Health Check: The numbers are in on a crucial election result … and then

• The ginger group seeking change on the Genetic Signatures board partly succeeds in its quest
• With the quarterly report deadline looming, a flood of biotechs have aired their wares 
• Neurizon targets mid-2027 for ALS trial topline readout

Psephologists today are absorbing the ramifications of a crucial election that resulted in a tight and indecisive outcome.

Oh – and then there was the Israeli poll that has left no party with the ability to govern in its own right.

We’re referring to Genetic Signatures’ (ASX:GSS) extraordinary general meeting today, which saw the election of former CEO John Melki to the board.

Melki’s nomination was backed by BCAL Diagnostics (ASX:BDX), which wants to thwart the proposed merger of Genetic with Microba Life Sciences (ASX:MAP).

Melki was duly elected on a circa 60-40% margin.

However, the other proposals from the BCAL camp failed convincingly.

They were resolutions to remove chairman Michael Aicher and director Jenny Harry and appoint a new director, Susan Forrester.

Through gritted teeth, Genetic said: “the board welcomes Mr Melki and looks forward to working with him as the company continues to focus on delivering value for shareholders.”

We guess that means Genetic now has one more director, but we’re sure they can ‘shove up’ around the board table and share the bikkies equally.

Genetic shareholders now vote on the merger scheme of arrangement, at the company’s November 16 AGM.

Given BCAL’s potential blocking stake, more drama looms than in the next fragmented Knesset.

Quarter-time scores

With the end-of-month deadline for quarterly reports looming, biotech finance departments have been busier than the Israeli election officials deciding who will run the joint.

Dozens of life sciences companies today aired their numbers or – more importantly – their summary of what they achieved during the stanza.

In some cases, progress has been as painfully slow as trying to run a democracy in the Middle East.

But that’s the nature of drug and device development: everything takes about 10 times as long as investors would like.

Cold calling on the US

Cryopreservation play Vitrafy Life Sciences (ASX:VFY) highlights its US activities, as evidenced by CEO Brent Owens relocating there as of November 1.

On a base salary of US$535,000 ($760,000) and long-term target incentive of 150%, just sayin’.

Vitrafy said its Guardion device had coverage of 175 of the country’s civilian blood collection centres.

These account for 179 fixed-point sites, collecting 2.4 million units annually.

The company focuses on red blood cell and platelet products.

Guardion devices enable more efficient freezing and thawing and obviate the need to ‘wash’ the samples .

On September 30, Vitrafy announced its third US civilian blood partnership, with Versiti Blood Health.

Vitrafy will initially place two Guardion devices at Versiti’s Blood Research Institute in Milwaukee.

The Versiti partnership builds upon the previously-announced partnerships with Vitalant and Hoxworth Blood Center.

Vitrafy’s tech removes heat from a sample “in a controlled and consistent way at various temperatures and speeds”.

Freezing and thawing take minutes, rather than hours, thus reducing the risk of the specimens degrading.

In the US, the company says, 20% of blood platelet samples need to be thrown out because of inadequate cryopreservation, costing the health sector US$280 million annually.

While US authorities have not yet approved Guardion, the company has built nine devices at its Ballarat nerve centre, with six more scheduled in the coming half.

Vitrafy reported customer receipts of $100,000 and net operating cash outflows of $4.9m. The company had end-of-quarter cash of $38.3m.

LTR Pharma’s early sales hold up

While LTR Pharma (ASX:LTP) is focused on the US rollout of its erectile dysfunction (ED) aid Roxus, the company also highlights the cadence of local sales under the special access and authorised prescriber schemes.

Last week the company said it had sold more than 2000 bottles of Spontan – essentially the same as Roxus – under the local pathways that apply to unapproved therapies.

Spontan/Roxus are faster-acting nasal spray versions of the common ED tablets.

“More than 120 clinicians had prescribed Spontan on more than one occasion, with dispensing across all six Australian states and the Australian Capital Territory.”

Great to see the pollies can stand up for something worthwhile.

“Prescribing has been concentrated in men with moderate or difficult-to-treat erectile dysfunction, including those with an inadequate response [tablets such as Viagra] following prostate cancer surgery.”

Following encouraging early trials and ‘real world’ evidence, the company plans a phase III trial.

Meanwhile, the company this month received its first US prescription for Roxus, which is being sold via a similar special access scheme.

LTR reported quarterly receipts of $366,000, consisting of $70,000 from Spontan and $296,000 from supplying Roxus raw materials in the US.

The company had cash outflows of $1.6m, leaving an $18.2m cash balance.

Clever Culture plates up Big Pharma patronage

Clever Culture Systems (ASX:CC5) reports three more sales of its APAS Independence automated agar plate monitoring units.

The devices are relevant for large drug-making facilities that require strictly sterile conditions.

Clever Culture said existing customers Novo Nordisk and Astra Zeneca acquired the units. The company expects another top 20 Big Pharma company to start a paid APAS evaluation.

This would take the number of top 20 customers to nine.

Two other existing clients should “progress to a purchase, as they finalise their evaluations.”

All up, Clever Culture expects to sell eight units in the current half, at around $500,000 a pop. This matches the tally for the entire 2025-26 year.

While Clever Culture has chased the biggest drug makers with multiple facilities, the company this month inked a partnership with US pharma supplier PSC Biotech.

The lead generation deal will enhance Clever Culture’s ability to tap into the mid-market without needing an army of salespeople.

Amplia girds for pivotal pancreatic cancer study

The developer of a potential pancreatic cancer drug, Amplia (ASX:ATX) says one patient remains on its Accent trial after 19 months.

Two more have completed 24 months and continue treatment under a compassionate access scheme.

Dubbed Accent, the 64-patient trial appraised Amplia’s focal adhesion kinase inhibitor candidate, narmafotinib (AMP-945).

Presented to a recent US cancer research powwow, the results included an “unprecedented” complete response of 7.8% (a.k.a: a cure). This compared to only 0.2% for chemo alone.

The overall response rate was 36%, or 42% including unconfirmed responses.

Amplia is in late-stage planning for a registrational trial, combining narmafotinib with chemo across two to three dosing levels.

Three Australian sites have commenced start-up activities, with ethics approval “imminent”.

The company will use the data to select a dosage for the Big Kahuna trial.

It plans to meet with the US Food and Drug Administration (FDA) in the first half of 2027, to agree on the final design.

Amplia also has entered a collab with Eli Lilly, the world’s biggest pharma company, to explore combining narmafotinib with Lilly’s kRAS inhibitor.

Combating the mutant protein kRASes is a hot cancer research area.

Amplia reckons combining narmafotinib could make them more effective. The parties are tackling non-small cell lung cancer as a first port of call.

Neurizon promises topline trial peek next year

Still on drug development, Neurizon Therapeutics (ASX:NUZ) says strong enrolment in a pivotal motor neurone disease (MND) trial means it can bring forward the timing of a topline readout to the June quarter of 2027.

The company has enrolled all 250 participants in regimen one of the phase II/III study, for amyotrophic lateral sclerosis, ALS, the most common form of MND.

The study is part of a collective US platform called Healey, which road tests several ALS drug candidates.

Neurizon reports that Healey activated 78 clinical sites, resulting in faster-than-expected enrollment.

Late in the quarter, the company had a chat with the FDA, with the agency opining that Healey could serve as a single registrational study for Neurizon’s candidate NUZ-001.

Neurizon reported September quarter operating outflows of $7.9m and as of September end, the company had cash of $11.4m.

“Neurizon remains fully funded through the Healey topline readout and completion of the study.”

Neurizon has taken out a $17.5m research and development financing facility with Dare Capital and drew down an $8.3m tranche in August.

An increasingly common form of non-dilutive short-term funding, these facilities are a forward payment of expected R&D tax rebates.

 At Stockhead we tell it as it is. While Clever Culture, LTR Pharma and Neurizon are Stockhead advertisers, the companies did not sponsor this article.

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