Oculis Holding AG Ordinary shares H.C. Wainwright 28th Annual Global Investment Conference
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Welcome to the H.C. Wainwright 28th Annual Global Investment Conference. My name is Yi Chen. I am an equity research analyst at H.C. Wainwright. For this session, we will have a fireside chat with Dr. Riad Sherif, Chief Executive Officer of Oculis.
Welcome, Riad. Thank you, Yi.
My first question is, following the DIAMOND trial in DME, has the company changed the objective clinical and financial criteria used to decide which program should advance or be redesigned or discontinued? Should investors believe that the current programs of Privosegtor and Licaminlimab have lower phase II to phase III translation risk?
Thank you for your question. In this question, you have two types of question. One is if you change something, you will change something in terms of selection and execution. The good news is when we see the execution of DIAMOND-1 and 2, actually it was better execution than phase II. We have KPIs, the typical KPIs we have. Therefore, nothing really to say about execution, and we just need to continue to focus really to be obsessed about execution. In terms of profile, Licaminlimab and Privosegtor are really different biologists. One is a TNF inhibitor, which is a validated biology on inflammation, and we know inflammation is a core component of dry eye. Furthermore, we are doing enrichment with the TNFR1 biomarker.
Privosegtor is a new molecular entity. The result in a phase II were very strong, 18 letters difference, and we are really in both trial. Good news, I would say, really in both trial with Licaminlimab with PREDICT-1 and with PIONEER-1, we are in fact repeating exactly the same thing, the same study we did in a phase II.
Okay. Therefore, I would say, no, it looks good now.
Drug development is always risky, but we are doing everything possible to reduce this risk and drive probability of success in both trials.
Okay, got it. I understand the next upcoming catalyst is the PREDICT-1 trial readout in dry eye disease. What treatment difference in global ocular discomfort at day 29 would be both clinically meaningful and also persuasive to the regulatory agencies in your view?
Yeah. So basically, if I take the result we had in a phase II- we had 4 point in a VAS score.
We had 4-point difference in Oculomics between the active versus placebo, and we had 28-point difference in a TNFR1 positive patient. I would say 4 point is similar to what any other product approved is in the market.
Therefore, I would say if we achieve the double, 8-point difference- is already meaningful.
But more importantly than meaningful, is meaningful and very competitive vis-à-vis the rest.
Correct. Remember, we achieved 28 points.
Therefore, this biomarker truly help us to address TNFR1 positive patient in dry eye. We think about it not as dry eye product.
We think about it as TNFR1 positive patient in dry eye. This is our population. Okay.
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