Health Check: Control Bionics’ tie-up with Apple looks a crunchy bite 

• Control Bionics’ assistive communication tools are now compatible with Apple devices, opening up myriad opportunities
• Nyrada plans a phase IIa cardioprotection trial
• Clinuvel scores a (grudging) broker upgrade

Control Bionics (ASX:CBL) CEO Jeremy Steele admits the minutiae of the company’s newly minted tie-up with Apple defies easy explanation.

But investors are well aware of the potential, having pushed Control Bionics shares up as much as 90% yesterday.

A developer of augmentative and alternative communication (AAC) technology, Control Bionics helps people with disabilities to communicate when otherwise they would not be able to do so.

Its flagship product Neuronode is a small, round wearable sensor, enabling  users to control devices via physiological signals from the nervous system.

This could be a thought, or a minute level of muscular activation.

Apple, meanwhile, has developed its new Brain-Computer Interface (BCI) Human Interface Device (HID) protocol.

Similarly, this enables users to control Apple devices using only their thoughts.

The compact means that Neuronode now meshes more easily with Apple devices.

“This allows us to integrate seamlessly with the Apple environment and display the quality and strength of that signal and use it to control technology,” Steele says.

The Apple protocol should reduce reducing common “pain points”,  such as configuring scanning times and modes.

“This advancement eliminates barriers to setup for users and caregivers, reducing the need to configure settings and enabling a genuine plug-and-play experience for Neuronode users,” the company says.

“In effect, users experience reactions that are more immediate and intuitive.”

‘Reputation by association’

For some time, Apple has “referenced” Control Bionics’ tech as being able to be used with Apple’s  disability features.

“But this is another step forward,” Steele says.

“Giving us early access to this protocol means we can bring this product to market with an Apple-endorsed agreement behind it.”

Steele says the share price jump partly reflects the “reputation by association” of Apple officially recognising Control Bionics’ tech.

“The bigger thing is this will create a new wave of opportunity,” he says.

“I can’t imagine where this will go.”

The tie-up does not involve any exchange of monetary value.

But as with Apple’s app model, the tech giant will clip the ticket on uses that evolve from the platform.

Steele says third parties are looking at “innovative things” in non-disability sectors including gaming and sports.

“They [Apple] are excited about the opportunities it will create for their products, not just for accessibility but beyond that.”

Steele is aware of only two other AAC companies with access to the Apple protocol:  the private and much bigger Synchron and Cognixion.

But Control Bionics is the only one with an approved product.

“This is a commercially released use of Apple’s BCI protocol that doesn’t exist anywhere else,” Steele says.

Control Bionics shares took a well-earned rest this morning, down 18%.

Filthy bourgeoisie latches on to Nyrada’s potential

Nyrada (ASX:NYR) chairman John Moore draws on the unlikely inspiration of Vladimir Lenin to describe the cardioprotection drug developer’s progress this year.

“There are years where nothing happens, and there are months where decades happen,” he told the company’s AGM today.

“For Nyrada, the past 18 months have felt like many decades have happened.”

Moore was referring to the company’s completed phase I safety study of its lead candidate Xolatryp, a first-in-class therapy targeting transient receptor potential canonical channels.

That’s TRPC, or ‘tripsy’ to friends.

TRPCs are ion channels that regulate calcium levels following trauma.

Nyrada targets myocardial ischemia reperfusion injury.

This is a common effect of blood flow being restored after coronary PCI (angioplasty) procedures.

The company is seeking regulatory clearance for a local phase IIa study, with a view to treating the first patients in March next year.

Nyrada CEO James Bonnar told Stockhead the company would seek to recruit up to 200 patients, initially with six sites (increasing to ten).

The study duration is expected to be nine to 18 months.

“It is primarily powered for safety, but we are going to look at a basket of secondary endpoints,” he says.

These include infarct (tissue loss) size as measured by MRI and “functional outcomes” such as left ventricle ejection fraction (heart blood flow strength) and the incidence of arrythmias.

“Beyond our focus on cardioprotection, we continue to explore the broader therapeutic potential of TRPC inhibition,” Moore told holders.

“Emerging research suggests opportunities in autoimmune, pulmonary and  oncological  diseases.”

Displeasingly for Vladimir, the capitalists have responded to Nyrada’s progress by pushing up the shares more than 720% year to date.

The bourgeoise is on notice, but the revolution can wait.

“Polarising” Clinuvel wins an upgrade

Broker Morgans has upgraded the “polarising” skin drug developer Clinuvel Pharmaceuticals (ASX:CUV) from a ‘hold’ to a ‘speculative buy’, but we’re not exactly feeling the good vibes.

In a note dubbed ‘cheap but not entirely cheerful’, the firm notes that management proffered upbeat in its commentary at its October 17 AGM.

But it “underwhelmed in [not] positively steering investors to several upcoming catalysts”.

The company also copped its third executive ‘strike’ against the remuneration report vote, with 63% of casting holders objecting (the threshold for rejection is 25%).

The firm reckons sentiment towards the stock is “bottom of the barrel”, the result of concerns about strategy and competitive threats.

Somewhat perversely, the profitable Clinuvel has been under fire for holding allegedly excessive cash reserves – $224 million as of the end of June – with no debt.

The company has defended its ultra-prudent balance sheet as the right approach in an uncertain world. “We see it as part of our strategic arsenal,” CEO Philippe Wolgen told the AGM.

But the cash accounts for close to half of the company’s $555 million market cap and many investors would like the lazy capital to get off the banana lounge.

Morgans says: “In our view, investors should have the opportunity to support major initiatives – including mergers and acquisitions or outsized research and development – through transparent funding mechanisms such as placements or entitlement offers”.

This is in preference to “seeing nearly half of the company’s value tied up in low-yielding cash”.

Clinuvel has an approved, revenue generating drug called Scenesse, for a rare skin intolerance disorder.

The company has another program for the much more common vitiligo and also has a commercialised sideline in photocosmaceuticals.

Morgans values Clinuvel at $14 a share, implying around 25% of upside.