Health Check: Opthea investors have $80m less to fight for after cash-burning quarter
Poynovo shares gain 10% after a cracker full-year result
Microx leads today's sector gains after a US deal with a mystery party
The financial fallout from Opthea's (ASX:OPT) two failed eye disease trials has become starkly apparent.
Despite ceasing its two pivotal phase III trials, Opthea recorded US$53.5 million ($82 million) of outflows in the June quarter.
This takes residual cash to US$48.4 million, from US$101.4 million as at the end of March.
The costs mainly related to the winding down of the Coast and Shore trials, for wet age-related macular degeneration.
Each of them enrolled close to 1000 patients, so they were meaty studies.
Following the March 24 trial bombshell, in April the company shed its workforce by 65%. In June four directors – half the board – departed.
Future uncertain
Under the terms of a development funding agreement (DFA), Opthea could owe investors somewhere between nothing and US$680 million.
Given Opthea has US$170 million of debt, any bumper return would be hypothetical.
Opthea 'remains in active negotiations with its DFA investors to deliver an outcome that is in the best interests of the company and its shareholders'.
Opthea shares have not traded since the March disaster, so any passer-by from Mars would think they are still valued at 60 cents for a $738 million market cap.
The only bright note is the company earned US$700,000 of interest.
Microx shares surge on US deal
Microx shares this morning went on a 33% share romp after the device maker announced a US customer for its Rover mobile X-ray units.
The customer has requested anonymity, but it's a "top tier US healthcare group" that runs 700 hospitals.
The company says the three year deal is subject to normal commercial conditions, but it does not quantify the expected revenue.
Given the share surge, investors presume it's kinda, like, material.
Polynovo shakes off The Troubles
Wound repair house PolyNovo (ASX:PNV) has shrugged off corporate governance issues by reporting a strong recovery in revenue and profits.
At its full-year results later next month, Polynovo should report sales of $118.6 million for the year to June 2025, up 30% year on year.
Second (June) half cash flow swung to a positive $15.7 million, compared with a $12.5 million deficit in the first half.
Management expects full-year earnings before interest tax depreciation and amortisation of $11.2-12.4 million.
This compares with the previous year's $3.6 million.
Of the revenue, $88.4 million derived from the US, up 29%.
The company gleaned most of its sales from its flagship product, Novosorb BTM.
'I like to review the year and the go-forward from a high level and all I see is growth and opportunity,' chairman David Williams chirps.
In mid-March the company said CEO Swami Raote would depart, amid claims of bullying and inappropriate behaviour against Williams.
The board engaged independent lawyers to probe the claims.
It also bought in former Westpac chairman Lindsay Maxsted to advise the board on governance matters.
The unashamedly outspoken Williams denies any wrongdoing and like the Irish, The Troubles seem to be forgotten.
Macquarie Equities similarly is enthused, ascribing a $2.45 per share valuation relative to yesterday's closing value of $1.22.
'We see several near-term positive catalysts for Polynovo, with a significant longer-term opportunity in additional indications.'
Yesterday, peer Kiwi wound repair house Aroa Biosurgery (ASX:ARX) also found investor favour after reporting its third successive quarter of positive cash flow, of NZ$1.7 million.
Aroa has guided to revenue of NZ$92-100 million for the year to March 2026, with normalised underlying earnings of NZ$5-8 million.
Emvision's Emu trial is in full stride…
Portable brain (stroke) detection device maker EMvision Medical Devices (ASX:EMV) says its pivotal trial to support FDA approval is 'progressing well'.
Pertaining to the company's lightweight bedside unit Emu, the trial is recruiting up to 300 stroke patients across four US and two Australian high-volume stroke centres.
A variant for road and air ambulances, First Responder has been trialled by the Royal Flying Doctor Service. A Melbourne stroke ambulance has also had a look-see.
Emvision recorded June quarter outflows of $2 million, taking cash to $10.5 million.
But the company will benefit from a non-dilutive $5 million grant from the Industry Growth Program, to develop First Responder.
The aforementioned Microx is also developing a portable head CT scanner to diagnose strokes.
… while Actinogen's trial recruitment passes halfway mark
Actinogen Medical (ASX:ACW) reports that its keenly anticipated phase 2b/3 Alzheimer's disease study has enrolled 123 of the targeted 220 patients.
Dubbed Xanamia, the trial has recruited across 20 US and 15 Australian sites, targeting patients with mild to moderate progressive Alzheimer's.
Actinogen's compound Xanamem targets elevated levels of a protein called pTau181. The novel mechanism of action inhibits production of cortisol, which is toxic to the brain in excessive amounts.
Having recruited its 100 th patient, Xanamia is subject to an interim 'futility' review next January. This will determine whether the trial is worth continuing.
With Xanamia hotting up, Actinogen disclosed June quarter cash outflows of $5.1 million, leaving June-end cash of $16.5 million.
The company also has access to a $3 million loan, the first component of a $13.8 million advance of expected research and development tax incentives.
Often a supplement to equity raisings, R&D loans have become increasingly popular with biotechs seeking to bring forward cash flow.
Ozempic maker's fat profits become thinner
The fate of Europe's biggest drug maker shows that boom conditions in the drug-making game rarely last – even with miracle fat-busting drugs.
The maker of the anti-obesity and diabetes drugs Ozempic and Wegovy, Denmark's Novo Nordisk overnight issued a profit warning that sent the shares tumbling up to 28% on the Nasdaq Copenhagen exchange.
The company slashed its outlook for 2025 sales growth to between 8-14%, from between 13-21% previously.
According to Reuters, sales have been affected by custom-made compounded drugs that emulate the branded versions.
The US bars pharmacies from replicating approved drugs, but allows 'compounding' for patients needing custom doses or formulations.
Dial 'L' for loophole.
The company also faces turmoil from the abrupt removal in May of CEO Lars Fruergaard Jorgensen. The board replaced him with veteran insider Maziar Mike Doustdar.
Slowing fat drug sales aside, Doustdar also faces the prospect of a 15% tariff on goods imported into the US.
'We need to increase the sense of urgency and execute differently,' Doustdar told investors.
Sounds about right.
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ASX Health Quarterly Wrap: Neurizon turns up the dial on ALS drug progress
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News.com.au
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Doubling up: How ASX biotechs are multiplying their impact
ASX companies finding smarter ways to stretch value of existing assets and launch into broader clinical areas LTR Pharma leveraging proven intranasal platform for erectile dysfunction treatment to target non-invasive relief for patients with swallowing difficulties From concussion to Alzheimer's the CogState Cognigram digital cognitive assessment system is used by physicians to monitor brain function As global biotech faces increasing pressure to deliver more with less, several ASX-listed healthcare companies are working to find smarter ways to stretch the value of their existing assets. Whether it's repurposing a drug delivery platform, extending the reach of a diagnostic tool or developing next-generation compounds that act on the same biological pathway to treat other conditions, these companies are using proven science as a launchpad into broader clinical territory. The strategy is playing out globally, with Novo Nordisk and Eli Lilly providing high-profile examples of repurposing GLP-1 drugs – originally developed for type 2 diabetes – for weight loss. Blockbusters like Ozempic/Wegovy (Novo Nordisk) and Mounjaro/Zepbound (Eli Lilly) are now reshaping treatment for obesity and related conditions. It's a compelling demonstration of how one well-validated mechanism of action can be leveraged across multiple disease areas in turn lowering development risk, tapping into existing safety and efficacy data, and accelerating time to market. For ASX healthcare companies navigating tighter capital conditions, similar strategies are proving to be a smart and resourceful way to unlock broader clinical value from their existing platforms. LTR Pharma rises above ED with nasal spray tech targeting broader conditions Developer of a nasal spray treatment for erectile dysfunction (ED), LTR Pharma (ASX:LTP) has turned to a secondary program using its innovative intranasal delivery platform but this time for oesophageal motility disorders (OMD). In May, LTR Pharma announced it had inked a collaborative development agreement with US-based Strategic Drug Solutions (SDS) to develop Oroflow a spray for OMD – a group of conditions that cause impaired swallowing (dysphagia). The program leverages LTR's proven proprietary intranasal delivery platform and foundational work from its Spontan and Roxus ED treatments to target rapid symptom relief for patients with swallowing difficulties, potentially offering a non-invasive alternative to current treatments. Oroflow aims to deliver relief in 10 minutes, bypassing swallowing barriers and offering a compelling althernative to treatments including invasive procedures such as pneumatic dilation, surgery, or botulinum toxin injections. LTR Pharma is addressing a $4.5 billion OMD market projected to reach $8.1 bn by 2034 with the company announcing in its latest quarterly report that proof-of-concept testing preparations were underway. LTR Pharma executive chairman Lee Rodne said Oroflow represented an exciting expansion of its nasal spray platform. "For patients with swallowing difficulties, oral medications present obvious challenges for patients," he said. "Our nasal spray technology is designed to offer a patient-friendly solution that avoids the need to swallow medications, have surgery or undergo other problematic treatments while providing rapid symptom relief. Neuren targeting broad set of neurological conditions Neuren Pharmaceuticals (ASX:NEU) is another standout. The company and US partner Acadia was in 2023 granted the first US Food and Drug Administration (FDA) approval for a drug to treat Rett syndrome, a rare neurological disorder mostly affecting girls and emerging in infancy. Trofinetide, marketed as Daybue, is a synthetic analog of part of the hormone insulin-like growth factor 1 (IGF-1), which is a potent regulator of central nervous system development. Neuren is now advancing NNZ-2591, which also targets IGF-1. Building on the scientific foundation of trofinetide, NNZ-2591 is structurally optimised to improve brain penetration, enhance tolerability, and expand therapeutic reach across a broader set of neurodevelopmental conditions. Using a strategy that targets multiple indications from one compound, Neuren aims to accelerate development while reducing R&D expenses. Currently in phase II trials, NNZ-2591 could open new treatment avenues for other underserved neurodevelopmental conditions like Phelan-McDermid, Angelman, and Pitt-Hopkins syndromes. The company is preparing to start a phase III study of NNZ-2591 for its most advanced program Phelin McDermid. It also plans to consult with the FDA this year to establish a clinical path for NNZ-2591 to treat hypoxic-ischemic encephalopathy (HIE), which results from a baby's brain not getting enough oxygen or blood flow before, or shortly after, birth. "We believe the mechanism of action of NNZ-2591 can be broadly applicable to neurodevelopmental disorders, independent of the genetic origin," CEO Jon Pilcher told Stockhead. "We are striving to be successful in multiple settings, for the benefit of both the impacted families and our shareholders." Tracking cognition from concussion to Alzheimer's From footy fields to neurology clinics, the CogState (ASX:CGS) Cognigram digital cognitive assessment system is used by physicians to monitor key aspects of brain function – including processing speed, attention, visual learning, working memory and executive function. The test can assess cognition at a single point in time or track changes over multiple assessments. You may have heard of it referred to as the Cogstate concussion test in footy coverage. However, Cognigram has since evolved into a widely used tool in healthcare and research. Cogstate is riding a wave of global demand for cognition-related clinical trials, particularly in the race to treat Alzheimer's disease and related dementias. The company recently upgraded its financial guidance for FY25, reflecting strong performance and improved outlook across key financial metrics. Full-year profit before tax is forecast to be in the range of $12-14m, an improvement of 69% to 97% on FY24. "We are now using Cognigram, which is the same cognitive assessment used to assess AFL footballers for concussion, to prescreen for clinical trials in the earlier stages of Alzheimer's," CEO Brad O'Connor told Stockhead. "We have a contract with a large pharmaceutical company screening for 20,000 patients in the community to find those that might be appropriate to include in their very early stage Alzheimer's trials.
