Hello, everyone. Happy to be here.
Let me see.
Hello, everyone. Happy to be here.
Let me see. Good morning, everyone. Thank you for joining the H.C. Wainwright 26th Annual Global Investment Conference. My name is Sumaira Zamarrud, and I'm an associate here at H.C. Wainwright. We're confident we're going to be able to provide value to you with over 600 companies presenting at this conference in multiple sector tracks devoted to life sciences, cryptocurrency, blockchain and fintech, technology, media and telecommunications, clean tech, metals and mining, and growth. H.C. Wainwright is a full-service investment bank dedicated to providing corporate finance, strategic advisory, and related services to public and private companies across various sectors and regions. We have a total of 24 publishing senior analysts and over 636 companies covered across all sectors. Please visit our website for more information.
Please also join us for one-on-one meetings, corporate presentations, and panels that will be available live and for streaming. With that said, we hope you have a productive and enjoyable day, and now I'd like to introduce our next speaker, Riad Sherif, who is the CEO at Oculis, which is a company specializing in developing ophthalmology treatments, so thank you and welcome.
Thank you, Sumaira. I'm very happy to be here to introduce Oculis. Oculis is an ophthalmic company focusing on treatment. These are our safe harbor statements. Our purpose is really to drive innovation to save sight and improve eye care. This is just a snapshot of 2023 and 2024. 2023 was a big year for us with the listing in Nasdaq, but also with a positive result in stage one, phase III, with an eye drop in DME, which is the first time ever we have topical product working in a retinal indication. We also started the phase II-B trial in dry eye with biologic TNF blocker.
2024 started very strong also with the continuation of the phase III DIAMOND I and DIAMOND II in DME, with a positive result in the RELIEF trial, which is DED, dry eye disease with Licaminlimab, which is a TNF inhibitor. We expect readout of OCS-05 in acute optic neuritis, which is upcoming in Q4. We also did a listing in Nasdaq Iceland, which was actually mainly requested by our investors who are based in Iceland. As you know, or as you may know, this company originally was originated in Iceland. So, Oculis has a portfolio of three clinical trial, three clinical asset, OCS-01, OCS-02, and OCS-05.
OCS-01 is the first product which was, actually, invented by Oculis, which is based on a technology which is called Optireach. This product is in phase III in two programs, DME and ocular surgery. OCS-02, Licaminlimab, is a TNF blocker, is inflammation in dry eye and uveitis. OCS-05 is a new class of therapeutics, SGK2 activators in neuroprotection. The product is ongoing in an indication which is called acute optic neuritis. These are our programs, so OCS-01 in two indications in phase III. Next catalyst for OCS-01 in DME is a full enrollment in the two phase 3s, DIAMOND I and DIAMOND II. For ocular surgery is FDA NDA readiness for Q1 2025.
For OCS-02, we had a positive readout in a phase II trial this year, and we expect a consultation with FDA to prepare for the design of the next trial in Q1 2025. For acute optic neuritis, we expect, as I said, readout in the end of this year. If I start with OCS-01 in DME, as you know, DME is a complication of diabetes. We are speaking about millions of patients. Only invasive treatments are available, which lead to a situation where more than 50% of patients today are not treated. If we take the US data, AAO, which is American Academy of Ophthalmology, released a report, and they follow more than 200,000 eyes, and they show that more than 60%, 6-0, 60% of patients are not treated 12 months after the diagnosis.
Huge unmet medical need. What we did, after a positive phase II, we met with FDA, and we agreed with FDA to do this program, which is called DIAMOND program, divided in two stages, stage one and stage two. Stage one, I will be sharing with you a result of stage one. And the stage one, we had two questions, basically, how much we can drive efficacy with an induction phase, and are we able to maintain it with the maintenance phase? The stage one was a clear success, and I will show you the data. And we started the stage two, which is ongoing with DIAMOND I, which started in the very end of the last year, and DIAMOND II, which started in Q1 this year.
The protocol between stage one and stage two are the same in terms of inclusion criteria and in terms of endpoint. Endpoint are the regulatory typical endpoint, BCVA and gainers. So in conclusion, and I will go into the details after, BCVA, OCS-01 delivered 7.2 letters gain in BCVA at week six, and 7.6 at week 12. When you see this data and you compare them with monthly injection of anti-VEGF, they are identical. This is exactly what we get with the monthly injection of anti-VEGF. So amazing success, and benefit with the topical product. The second endpoint was, how many patients gained more than 15 letters. 25% of patients gained more than 15 letters at week six, and 27 at week 12. This is also equivalent to what we get with anti-VEGF.
We see a rapid reduction in retinal edema already at week two, so the product works, and it works very fast. The product was well-tolerated with no unexpected adverse event, and the results supported stage two initiation, which is ongoing currently. These are results, as I shared with you previously in the summary, seven point two letters at week six, seven point six letters at week twelve. These are the gainers, 25% at week six and 27% at week twelve. Now, when you think about this product and you envision how this product will be used, and this is basically it shows the continuum of the disease or the evolution of the disease. The diagnosis is made with an OCT, where we see the inflammation in the retina, and then the vision start to deteriorate.
Today, first, we have the biggest pool of patients, almost two-thirds of patients are not really treated. They are waiting. It's really a disease where we basically say to patients, "When it is worse, come back to me." And therefore, we are starting late, and we end up in a situation where the first table, which is lack of pre-invasive treatment, we do not have any pre-invasive treatment, and we wait, and once the vision start to truly deteriorate, then patient accept injections. And we know in DME, where 60% of patients will respond well, and how the community, they define good response is really gaining more than one line or five letters. So for this patient, great if they respond to anti-VEGF, but 40% of the patients will not respond appropriately to anti-VEGF.
So you can see easily that without actually even touching the current standard of care, which is addressing only in the end of the day, and you see it here when you do the math, 20% of the total pool, you have two segments which are completely unaddressed. One is early intervention. As soon as you have the disease, you can treat. And this is really what we hear also from our investigators who do clinical trial. They say it's so easy to enroll in your study because patients are very happy to start with an eye drop. So the first pool of patient which represent actually a pool which is bigger than the current treated pool, is first-line treatment.
The second, unaddressed segment is patients who are not responding to anti-VEGF, and this patient could be switched to OCS-01, or we could combine with OCS-01. So therefore, this product will have huge implication and impact in terms of where we deliver care to DME patient by broadening the patient pool, being able to treat early, but also customizing the treatment to patients who are not treating early, and therefore broadening the patient pool and broadening also the prescriber pool by giving a solution to the ophthalmologists who are making the diagnosis today, but not treating. This is just the conclusions in the previous trial, stage one, phase III, the product met all functional in-clinic and pharmacodynamic endpoint.
As I shared with you, the phase II is ongoing and actually on track and very happy with the evolution and the feedback from the doctors. In terms of understanding of where this product will be used, there are really two groups of patients. First is pre-anti-VEGF or pre-invasive treatment, where it is the biggest pool, they're underserved, they are not treated. The second group of patients who are patients who have been treated with anti-VEGF and not responding to anti-VEGF. In fact, when you see the demographic of all our clinical trials, we end up actually with always two-thirds naive patients who were not treated by anything, and one-third of patients who were treated by anti-VEGF and didn't respond to anti-VEGF.
It mirrors very nicely what we see in the demographic of our clinical trials. In conclusion, this product could truly create a market, actually, which is bigger than the current DME market, just because the pool of patients to address is bigger than the current pool of patients to be treated. If I move to the second asset, dry eye, with OCS-02, as you know, dry eye is a big market expected to double in the next five to ten years. And as reported by AAO also, 87% of patients are unsatisfied. It's a market which is really driven by trial and error.
It's difficult to treat this patient, and 87% are not satisfied, and we will see in the next slide, between eight to nine patients out of ten will stop their treatment the first year of treatment. And when you see the product which I use are mainly anti-inflammatory, 95% of them are anti-inflammatory. And the main reason is because inflammation creates symptoms, and this is why they basically go to the doctors because of the symptoms they have. This. So despite recent launches, we continue in a very unsatisfied market. 85%-90% of discontinuations are within the first six months. So what do we have? We have a TNF blocker, which is a validated biology, as you know, is anti-inflammatory, anti-apoptosis. It's small.
We have only the active part of the antibody, just the fragment, which allows us to have high concentrations and a good ocular tissue penetration, and I will be speaking also about the genetic biomarker, which we have been able to identify and develop. But why really going into the TNF? We go into the TNF because when you see other anti-inflammatory market and other inflammatory diseases in the body today, biologics represent 90% of the inflammation market in all other inflammatory diseases, and TNF represent the two-thirds of them, so this is a very solid anti-inflammatory biology, which works extremely well and showed strong efficacy, showed rapid onset, and showed sustained relief. OCS-02 or Licaminlimab is a very potent TNF blocker. It's more potent than HUMIRA and infliximab. It's active on inflammation and apoptosis.
Product went into a very broad de-risking with three clinical trials. Two first in symptoms, which showed consistent benefit in ocular discomfort, but also the second DED two allowed us to identify TNFR1 genetic biomarker, where we saw very high correlation between the presence of this biomarker and the response. In symptoms, it was seven times more. So patient with the TNFR1 biomarker showed seven times more response versus all comers. In the DED three, what we did, we focused on signs. Our aim was to identify the best sign to move with into phase III, but also we had a hypothesis about this TNFR1 biomarker to see if we see the same behavior of this patient, not only in symptoms, but in signs. This is DED two, where product showed efficacy in symptoms. I will go rapidly.
It's significant as well. And this is the first DED two, where we see that patient with TNFR1 showed a very high response than patient than all comers. So in the DED three, we had three objectives. The first, evaluate efficacy of Licaminlimab in the treatment of signs. The second, the validation of the TNFR1 biomarker, and the third, to really select among all the signs which are regulatory approved by FDA signs, which one will be the best, which fits with the biology of OCS-02? So just to give a landscape, this is the label of Xiidra, which is a successful dry eye product. We are going to compare with day 42 because it was six weeks trial, so day 42 is the same.
When you see stain-staining, the Xiidra was able to reduce staining by - 0.03 to - 0.10 at day 42. These are our results. In all comers, we have results which are equivalent or slightly better than the best phase III of Xiidra. But when you see the TNFR1, it is six times better. So, and this is extremely positive for us because for this population, we saw seven times more improvement in symptoms. We see here five to six times more improvement in signs. So very consistent and validated approach in terms of precision medicine for the future. We see also is day-by-day an improvement. We see that the product works fast. It's already at day 15, it's four times more than the potential competitor. At day 42, six times more.
This is just a way to show reduction of inflammation, which is very consistent and significant at day 43. When we see all the other signs, the product works in all comers, but in TNFR1, the product is positive in all signs or all regulatory signs. This is extremely rare to see in dry eye population. Safety was excellent, really nothing to highlight. This product is extremely safe, and the drop comfort scale is superior equivalent to artificial tears. And this is really important because in a population which has symptoms, they look for something which is comfortable, and many product actually today, which are available, are not comfortable for this patient. So in conclusion, really opportunity for highly differentiated product profile, which could drive precision medicine.
With the new mode of action, which is extremely well-validated in all other inflammatory diseases, with a rapid onset, this product works, it works fast, and it's safe. And the last point is ability truly to predict treatment response, and to have, for the first time ever, in dry eye, which is really market-driven by trials and error, first time ever, precision medicine approach with, with the TNFR1. And just rapidly about the TNFR1, so it's a very easy diagnostic to do. It's a qPCR. So it's like COVID, COVID test. It's 20 minutes, it's rapid, it's cheap. As it's, it's truly like COVID test. It's the same process. So it's very rapid and could be done at the lab, but could be done also at point of care as well. So this is just the conclusion.
As I said, the product is efficacious, it works, and it's safe, and it allows precision medicine. And the next step is really consulting with FDA to discuss the next step for the phase III trial. This is on OCS-02. Rapidly, I will be rapid here. OCS-05, it's product we showed in animal data. It has a very complete preclinical data set, where in seven animal data, in three animal models, glaucoma, acute optic neuritis, and multiple sclerosis, product showed that we are able to reduce retinal ganglion cell death in retina, and the product was able to reduce demyelination in the optic nerve. These are the animal data. I am just sharing three here, and you can see extremely well.
But the last one on the right, we do not show only on imaging that we are able to reduce demyelination, we are able to reduce the retinal ganglion cell. We show that functionally, animals receiving OCS-05, they do better in terms of functional mobility versus animal not receiving OCS-05 in a multiple sclerosis model. So where is this product? So the product, we are doing first, the ACUITY trial, which is first in-patient trial in Europe. We are also submitting IND in the US. We expect readout of ACUITY in Q4.
If this product works, it really opens the door for multiple clinical applications in the retina, such as glaucoma, GA, and DR, but also in cornea with in neurotrophic keratitis, which is still a big unmet medical need, and it could have a leg as well in CNS. So I would say, really, next step is Q4 readout. So summary, this is just a snapshot of the company. We have been able to raise more than $300 million in total. 110 as a private company, 200 as a public company. We are well-financed till end of 2026, and we have been able to bring O1 from a hospital project to phase III, bring O2 and move it to phase III now, and advance O5.
In terms of key milestones, really, we delivered all what we said on time or in advance. In Q4, we have a readout of OCS-05 in acute optic neuritis and IND, and we expect a rich first half of 2025. Thank you very much.