Health Check: CSL shares tumble after recovery proves to be a false dawn

• CSL shares are having a stinker of a day after gloomy update
• Syntara says the FDA has provided a clear path for its next myelofibrosis trial
• Optiscan reports an “eventful” September quarter

Investor hopes for the dawn of a recovery at CSL (ASX:CSL) have been severely dented after this morning’s AGM, which saw management trim earnings guidance as a result of the vaccination climate in the US.

The company now projects revenue growth of 2-3%, compared with the 4-5% guided to at the company’s August 19 full-year results.

Net profit growth expectations have been trimmed to 4-7%, compared with the previously envisaged 7-10% increment.

Low US vaccination rates also mean the company has deferred plans to demerge its Seqirus vaccines division to beyond the current financial year.

While CEO Dr Paul McKenzie envisages a profit recovery in the 2026-27, this depends on improved US jab rates – an outcome that can hardly be relied on given the Trump administration’s sceptical stance on such prophylactics.

“I wish to reiterate that in the longer term, the strategic direction for both CSL and Seqirus is unchanged,” chairman Brian McNamee told the gathering.

“Separation continues to be the preferred approach to unlock simplification and focus and sustained long-term growth for each of these great businesses.

“However, our priority is to maximise shareholder value. Given the heightened volatility in the current US influenza vaccine market, we have concluded that advancing with the previously proposed demerger timing will not fully capture Seqirus’ value potential.”

CSL shares this morning tumbled up to 17% on the gloomy outlook.

In August the company outlined a multi-pronged get-fit plan including the Seqirus bifurcation, mass redundancies and a shaved research and development budget.

McNamee says the prospects for the core Behring plasma arm remain “intact” and the company has responded from challenging periods before.

“The reality is that for some time now CSL has been operating in a way that is too complex and this has impacted our ability to react decisively to geo-political headwinds and to maintain our market position,” he says.

“It is clear to the board … that changes must be made rapidly and effectively.”

It is 2b: Syntara maps out a new study

Myelofibrosis drug developer Syntara (ASX:SNT) says the FDA has given the company a “clear path” forward for the next trial of its candidate amsulostat.

“We’re now focused on finalising the design of the next trial,” says CEO Gary Phillips.

On August 11 Syntara shares lost half their value after the US Food and Drug Administration (FDA) advised the company to do a placebo-controlled phase II trial.

The agency wanted “additional safety and efficacy data”.

This setback meant the company couldn’t leapfrog to a planned phase II/III trial, as planned.

The company now is likely to carry out a 90-patient phase 2b study, probably with 60 on active treatment and 30 on placebo.

Phillips estimates the cost “in order of US$25 million”.

But in September the shares partly recovered on the back of updated data from its phase IIa effort, showing “sustained” safety and efficacy out to 52 weeks.

Combo treatment

The trial tests the company’s lead candidate amsulostat, in combo with the standard-of-care ruxolitinib.

At six months treatment and beyond, 73% of patients achieved a 50%-plus improvement in symptoms.

More than 25% recorded spleen volume reduction –  a good thing – with durable benefits and no treatment-related serious adverse events for up to 12 months.

So the results look promising, but Syntara has to take the long road to approval.

Myelofibrosis is a rare and poorly treated blood disease and patients can expect to live for only five years on average.

In today’s quarterly report, Phillips says the company is expanding into a second blood-cancer indication with a study dubbed Azalox.

Initiated in Germany, this phase Ib/2 study is for myelodysplastic
neoplasms.

Syntara also has secondary studies underway including for hypertrophic and keloid burns scars.

All up, the company hopes to deliver results from five clinical studies in calendar 2026.

Syntara reported September quarter net cash outflows of $649,000 and a closing cash balance of $14.3 million.

Optiscan girds for FDA submissions

Digital pathology innovator Optiscan (ASX:OIL) reports customer receipts of $139,000, which helped to reduce cash outflows to $2.14 million compared with $2.32 million in the June quarter.

The company ended with cash of $19.9  million, following a $17.75 million rights raising underwritten by major holder Peters Investments Pty Ltd.

In an “eventful” quarter, the company imaged its first patient in its breast study at the Royal Melbourne Hospital.

With a planned enrolment of 50 patients, the study appraises Optiscan’s real-time surgical assist tool, Invue.

Optiscan is a leader in a non-invasive imaging method called confocal laser endomicroscopy, or CLE.

CLE eliminates the age-old and unreliable method of analysing tissue samples under a traditional microscope.

CLE involves a single optical fibre in a probe projecting laser light on to live tissue, treated with fluorescent dye.

This creates real-time digital microscopic images at a magnification 1000 times that of computed tomography (CT), or magnetic resonance imaging (MRI) scanning.

The company has also launched a pathology variant, Inform and a veterinary tool called Inspecta.

The company is preparing for FDA approval submissions for these devices “over the next 12 months”.

“The coming year is also shaping up as an exciting time for the broader digital pathology market segment, with large institutions like the [Minnesota based] Mayo Clinic now  actively exploring the  upside it is projected to offer,’’ says CEO Dr Camile Farah.

Anteris enrols first heart trial patients

Anteris Technologies (ASX:AVR) says a Denmark hospital has treated the first patients in its 1000-subject global trial of its transcatheter heart valve called Duravr.

These patients had severe calcific aortic stenosis.

Dubbed Paradigm, the trial builds on Anteris’ existing data gleaned from 130 patients. These included first time aortic stenosis cases, valve-in-valve patients and “complex anatomies” such as bicuspid aortic valve patients.

“This head-to-head study will provide robust comparative evidence across all surgical risk groups, which we believe will differentiate our platform based on efficacy, safety and ease of use,” says Anteris chief medical officer Dr Chris Meduri.

The company plans to expand Paradigm to US, European and Canadian sites.