Key Highlights

  • Ceryvyn Therapeutics Ltd (ASX:CYV) shares closed at $0.011 on 21 October 2026, up 10.00%.
  • FY26 profit after tax was A$330 million, driven by a A$357 million gain on derecognition of the Development Funding Agreement.
  • Cash at 30 June 2026 was A$30.0 million with no debt, and the lead program CYV-101 is in the pre-clinical stage for LAM.

Ceryvyn Therapeutics Limited (ASX:CYV), formerly Opthea Limited, shares rose 10.00% to close at $0.011 during the trading session on 21 October 2026, while the S&P/ASX 200 (XJO) stood at 8,809.20, down 7.70 points or 0.087%. Ceryvyn is an Australian clinical-stage biotechnology company developing targeted therapies for serious diseases, with an initial focus on lymphangioleiomyomatosis (LAM).

What Ceryvyn Therapeutics does

Ceryvyn’s lead program is CYV-101, a first-in-class fusion protein designed to bind and neutralise VEGF-C and VEGF-D, signalling proteins that activate VEGFR-3. The molecule was previously known as OPT-302 and was developed for ophthalmology. The company is now developing CYV-101 as an inhaled therapy for LAM, a rare, chronic and progressive lung disease that predominantly affects women.

The company says it is pursuing a stage-gated development strategy with predefined scientific, operational and capital-allocation decision points, funded from existing cash. VEGF-D is already used clinically as a diagnostic biomarker in LAM.

FY26 results

Separately from the day’s trading, Ceryvyn’s Appendix 4E for the year ended 30 June 2026, dated 31 August 2026, is outlined below. Profit attributable to owners was A$330.4 million, compared with a loss of A$251 million in the prior year. The company attributed the profit to a A$357 million gain on derecognition of the Development Funding Agreement (DFA) associated with its previous ophthalmology program.

Net tangible assets per ordinary security were 2.16 cents, compared with negative 24.93 cents a year earlier. No dividends were paid, recommended or declared, and the financial statements received an unmodified audit opinion.

Balance sheet and cash

At 30 June 2026, Ceryvyn held A$30.0 million in cash and cash equivalents with no debt, down from A$73.9 million a year earlier, after a net decrease in cash of A$43.4 million during the year. Total assets were A$31.9 million, and net assets were A$29.6 million compared with net liabilities of A$306.9 million at 30 June 2025.

The company stated that settlement of the DFA removed a substantial liability, restored its solvency and allowed the Board to review strategic alternatives, which included returning capital to shareholders, acquisitions, a merger or redeploying existing assets into a new indication.

Strategic direction: CYV-101 in LAM

Following the review, the Board decided to redirect CYV-101 toward LAM. It cited an extensively characterised molecule with a substantial clinical safety database, previously manufactured commercial-scale drug supply, a manufacturing and chemistry package, and about US$120 million (A$179 million) previously invested in manufacturing and development.

During the year, the company began developing an inhaled formulation for direct lung delivery, and plans to progress preclinical work and engage with regulators. The report states the LAM program is in the pre-clinical stage, with no regulatory approval.

Disease background and positioning

LAM mainly affects women and involves the lungs, leading to progressive loss of lung function, and the company states there is no cure and substantial unmet need remains. Ceryvyn says CYV-101 is intended to determine whether direct inhibition of the VEGF-C/D–VEGFR-3 pathway can modify disease biology while complementing current standard of care, which acts through the mTOR pathway.

The report also states that there is currently no indication that competitors are developing comparable technology or will commercialise more quickly, while acknowledging that the biotechnology industry is highly competitive and subject to rapid change.

Sector context

Rare-disease programs can qualify for orphan drug incentives and often rely on specialist clinical centres and biomarkers to inform trial design. Biotechnology development is subject to long timelines, regulatory processes and capital needs. The report notes that the value of Ceryvyn’s quoted shares was materially affected by the results of the Phase 3 COAST and ShORe trials in March 2025, which did not demonstrate efficacy of sozinibercept in wet age-related macular degeneration.

Risks and uncertainties

The report states there is no guarantee of success in a LAM patient trial and no assurance the company’s strategic, clinical or financial objectives will be achieved. The program is pre-clinical, and the FY26 profit arose from a non-cash gain on derecognition of the DFA rather than operating revenue. Cash fell during the year, and further funding may be needed. The shares are priced at $0.011 and can move sharply. The documents discussed are dated 31 August 2026.

What’s next

Ceryvyn plans to progress the inhaled CYV-101 formulation, complete necessary preclinical work and engage with regulatory authorities, with progression through each development stage dependent on the quality of the scientific data rather than predetermined timelines.