Nexalis Therapeutics Ltd Posts Positive IRX-616a Phase 1 Result Amid Funding Reset
Nexalis reports positive IRX-616a Phase 1 result as it recalibrates funding path
Nexalis Therapeutics Ltd (ASX: NX1) has reported that its IRX-616a Phase 1 clinical trial is complete, with results exceeding expectations and no Serious Adverse Events (SAE) reported.
The positive clinical outcome arrives alongside a shift in the Company’s funding position. Negotiations with potential funder Point8 Capital Pty Ltd have ceased, and Nexalis is now assessing a revised clinical development plan for its portfolio.
On the near-term cash front, the Company received $490k in Research & Development Tax Incentive (RDTI) proceeds following lodgement of its 2025 income tax return. Notably, the Company has advised there are presently no meaningful discussions underway regarding alternative funding.
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IRX-616a Phase 1 delivers safety and dose-ranging insights
The IRX-616a Phase 1 trial, conducted in healthy volunteers for the Company’s Panic Disorder candidate, is now complete. Nexalis reported that the results have exceeded expectations, with no Serious Adverse Events (SAE) recorded during the study.
The first patient dosed in the IRX-616a trial in March 2026 entered a randomised, double-blind, placebo-controlled design spanning three sequential dose cohorts, with the program structured to reach last-participant dosing before the end of June 2026.
The data has confirmed the safety and tolerability of the drug candidate in healthy volunteers. It also provided dose-ranging insights that can be applied to the patient population when designing the next stage of the clinical development programme.
The IRX-616a Phase 1 trial is now complete, and the Company is delighted to report that the results have exceeded expectations with no Serious Adverse Events (“SAE”) reported.
The suspension of the IRX-616a Phase 1 Study Order with iNGENū CRO Pty Ltd will delay completion of the formal Clinical Study Report (CSR). However, management has advised it has access to sufficient data and intelligence from the trial to allow Phase 2 trial design planning to progress without delay.
It keeps Phase 2 planning alive for the asset even as the formal reporting timeline shifts, providing continuity despite the operational setback.
Funding facilities: where things stand
The funding picture involves two separate parties, and the distinction matters for understanding the Company’s position.
On 28 May 2026, Nexalis announced it had signed a binding Letter of Intent with Point8 Capital Pty Ltd (Point8) for a new funding facility intended to replace the LFO Facility. Despite meaningful engagement by both parties, the Company was unable to progress negotiations to a formal agreement and has now formally withdrawn from the process.
While the Company will continue to work towards identifying and securing suitable alternative funding solutions, it has confirmed that no meaningful discussions are presently underway in that regard.
The second party, Linlithgow Family Office Pty Ltd (LFO), permanently cancelled the remaining available commitment under its debt funding facility, as advised in the 28 May 2026 announcement. Since inception of the LFO Facility, a total of $2.4 million of drawdown requests were submitted, of which $0.8 million was received prior to cancellation.
The Company is firmly of the view that LFO is obliged to honour the $1.6 million of eligible funding requests that were outstanding when the facility was withdrawn. Nexalis has contacted LFO with a resolution proposal, with a view to concluding the arrangements in a satisfactory manner.
| Item | Amount | Status |
|---|---|---|
| Total drawdown requests submitted | $2.4M | Submitted since inception |
| Funding received | $0.8M | Received prior to cancellation |
| Eligible requests outstanding | $1.6M | Disputed / resolution proposal submitted |
What the 505(b)(2) pathway means for NX1
Nexalis is an Australian clinical-stage drug development company focused on rapid-onset therapies for the pain management and mental health sectors. Its portfolio comprises three candidates:
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IRX-211 for Breakthrough Cancer Pain (BTcP)
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IRX-616a for Panic Disorder (PD)
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SRX-25 for Treatment-Resistant Depression (TRD)
The Company’s overarching goal is to pursue U.S. FDA approval using rapid and cost-effective regulatory pathways, such as 505(b)(2).
Revised clinical development priorities
Following the cancellation of the LFO Facility’s funding commitment, the Company provided written notice to iNGENū temporarily suspending the current study orders for IRX-211 and IRX-616a. While this suspension remains in place, management is focused on evaluating how best to progress each development asset once funding, in whatever form, becomes available.
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IRX-211 (Phase 2): A detailed review of the current trial state to determine the root cause of the recent lack of progress in patient recruitment and screening. This includes assessing recruitment processes across different sites, with consideration given to amending the Phase 2 protocol, including patient inclusion and exclusion criteria and trial design, should this prove necessary or prudent.
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IRX-616a (Phase 2 design): Development of a more flexible and scaled approach compared with the large-scale IRX-211 design. This may include a cost-effective proof-of-concept study to demonstrate the therapeutic application and efficacy of IRX-616a in the patient population as a preliminary step.
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SRX-25 (oral programme): The candidate remains in the planning phase, with the intent to finalise the trial design for a Phase 1 in Australia. The plan is to achieve this without diverting time, attention or available financial resources away from the Phase 2-ready candidates.
The SRX-25 oral esketamine programme is targeting the treatment-resistant depression market, which is projected to reach approximately US$4 billion by 2030, and received a regulatory tailwind in April 2026 when a U.S. Executive Order introduced acceleration initiatives that could shorten FDA approval timelines for mental health therapies.
The approach reflects capital discipline, prioritising the Phase 2-ready assets while progressing SRX-25 without resource diversion.
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Near-term cash and the road ahead
The Company recently received $490k in RDTI proceeds following the processing of its 2025 income tax return, providing a concrete near-term cash inflow.
The update presents a balanced picture: a strong Phase 1 clinical result and a defined asset-prioritisation strategy, set against unresolved funding and the ongoing LFO resolution process. Nexalis has advised that further updates will be provided as funding opportunities and the LFO and clinical reviews develop.
Key takeaways
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IRX-616a Phase 1 complete, with no SAEs and safety and tolerability confirmed
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$490k RDTI proceeds received
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Point8 negotiations ceased; alternative funding being sought
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$1.6m LFO dispute, with a resolution proposal submitted
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Revised clinical development plan under assessment
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