NewAmsterdam Pharma Company N.V. Ordinary SharesNAMS
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NewAmsterdam Pharma Company N.V. Ordinary Shares Wells Fargo 21st Annual Healthcare Conference

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Yanan ZhuAnalyst

Okay. Thanks everyone for being here. My name is Yanan Zhu, and I am one of the biotech analysts here at Wells Fargo. It is my great pleasure to be joined by the management team of NewAmsterdam Pharma. With me here, Michael Davidson, CEO of the company, and Matt Philippe, Head of Investor Relations. Thank you for being here.

Michael DavidsonCEO

Thank you. Thanks, Yanan. Thank you.

Yanan ZhuAnalyst

Great. To kick things off, I hope you could give a brief overview of the company and then we can jump into some questions.

Michael DavidsonCEO

Sure. Thank you for hosting us. NewAmsterdam Pharma is a startup biotech company. We are now six years old. We are developing obicetrapib, a CETP inhibitor for lowering cholesterol, but it has a very differentiated profile from anything else. It is a potent LDL lowering drug. It also raises HDL by 150%. It lowers the risk of diabetes, lowers Lp(a), lowers the risk of p-tau217, a great biomarker for Alzheimer's disease, and it is very differentiated from anything else in LDL lowering. We finished phase III for LDL lowering, and we got approval in Europe, and we are finishing our large phase III cardiovascular outcome trial called PREVAIL. It is our next big study to read out other than we do have one more phase III trial called RUBIN finishing this year for diabetes patient population.

Michael DavidsonCEO

But once we finish PREVAIL, we plan on filing and then launching the drug in the next 12 to 18 months.

Yanan ZhuAnalyst

Great. Thanks for that overview. I wanted to perhaps start the discussion on Lp(a).

Yanan ZhuAnalyst

Right. Given the very big news that came out of Novartis’ HORIZON study, there is some connection with your drug because your drug also lowers Lp(a) to a degree.

Yanan ZhuAnalyst

Could you talk about this outcome? Does it surprise you? What might be your guess of the cause of the failure, and what might be the implication for your program?

Michael DavidsonCEO

Right. I am a lipidologist cardiologist. I see a lot of patients. Lp(a) is a very important cardiovascular risk factor. It attaches to LDL and makes LDL more likely to clog up the arteries or has increased clotting effects. It is a very strong risk factor for heart disease. We know that is clear. We know that genomic studies support its risk and over long-term periods, having lower Lp(a) means lower cardiovascular risk. HORIZON was set up to look at a population that had very well-controlled LDL. In fact, LDL was 60 at baseline. Everyone was put on aggressive LDL lowering therapy prior to entering the randomized period of the trial. What we do know is that does help a lot reduce risk already. When you have a low LDL, Lp(a) risk is significantly reduced.

Michael DavidsonCEO

The question is whether further lowering Lp(a) would in fact, make a difference, and this is what HORIZON was trying to answer that question, looking at 2 different thresholds. As you mentioned, the readout was not positive. It was a disappointing study. There are many reasons why it may not have worked. One thing is we were aware of is it had a pretty high dropout rate. It started during COVID. There was side effects from the skin site reactions, and it may have been that diluted the benefit, and if they looked at other populations like on treatment or subgroups, there may still be a benefit. What is important for us is, yes, we do lower Lp(a). It is one of our differentiating features.

Michael DavidsonCEO

We have always said, but for us, we already have our own data on benefits on cardiovascular events from our phase III trials, BROADWAY being the largest. It was a large study, 2,500 patients. We showed that in that study, a 21% relative risk reduction on 4-point MACE. We also published that in the analysis looking at Lp(a) lowering, that the lower the Lp(a) got on obicetrapib, the lower the event rates. We already have our own data that obicetrapib in the setting of high Lp(a), the lower the Lp(a) got on treatment, the lower the risk. We already have our own independent data. We also know from the Merck CETP inhibitor, anacetrapib, that when you had a high Lp(a), you had a greater relative risk reduction. We purposely designed PREVAIL to be enriched for having high Lp(a) patients as one of the enrichment criteria.

Michael DavidsonCEO

Either you had to have an LDL over 100, pre-existing heart disease, LDL over 100. If your LDL was 70-100, you had to have either high Lp(a), low HDL, high triglycerides, or diabetes. All risk enhancers that in the Merck anacetrapib trial show a greater relative risk reduction. If we see similar benefits in PREVAIL showing that, like we did in BROADWAY, that when you have higher Lp(a), you have greater relative risk reduction and greater benefits, the lower the Lp(a) becomes on treatment. That provides already substantial evidence that obicetrapib would be a good drug to use for high ApoB patients.

Michael DavidsonCEO

At the very least, we know if HORIZON shows nothing other than, again, low LDL, ApoB doesn't matter, we know that it's still an important risk factor, so getting LDL levels as low as possible is still a very important treatment consideration for those that have high ApoB, and we have a great drug to do that. We feel this as a, no matter what HORIZON shows, we believe that we now become the first, quote, "ApoB lowering drug" available for patients when it gets approved, hopefully after PREVAIL in the next 18 months or so, that it'll be the go-to option for the high ApoB patient and still one of our important differentiators. But it's not the only one. We have other important factors, like I mentioned, the small particles, the total particles, the diabetes prevention, the Alzheimer's prevention benefit.

Michael DavidsonCEO

All those things make obicetrapib have a very unique LDL-lowering therapy that we think is going to be very well-adopted into the utilization paradigm for those that have high LDL cholesterol.

Yanan ZhuAnalyst

Got it. That's very helpful. You did mention additional differentiations beyond LDL lowering. You mentioned diabetes. Of course, there's potential small particle effect, that aspect. But I think diabetes is the outcome that you could observe, right?

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