Opthea, the Australia-based biopharma developing a novel therapy to treat exudative retinal diseases, closed out a busy summer with a US Securities and Exchange Commission (SEC) filing for an initial public offering (IPO) said to be valued at $150 million.
The cash would give Opthea a boost in developing OPT-302, the inhibitor of vascular endothelial growth factor (VEGF) C and D to block the abnormal growth and leakage of blood vessels that cause vision loss in wet age-related macular degeneration (AMD) and diabetic macular edema (DME). Opthea is developing OPT-302 to be used in combination with anti-VEGF-A therapies such as Lucentis (ranibizumab, Genentech/Roche) and Eylea (aflibercept, Regeneron Pharmaceuticals). The idea is to target a broader cascade of overexpressed VEGF proteins.
A Burst of Activity
The SEC filing caps a frenetic summer for Opthea. In late August, the company completed meetings with the US Food and Drug Administration and the European Medicines Agency to discuss OPT-302 Phase III clinical trials and associated manufacturing processes.
A few days later, the company announced that it had submitted a draft registration statement to the SEC for a potential IPO of American depository shares (ADS) in the US, a prelude to the formal IPO filing. Its ordinary shares would remain listed on the Australian Securities Exchange (ASX) with a concurrent listing on Nasdaq.
The US IPO is intended to support product development, including those Phase III trials. Fierce Biotech estimated the US IPO would raise around $150 million.
If share price is any indication, the combination of news has had an impact. Opthea’s share price rose after both announcements, including a spike from $AU2.33 up to $AU2.55 on August 21. Over the past few weeks shares have steadily climbed to break the $AU3 mark this week. The trend of ophthalmology drugs generally shrugging off the COVID-19 effect that characterized setbacks in Q2 prices may also play a role in the growth of its share price.
DME and wet AMD have unmet needs in the retinal disease space. About 45% of wet AMD patients show some resistance to current treatment, including suboptimal vision improvement and persistent retinal fluid. Opthea hopes to improve these outcomes with its combination therapy.
Opthea plans to run two concurrent multicenter, randomized, sham-controlled studies evaluating OPT-302 in combination with Lucentis (the “ShORe” study) and Eylea (the “COAST” study). Each trial will compare the efficacy of the combination therapy with a four- or an eight-week dosing regimen of either agent alone.
Opthea intends to enroll 900 patients worldwide for the studies. After one year, each patient will receive treatment for an additional year so Opthea can evaluate safety and tolerability over a two-year period.
“We remain focused on further demonstrating, in our Phase III program, the potential of OPT-302 combination therapy as a novel and transformative treatment for wet AMD patients suffering vision loss,” said Opthea CEO Megan Baldwin, PhD, MAICD, in a press release.
“The analysis approach for our Phase III clinical trials allows the initial analysis of outcomes to be evaluated in the patient group which, based on data from our Phase IIb trial, would be expected to have the best response to OPT-302 combination therapy,” she continued.
“Further pre-specified statistical analyses also allow us to evaluate the primary endpoint in the total patient population including minimally classic, occult, and predominantly classic lesions, which maximizes the commercial opportunity for OPT-302. We believe this approach achieves the highest probability of success for our Phase III program and commercialization strategy.”
Wet AMD accounts for about 10% of AMD patients but 90% of legal blindness. According to National Institutes of Health data, AMD affects about 2 million people in the US. That’s expected to climb to about 3.5 million by 2030 and to nearly 5.5 million by 2050.
Citigroup and SVB Leerink are acting as joint bookrunning managers for the IPO. Oppenheimer & Co. and Truist Securities are acting as lead managers.