Nexalis Therapeutics Ends Point8 Negotiations, Reports Successful IRX-616a Phase 1 Data
Nexalis Therapeutics has ended funding negotiations with Point8 Capital after failing to secure a formal agreement, while successfully completing its IRX-616a Phase 1 trial with no serious adverse events. The company is reassessing clinical priorities amid funding uncertainty.
- Point8 Capital funding negotiations ceased
- IRX-616a Phase 1 trial confirms safety and tolerability
- LFO funding facility cancelled with outstanding drawdowns
- Clinical trials temporarily suspended pending funding
- Received $490k from 2025 R&D Tax Incentive
Funding Negotiations Collapse with Point8 Capital
Nexalis Therapeutics Ltd (ASX:NX1) has formally withdrawn from funding negotiations with Point8 Capital Pty Ltd after failing to progress to a binding agreement. This development follows the recent cancellation of the Linlithgow Family Office (LFO) debt facility, which left $1.6 million in drawdown requests unresolved. To date, Nexalis has received only $0.8 million of the $2.4 million requested under the LFO facility. The company insists LFO remains obligated to honour the outstanding funding and is pursuing a resolution.
IRX-616a Phase 1 Trial Exceeds Safety Expectations
On the clinical front, Nexalis reported successful completion of the IRX-616a Phase 1 trial targeting panic disorder, with results surpassing expectations. The trial confirmed the drug candidate’s safety and tolerability in healthy volunteers, with no serious adverse events recorded. Dose-ranging data gathered will inform the design of subsequent patient studies. However, the suspension of the formal Clinical Study Report (CSR) due to halted study orders with CRO iNGENū will delay official documentation, though management states sufficient data exists to progress Phase 2 planning without delay.
Clinical Development Plans Under Review Amid Funding Gaps
Funding uncertainty has forced Nexalis to temporarily suspend study orders for both IRX-211 (Breakthrough Cancer Pain) and IRX-616a programs. The company is conducting a detailed review of its clinical pipeline to prioritise development once funding is secured. This includes investigating patient recruitment challenges in the IRX-211 Phase 2 trial, with potential protocol amendments under consideration to improve enrolment efficiency and reduce costs. For IRX-616a, Nexalis is exploring a more flexible Phase 2 trial design, possibly starting with a smaller, cost-effective proof of concept study to establish therapeutic efficacy.
The oral SRX-25 program for treatment-resistant depression remains in the planning phase, with intentions to conduct a Phase 1 trial in Australia without detracting from the more advanced candidates.
Research & Development Tax Incentive Boosts Cash Position
In a modest positive, Nexalis received $490,000 in Research & Development Tax Incentive proceeds following the lodgement of its 2025 income tax return, providing some financial relief amid the funding challenges.
Bottom Line?
Nexalis faces a critical juncture as it recalibrates clinical priorities without secured funding, making upcoming financing developments pivotal for its drug development trajectory.
Questions in the middle?
- Will Nexalis secure alternative funding to resume suspended clinical trials?
- How will the company address patient recruitment hurdles in the IRX-211 Phase 2 trial?
- What impact will a scaled Phase 2 trial for IRX-616a have on timelines and costs?
