Health Check: Coronary plaque buster Artrya launches $80 million raising

• Artrya’s chunky raising shows biotech investor wallets are loosening
• Telix talks turkey with the FDA on brain cancer imaging agent
• Argenica’s “brutal” share swoon is overdone, says Petra Capital

In a further promising sign of improving fundraising conditions for biotechs, heart disease diagnosis play Artrya (ASX:AYA) has executed a $75 million placement, with a $5 million share purchase plan (SPP) to come.

Artrya will use the moolah to support the US rollout of Salix, its approved AI-enabled tool for detecting coronary plaque.

The funding involves a two-tranche placement at $2.05 a share, a 6% discount to Friday’s closing price ahead of a trading halt.

The first $60 million slice is immediate; the remainder needs shareholder approval.

As well as supporting general commercial expansion, the funds will back a flagship plaque study known as Sapphire.

In mid-August the US Food and Drug Administration (FDA) approved the company’s Salix Coronary Plaque (SCP) module. This is for the “near real time, point of care assessment and management of coronary artery  disease”.

The device will integrate with the approved Salix Coronary Anatomy (SCA) platform, which the company has sold in the US since July.

SCA analyses data from computed tomography (CT) scans.

SCP approval paves the way for attractive per-scan fees of US$950.

High-risk plaque often indicates heart disease, yet it’s often missed by current surveillance means and is often fatal.

SCP will provide clinicians with a highly detailed assessment of coronary artery plaque in under ten minutes.

The company expects the FDA to approve a third device – Salix Coronary Flow – early next year.

Happy days!

Investors aren’t throwing money around like drunken sailors, but they will dig deep for worthy causes.

In mid-May EBR Systems (ASX:EBR) raised $56 million in a placement and then $20 million in an SPP, to support the US rollout of its left-ventricle heart assist device, Wise.

Yesterday Alterity Therapeutics (ASX:ATH) said it had raised $20 million in a placement, to back its phase II multiple system atrophy trial.

Last week stem cell developer Mesoblast (ASX:MSB) raised $76.5 million in a convertible note issue. Last month, pancreatic cancer drug developer Amplia (ASX:ATX) raised $27.6million in a placement and SPP.

In March Imricor Medical Systems (ASX:IMR) raised $70 million in a placement, to support development of the world’s first MRI-compatible cardiac ablation catheter.

Telix and FDA find a way with glioma

Telix Pharmaceuticals (ASX:TLX) says it has agreed with the FDA on a path to resubmitting the company’s marketing application for its brain cancer imaging agent, Pixclara.

In late April, the agency rejected the application via a complete response letter (CRL). The FDA wanted “additional confirmatory clinical evidence” but was not worried about safety.

Under the agreement, Telix will undertake a “confirmatory efficacy study” analysis of existing data.

The company does not have to undertake an additional trial.

Telix plans to resubmit the new drug application in the December quarter.

Pixclara will be the company’s third approved radio imaging agent, behind the prostate cancer imaging tool Illuccix and Gozellix.

Pixclara images glioma, a rare and life-threatening brain cancer.

In late August Telix also received a CRL pertaining to its marketing application for its kidney cancer imaging agent, Zircaix.

In this case, the FDA wants to be sure that the drug would be tickety-boo when manufactured at scale.

At the time Telix said the problems were “readily addressable” and submission remediation would begin immediately.

Telix’s under-pressure shares rose as much as 10.5% this morning.

Argenica achieved “clinically meaningful” result, says broker

Petra Capital dubs the market’s response to Argenica Therapeutics’ (ASX:AGN) phase II stroke trial as “brutal” and argues the company still has a clear route to market.

But it will take longer than first envisaged, of course.

Argenica last week said the 92-patient study of ischaemic stroke patients achieved its primary endpoint of safety.

The study achieved its secondary efficacy endpoint across a patient sub-group.

The study trialled Argenica’s drug candidate ARG-007, which aims to save brain cells deprived of blood post-stroke (blockage).

The drug reduced infarction (cell loss) by an average 15%, in an intermediate patient group with slow collateral blood flow.

This means blood has found its way around the blockage, but the flow still is inadequate.

Petra Capital analyst Tanu Jain says the results provide “a clinically meaningful outcome in a high-risk pre-specified sub-group [and serves] as a proof-of-concept for the neuroprotective ability and safety of the drug.”

Jain expects Argenica to analyse the data completely by the end of 2025 and launch a phase 2b trial for the ‘slow collaterals’ in the second half of 2026.

“In stroke, doctors tend to use all tools in their box to treat a patient,” she says in a note.

“As long as the drug is safe, they will likely prescribe it off-label even if it has modest efficacy”.

Of course, pricing need not pose a barrier.

Thus, ARG-007’s clean bill of health bodes well for commercial prospects, “even if the drug is approved initially for a narrower label.”

Collab corner

Regenerative medicine developer Osteopore (ASX:OSX) is teaming up with Singapore’s Tan Tock Seng Hospital to develop a novel implant for avascular necrosis (AVN).

Blood supply interruption causes AVN, leading to necrosis of bone tissue. This condition mainly affects the hip joint, causing pain and discomfort.

About 10% of AVN cases result in the need for a total hip replacement.

Osteopore cites the projected value of the AVN market at US$10.2 billion by 2030. This implies a compound annual growth rate of 8.5%.

Meanwhile, neurological drug developer Neuren Pharmaceuticals (ASX:NEU) has entered a “formal partnership” with a patient support group. This is to further its drug candidate NNZ-2591 for hypoxic-ischemic encephalopathy (HIE).

The group is called Hope for HIE.

Potentially fatal, HIE  results when a baby’s brain does not receive enough oxygen or blood flow. This can be before, or shortly after, birth.

HIE symptoms include developmental delays, cognitive impairment, cerebral palsy and seizures.

The parties hope that NNZ-2591 can better the current standard of care of ‘temporary hypothermia’.

Cooling the bub’s head, that is.