• Medibio jumps after completing Phase 1 clinical trial
  • Cann Group’s latest crop harvest is at a scale twice that of previous harvests
  • 4DMedical wins a $1.1 million from the Fed government


Microcap Medibio (ASX:MEB) jumped 50% this morning after announcing the completion of its Phase 1 clinical trial of Sleep Signal Analysis for Current Major Depressive Episode study (SAMDE), with promising results.

The main highlights were: an algorithm sensitivity of 71.65%, a specificity of 71.43%, a Positive Predictive Value of 35.38%, and a Negative Predictive Value of 92.11%.

These preliminary results exceeded the current standard of care used to screen for the likelihood of cMDE (current major depressive episode) in individuals referred to sleep clinics for a polysomnography assessment.

They also indicate a robust bidirectional relationship between mental illness and sleep, making sleep analysis a perfect environment for behavioral health research and development – presenting a big market opportunity for Medibio.

Medibio says the Phase 1 data – which was based on the testing of 313 subjects across 12 sleep centres in five US states – will now be used towards ongoing algorithm development and cMDE clinical validation during the first half of 2024.

Phase 2 enrolment is set to complete shortly, with data to be used for near term FDA submission.

Mediobio CEO Dr Tom Young said the preliminary results have exceeded his expectations.

“The initial indications now provide the company with a strong framework for ongoing analysis of the Phase 1 results through to the commencement of the Phase 2 trial,” said Young.

Perth-based Medibio is a mental health technology company pioneering the use of objective measures to aid in the early detection and screening of mental health conditions.


Cann’s cannabis harvest twice scale of previous ones

Cannabis stock Cann Group (ASX:CAN) announced that it has successfully completed a crop harvest at a scale twice that of previous harvests.

Cann believes this is a key step towards achieving the company’s target of reaching annualised production volumes of 12.5 tonnes at its Mildura GMP facility, and reaching EBITDA profitability by FY25.

The latest harvest involved more than 320 square metres of crop, which is twice the area of crop that had been harvested previously.

The harvest was also achieved ahead of schedule, with high quality dry flower yield, some 17% ahead of target. The crop area harvested equates to an annualised production level of 8 tonnes.

“We will continue to scale up production over coming months, reinforcing our competitive advantage and keeping us on the path to EBITDA profitability,” said CEO, Peter Koetsier.


4DX wins $1.1m grant

Devices company 4DMedical (ASX:4DX) has won a $1.1 million CTCM (Clinical Translation and Commercialisation Medtech) funding to develop perfusion capability for its XV Scanner.

The non-dilutive funding was announced by Federal Minister for Health and Aged Care, Mark Butler, MP.

Last year, 4DMedical unveiled the world’s first and only dedicated lung scanner, the XV Scanner, at the Prince of Wales Hospital in Sydney.

The XV Scanner integrates 4DMedical’s XV Technology into a purpose built platform, providing doctors and patients with unprecedented and highly visual insight into lung function.

The funding will now allow the company to broaden the capability of its XV Scanner beyond ventilation to include the measurement of blood flow (perfusion).


Cynata ups the ante

Meanwhile, Cynata Therapeutics (ASX:CYP) said that a strategic review of its clinical development portfolio has been completed, led by the recently appointed CEO Dr Kilian Kelly.

The review was designed to ensure timely progress and completion of its Cymerus mesenchymal stem cell (MSC) clinical trial programs.

Following the review, Cynata says it remains dedicated to successful execution of clinical trials, and aims to sharply focus resources on achieving recruitment targets in the new financial year.

Its Graft Versus Host Disease (GvHD) trial is progressing well, with planned Phase 2 trials in the US, Australia, and Europe.

Cynata’s osteoarthritis Phase 3 trial has seen accelerated enrolment despite initial challenges and its Diabetic Foot Ulcer (DFU) Phase 1 trial is ongoing with proactive steps to address recruitment issues.

Cynata is also working with Leiden University Medical Centre for a Phase 1 trial in Renal Transplantation, with regulatory approval anticipated soon.


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