ASX Quarterly Healthcare Wrap: Clinical milestones, big deals and a new CEO

• Entropy progresses its proprietary TRP-8803 IV-infused psilocin program during the September quarter, led by encouraging results in phase II treatment-resistant binge eating disorder trial
• Neurizon’s global search for a new CEO came to an end in Q1 FY27 with the appointment of Dr Chris Bremer, bringing 20-plus years of pharmaceutical experience
• Singular Health advanced its first state-funded program during the September quarter for its flagship 3DICOM and Medical File Transfer Protocol technology

For ASX healthcare investors, the September quarter offered fresh signs that the sector is finding favour again after an extended period of underperformance.

The S&P/ASX 200 Health Care Index has climbed more than 30% since the start of July, as investors rotate back towards defensive sectors and gains in the US healthcare market help lift sentiment.

For smaller ASX healthcare stocks, however, the focus remains on execution, including advancing clinical programs, reaching regulatory and commercial milestones, and building the foundations for long-term shareholder value.

Entropy Neurodynamics (ASX:ENP)

• Entropy’s phase II trial of lead IV-infused psilocin candidate TRP-8803 for treatment-resistant binge eating disorder delivers encouraging results
• A 72-patient, eight-indication phase 1b/2a basket study has gained ethics approval, and a UCSF-led US depression trial against escitalopram is targeted for H1 CY27
• Cash of $3.6m plus a $2.6m undrawn facility gives about 3.4 quarters of funding, with Cohort 2 topline data in the binge eating disorder trial due by the end of CY26

ENP made significant progress across its proprietary TRP-8803 IV-infused psilocin program during the September quarter, led by encouraging results in a phase II treatment-resistant binge eating disorder (BED) trial.

Cohort 1 of the Swinburne University collaboration showed all six patients achieved a clinically meaningful improvement, with half reaching complete remission.

The gains held at the 12-week mark. Weekly binge-eating episodes were 73% below baseline, in line with the 74% reduction at four weeks, and three patients had no episodes at all across the 84-day follow-up. Participants had lived with BED for a median of 15 years and had all failed at least one prior treatment. The company says the sustained response followed only two infusions.

ENP has also secured ethics approval for a 72-patient, eight-indication phase 1b/2a basket study. It covers anorexia nervosa, body dysmorphic disorder, OCD, generalised anxiety disorder, PTSD, treatment-resistant depression, fibromyalgia and irritable bowel syndrome, with the aim of identifying which conditions to prioritise ahead of potential phase II trials.

The company has also signed a preclinical trial agreement with the University of California, San Francisco (UCSF) for a US phase II study pitting TRP-8803 against widely used escitalopram in up to 80 young adults with major depressive disorder. The trial is targeting a start in H1 CY27, subject to FDA acceptance of an Investigational New Drug application.

ENP also signed a development and manufacturing agreement with Australian contract development and manufacturing organisation (CDMO) BioCina for GMP production of TRP-8803. Its intellectual property was also boosted with Australian and South African patent grants, both running to September 2043.

Since quarter end, the first Cohort 2 patient in the phase II BED trial has completed a shortened 60-minute infusion, down from 140 minutes in Cohort 1, reporting a peak psychedelic intensity of 9/10. A shorter session is central to the commercial case, as it cuts clinician time and treatment-room demand. Cohort 2 is fully recruited, with topline results due by the end of CY26.

“We believe the progress achieved during the quarter has significantly strengthened Entropy’s position and established a solid foundation for the next phase of clinical development, as we work towards delivering additional clinical data, expanding our international presence and unlocking the broader commercial potential of TRP-8803,” CEO Jason Carroll said.

Neurizon Therapeutics (ASX:NUZ)

• During Q1 FY27 Neurizon appointed Dr Chris Bremer appointed CEO, bringing 20-plus years of international pharmaceutical leadership
• Completed enrolment of all 250 participants in Regimen I of the phase 2/3 HEALEY ALS Platform Trial across 78 activated US clinical sites
• Expanded Access Program approved for NUZ-001 in the US, fully funded through a multi-year US National Institutes of Health grant

NUZ highlighted strong progress in the clinical development of its lead drug candidate NUZ-001 for amyotrophic lateral sclerosis (ALS) during Q1 FY27, as its global search for a new CEO came to an end with the appointment of Dr Chris Bremer.

Enrolment of all 250 participants in Regimen I of the phase 2/3 HEALEY ALS Platform Trial across 78 activated US clinical sites was completed during the quarter, bringing forward the anticipated topline readout to late Q4 FY27.

An Expanded Access Program (EAP) for NUZ-001 was also approved, fully funded through a multi-year US National Institutes of Health grant. The EAP will provide access for up to 200 people living with ALS in the US for up to 96 weeks.

Subsequent to quarter end, FDA Type C meeting feedback noted the HEALEY trial may serve as the single registrational study to support a traditional approval pathway for NUZ-001, subject to meeting the requirement for substantial evidence of effectiveness.

NUZ has also advanced its regulatory program, receiving scientific advice from the European Medicines Agency (EMA) outlining the requirements for a potential EU marketing authorisation for NUZ-001, consistent with the company’s expectations.

During the quarter NUZ announced the appointment of Dr Chris Bremer as CEO, bringing 20-plus years of international pharmaceutical leadership and more than US$1Bn in executed licensing transactions.

Bremer took over the leadership role on October 1, with Sergio Duchini transitioning from interim executive chairman back to non-executive chairman.

During the quarter NUZ executed an R&D financing facility of up to $17.5m with Dare Capital, completing an initial non-dilutive drawdown of about $8.3m in August.

It also redeemed one million Obsidian convertible notes, leaving 750,000 on issue. The company finished Q1 FY27 with $11.4m cash and said it remained fully funded through the HEALEY topline readout and completion of the study.

“My immediate priority is disciplined execution as Regimen I progresses towards topline results, while ensuring Neurizon is ready for the regulatory, partnering and commercial pathways that may follow,” Bremer said.

LTR Pharma (ASX:LTP)

• During the quarter and after its end LTR Pharma progressed US fulfilment of ROXUS and Australian patient access to SPONTAN, its intranasal erectile dysfunction treatments
• Finalised a telehealth distribution agreement with Shed Holdings to commercialise ROXUS in the US and a compounding and supply deal with Strive Specialties
• Subsequent to quarter end, the first ROXUS prescriptions were fulfilled in the US, while the final report for the SPONTAN phase II pharmacokinetic study confirmed interim results

Executive chairman Lee Rodne described the September quarter for LTP as all about “converting agreements into execution” for its intranasal erectile dysfunction (ED) treatments ROXUS and SPONTAN.

“In July we executed definitive agreements with Shed and Strive Pharmacy, securing the telehealth and pharmacy fulfilment components of our U.S. commercial framework for ROXUS,” he said.

Post-quarter, earlier this month, LTP said the first patient-specific ROXUS prescriptions were received through Shed’s Mavrox telehealth platform and fulfilled in the US by Strive Pharmacy.

ROXUS uses the same proprietary intranasal delivery platform as SPONTAN to deliver vardenafil as a rapid-onset nasal spray and is intended to reach patients sooner via the US 503A personalised medicine pathway, while SPONTAN progresses through the FDA 505(b)(2) pathway.

“We have moved from implementation to serving patients, and our focus is now on supporting our partners as prescribing activity builds,” he said.

In August LTP reported outcomes from a 147-patient real-world study of SPONTAN, with a 93% response among men seeking greater convenience and spontaneity.

Data from the study was presented by nurse practitioner and sexologist Melissa Hadley Barrett at the Asia-Pacific Prostate Cancer Conference in Melbourne during August and subsequent to quarter end at the Sexual Medicine Society of North America Fall Scientific Meeting in Orlando, Florida, with the manuscript submitted to Sexual Medicine for peer review.

During the quarter LTP entered into an exclusive pilot commercialisation deal with US pharmaceutical company Marius Pharmaceuticals to introduce FDA-approved oral testosterone therapy KYZATREX to Australia.

The company is also off to a good start for Q2 FY27. Post-quarter, LTP said that the final phase II report on SPONTAN confirmed its May interim results and completed the pharmacokinetic dataset agreed with the FDA for a planned US 505(b)(2) submission.

It has also secured ethics approval for an investigator-initiated clinical study evaluating SPONTAN in patients with newly diagnosed, untreated pulmonary arterial hypertension. It will be conducted by Professor David Celermajer, head of the department of cardiology at Royal Prince Alfred Hospital, and his team.

LTP finished the quarter with $18.82 million in cash and no debt, with net operating outflow of $1.6m.

Singular Health Group Ltd (ASX:SHG)

• Memorandum of Understanding executed with Florida International University (FIU) to design, deliver and operate a secure medical imaging repository using flagship 3DICOM technology
• Continued progress across the Provider Network Solutions (PNS) network with 1000 contracted 3DICOM MD licenses deployed
• Development and validation of Singular Health’s AI-powered imaging appropriateness module ImageIQ progressed during the quarter

SHG made strategic and commercial progress during the September quarter, with a key development being its first state-funded program.

The company signed a Memorandum ofUnderstanding (MOU) with Florida International University (FIU) for the delivery of a medical imaging repository using 3DICOM and its Medical File Transfer Protocol technology, to support the Florida Medicaid system.

The State of Florida has appropriated US$3m (~$4.17m) to FIU for the repository, with SHG’s share of the funding about 85%, or US$2.55m (~$3.5m), to be paid on milestones, with delivery and payment by June 30, 2027 or earlier.

During the quarter, SHG continued discussions with Provider Network Solutions (PNS) on renewal and potential expansion, including deployment of new licenses and broader adoption across its network.

PNS is SHG’s largest customer agreement, with 1000 3DICOM MD licenses contracted at US$800 per physician per year across the organisation’s network. The agreement is due for renewal by December 31, 2026.

SHG’s 3DICOM Gateway and Patient tools remained in use at Life Radiology in Florida, replacing CDs with secure digital access to imaging. The company is tracking utilisation and patient adoption to support further imaging centre deployments.

Onboarding continued for a paid 3DICOM EDU pilot across five technical colleges at Miami-Dade County Public Schools, the third largest public school district in the US. The pilot gives up to 150 students and instructors access to support anatomy and healthcare training and is being delivered with US distribution partner CG1 Solutions.

SHG progressed talks with providers, health plans and partners across the US and Puerto Rico, including Triple-S, using a partner-led approach with established networks rather than a large in-house salesforce.

Development and validation also continued for ImageIQ, the company’s AI module designed to help clinicians choose the right scan before it is ordered. It is not yet commercially released and is intended as an add-on for networks already on 3DICOM.

SHG also passed an MDSAP surveillance audit to retain its certification and progressed preparations for HITRUST certification, a security framework widely used by US health plans and providers.

This story does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

At Stockhead we tell it like it is. While Entropy Neurodynamics, Neurizon Therapeutics, LTR Pharma and Singular Health Group are Stockhead advertisers, the companies did not sponsor this article

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