- 01CYV-101 advanced toward inhalation testing for LAM.
- 02Xe-MRI planned for proposed Australian study.
- 03Ceryvyn held $27.5m cash at quarter-end.
Ceryvyn Therapeutics (ASX: CYV) has advanced preclinical development of CYV-101 for lymphangioleiomyomatosis (LAM), a rare progressive disease that predominantly affects women and damages lung function.
The September quarter work centred on biological assessment and inhalation studies designed to establish whether the treatment formulation can be delivered through a nebuliser.
The biotechnology developer has also contracted Polarian to introduce specialist lung imaging into its proposed Australian clinical study, as it prepares the next stage of development.
Ceryvyn finished September with $27.5 million in cash and equivalents, providing funding for the staged program while its progression remains subject to scientific, operational ,and capital allocation criteria.
Testing Inhaled Treatment
CYV-101 is a fusion protein designed to bind and neutralise vascular endothelial growth factors C and D, signalling proteins implicated in the abnormal lymphatic vessel growth associated with LAM.
Stage 1 involves preclinical biology, nebulisation feasibility, and preliminary safety and tolerability work in animal inhalation studies, supported by specialist rare disease partners.
The inhalation approach is intended to direct development towards the lung-related burden of LAM, for which currently available therapies do not provide a cure.
Researchers are continuing to assess disease-relevant biological effects and the feasibility of delivering the formulation through nebulisation before decisions on progression.
The overall development plan comprises three stages, with advancement dependent on predefined milestones reviewed by the board.
Imaging and Trial Preparations
Under the Polarian agreement, the proposed study would use hyperpolarised xenon-129 magnetic resonance imaging (Xe-MRI ) to measure regional lung ventilation and gas exchange without radiation exposure.
Ceryvyn expects the technology could identify early physiological changes during treatment alongside conventional pulmonary function tests, although it is not an established substitute for demonstrating clinical benefit.
Following a request for proposal process during the quarter, the developer selected an Australian-based contract research organisation (CRO) with international capabilities after quarter-end.
The proposed CRO engagement covers protocol and ethics preparations, clinical site assessment, participant and pharmacy materials, medical monitoring and support for data management and analysis.
A master services agreement and individual work scopes remain to be finalised as Ceryvyn determines participant numbers, site requirements, imaging arrangements and the study budget.
Inaugural SAB Meeting
Ceryvyn convened its inaugural scientific advisory board (SAB) meeting on 20 October, bringing together expertise in LAM, pulmonary medicine, patient care, and translational research.
The SAB supported Xe-MRI as an early signal-finding measure and discussed patient selection, study design, and lung function assessment, while also making further progress conditional on completion of Stage 1 requirements.
Patient advisers are also informing engagement initiatives intended to reflect disease burden, participation demands, and accessible communication about clinical research.
Quarterly operating cash outflow was $2.4m compared with $1.1m in the preceding quarter, including $0.9m in research and development expenditure and $1.8m in administration and corporate payments, partly offset by $0.3m in interest income.
The cash balance declined from $30.0m at the end of June, with the company reporting an estimated 11.6 quarters of funding at the September operating cash expenditure rate.
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