Health Check: These biotechs are awaiting key announcements on St Patrick’s Day

On St Patrick’s Day, investors hope for some good fortune ahead of Opthea’s key phase III trial update and Imricor’s fund raising.

All biotechs need a little bit of the luck of the Irish, to be sure, to be sure. Pic via Getty

• Opthea shares enter trading halt on St Patrick's Day ahead of a “material” trial update

• Imricor is on the hunt for funds, reportedly up to $80 million

• Race Oncology is in pole position for phase I trial start

In the difficult drug development game, the luck of the Irish is sometimes required.

That's along with scientific and commercial nous and enough cash to shout the whole of Dublin on its Guinness-swilling national day.

Perhaps good fortune will land on Opthea's (ASX:OPT) side. The company has today requested a trading halt ahead of a "material announcement".

This is “in relation to” the top-line results from Opthea's phase III eye disease trial.

The study in question, Coast, is one of two trials pitched at winning regulatory approval for sozinibercept (OPT-302).

OPT-302 is Opthea’s candidate for wet aged-related macular degeneration (wet AMD), the most common cause of blindness.

Enrolling close to 1000 patients each, the Coast and Shore trials are designed to assess the safety and superior efficacy of sozinibercept.

This is in combination with standard-of-care anti-VEGF-A therapies (Lucentis or Eylea) compared to standard-of-care alone.

The trials only need to emulate the results of an earlier, 366-patient phase II study, showing a combination treatment was significantly more effective than the standard-of-care drugs alone.

Still, the top-line Coast results are not due until early in the second (June) quarter, while the Shore results are due to wash in in mid 2025.

“Sozinibercept has the potential to become the first therapy in 20 years to improve visual outcomes in patients with wet AMD," the company says.

The trading halt is due to lift on Wednesday, so nervous investors won’t have to wait too long.

Opthea shares edged up 0.8% on Friday but have lost 40% of their value over the last month.

Still, with US$227 million ($360 million) of cash the company is well positioned to finish the trials – and shout the rowdy patrons of Dublin’s famed Temple Bar Pub today.

Imricor hunts for cash

Imricor Medical Systems (ASX:IMR) is hunting for equity to support its US marketing applications for its cardiac ablation guidance tools.

The company’s shares this morning entered trading halt ahead of completion of the raising, reportedly for up to $80 million in what’s a tough market.

Imricor is about guiding cardiac ablation procedures by real-time magnetic resonance imaging (MRI), rather than by conventional x-ray fluoroscopy.

The desired result is faster, safer (radiation-free), and more effective treatments of cardiac arrhythmias compared to conventional means.

Imricor is the world's only company that provides MRI-compatible consumable devices, such as single-use ablation catheters.

Last month Imricor submitted a pre-marketing approval to the US Food and Drug Administration (FDA), for its second module.

This covers the company’s manufacturing processes across seven devices.

Under a modular process, the company submits items to the regulator in a staged manner.

This enables a streamlined review.

CEO Steve Wedan says the company is “one step closer to getting entire platform of technology” approved in the US.

Race Oncology is out of the blocks

Perhaps inspired by McLaren Formula One victor Lando Norris, Race Oncology (ASX:RAC) shares soared 21% on Friday after the company won ethics approval for a phase I safety trial of its anti-cancer agent.

Today, the shares took a brief pit stop.

The two-stage trial will administer Race's candidate bisantrene (RC-220) alone and then in combination with the standard-of-care chemotherapy, doxorubicin.

In the first stage, up to 33 patients will receive an intravenous (IV) infusion of RC-220 alone on day one.

They then will undergo a combination treatment, receiving IV RC-220 and then IV doxorubicin on a 21-day cycle.

In collaboration with the Cancer Care Foundation, 10 Australian sites are carrying out the open-label trial.

Enrolment should start this month.

As well as probing the usual safety factors, the study will assess other endpoints including the therapy's ability to protect the heart from the effects of chemotherapy.

Race chief medical officer Dr Michelle Rashford said the approval was an “important landmark” for the company.

“We are close to patients receiving RC-220 for the first time”.

Ding! Ding! Round two for Percheron

Percheron’s luck of the Irish is more akin to potato famines and troublesome British occupiers, with the company facing a second spill vote having narrowly survived the first one.

The agitants, Powerhouse Ventures are seeking to remove three directors, including CEO James Garner and chairman Dr Charmaine Gittleson and replace them with their own candidates.

At a March 3 showdown, separate challengers failed to remove the board.

At that pow-wow, Powerhouse moved a failed motion that should the challengers succeed, a second vote would be held to remove their board appointees in favour of Powerhouse’s.

Showdown 2.0 is scheduled for 4 pm April 24, on the cusp of the Anzac Day long weekend.

How convenient!

The board drama follows last December catastrophic failure of Percheron’s Duchenne muscular dystrophy trial.

In effect the parties are squabbling over Percheron’s $17 million of residual funds, or less than that when trial wind-up expenses are considered.

As the heavily-gravid cop Marge Gunderson philosophised in Fargo: “For a little bit of money? There's more to life than a little money, don'tcha know that?”

At Stockhead, we tell it is as it is. While Imricor and Race Oncology are Stockhead client, the company did not sponsor this article

Originally published as Health Check: These biotechs are awaiting key announcements on St Patrick’s Day