Highlights

  • Ceryvyn selected an Australian trial contractor after quarter-end, although its master services agreement and statements of work remain unfinished.
  • The company signed imaging contracts with Polarian while continuing Stage 1 preclinical biology and animal inhalation studies for CYV-101.
  • Ceryvyn held A$27.463 million at September-end, compared with A$30.021 million in June, and reported no debt facilities available.
  • The board will assess scientific, operational and capital criteria before advancing the programme, which reports no human LAM efficacy data.

A contractor selection and imaging agreement have moved Ceryvyn Therapeutics Limited’s (ASX:CYV) planned lung disease programme forward, while the treatment itself remains in preclinical work. The September 2026 quarterly update reports A$27.463 million in cash and preparation for a signal-finding study in lymphangioleiomyomatosis, or LAM. Human dosing and clinical efficacy findings are not reported.

Inhaled Programme Follows Opthea Reset

Formerly Opthea, Ceryvyn redirected its lead asset after the Phase 3 COAST and ShORe eye-disease trials failed to demonstrate efficacy in March 2025. Trading resumed in June 2026, and the name change took effect on 6 July.

CYV-101 is a fusion protein designed to bind and neutralise VEGF-C and VEGF-D. These signalling proteins are linked to abnormal lymphatic vessel growth. The company is developing an inhaled approach for LAM, a rare progressive disease mainly affecting women.

Stage 1 examines nebuliser delivery, biological activity in relevant models and preliminary safety and tolerability in animal inhalation studies. Management describes that work as on track.

Study Preparation Remains Conditional

Ceryvyn signed contracts with Polarian for hyperpolarised xenon-129 magnetic resonance imaging in the planned clinical programme. The imaging is intended as an early signal-finding measure, rather than a substitute for evidence of clinical benefit.

Following a request-for-proposal process, the company selected an Australian contract research organisation after quarter-end. Final agreements remain open. Planned work covers protocol development, ethics submission preparation, site feasibility, nebulised dosing materials and safety committee support.

The Scientific Advisory Board met on 20 October and supported the imaging approach and programme progression, subject to Stage 1 requirements. A patient engagement strategy has also been developed with advisers.

The three-stage programme requires board review against predefined scientific, operational and capital allocation criteria. Final Stage 2 scope and budget will depend on participant numbers, sites and imaging requirements.

Cash Supports Work with Spending Qualifications

September cash declined from A$30.021 million at June-end to A$27.463 million. Net operating cash outflow was A$2.364 million, compared with approximately A$1.1 million in the preceding quarter.

Research and development payments totalled A$925,000, administration and corporate costs A$1.781 million, and interest received A$277,000. Foreign exchange reduced cash by A$194,000. No financing activity occurred, and no debt facilities were available.

The estimated 11.6 quarters of funding assumes spending remains at the latest quarterly rate. It does not fix the cost of a later-stage clinical programme.

FY26’s A$330.4 million after-tax profit principally reflected a A$357.1 million gain on derecognition of a funding agreement; the operating loss was A$11.9 million. That accounting gain is separate from treatment progress and current cash resources.

The next steps are continuing preclinical studies, finalising contractor terms and completing the study protocol. None has a published completion date.