Opthea Limited, a clinical-stage biopharma company developing novel therapies to treat highly prevalent and progressive retinal diseases, has announced a non-dilutive financing transaction for up to US$170 million from investment funds working with Launch Therapeutics (Launch Tx) to finance and advance the ongoing phase 3 clinical trials and pre-commercialization activities of OPT-302 for wet age-related macular degeneration (wet AMD).
Under the terms of the agreement, the funds managed by Carlyle and Abingworth, in collaboration with Launch Tx, will commit $120 million in three installments at fixed time points and retain an option to commit another $50 million, representing total funding of up to $170 million for Opthea.
If OPT-302 is approved in a major market, Opthea will make a milestone payment after regulatory approval and then six subsequent annual fixed success payments and variable success payments of 7% of net sales, with cumulative payments capped at four times the amount funded to Opthea. Opthea retains full worldwide commercial rights for OPT-302 and has the option to prepay its obligations in full at any time.
“Opthea is thrilled to enter this strategic arrangement with Launch Tx, and to receive funding from world-leading investors in Carlyle and Abingworth. This strategic transaction is expected to fund us through phase 3 topline data expected in mid-2024 and strengthens our strategic position to maximize the value of OPT-302,” said Megan Baldwin, CEO at Opthea.
“This transaction with Launch Tx is non-dilutive for shareholders of Opthea, and we are proud to have been selected as Launch Tx’s first partner since its formation.”
Anshul Thakral, CEO of Launch Tx, said: “We are excited to partner with Opthea on OPT-302, a novel drug candidate that has demonstrated superior visual acuity in phase 2 trials over standard of care anti-VEGF-A therapy in patients with wet AMD. With this collaboration, we will advance OPT-302 through its ongoing phase 3 trials and hope to reach regulatory approval in a timely manner, with the intention of bringing this important medicine to patients in need.
“At Launch Tx, we are committed to working with pharma and biotech partners to expedite late-stage drug development programs. We do this by designing innovative funding models tailored to our partners’ specific needs and leveraging our extensive clinical development, regulatory, and commercialization expertise as needed. This partnership with Opthea is a great example of one such model.”
OPT-302 is a first-in-class intravitreally administered biologic “trap” inhibitor of vascular endothelial growth factors C (VEGF-C) and D (VEGF-D) currently being investigated in two concurrent phase 3 pivotal registrational trials that will each enroll ~990 treatment naïve patients, in combination with two approved anti-VEGF-A treatments, ranibizumab (ShORe trial) and aflibercept (COAST trial).
It is a soluble form of vascular endothelial growth factor receptor (VEGFR)-3 expressed as an immunoglobulin G1 (IgG1) Fc-fusion protein. It binds and neutralizes the activity of vascular endothelial growth factor (VEGF)-C and VEGF-D on their endogenous receptors, VEGFR-2 and VEGFR-3. Targeted inhibition of VEGF-C and VEGF-D can prevent blood vessel growth and vascular leakage, which contribute to the pathophysiology of retinal diseases including neovascular “wet” AMD.
OPT-302 has the potential to be positioned as complementary and agnostic with any combined anti–VEGF-A therapy for the treatment of wet AMD, a strategy intended to maximize the commercial opportunity for the therapy.
Global expert in the treatment of retinal diseases and chief investigator for the phase 3 COAST study, Charles Wykoff, director of research, Retina Consultants of Texas, said: “In a treatment landscape increasingly crowded with biosimilars and long-acting VEGF-A inhibitors, it is exciting to contribute to the advancement of OPT-302, the only investigational agent in late stage development with the potential to improve vision outcomes over standard of care for patients with wet AMD.”