Highlights

  • Ceryvyn Therapeutics (ASX:CYV), formerly Opthea, pivoted to a rare lung disease programme after its 2025 Phase 3 ophthalmology failure.
  • CYV-101 is being developed as an inhaled treatment for lymphangioleiomyomatosis, with preclinical Stage 1 studies on schedule.
  • The FY26 Annual Report showed $30.0 million in cash at 30 June 2026, with no debt, to fund the programme.
  • The company reported a $330.4 million profit in FY26, driven by a non-cash accounting gain, not operating revenue.

Opthea's Phase 3 failure in wet age-related macular degeneration in 2025 left a company, a management team and a drug — but no clear path forward. Ceryvyn Therapeutics (ASX:CYV) is the answer to that question. Under a new name and a narrowed focus, the company is redirecting CYV-101 from the eye to the lung, targeting a rare disease called lymphangioleiomyomatosis and leaning on $30 million in remaining cash to find out whether the science holds up.

What the Company Does Now

Ceryvyn describes itself as a clinical-stage biopharmaceutical company. CYV-101 is a fusion protein designed to bind and neutralise VEGF-C and VEGF-D, two growth factors linked to abnormal growth of lymphatic vessels. Lymphangioleiomyomatosis, or LAM, is a rare progressive disease that damages lung function; current treatments manage symptoms rather than address the underlying cause.

Management is developing an inhaled, nebulised formulation to deliver the drug directly to the lungs. Stage 1 of the programme covers preclinical biology and inhalation studies, including early animal safety and tolerability work, run through rare disease partners. The June 2026 Quarterly Report confirmed Stage 1 remained on schedule.

The Numbers Behind the Reset

The annual report for the year to 30 June 2026, signed on 31 August 2026, shows how dramatically the company has been restructured. Ceryvyn reported a profit after tax of A$330.4 million, against a loss of A$251.1 million a year earlier. That profit was driven by a A$357.1 million accounting gain from derecognising a Development Funding Agreement — not by trading activity.

Research and development expense fell to A$2.2 million from A$193.8 million. Administrative expenses fell to A$9.7 million from A$48.2 million. Cash was A$30.0 million at 30 June 2026 with no debt, down from A$73.9 million at the prior year end; operating cash outflow for the year was A$12.5 million. No Dividend was paid, recommended or declared.

Corporate Milestones

ASX trading resumed on 3 June 2026. Shareholders approved the name change on 3 July 2026 and the company began trading under the CYV code on 9 July 2026. Jeremy Levin is interim Chair and CEO; the board intends to appoint a permanent chief executive. A scientific advisory board has been formed, co-chaired by Professor Deborah Yates of Sydney and Professor Frank McCormack of Ohio. A new US provisional Patent application covers nebulised VEGF inhibitors for pulmonary diseases including LAM.

Risks and What to Watch

CYV-101 remains preclinical in LAM — no clinical data in patients has been reported. The company plans a stage-gated approach with predefined stop criteria, targeting assessment of target engagement, biological activity and safety over roughly 18 months. Capital needs for later stages have not been disclosed. The programme is said to be funded from existing cash, but there is no other committed external funding; Research and Development tax rebates are confirmed only for FY26 and FY27; and patent protection currently rests on provisional filings that must later be converted. Interim Leadership adds execution risk. The main milestones to watch are Stage 1 results, the appointment of a permanent CEO and any board decision to progress to the next stage.