SMH article, page-5

Bioshares provided an update on Opthea this week. Nothing particularly new.
Here is a brief summary. Megan Baldwin attended meetings earlier this month around the JP Morgan Healthcare Conference in San Francisco. She took the opportunity to meet with potential pharmaceutical partners and investors. Baldwin said it was a really great meeting for the company. There was increased interest this year in Opthea from investors for two reasons. The first is that Opthea has advanced into clinical studies with its lead drug candidate OPT-302 for the treatment of wet AMD. Opthea has released positive Phase I- study data from 20 patients with data from an additional 31 patients in a Phase IIa study due to be released in Q1 this year. The results from the Phase I/IIa study out this quarter will have data on 51 patients, which should give reasonable information around both safety and efficacy. Another driver of investor interest in the US has been due to the setback experienced last year from a competing drug candidate Fovista from Ophthotech Corporation. Ophthotech's drug, Fovista, failed in two Phase III studies in AMD, combining Fovista with Lucentis. That result puts a serious question mark over the approach of blocking the PGDF pathway in treating wet AMD, which works strongly in Opthea's favour. Baldwin said that meetings with corporates (potential biotech/ pharmaceutical partners) was with those already on its list, with the meeting an opportunity to maintain dialogue and update on progress. Opthea expects to move into Phase IIb studies in the second half of this year. Results from the Phase IIa study will be used to inform the design of the Phase IIb trial (with respect to study size and achieving statistically significant outcomes). While the regulatory standard is to focus on treatment naïve patients, the company may also seek to build data around combination treatment of patients who have previously been treated with VEGF-A inhibitor therapy (Lucentis or Eylea). Baldwin said that the Phase IIb study will be statistically powered and will be conducted to a globally relevant standard that will see the trial and the company recognised internationally. The Phase IIb study will be conducted in the US and Europe, and potentially Australia. Opthea is funded to conduct a “good sized” study according to Baldwin.

Perhaps the last comment leaves the door slightly ajar in terms of if a larger study was to be looked at then a capital rising would be required