Ceryvyn Therapeutics Resumes ASX Trading, Advances CYV-101 LAM Program with Expert Scientific Advisory Board

ASX Trading Reinstatement and Corporate Rebranding Finalised

Ceryvyn Therapeutics Limited reached a key corporate milestone in Q4 FY26 by having its securities reinstated to ASX trading on 3 June 2026. This followed the company’s strategic pivot to advance CYV-101 for treating lymphangioleiomyomatosis (LAM), a rare pulmonary disorder. Shareholders approved the company’s name change from Opthea Limited to Ceryvyn Therapeutics Limited at an Extraordinary General Meeting on 3 July 2026. Trading under the new ticker 'CYV' commenced on 9 July 2026, marking the start of its new operational phase under the updated brand.

The rebranding reflects the company’s renewed strategic focus on rare disease therapeutics, shifting away from its prior pipeline to concentrate exclusively on innovative treatments for rare conditions. This process underscores Ceryvyn’s commitment to establishing a clear market identity aligned with its clinical development priorities and shareholder expectations.

Advancement of CYV-101 Preclinical Development Program

Ceryvyn’s lead program, CYV-101, is a novel fusion protein designed to selectively bind and neutralise VEGF-C and VEGF-D, key proteins implicated in pathological lymphangiogenesis. The company is investigating nebulised delivery of CYV-101 to target the lungs, addressing the primary clinical manifestations of LAM. In Q4 FY26, Ceryvyn progressed Stage 1 preclinical biology and inhalation studies, conducted by specialised rare disease partners, remaining on schedule.

Stage 1 includes detailed evaluation of LAM-relevant biological effects and initial safety and tolerability assessments in animal inhalation models to guide further development. The nebulisation feasibility studies aim to confirm effective delivery of CYV-101 to lung tissue, potentially offering clinical benefits for patients with pulmonary LAM. The three-stage development framework incorporates predefined scientific, operational, and capital criteria at each checkpoint, with Board oversight ensuring robust evidence-based progression.

Formation of Scientific Advisory Board with Leading LAM Specialists

Ceryvyn has established a Scientific Advisory Board (SAB) to provide independent scientific and clinical guidance for the LAM program. The SAB includes internationally recognised experts in LAM, pulmonary medicine, and translational research. Founding co-chairs are Professor Deborah Yates (Sydney, Australia) and Professor Frank McCormack (Ohio, USA), with Dr Elizabeth Daugherity (Texas, USA) completing the panel.

This expert group brings extensive knowledge of LAM biology, patient management, and translational science, directly supporting Ceryvyn’s staged development approach. Their guidance will enhance clinical trial design, biomarker selection, patient stratification, and regulatory strategies, providing independent oversight to strengthen the program’s scientific rigor.

Refined Intellectual Property Strategy with New US Provisional Patent

In Q4 FY26, Ceryvyn refined its intellectual property approach by withdrawing two prior US provisional patent applications filed in August 2025 and submitting a new US provisional patent application focused on nebulised VEGF inhibitors for pulmonary diseases including LAM.

This strategic refocus aims to secure stronger patent protection around the nebulised delivery of CYV-101, highlighting this mechanism as a key differentiator. Provisional patent filings establish priority while allowing further development before conversion to permanent patents.

Strong Financial Position with AUD $30 Million Cash Reserves

As of 30 June 2026, Ceryvyn held AUD $30.0 million in cash and equivalents, down from AUD $31.2 million at 31 March 2026. The quarterly cash decrease of AUD $1.2 million reflects operating expenses. Operating cash outflow for Q4 FY26 was AUD $1.1 million, improved from AUD $1.5 million in the previous quarter.

R&D expenses for the quarter were AUD $0.1 million, with administration and corporate costs at AUD $1.2 million. No personnel expenses were recorded during this period. Interest income amounted to AUD $0.2 million, and Director payments totalled AUD $0.3 million per ASX Listing Rule 4.7C.3. For the full year ending 30 June 2026, R&D expenses were AUD $13.127 million, administration and corporate costs AUD $7.499 million, and government grants and tax incentives totalled AUD $10.968 million, resulting in a net operating cash outflow of AUD $12.5 million.

Lymphangioleiomyomatosis: A Significant Market with Unmet Medical Needs

Lymphangioleiomyomatosis (LAM) is a rare, progressive systemic disease primarily affecting women, characterised by lung involvement leading to deteriorating lung function. The disease is driven by abnormal lymphangiogenesis. Current treatments provide symptomatic relief but no cure, leaving a substantial unmet need.

CYV-101 targets VEGF-C and VEGF-D, proteins fundamental to LAM progression, offering a differentiated therapeutic approach. Nebulised delivery aims to target the lungs directly, potentially enhancing efficacy while reducing systemic exposure. This lung-focused strategy aligns with LAM’s clinical burden and benefits from regulatory incentives available for rare diseases.

Structured Three-Stage Development Framework

Ceryvyn’s CYV-101 program is organised into three development stages, with Stage 1 preclinical biology and inhalation studies currently in progress. Specific timelines, scientific endpoints, and capital needs for Stages 2 and 3 have not been disclosed. Progression depends on data review against predefined scientific, operational, and financial criteria, overseen by the Board.

This stage-gate model allows flexible, data-driven decision-making to manage risks and capital efficiently. The company plans to provide market updates as the program advances and key milestones are achieved.

Outlook and Anticipated Milestones

Looking ahead, Ceryvyn’s LAM program continues Stage 1 activities, with progression to subsequent stages contingent on Board-reviewed criteria. While no specific timelines have been announced, investors may anticipate updates on preclinical biology and inhalation study completions.

The company commits to ongoing market communications as milestones are reached. Potential near-term catalysts include completion of animal inhalation studies, scientific conference presentations, regulatory engagements, and Board decisions on Stage 2 initiation. With AUD $30.0 million in cash and a quarterly burn rate of approximately AUD $1.1 million, Ceryvyn is positioned to fund program advancement for a significant period, though no specific cash runway guidance has been provided.

Focused Biopharmaceutical Strategy Addressing Unmet Needs

Ceryvyn Therapeutics operates as a clinical-stage biopharmaceutical company dedicated to translating human biology advances into transformative medicines for serious diseases. Its strategy prioritises targeting biological mechanisms driving disease, focusing on VEGF-C and VEGF-D pathways in LAM.

The company’s mission emphasises scientific excellence, rigorous clinical development, and improving patient outcomes while creating sustainable shareholder value. The formation of a Scientific Advisory Board with global experts reflects this commitment. The strategic pivot to LAM and rebranding as Ceryvyn Therapeutics underscores a focused dedication to rare disease development, a sector offering less competition and regulatory incentives such as orphan drug designation.