Health Check: Audeara strives to be ‘the next Cochlear’ in affordable hearing collab 

•  Audeara and Ear Science Institute Australia will strive to develop a more affordable bone-conduction hearing device
• Auditor voices “substantial doubt” over Universal Biosensors’ viability
• Freeze a jolly good fellow: Brent Owens take over at cryopreserver Vitrafy

Do we hear the next Cochlear (ASX:COH)?

Hearing tech group Audeara has entered a project agreement with Ear Science Institute Australia (ESIA). This is to develop bone-conduction hearing tools for Australian high-need communities.

ESIA contributes $100,000 and its considerable expertise.

Bone conduction involves transmitting vibrations through the skull. This bypasses the eardrum and allows users to hear ambient sounds alongside audio.

One target market is children who need help to hear in class, especially in regional areas.

The WA-based ESIA has extensive experience in remote parts of the state – especially in indigenous communities – while remote teachers already use Audeara’s headphones and buds.

“It’s about finding a solution that can be delivered at scale, to enable access in cases where people don’t have it,” Audeara CEO Dr James Fielding says.

“Also, if we can find a way that is a bit more consumer friendly then more people will use it.”

He says the problem is not necessarily hearing loss: the kids might have fluctuating hearing, speech processing disorder or an autism spectrum condition.

“It’s really looking at how we can give kids the best chance of getting the information so they can learn from it.”

The parties expect the project to kick off next month.

Cochlear’s Baha devices – as in bone-anchored hearing aid – cost around $10,000 locally.

Strictly speaking, the $4 million market cap Audeara doesn’t plan to challenge the $20 billion Cochlear any time soon.

“But if we can be the next super partner of Cochlear that would appeal to me greatly,” Fielding says.

Universal Biosensors is on the ropes

Universal Biosensors (ASX:UBI) is fighting for its life.

The company today reported half-year revenue of $2.2 million, down 11% and a $10.4 million loss compared with $7.23 million previously.

(By dint of history, Universal is US domiciled and thus reports to the Securities and Exchange Commission.)

Universal’s June quarter deficit came in at $6.6 million, compared with a $3.72 million loss previously.

The unflattering numbers prompted a stern “substantial doubt” warning from auditor Price Waterhouse, which questions whether the company can continue as a going concern.

“The company has experienced recurring losses since its inception and has not generated any significant revenues,” says the notes to the accounts.

“The company has not generated significant revenues resulting in the net cash outflows and accumulated losses to date.”

The board forecasts “further cash outflows while growing the business over the coming period”.

Over time, Universal has accrued $113.6 million of losses.

Management plans to fund the business by “growing revenue, pursuing joint venture or partnerships for its product portfolio, [selling] assets and raising cash through debt funding”.

Related party loan to the rescue?

On July 2, Universal signed a non-binding term sheet for a loan facility of up to $8.5 million, with substantial shareholder Viburnum Funds Pty Ltd.

(Viburnum’s Criag Coleman resigned from the board to avoid a conflict of interest.)

The company said it also planned an equity raising.

Subject to approval at a shareholder meeting on August 29, the 18-month facility has a 15% interest rate plus royalties.

The facility is due to be finalised this Friday.

Parlous financial state aside, Universal has applied its proprietary electro-chemical sensors in interesting ways.

During the half, Universal derived most of its revenue from anti-coagulation human testing (Xprecia Prime) and a winery quality control tool (Sentia).

The company has also developed a water pipe impurity sensor (Aquascout) and glucose monitoring for dogs and cats (Petrackr).

Management says while no binding capital measures are in place, the company “has successfully raised new equity capital in the past.”

A change at the top no-one thaw coming  

A mere six months after the cryopreservation group’s ASX listing, Vitrafy Life Sciences (ASX:VFY) CEO Kate Munnings will step down in favour of co-founder and deputy CEO Brent Owens.

The former head of IVF provider Virtus Health, Munnings remains on the board.

The company says its next stage would benefit from a “leader with a deep knowledge of Vitrafy’s cryopreservation technology, as well as the biotech sector”.

As joint founder – and 2014 Masterchef winner to boot – we guess Owens ticks those boxes.

Vitrafy is developing its cryopreservation hardware and Lifechain cloud-based management platform. This is for applications including cell and gene therapies, aquaculture (salmon breeding) and bovine reproduction.

Vitrafy’s US efforts centre on a collaboration with the US Army Institute of Surgical Research, which carried out a successful phase I study on blood platelet preservation.

The project aims to improve the shelf-life of emergency blood platelets on the battlefield.

More FDA turmoil …

The turmoil at the US Food & Drug Administration (FDA) again has hit the headlines, with revelations of last-minute meddling in a drug-approval decision.

On July 22, shares in the Nasdaq-listed Replimune group tumbled 77% after the agency issued a Complete Response Letter.

This pertained to the company’s proposed melanoma drug RP1.

In effect, the FDA rejected the approval application in the late stages of the review process.

According to the biotech newsletter Stat, internal FDA reviewers supported the therapy before a senior official stepped in.

It’s suggested that Replimune was caught in the crossfire of leadership changes, staff upheaval and internal dysfunction.

The official was not biologics head Vinay Prasad. The Trump appointee last month was sent packing amid a shambolic episode involving the withdrawal and then reinstatement of Sarepta’s Duchenne muscular dystrophy drug, Elevidys.

America being America, both Replimune and Sarepta already are subject to shareholder class actions.

… but Immutep’s not complaining

But our very own Immutep (ASX:IMM) has no complaints about the FDA’s deportment.

The oncology dug developer today said the agency delivered positive feedback on the company’s proposed development of its first line treatment of recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).

Based on Immutep’s clinical trial Tacti-003, the FDA concurs the company’s drug candidate Efti should be evaluated in combo with the checkpoint inhibitor Keytruda.

This paves way for a placebo-controlled registration trial, or a smaller single-arm study of 70 to 90 patients.

Immutep chief Marc Voigt says the FDA’s feedback highlights the unmet needs of the targeted group of HNSCC patients, who express low levels of the biomarker PD-L1.

In the meantime, Immutep remains laser focused on its pivotal phase III lung cancer trial, Tacti-004.