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Having wrapped up the acquisition of Access Managed Services, Respiri (RSH: $0.03) has quickly moved to securing new initial patient monitoring contracts.
A robust 1H23 in recorded clinical trial sales amounting to US$27.3M was followed by a reduction of approximately 75% in 2H23, with sales totalling just US$6.7M. This marks a decline in overall clinical trial sales of 59% from the record reported in FY22 of US$82.5 million.
Imugene (IMU: $0.065) has announced it will acquire its fourth technology platform in cancer immunotherapy. The company is in-licensing an allogeneic CAR-T program, called Azer-Cel, from US company Precision Biosciences.
For FY2023, Clinuvel Pharmaceuticals (CUV: $18.15) achieved total revenues of $83 million, which was up 24% on the previous year. The net profit for the year increased by 47% to $30.6 million. The company finished the year with $157 million in cash.
Keynote address
Dr. Yuman Fong is a surgical oncologist at the City of Hope Medical Centre and was Keynote Speaker at this year's Bioshares Biotech Summit. As a clinician and scientist, while Dr. Fong's "day job" is surgery, he also works as an immuno-oncology researcher with his work partnered with Imugene (IMU: $0.089). Dr. Fong also has industry facing experience, having held regulatory roles in the approval process for immunotherapies and experience working with Genentech.
Pharmaxis (PXS: $0.05) has released interim results from its Phase II study with PXS-5505 in patients with myelofibrosis. Results from the first 10 patients who completed six months of treatment are now available.
Respiri (RSH: $0.034) CEO Marjan Mikel said that for 40 years the healthcare system has been seeking to reduce healthcare costs by moving patients out from expensive treatment settings into cheaper areas such as GP clinics or treatment in the home. However, the same narrative remains unchanged and largely unsuccessful, something Respiri is seeking to change.
Dimerix (DXB) CEO Nina Webster had encouraging news to share regarding the status of DXB's ACTION3 trial at the 17th annual Bioshares Biotech Summit. The pivotal Phase III trial is a randomised, double-blind, placebo-controlled trial of the efficacy and safety of DMX-200 for the treatment of Focal Segmental Glomerulosclerosis (FSGS), a rare form of kidney disease.
Neuren Pharmaceuticals (NEU: $14.20) announced this week a significant expansion of its partnership with US biopharmaceutical company Acadia Pharmaceuticals (NASDAQ: ACAD). The agreement not only sees Acadia's exclusive licence for trofinetide in North America expand to a worldwide licence, but also Acadia's acquisition of the exclusive worldwide licence for NNZ-2591 in Rett Syndrome and Fragile X Syndrome.
Pharmaxis (PXS: $0.048) recently wrapped up its PXS-6302 Solaria 2 Trial, showing "encouraging" results. The double-blind placebo-controlled study followed 42 adult patients with an established scar (>1 year old) for three months. Patients were treated with PXS-6302 with the collagen content of scarred skin assessed using biopsy. Patient and Observer Scar Assessment Scale (POSAS) measurements were also taken for both experimental and control groups before and after the course of treatment.
EBR Systems (EBR: $1.12) is developing the world's first wireless pacing system for the left ventricle of the heart. The company recently announced positive clinical results from its pivotal US study which opens the path for FDA registration of the device.
The FDA has removed a clinical hold on Immuron's (IMC: $0.08) study for a new therapeutic to prevent infectious diarrhea, caused by two bacteria, E. coli and Campylobacter.
The results from EBR Systems'(EBR: $0.905) pivotal study will be presented at the Heart Rhythm 2023 meeting this weekend. EBR is holding a webinar this Monday morning to discuss the results.
Dimerix (DXB: $0.072) is seeking to raise $12 million at $0.08 per share. Confirming the difficult capital markets, the raise will include a rights issue and also convertible note financing.
Chimeric Therapeutics (CHM: $0.039) has announced a capital raise for up to $6.3 million, which comprises of a $1.04 million placement to board and management and a $5.25 million SPP.
Anteris Technologies (AVR: $23.00) finished the March quarter with $32 million in cash following a $35 million capital raise in the quarter at $24 per share. The company's net cash outflow for the last three quarters from operational and investment activities was $14.5 million.
Eli Lilly has achieved unequivocally positive efficacy outcomes from its Phase III study with the drug candidate donanemab for the treatment of early stage Alzheimer's disease. It's the second positive late stage study result in the last year, with Eisai & Co achieving similarly positive results with its drug Leqembi (lecanemab).
Pharmaxis (PXS: $0.061) CEO Gary Phillips said the company is approaching a point when it is about to realise the benefits from the investment that has been made in its clinical programs, with the results from two clinical trials forthcoming. Phillips said it has taken several years to get to this point.
Immuron's (IMC: $0.078) business was severely impacted by the pandemic, with its lead product, Travelan, sold to prevent traveller's diarrhea. Sales fell from $2.7 million in FY2020 to just $166,000 in FY2021.
Imugene (IMU: $0.15) has in-licensed three core technologies. The first and the one on which the company was founded was HER-Vaxx (2013). This technology stimulates the body to develop antibodies against HER2, which is present on breast and gastric tumours in specific patients (who are HER2 positive).
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