Highlights

  • Preclinical nebulisation feasibility work on CYV-101 is on track.
  • Contracts were signed with Polarian to use xenon-129 MRI imaging in the planned clinical program.
  • An Australian-based CRO was selected after the quarter to support Stage 2.
  • Cash stood at $27.5 million, with an estimated runway of about 11.6 quarters.

Ceryvyn Therapeutics Limited (ASX:CYV) has released its quarterly activity report and Appendix 4C for the three months ended 30 September 2026. The company progressed its lead program, CYV-101, for lymphangioleiomyomatosis (LAM), a rare and progressive lung disease that mainly affects women.

CYV-101 Program Overview

CYV-101 is a first-in-class fusion protein designed to bind and neutralise VEGF-C and VEGF-D, targeting pathological lymphangiogenesis. The LAM program is structured in three stages, with Stage 1, covering preclinical biology and inhalation studies, currently underway. Progression between stages depends on predefined scientific, operational and capital allocation criteria reviewed by the Board.

During the quarter, preclinical feasibility work on nebulising the CYV-101 formulation remained on track, and preliminary animal inhalation safety and tolerability studies are ongoing.

Imaging Partner, CRO and Advisory Board

Ceryvyn signed contracts with Polarian to use hyperpolarised xenon-129 MRI in its planned clinical program. The radiation-free imaging method is intended as an early signal-finding tool. After the quarter, an Australian-based contract research organisation with international capability was selected to support Stage 2, with a Master Services Agreement still to be finalised.

The company's inaugural Scientific Advisory Board meeting was held on 20 October 2026. The board discussed CYV-101's biological rationale, the proposed Australian study design and patient selection, and endorsed xenon MRI as an appropriate primary early signal-finding measure. A Patient Engagement Strategy was also developed with input from patient advisers.

Financial Position and Next Steps

Cash and equivalents stood at $27.5 million at 30 September 2026, down from $30.0 million at 30 June. Operating cash outflow for the quarter was $2.4 million, including $0.9 million on research and development. The company has no debt facilities and estimates about 11.6 quarters of funding.

Next steps include finalising agreements with the selected CRO, refining the study protocol using Scientific Advisory Board recommendations, completing Stage 1 preclinical requirements and a Board review of stage progression criteria.

Key Takeaways

  • Ceryvyn is advancing CYV-101 as a potential treatment for the rare lung disease LAM.
  • Key partners for imaging and clinical research have been selected.
  • The Scientific Advisory Board endorsed the proposed imaging approach.
  • A cash balance of $27.5 million supports the program through its next stages.