At the end of last year, Opthea had US$132 million in cash, with those funds sufficient to fund operations into the third quarter of this year (post results). Its cash needs are expected to remain at around US$35 - US$40 million a quarter as it prepares for commercial launch. Around 100 people are expected to sell the therapy when approved into 40 territories in the US.

 

Wet AMD landscape is legacy-heavy

Pending positive results, the company aims to file its marketing application (BLA) in the first half of next year and potential approval by late 2026, with the company being given fast track designation by the FDA.

Just 1,400 physicians drive 80% of injection volume, and just three therapies – Vabysmo, Eylea + HD, and Avastin – account for 90% of all injections. Biosimilars have had significant difficulty penetrating the wAMD market. Around 90% of wAMD US patients are covered under Medicare.

According to the company at a recent briefing, there are no other companies with drug candidates in the clinic that target VEGF-C, which is one of the targets for sozinibercept.

 

Opthea's future looks bright

Opthea wants to retain US rights. One disappointing outcome with this company is that there have been no ROW licensing deals completed so far.

Also, sozinibercept will need to be delivered as a separate second injection, with co-formulation studies (combining sozinibercept with a VEG-A inhibitor such as Lucentis into the one injection) still at the feasibility stage, even though funds were directed to this project as early as 2021.

Opthea's share price has increased by 191% this financial year in anticipation of the Phase 3 results. Opthea is capitalised at $1.2 billion.

Bioshares recommendation: Take Profits

 

 

 

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