Bionano Genomics, Inc. Common Stock H.C. Wainwright 28th Annual Global Investment Conference

Albert? Thanks, Ahmed, and it is a pleasure to be here this morning.

Beautiful weather. Our forward-looking safe harbor statement for everybody. This morning, I am going to describe Bionano, and this is a company that has digitized the human chromosome. In so doing, it is really changing the practice of laboratory medicine. Our technology is referred to as optical genome mapping, or OGM, so you will hear that a lot during this talk. It is a wonderful genomic analytic technique that is transitioning strongly into the clinic right now and is transforming the structural analysis of chromosomes for medical indications. We are obsoleting many of the major laboratory standards, and I will show you some of those later on. The reason it is doing this is because we can consistently identify previously undetected anomalies in chromosomal structure, which are directly linked to disease.

There is a tremendous amount of global clinical evidence that is building up for the last 7-10 years. We will show you some of that uptake later. It is really establishing the utility of this application across many branches of medicine, and especially in hematologic oncology and constitutional genetic diseases. We are also gaining tremendous traction in the clinical setting because of the reimbursement that is being realized by the technology. In January, we were granted CPT coding for both hematologic oncology and also for constitutional genetic diseases. These went live in January. In addition to that, we received very favorable news back in late August from MolDX.

You can read in the italics here, the provisional LCD, which is being considered now, it is open for public comment, is for OGM-based genomic wide molecular assay for the detection of copy number alterations, that is CNVs, and structural variants, SVs, in hematologic neoplasms. This is a big move for us, and I will show you a map what that potential coverage means later in the talk. We also have other applications beyond the immediate human clinical applications, and that is in the quality control of re-engineered cells for therapeutic benefit. We think the market, by the way, is approaching $10 billion. There have been a lot of decades of diagnostic disruption. I have lived through all of these, so I can speak with some certainty about them.

Starting in the 90s with the in situ hybridization technology that really was automated and made practical by Ventana, which is now part of Roche. Then PCRs, and one of the major innovators in PCR is sitting right in front of me, Dr. Erik Holmlin, who helped move agar plate bacteriology onto polymerase chain reaction based methodology, genome sciences. Then finally, next generation sequencing. Our friends at Illumina have really redefined the sequencing space. Finally, what Bionano has done is really altered or entered a new era of genomic-type medicine, which is all digital. It is digital pathology. This is a major move in pathology, and this is a cartoon which really shows a little bit of a lab look and speaks about cytogenetics, molecular technology, and then anatomic and clinical pathology, and the different types of techniques that are used there, karyotyping, FISH, RNA transcriptomics, DNA sequencing, et cetera.

Many of these are analog technologies and how they are consolidating it down to a digital approach. OGM is covering the majority of cytogenomic and some of the molecular technologies, and then sequencing is taking on the rest of this sphere. I find it easier to talk about this if you take a look at the chromosome. On your left, you see a chromosome that has been linearized, and from the whole chromosome down to a single base pair running left to right.

If you come down, you see cytogenetics used as a major cancer diagnostic, karyotyping and FISH, which is targeted to look for specific alterations, and then arrays to look for copy loss or gain. Then you see a coverage gap, and as you get down to smaller and smaller regions, you have more difficulty targeting those until you finally get into very short sequences and down to single base pairs, and that is all covered by sequencing. What is really interesting is OGM covers the majority from the whole chromosome all the way down to about 500 base pairs of size. It is really quite a spectacular range, and it offers an orthogonal view of what the chromosome looks like and complements long-read and short-read sequencing results.

We also have a software called VIA, which links all these technologies together and comes up with a comprehensive recommendation of what the problems are with this particular patient. With karyotyping, this is something that has been around for many years. It is being practiced less and less because it is difficult to do, and it is expensive. It is not well reimbursed. There is a high error rate with it in terms of its ability to predict an outcome or particular disease. With fluorescent in situ hybridization, you are really guessing which probes you want to use, and therefore, if you do not estimate correctly, you really have a rule-out test, not a rule-in test for use there. Lastly, microarrays are really good for copy number, and that is about it.

We also note that as you look at the technologies, nothing is really sufficient to completely look at re-engineered cells in terms of their ability to go back into patients and authenticate that you have changed that region of the chromosome that you want to change. This is what our technology looks like, and I couldn't resist putting this slide in. You're looking at a Saphyr system on top, and on the bottom, a cartoon of what the flow cell actually looks like. You'll see a reservoir, a lip on a reservoir, and the purified DNA, which is also labeled with a fluorescent tag, is offered to the flow cell, and then it is forced through channels until it finally reaches the nanochannels. There's well over 100,000 nanochannels. What you're seeing on the right is the image of whole strand, double-stranded DNA flowing through the chip.

It's really kind of a spectacular demonstration of technology. What we then do is we take a shot once it's streaming properly, and we deconvolute that image and reconstruct the chromosomal structure from those images. In this slide, we just compare what you're looking at. Every one of those little fluorescent dots in this image represents a base pair motif, and each one is about 500 base pairs, roughly, from the next dot, as compared to something that is about 5 megabases, which is the typical size of a band that you would look at if you're looking at chromosomes. The resolution is spectacular compared to the old technology and offers a really new, great way to look at what's happening to the patient. This is our system. It's comprehensive. It starts on your left, you see our separation technology. It's called Ionic. We also offer a manual isolation.

Once the DNA is isolated, it's then labeled with a labeling kit, and then it's offered to the chip, which you can see on the bottom here. It's run in the analyzer, and this is our Stratys, which is our higher throughput analyzer. Then it's analyzed on a dedicated high-performance server, which is powered by NVIDIA GPUs. All this is deconvoluted into what you see on the very far right, is called the Circos Plot, which is very typically used in medical genetics to understand where there are structural alterations that are not normal. I mentioned that it's been strongly validated in the field. There are thousands of publications now, all clinical. You see last year, we counted 450 publications in the field. This year, we'll probably exceed that. This is a global effort.

Every continent on the planet is practicing this technology. On the far right, you see the number of genomes that have been looked at using our technology, and is now in excess of 16,000, and I remember when the first one was done. How do you focus commercially on this activity? We've focused where we believe cytogenetics doesn't work well, and that's in hematologic oncology, in constitutional genetics, and in cell and gene therapy. At the moment, our major focus is in heme/onc, and you can see the driving principle behind all this is the increase in yield from the potential diagnosis of a patient here. That's true in heme/onc, it's true in constitutional genetics, it's also true in cell and gene therapy. Let me tell you a little bit about the business.

I am showing you numbers that are based on the end of 2025, and at that time, we had 221 active sites with approximately 387 active instruments. We were looking at who is actually the main customer here. What we realized was about 25% of our customers were responsible for the majority of our sales. We label these customers routine use customers. There is more detail on them on the far right. Of approximately 130 major sites, all routine, those sites which have validated LDTs in their laboratory were doing about $131,000 per site. Whereas those that were working on approved LDTs were about one-third of that. What you can clearly see is once the technology is validated in the laboratory clinical setting, they become major users, and this has been the focus of our company.