ASX Health Quarterly Wrap: Island completes Phase 2a/b dengue trial
Investor jitters have grown amid staffing upheaval at the US Food and Drug Administration (FDA), where reported mass layoffs under Elon Musk's Department of Government Efficiency (DOGE) were swiftly followed by a partial rehiring, raising then easing concerns about the regulator's ability to manage clinical trials and drug approvals.
Against the uncertain backdrop, Stockhead's healthcare clients have been showing signs of resilience reporting business as usual in their latest quarterly reports.
Island Pharmaceuticals (ASX:ILA)
During Q3 FY25 Island completed its Phase 2a/b PROTECT trial of ISLA-101 in dengue fever with top-line results from both cohorts forecast to be reported in May.
Island completed Phase 2b enrolment and dosing on schedule and with no delays in February after announcing in November the trial's safety review committee (SRC) deemed ISLA-101 safe and exhibiting evidence of anti-dengue activity.
Pharmacokinetic data for 2b cohort was received post quarter-end with target blood level concentration achieved in all participants.
During the quarter Island continued to advance pipeline expansion opportunities, with particular focus on the opportunity to acquire Galidesivir from Nasdaq-listed BioCryst Pharmaceuticals.
Galidesivir is an antiviral with a broad spectrum of activity across more than 20 RNA viruses, including high-priority threats such as Ebola, Marburg, MERS, Zika, yellow fever, and SARS-CoV-2.
The company raised $1.94 million during Q3 FY25 via the exercise of more than 32 million options, which expired in March.
The options were issued to shareholders who took part in Island's fully underwritten rights issue in March 2024, which raised ~$1.94m.
Island carried out several shareholder engagement and promotional activities during the quarter, highlighted by presentations at two major investor conferences and a series of meetings with Australian investors.
Net cash used in operating activities totalled $874,000 for Q3 FY25, primarily related to R&D associated with its Phase 2a/b PROTECT trial, as well as administration and corporate costs.
Island ended the quarter with $4.82m in cash.
"Q3 FY25 marked a period of considerable progress, underscored by key developments for the Phase 2b cohort of our PROTECT trial, which has the potential to highlight ISLA-101's utility as a treatment for dengue fever," CEO and managing director David Foster said.
Tryptamine said it made advancements in the clinical development pathway its novel IV-infused psilocin formulation TRP-8803 during the March quarter.
The company inked a clinical trial research agreement with Swinburne University to start what it describes as a "world-first" open-label trial to assess the safety, feasibility and efficacy of TRP-8803, when administered together with psychotherapy for adult patients with binge eating disorder (BED).
The trial will recruit 12 patients, in two six-person cohorts, with participants to be administered two doses of TRP-
8803 two weeks apart.
In January CEO and managing director Jason Carroll presented Biotech Showcase in San Francisco. The conference provides private and micro-mid-cap biotechnology companies with the opportunity to present and connect with investors, industry participants and executives.
BDO Audit Pty Ltd was appointed as auditor in January, following resignation of William Buck Audit (VIC) Pty Ltd.
Tryptamine has also appointed Hamish George as company secretary, following the resignation of David Franks.
Tryptamine held $4.58m in cash at the end of the quarter with an expected ATO R&D tax refund of ~$900,000 to $1m.
"The work undertaken during the last quarter has laid a very strong foundation for the coming months, allowing the Company rapidly advance its clinical development pathway for TRP-8803," Carroll said.
Dimerix (ASX:DXB)
During the March quarter Dimerix continued to progress its ACTION3 phase III trial of lead drug candidate DMX-200 in focal segmental glomerulosclerosis (FSGS), including holding a positive Type C meeting with the FDA in March 2025.
The meeting confirmed the acceptability of proteinuria as an appropriate endpoint for full marketing approval in the US. The company said 183 patients have currently been randomised/dosed in the ACTION3 trial with the first paediatric patient recruited.
During the quarter Dimerix entered in exclusive licence deal with Fuso Pharmaceutical Industries to develop and commercialise DMX-200 in Japan to treat FSGS.
It is the third licensing agreement that Dimerix has successfully executed for DMX-200 in FSGS with the company saying it continued to receive strong partnering interest.
In other highlights for the quarter Dimerix was admitted to the S&P/ASX All Ordinaries index and presented at several key conferences.
The company had net operating cash outflows for the quarter of $4.3m. It ended the quarter with $17m cash.
Dimerix said this does not include the anticipated $4.1m first milestone payment from its Fuso licensing agreement anticipated in the second quarter of 2025 or up to $6.3m from the exercise of outstanding options expiring in June.
Post quarter the company today announced it had inked an exclusive licensing deal with Nasdaq-listed Amicus Therapeutics to commercialise its phase III drug candidate DMX-200 in the US.
Optiscan (ASX:OIL)
Optiscan said a highlight of the quarter was the unveiling in February of InForm, its next generation microscopic medical imaging device specifically for pathology laboratory workflows which marks a significant milestone in technological advancements for the company.
InForm is a first-in-class microscopic medical imaging device specifically designed to transform pathology by delivering real-time digital insights across the full workflow from the very point of contact with a tissue sample.
The company completed beta-phase work on its cloud-based Telepathology platform with feedback from potential users
gathered.
Optiscan said the insights were analysed and addressed, leading to implementation of various enhancements with the company on track to deliver the final minimum viable product for its Telepathology platform in Q4 FY25.
The company has also significantly progressed plans to enter the veterinary market. Development of a dedicated veterinary product continues with a prototype device also set to be unveiled this quarter.
As planning for a trial at Royal Melbourne Hospital started during the quarter, Optiscan said more InVue systems were being manufactured.
Patient recruitment is anticipated to begin in Q4 FY25, with early-stage data to shape protocols for expanded clinical trials planned for the US in FY26, pending US FDA approvals.
During the quarter Optiscan's regulatory team worked closely with expert consultants in strategising the best regulatory path forward for its InVue and Inform devices.
New key executive appointments were made also made during the quarter to implement Optiscan's transformation plan that is strategically focussed on clinical, regulatory and commercial outcomes.
The company has also undertaken significant enhancements to its Melbourne facilities in preparation for increased demand on its manufacturing and assembly capabilities and extensive R&D work
During the quarter Optiscan received a $1.775m R&D tax refund, which was $1m more than in previous years, due to its successful Advance and Overseas Finding application.
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