheme of Arrangement with an 82% approval based on total shares voted (75% required) and 62% of shareholders voting in favour (50% required). The Scheme was approved by the Supreme Court of NSW last week.

ResApp Diagnostics made a backdoor listing onto the ASX in 2015 through an acquisition by Narhex Life Sciences and being renamed ResApp Health. At the end of December last year the company had accumulated losses of $40.4 million with $3.4 million in cash.

September 19th, 2022

Pharmaxis: Can PXS-6302 'Un-scar the Scar'?

Pharmaxis (PXS: $0.084) is using its lysyl oxidase platform to develop a topical application for the removal of scars. Results are due around year's end and may be a driver for this stock over coming months.

Pharmaxis CEO Gary Phillips said that the company has the first-in-class and best-in-class compounds in this field. According to Phillips at an R&D day earlier this year, the reason why Pharmaxis has extended its R&D programs into scarring is because it's where the science has led the company to.

September 19th, 2022

Imugene to Raise $80 Million

Imugene (IMU: $0.22) has announced it intends to raise $80 million through a private placement that includes two specialist biotech investment funds with commitments secured. The funds to be raised will support the company's portfolio of immuno-oncology drug development assets. Imugene will have a proforma (June 30) cash balance of $175 million.

September 19th, 2022

Cogstate - Investors Await Lecanemab Phase III Data

Cogstate (CGS: $1.46) has seen its share price oscillate in recent weeks, in sync with the share prices of Eisai Co and Biogen. All three companies will be impacted by the results of the Phase III study with the Alzheimer's disease drug candidate, lecanemab, which is jointly owned by Eisai and Biogen and in clinical development by Eisai. Topline results are due at the end of this month.

September 9th, 2022

Pharmaxis Repurposes PXS-4728 for Parkinson's Disease

Since Boehringer Ingelheim returned the Pharmaxis (PXS: $0.076) drug candidate PXS-4728 in 2020, Pharmaxis has been seeking to find a new indication to trial for the compound, given the level of development work that had been carried out on the compound by Boehringer.

September 9th, 2022

Patrys Passes Final Manufacturing Tests for PAT-DX1

Patrys' (PAB: $0.024) lead drug antibody drug candidate, PAT-DX1, has passed the final manufacturing assessment meeting all of the specification requirements. This allows Patrys to move into final preclinical toxicology testing ahead of the first clinical study planned for the second half of 2023.

September 9th, 2022

Anteris Technologies to Present Key Data at TCT this Month

Anteris Technologies (AVR: $21.50) presented at the inaugural E&P Healthcare conference this week.

CEO Wayne Paterson believes that the technical risk for the company's novel aortic valve, the DurAVR 3D, has been significantly diminished, down to only 5%-10% following successful implantation into 13 patients. The remaining risk for the company relates primarily to execution.

Anteris is developing a single piece aortic valve that is implanted via catheter, rather than open-chest surgery.