Australian company Opthea (ASX:OPT) has announced it is seeking to raise approximately $227.3 million to advance the late-stage development of OPT-302 (sozinibercept), a drug for progressive retinal diseases, including wet age-related macular degeneration.
The company said it expects the net proceeds with cash on hand to fund the anticipated Phase 3 topline data readouts for COAST (Combination OPT-302 with aflibercept Study) and ShORe (Study of OPT-302 in combination with aanibizumab).
The company said the funds will be used to progress chemistry, manufacturing, and controls activities, prepare Biologics License Applications for FDA approval, and for general corporate purposes.
Based on the completion of enrollment in COAST in February 2024 and ShORe in May 2024, as well as Opthea’s internal expansion of its clinical development team, the topline data readout of COAST is now accelerated to early in the second calendar quarter of 2025, and the topline data readout for ShORe is anticipated in mid-calendar year 2025.
The $227.3 million capital raise comprises $10.0 million via a placement and $217.3 million via an entitlement offer.
Opthea is led by former Novartis Australia head and Medicines Australia board member Fred Guerard.
“This institutional Placement and Entitlement Offer will strengthen Opthea’s cash position, and we expect to fund operations through the anticipated topline data readouts of both our pivotal trials, which have enrolled a total of 1,984 wet AMD patients. Opthea also plans to complete the manufacturing of the commercial-scale drug batches required for the BLA,” he said Fred Guerard.
“We are excited about the potential for sozinibercept to become the first treatment in over 15 years to demonstrate superior vision outcomes in wet AMD when combined with standard-of care anti-VEGF-A therapies.”
Sozinibercept is a novel, first-in-class VEGF-C/D ‘trap’ designed to be used in combination with standard-of-care anti-VEGF-A therapies. VEGF-C and VEGF-D are known to independently stimulate retinal angiogenesis and vascular leakage and permeability, while VEGF-A inhibition can also lead to the upregulation of VEGF-C and VEGF-D.
"Research shows that the targeted inhibition of VEGF-C and VEGF-D with sozinibercept can prevent blood vessel growth and vascular leakage, which both contribute to the pathophysiology of retinal diseases, including wet AMD," said Opthea.