Biomea Fusion, Inc. (BMEA) Earnings Call Transcript & Summary

[Presentation]

You have no historical precedent. You can't see what others had done before because you're the first one doing it. But that's also a part of the excitement as an innovator, as a trailblazer is that you're paving the path for the first time.

In type 2 diabetes, the beta cells play a very critical role. This pool of beta cells begins to deplete, leading to increasing levels of blood glucose. And this could be because the cells are dying, the cells are unable to regenerate or replicate or all of the above.

It has been estimated that at the time of diagnosis of type 2 diabetes, a patient has already lost 50% or perhaps greater their beta cell mass and their beta cells' so-called function. And many of our patients with type 2 diabetes, at the end of the day, will require insulin in order to attain and maintain good glucose control. But none of the existing therapies today cure type 2 diabetes.

For curing the disease, it appears that one has to address the root cause of the disease, which is the efficiency of beta cells. So in that context, it appears that BMF-219 would play an important role because it would be addressing the root cause of diabetes.

Menin is a protein that controls the number of beta cells. The beta cells insulin. The cause of diabetes is insufficient insulin. BMF-219 regulates the activity of menin, and in so doing, allows us to have a meaningful impact on diabetic patients.

This is a 3D print of menin, and this allowed us to really have a deep understanding how the scaffold protein works. And what I had in appreciation for were all the different nodules and hooking points that you see with this protein. And that explains why menin has over 1,000 binding partners. We used BMF-219 to form a covalent bond inside. This renders the protein futile and is sent outside of the nucleus. And so that allows us to disrupt or to impact any protein-protein interaction that menin wants to form with because we take it out of the nucleus. Last year at ADA, we were able to highlight 2 key preclinical studies that we conducted with BMF-219. We showed that these animals could restore their glycemic control by inhibiting menin.

Now we have clinical experience. We have actually reported top-line clinical data at the end of March of this year. And importantly, the clinical experience thus far with BMF-219 in diabetes has completely paralleled what we would have predicted from the preclinical data we presented last year.

We have exactly seen the same pattern in the clinical setting. Almost 90% of patients had some kind of reduction in A1c, 78% had 0.5 or more reduction in A1c and more than 50% of patients had 1% or more reduction in A1c. So this has been very remarkable data.

I have a patient that started the A1c. It was an 8.0. This patient now, week 12, now is 6.9 A1c. So you can see some amazing decrease and it remains steady and remain stable in the number of A1c. And this medication does not cause any side effects, especially hypoglycemia or GI symptoms like diarrhea, like in metformin. These patients, they are super happy. We do a physical exam when they to the office and they are doing amazing.

What excites us about the data are a few things. First and foremost, it's really targeting the underlying pathology of the disease. The second thing that we really like is that it can be given on top of standard of care, very early on background medicines. And then thirdly, it's an oral therapy.

People who are not on chronic therapy, they get an oral agent. Nothing needs to be injected. And once the pool has grown, you go your merry way until the pool depletes again.

The base case we believe for BMF-219 is that we make standard of care diabetic agents better because many of those agents need a functional beta cell pool to have their anti-diabetic activity.

The strategy of Biomea is flawless, it's irrefutable. And the fact of the matter is if it works, I mean, let's be honest, it's nothing short of brilliant. And the world needs these kinds of drugs for perhaps obvious reasons. So it really comes down to the effectiveness of the drug. If BMF-219 does what it appears to be able to do, then this is absolutely spectacular.

What it means to me to be able to have this opportunity to target patient population that's over 0.5 billion worldwide is to be able to address the root case. So what a wonderful opportunity it is for us to be able to deliver an agent for the first time in history that can increase your insulin production.