Company Interview / Opthea's ASX300 inclusion boosts visibility

Key points:

Inclusion in the S&P ASX 300 index boosts visibilityPivotal clinical trials for retinal therapies in final stagesTargeting FDA approval and US launch by end of 2026

Fred Guerard from Opthea discusses the company’s inclusion in the S&P ASX 300 index, calling it a significant milestone for a small-cap company. This achievement is expected to attract more institutional shareholders and enhance market visibility.

Fred shares updates on Opthea’s pivotal clinical trials for retinal disease therapies, which are in the final stages. These trials involve around 1,000 patients per trial globally. They’re comparing Opthea’s drug in combination with existing leading drugs to the standard of care alone.

Opthea is focused on treating wet age-related macular degeneration and diabetic retinal degeneration. Fred notes that FDA approval might be secured by the end of 2026, targeting the US for the initial launch.

Full unedited transcript below:

0:00

Let's get into company news. Opthea, a clinical stage biopharmaceutical company developing therapies for retinal diseases, added to the S&P ASX 300 index and to discuss the milestone, Andrew spoke earlier with Fred Gerard, CEO of Optima. Quite a milestone for us as a small cap company to be included in that very prestigious list of the largest companies in Australia. So now it is a big step towards, uh, reflecting the real value of the company. Um, and, uh, we're very glad we could achieve it before our top line data. What will it do, do you think? Just encouraging further investment and value to your company, given that perhaps some institutional shareholders will now take a look?

0:43

Yeah, that's going to certainly broaden the base of our shareholders because, um, in the in the past we for some of them, our market cap was maybe a bit too small. And now clearly being part of that club, uh, allows a lot more investors to have a look at our technology and decide, you know, if it's the type of investment they want to make. So, um, that's very good news for us. So can you bring us up to date with the development of your therapies for the treatment of retinal diseases? And what's the latest?

1:17

Yes. So we are in the middle of our pivotal program, which is the last stage of clinical research we need to do to get approved by the different authorities around the world, including the FDA in the United States, which, as you know, is the largest market. Uh, this is a very large, uh, set of two trials that is currently ongoing, around 1000 patients per trial. And these trials are conducting around the world. We have sites in, you know, everywhere in every continent. And, um, uh, we have, uh, two slightly different studies. The first one is, uh, comparing our drug in combination with the largest selling, uh, drug in that disease compared to, uh, that other drug alone. So basically comparing the combination with our product also

2:08

compared to the standard of care Alone, and the second trial is done with another drug called Lucentis. Uh, first trial will read out in the early second quarter of calendar year 2025. And the second trial we read out, uh, around the middle of calendar year 2025. So big, big milestones coming our way.

2:29

And how would you describe the progress there, just in terms of how well funded you are for those trials and, uh, and candidate patients being enrolled?

2:41

Yes. So on the back of very positive face to be data that has demonstrated superiority versus standard of care, we are now fully funded, uh, to deliver the data, the topline data required for us to file the licensing application in the United States and other territories. So, uh, we have enough cash into the third quarter of calendar year 2025, uh, which is beyond our second topline data. So essentially, then you're focused on the treatment of wet age related macular degeneration. Let's first take that. What is that exactly?

3:21

So that's a disease which is actually not uncommon in the elderly patients. Normally people over the age of 7075 get get affected for reasons we don't quite understand. There is no, uh, biologic marker. Uh, it just happens. Uh, it seems to happen a bit more for people who were smokers before. But basically, you start losing the center of your vision and you start having distortions of straight lines that become they become kind of rounded. And then over time, these dark spots in the center of the vision will grow. And this is the leading cause of blindness in developed countries around the world. So millions of people are affected. Uh, drugs exist. Uh, they've been launched for the last 20 years, but nobody has been able to demonstrate superior efficacy, uh, compared to these drugs that are now quite old and going generic around the world. So we would be the first drug approved. uh, to deliver

4:21

basically better visual outcomes for these patients. These drugs allow the patients to recover some vision, but not all. So what we are trying to do with our drug

4:31

is actually to help the patients to recover more vision, to recover more autonomy. Being able to read, drive, um, seeing the recognizing faces of people for a bit longer with these drugs and at the same time you're also focused on diabetic related retinal degeneration.

4:52

That's right. So that's another disease that presents, uh, differently and affects younger patients, not only diabetic patients that potentially some of them are as early as they're in their 40s or 50s. Uh, and the disease is really about these, um, uh, increasing vascular permeability and this sort of accumulation of fluid in the, in the retina. And, uh, we we are going to, um, start a program in that disease. Um, and we are preparing for it, and we would initiate that program after topline data in wet AMD, which is our first indication.

5:28

So Fred, given your your treatment there that you're developing, at what point do you think you might be able to reach FDA approval and then subsequently launch?

5:42

So it takes it takes around 6 to 9 months to put the dossier together. After we have all the clinical data we need, and we need 52 week data for filing, and then we need to have the two year safety data that we will file after. But to file you file after 6 to 9 months. And then the FDA normally takes a year to review a dossier in our case, because we have a fast track designation at the FDA to be as early as eight months of file. So we are talking, um, probably end of 2026, early 2027 for for the launch in the US. And then when we file with the in the US, we're going to start finding other jurisdictions like Europe and other countries like Australia, Canada as we go. Um, but the US will be first.