ASX Health Quarterly Wrap: Neurizon turns up the dial on ALS drug progress
Quarterlies offers a crucial opportunity to gauge business momentum and future prospects, particularly for the healthcare sector. After years of underperformance despite solid fundamentals, healthcare has been one of the market's long-suffering segments.
While the broader market rose 10%, the ASX healthcare sector decline 4% in FY25. However, recent gains suggest the sector's fortunes may be shifting.
The S&P/ASX 200 Health Care Index (ASX:XHJ) surged 5.4% last week, building on a 5% jump the week before and is up so far this week with optimising growing of a rotation back into healthcare stocks.
Neurizon advanced its development pathway for its lead drug candidate NUZ-001 during the quarter, achieving several manufacturing, preclinical, clinical, and regulatory milestones.
These included development of a liquid formulation of NUZ-001 and promising interim results in the 12-month open label extension (OLE) study in Amyotrophic Lateral Sclerosis (ALS).
Neurizon completed a series of foundational studies during the quarter, which deepen the company's "mechanistic understanding of NUZ-001, highlight its differentiated pharmacology, and support its expansion as a platform therapeutic beyond ALS".
During the quarter Neurizon made key appointments to its executive team bolstering expertise in finance, preclinical and clinical development as well regulatory strategy to position the company for its next phase of growth, drug development and commercialisation.
The company also expanded its global presence and strengthened its engagement with key stakeholders in ALS and neurodegenerative disease through active participation in leading scientific, industry and community events.
Neurizon said achievements during the June quarter provided the catalyst for crucial milestones post quarter-end, including an exclusive global license agreement with NYSE-listed Elanco Animal Health Incorporated for monepantel (NUZ-001).
Post-quarter end the biotech received positive written feedback from the US Food & Drug Administration (FDA) on its strategy to resolve the clinical hold for NUZ-001.
The company has submitted a comprehensive Clinical Hold Complete Response (CHCR) to the regulator requesting the clinical hold to be lifted, paving the way to advance its investigational new drug application (IND) and entry into the HEALEY ALS platform trial in the December quarter.
Neurizon has also announced it has executed a loan agreement for $1.5m with specialist R&D financing firm Radium Capital, which is secured against a small portion of its expected 2025 R&D tax rebate.
The loan provides provides non-dilutive funding on top of Neurizon's existing cash balance of $4,161,000 at the end of June to ensure the company can maintain its pipeline of work in advance of receiving this year's R&D tax rebate.
Arovella Therapeutics (ASX:ALA)
A biotech focused on developing its invariant Natural Killer T (iNKT) cell therapy platform, Arovella continued to progress its lead product, ALA-101, towards a first-in-human clinical trial and to expand its platform into solid tumours during the quarter.
During the quarter, Arovella expanded its management team in readiness for its first-in-human phase I clinical trial for ALA-101 with the appointment of clinical operations leader Jacqui Cumming as senior director, clinical development.
The company entered into an exclusive option to licence multiple patent families from Baylor College of Medicine to expand use and improve the performance of its iNKT cell platform.
Arovella also set up its own research laboratory within the Jumar Bioincubator, with the new facility enabling Arovella to speed up its research output as it expands its solid tumour programs and continues building on its IP portfolio.
At the end of the quarter, Arovella announced that Dr Thomas Duthy would retire as a non-executive director and chairman with current non-executive director Dr Elizabeth Stoner serving as interim chair.
Arovella's CEO and managing director Dr Michael Baker said it was a productive quarter, including preparing an IND submission for the FDA.
"We made significant progress preparing for submission of our IND application, and we believe we are positioning the company for the best chance of success with the FDA," he said.
The company finished Q4 FY25 with cash of $20.9m, which is expected to fund the company through to completion of patient enrolment for the phase I clinical trial for ALA-101.
The funding will also support the advancement of its solid tumour programs (CLDN18.2-CAR-iNKT targeting gastric cancer) and its armouring program (IL-12-TM).
During the quarter Perth-based medtech Singular Health signed a commercial pilot agreement valued at US$1.3m (~A$2m). with major managed service organisation (MSO) in the US Provider Network Solutions (PNS), which manages care for more than 3.7 million people.
The contract marks transition to phase three of the company's multi-phase engagement with PNS and involves co-development of a pilot program where 1,000 of Singular Health's 3DICOM MD licenses will be distributed to primary care providers.
Following quarter close Singular Health announced a six-month collaboration with radiologist and founder of Life Radiology in Doral, Florida Dr Alex Alonso, who will serve as a strategic advisor and radiology architect for the PNS pilot, offering technical insight into US standards and workflows.
Singular Health also progressed multiple commercial discussions across the US education and healthcare sectors during the quarter with proposals requested by private and public institutions.
The company commissioned an independent report by Signify Research to quantify the US market opportunity. The findings show a total addressable market exceeding US$19 billion, with ~1.3 million primary care physicians in the US and each representing an average licence opportunity of US$800 per year.
Singular Health continued to pursue strategic opportunities in Australia aimed at improving access to medical imaging data and supporting clinical training, including a proof-of-concept integration proposal submitted to government departments to address inefficiencies in retrieving imaging data across disconnected PACS environments.
During the quarter, a capital raise of $8m was completed at an issue price of 35 cents per share, led by the Wallabi Group. The raise included participation from several institutional and high-net-worth investors, with further investment from PNS and Marin and Sons.
On the regulatory front, the company successfully completed its ISO 13485 re-certification and confirmed SOC 2 Type 2 and HIPAA formal certification and also progressed technical development.
The company closed out quarter with $13.7m cash and no debt.
Nerve-repair company ReNerve reported quarter sales revenue rose by 25% to $94,000 and contributed to cumulative FY25 sales of $271,000, up 53% on the previous year.
During the quarter ReNerve entered a partnership with Berkeley Biologics to develop two new product ranges, strengthening its commercial portfolio in the regenerative tissue and biologics sector.
Launch of the first new product ranges under the ReNerve brand are expected in Q3 CY25 and second by end of CY25.
The company received marketing approvals for its NervAlign Nerve Cuff in Bahrain, marking the first regulatory approval secured through its exclusive distribution agreement with Union MediScience B.S.C.
ReNerve and Union MediScience are now progressing with commercial rollout processes for the NervAlign Nerve Cuff product in the country, with early clinical cases and data gathered now anticipated to support future regulatory submissions in additional Middle East and North Africa (MENA)jurisdictions.
In April ReNerve signed a deal with NetCentrix Ventures to pursue regulatory approval and commercialisation of the NervAlign Nerve Cuff in India. The Indian nerve repair market is valued at ~US$115 million and forecast to exceed US$270 million by 2030.
ReNerve's net cash position at the end of the quarter was $4.75 m.
Imagion Biosystems (ASX:IBX)
Focus on progressing MagSense HER2 breast cancer imaging agent program during quarter
Working towards filing IND application to US FDA in Q3 FY25 for phase II trial
Preparations underway for manufacturing of MagSense HER2 drug for use in trial
The majority of Imagion's activities in the quarter focused on progressing its MagSense HER2 breast cancer imaging agent program towards filing an IND application to the US FDA for its phase II clinical trial including:
Submission of a pre-IND briefing document to the FDA
Preparations for manufacturing of the MagSense HER2 drug for use in phase II trial
Surgical oncologist at University of Oklahoma Health Sciences College of Medicine Dr William Dooley appointed principal investigator
Subsequent to the quarter close Imagion received positive written formal feedback from the FDA regarding the pre-IND briefing documents submitted. The IBX clinical team then held a meeting with senior FDA advisors to review the IND submission, which could be filed as early as Q3 CY25.
Start of the phase II trial is subject to IND approval by the FDA, with a response expected in Q4 CY25.
During the June quarter, Imagion entered into a master service agreement with Biosensis Ltd, providing the company with the ability to keep its operating costs low by not having to maintain an R&D facility or personnel, while still having access to new nanoparticle formulations for future research programs.
The two companies previously entered a licensing agreement in 2024, allowing Biosensis to use Imagion's proprietary nanoparticle manufacturing methods to supply research markets.
During the quarter vice chair of innovation at University Hospitals and an associate professor of radiology at Case Western Reserve University in Cleveland Dr Leonardo Kayat-Bittencourt was appointed clinical advisor for the company's prostate cancer program.
Imagion ended the quarter with $883,000 cash, down $826,000 from the prior quarter. Operating cash outflow for the quarter was $818,000, a $141k improvement largely due to lower admin and corporate costs.
The company expects reduced outflows next quarter as it focuses on cost control and funding the IND application.
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