Geri Tenneti: Welcome, everyone. Thanks for joining us @listed at ASX. Today we have Megan Baldwin, the CEO and managing director of Opthea Limited ASX code OPT. Welcome Megan.
Megan Baldwin: Thanks, Giri.
GT: So can you give us a little bit of background about Opthea to start?
MB: I can, yes. So, of you is one of Australia's oldest biotechnology companies. It's listed on the ASX, listed in 1985 but really have been a drug development company in the biotechnology space since 2007. In 2007 we bought an intellectual property into the company around a particular family of molecules that is involved in retinal disease and we've been taking forward an asset through clinical development for the treatment of one particular eye disease called Wet AMD since that time. And we've been listed, as I say, that the whole time on the ASX and it's been quite a ride.
GT: Wet AMD. Could you tell us a little bit about that disease and how Opthea proposes to treat it?
MB: Yeah, so Wet AMD is Wet Age Related Macular Degeneration, it's a disease that affects the back of the eye. It's really characterized by the growth of blood vessels that form lesions at the back of the eye. Those blood vessels are often very leaky and there's swelling or edema and fluid that builds up at the back of the eye as well. And that, of course, affects the patient's ability to be able to see properly. And over time, there's chronic and often a very sudden loss of visual acuity. So that impacts their ability to recognize faces, be able to drive a car, be able to read, for example.
GT: Can you talk a little bit about the size of the opportunity and also how Opthea’s drugs would propose to treat the problem?
MB: It is a very prevalent disease. It is the leading cause of blindness in people over the age of 50. And so, it is a very large commercial opportunity. Right now, the current standard of care treatments, there's really only one class of therapies that are available for patients. So, if you're a patient that doesn't respond very well to those therapies and in fact, the majority of patients actually have a stabilization of vision, but they will, over time, go on to lose further visual acuity despite receiving the ongoing standard of care treatment. So, there is a need for new therapies. Our opportunity with OPT-302, which is our molecule in development, is to add on to those existing standard of care therapies with a view of giving those patients the opportunity to have a better vision response and if they have a better response, can see to a higher visual acuity that gives them a better opportunity to better maintain that over time and actually improve their quality of life and be able to continue to do all of those things that they'd like to do prior to starting to lose their vision.
GT: So that sounds to me then like you're not actually competing with the standard of care.
MB: That's exactly right. So, we are very much complementary to the standard of care. We're not developing this drug to compete with any of the existing therapies that are already available for patients that are very well-established brands and very familiar to the physicians who actually prescribe the drugs for the treatment of this disease. We seamlessly fit into clinical practice and we're simply saying to the physician and to the patients, if you want to give your patients the best opportunity to have the best response and to be able to see better add our drug onto the existing treatments. And that really enables us to tap into the entire market opportunity with our therapy. And that, of course, is a multi-billion-dollar opportunity right now. The two existing drugs, they generate revenues in excess of $9 billion just for the treatment of Wet AMD. So, you can see if we can add on to that market in all of those patients. This is a multibillion-dollar opportunity for OPT.
GT: indeed, and a chance to improve outcomes for a lot of patients.
MB: It’s the most important thing, I mean, right now that there is really limited treatment options for patients. And so to be able to have the physician have another option for them to give their patients, you know, a better outcome, that's exactly where we fit into that marketplace.
GT: So, can you tell us a little bit about where you're at in terms of clinical trials?
MB: Yeah. So right now, we're in that final stage of clinical development. So, the last stage of clinical development before you submit your data to the regulatory agencies around the world, which would then on the back of positive data lead to a marketing authorization, so you can actually make it available for patients is what is called the Phase Three Clinical Development Program. That's the phase that we are in. So, we've taken our molecule already through phase one. Through phase two, we've already generated a data package to show evidence of clinical activity of our molecule. We're very familiar with the safety profile about molecule, and now we're in that last stage of clinical development conducting about a 2000-page patient Phase three program. We expect to be recruiting patients through this calendar year and then looking forward to top line data readout towards the end of 2024, early 2025, which is a key milestone, a key catalyst for the company, and something that I think shareholders in the market is very much looking at. Opthea too because we're really a late-stage clinical development program fully owned by Opthea and a really excellent opportunity to get into the stock now and make a difference for patients.
GT: Just in summary, what can existing or prospective shareholders expect in the next year or so from Opthea?
MB: I'll be looking for our progress in our clinical studies, which is going very well. Really looking for the next milestone for us is to complete patient enrolment. As I said, we hope to be as early as December of this year to complete enrolment into what we call the Shore and the Coast Phase three clinical trials. That's a key milestone for us because it sets the clock on our top line data readout, which would be approximately 12 months after that point. So that's really the operational focus of the company right now. But really, after many years of clinical development, we're on that that final stage of potentially having a multibillion dollar drug be available to patients all around the world.
GT: That sounds very exciting indeed. Megan. So I wanted to thank you for coming in today and wish you all the best with the trial phase of Opthea.
MB: Thank you very much, Giri