Thank you for joining the H.C. Wainwright @ Home Event. My name is Yi Chen, and I'm an Equity Research Analyst at H.C. Wainwright. Today, we have the privilege to have a virtual fireside chat with Dr. Erik Holmlin, President and CEO of Bionano Genomics. Welcome.
Thanks, Yi.
Erik, I know that Bionano is a provider of optical genome mapping, or OGM solutions. Could you tell the audience what OGM technology is, and how is it differentiated from the traditional methods used for genome analysis?
Yeah, sure. Thank you, Yi, and thanks to H.C. Wainwright for this platform to talk about Bionano and our solutions. We're making really amazing progress in transforming the way the world sees the genome, especially in the cytogenetics laboratory. And the big driver of that is optical genome mapping, or, as you said, OGM for short. OGM refers to really a workflow, a process, or a technique going from sample all the way to a report that a clinical researcher might use to understand a subject's disease, such as hematologic malignancies, or blood cancers, or genetic diseases. It's also used in pharmaceutical drug development for applications in cell and gene therapy. And what that workflow consists of is a process of analysis of DNA from cells like blood cells, bone marrow cells, or cell lines that might be used in drug development, or solid tumors.
And the process goes from isolating ultra-high molecular weight DNA. That's one of the first differentiating points. So we will be analyzing in our instrument segments of DNA that are hundreds of thousands of base pairs long. And you can contrast that with the lengths of DNA that would be analyzed in a typical sequencing analysis. And those are in the hundreds of base pairs. And so our DNA molecule lengths are 1,000 times bigger or more than what is typically being analyzed in sequencing. And I'll come back to why that's important. But after you isolate this ultra-high molecular weight DNA, we use an enzyme to label the DNA. And that introduces markers at a specific sequence site across the entire genome. And it forms a pattern. And once we have that labeled DNA, it goes into our proprietary chip, which is called the NanoChannel Array.
On our Saphyr system, it's the Saphyr Chip. On the Stratys system, it's the Stratys Chip. And that chip then goes into the instrument. The instrument is a microscope, an inverted microscope with capabilities of conducting electrophoresis inside the chip. Now, these NanoChannel arrays are incredibly special. They have hundreds of thousands of tiny channels. Think of them as train tunnels inside this chip. And when the chip is in the instrument, the electric current that the instrument applies across the chip will draw DNA molecules inside. So if you think of these long DNA molecules like trains, they are being threaded into train tunnels. This is the NanoChannel itself. And inside there, we can then image the DNA molecules. And so the instrument, the Stratys instrument or the Saphyr instrument, play the role of linearizing the DNA inside the chip.
And then, as an inverted microscope, it can take an image of these DNA molecules at the single molecule level and reveal the pattern of labels that have been introduced onto the sample. And that pattern is sequence-specific. So DNA isolation, DNA labeling, and then imaging inside the chip, inside the instrument. And that's how you build your data set. And that process is repeated multiple times in succession on a per-sample basis until you collect sufficient data to be able to achieve the level of resolution and sensitivity that makes sense for whatever sample you're analyzing. And at that point, the computers take over. And so there's a process of digitizing those images and then extracting from them all of the information related to the patterns of these labels. Those patterns are then compared to a reference genome. And that reveals if there have been differences.
So the idea of OGM overall is to reveal changes in the DNA sequence of the sample, but on a very large scale. That's why we're looking at these incredibly long molecules. And so instead of looking at a change that might be one or a few hundred base pairs, we're looking at thousands of base pairs. These are called structural variations. And so the digitization process leads to analysis that reveals structural variations. And then our VIA software takes over. The VIA software processes these variant calls and allows the end user to visualize them in the context of the entire genome, interpret them in the context of all of the literature that exists in databases that our software automatically queries, classify them as likely pathogenic, nonpathogenic, a variant of unknown significance. Also classify the degree of complexity of the variation. This is important in cancer.
And then a report based on those findings is automatically generated. So optical genome mapping is sample all the way through to a report that can be handed to a clinical researcher in a cancer lab or a human genetic testing lab. And the process of optical genome mapping focuses on revealing the large structural variations that are so difficult to get by sequencing.
So if I understand correctly, OGM does not replace next-generation sequencing, but it's complementary to NGS. Is that right?
Yeah, that's, I think, a really important point because what we're looking at, I mean, if you think about genome variation, and I know in my high school and college biology classes, there wasn't such an emphasis on the diversity of genome variation. But in fact, there's all sorts of different types of genome variation. There can be these large structural rearrangements that I'm talking about. In cancer, in the cell division, the chromosomes can shatter. That's something called chromothripsis. They can completely come apart and then recombine. And when they recombine, it's a total mess. And so that's how the cells are reprogrammed. And this type of variation is critically important to reveal and see. And so variation at the genome level could be millions of base pairs in size all the way down to one base pair in size.
And it turns out that sequencing very reliably detects variants that are a base pair, maybe a few hundred base pairs in size. But after you get above a few hundred, it becomes increasingly difficult for sequencing to resolve those variants. And that's where optical genome mapping fits in. So as you say, mapping is for the large genome variations, let's say 500 base pairs up to a full chromosome. And sequencing is for the small ones, but they don't compete. And so a lab that is really trying to get to the most comprehensive answer should do mapping and sequencing. And we see a lot of our customers are doing this. MD Anderson Cancer Center, for example, in hematologic malignancy or blood cancer analysis, they map these leukemias, and they sequence them with an 81-gene panel.
And so that's how they pick up all of the sequence variants that might be present in the genes that they are focusing on. And then, of course, optical genome mapping reveals the large structural variants.
Got it. Got it. Yeah, that's very helpful. Can you talk about the company's existing and potential customers? I mean, who are they and what are their applications using OGM?
Yes. You know, it's interesting. We've been developing optical genome mapping for some time. And originally, the idea of these large structural variants was incredibly important throughout the basic discovery research arena. So Bionano has customers that are doing basic research at the university level. But in the last four-to-five years, we've really begun to focus in on a set of customers that we define as the cytogenetic laboratories within pathology departments. And we also commercialize into molecular pathology departments. But the primary end user is the cytogenetics lab. Why is that? Cytogenetics is a discipline. It's a whole science. And it's been developed to look at these large structural changes, chromosomal analysis. And they have relied primarily on three techniques historically, beginning with karyotyping. Then they use something called FISH or fluorescence in-s itu hybridization, and then chromosomal microarrays.
And these three techniques are used in combination to analyze samples to generate a set of reports that a researcher may use to investigate a sample. Optical genome mapping is now proven in the literature to be a total alternative. It can be a replacement of those three techniques. And so the cytogenetic labs are adopting optical genome mapping as an alternative to traditional cytogenetic methods. Cytogenetic labs are typically present in hospitals and large midsize and large commercial reference laboratories. And so when we look at our existing customer base and those customers that we intend to continue to commercialize into, we find them in large reference labs, which we have a few big names here in the United States. And then in Europe, there aren't as many of these ultra-large reference labs running tens of thousands of samples a year, but there are a handful.
Then after the reference labs comes the academic medical centers. And academic medical centers are very plentiful around the world. Examples of academic medical centers using optical genome mapping in the United States would be Memorial Sloan Kettering Cancer Center, MD Anderson Cancer Center as part of the University of Texas in Houston, and many others of this type. And so they're large centers that see a lot of samples coming through, participate in a lot of advanced clinical trials. And then your more medium-sized reference laboratories that might serve a community as well as smaller community hospitals. And so these are the types of customers that are adopting OGM and using it in the cytogenetic setting. And we estimate that just within the United States and Western Europe, there are about 2,500 of these labs.
And that they process right around a million samples or so per year in these labs. And of course, there's many, many more samples that run through these labs. But when we just look at the hematologic malignancy and genetic disease workflows now, these are the numbers that we're targeting. And I think the million is just in the United States. So it's probably double that when you look outside the United States. And the applications, I've been sort of mentioning them, but the applications are really three main areas of application. So the first one is for the analysis of cancers of the blood and the bone marrow. So leukemias, lymphomas, myelomas.
And one of the reasons that this is such an important application, and I would say it's the lead application when one of these cytogenetics laboratories is adopting OGM, is that medical guidelines that really define the way that these samples should be analyzed dictate that karyotyping and FISH should be used as the first-line primary analysis to look for a series of variant types or classes. And optical genome mapping is uniquely suited to detecting these variant classes. And it can do what karyotyping and FISH do together. And so this area of cancers of blood and bone marrow is really a primary application for optical genome mapping. And then the other is in what we call constitutional genetic disorders or rare diseases.
Rare diseases is such a misnomer because actually the actual genome variant that causes some type of, for example, developmental delay, certainly within the autism spectrum, there is a lot of genetic factors that are being analyzed, and other forms of disability, such as intellectual disability, these can have a genetic cause. It might be a sequence variant detected by sequencing, or it might be a structural variant detected by mapping, but they're called rare diseases because that particular event may occur only once or a few times in the case of a particular subject, but taken all together, these diseases are not rare. They're quite common, and so this is a really substantial market for optical genome mapping, and it's one where mapping and sequencing go together. It's really important to screen these samples for sequence variants and also to screen them for structural variants.
So we've got on that clinical research side, blood cancers, then the constitutional genetic diseases. And the third area that we see utilization of optical genome mapping in, and one that we also think is pretty substantial in size, is the whole arena of cell and gene therapy. First development in preclinical stages within pharmaceutical companies. But over time, we imagine that it'll be useful throughout the bioprocessing process to generate the therapeutic cells and could be needed for analyzing patient cells prior to administering the therapeutic cocktail. And so optical genome mapping in this arena does really two things. It allows researchers to look and confirm that the therapeutic modification, like in gene editing, for example, or CAR T therapy or stem cell therapy, that the desired modification has been introduced. So that would be the on-target analysis.
But perhaps more importantly, from a safety perspective, optical genome mapping is used to look for off-target effects. And so increasingly, what this community of cell and gene therapy developers are experiencing is that the modification machinery is becoming more and more complex, which gives the potential for higher and higher potential for off-target effects and the need for methods to look at them. And so optical genome mapping is known throughout the community as having a very high sensitivity. And then its resolution allows for analysis of large rearrangements that might be off-target related to the gene editing or genome modification that happens. And so within that whole bioprocessing, cell and gene therapy development arena, optical genome mapping can be an important QC tool.
Yeah, that's very helpful. It sounds like there's really a wide variety of applications where OGM can be used. Erik, you mentioned that there are two instruments, Saphyr and Stratys. Can you tell us what are the differences between the two?
Yes, sure. So the Saphyr system was introduced originally in 2017. And it's really the platform that we took into human genome analysis. Its predecessor had been used in microbial plant and animal genome analysis. But the Saphyr system in 2017 is what we entered into the human genome analysis. And we took it through a number of evolutions, including updates to the system itself, increasing its capacity, speeding it up, modifying the chips that are used by the Saphyr system as well as modifying the chemistry that's used in sample preparation and labeling. And the Saphyr really became the main platform for genome analysis that we used to finally enter 2020, 2021 into this whole cytogenetic space. And what we found in that process is that Saphyr works great for low-volume laboratories, but laboratories needed a much higher volume.
We began development of the Stratys system really as a follow-on to the Saphyr. We released the Stratys system. It's fully commercially available now since 2023 and full commercial ramp in 2024. The Stratys system has about four times the annual sample throughput of a Saphyr. Every lab sets up the workflow somewhat differently. But from a raw spec standpoint, if you used the Saphyr 24/7 and really maxed out its capacity, you could get about 2,500 genetic disease samples through it per year and about 1,250 cancer samples per year. That's the Saphyr. Stratys is four times that. Up to 10,000 samples per year on a Stratys system if you're running it 24/7. Most labs don't run it at that rate. But if they were to do that, they could get that throughput.
And so the Saphyr system is sort of an entry model. It's a lower-volume model. It's not as expensive as Stratys. It's about $175,000 for a Saphyr system, whereas the Stratys system is more. It's about $295,000. And so high-volume labs use that Stratys. What is also interesting about Stratys, though, in contrast to a lot of higher-throughput systems out there across the industry, I guess, is that the Stratys system works just as well if you're processing one sample as it does if you're maxing out the run. And so each chip in the Stratys system, the ratio is one sample, one chip. And that's a way of creating maximum flexibility for labs. Something that labs experience with sequencing is that they need to accumulate a rather substantial number of samples to generate economies of scale in a sequencing run. That's not the case with optical genome mapping.
The cost to the end user of running one sample versus at any given time, the Stratys can run 15 samples max per run, and of course, that can be replicated over the course of days in a week, but a lab can run one sample or 15, and the cost per sample is the same, so that's really beneficial to them, so the Stratys has a lot of flexibility, and so labs may adopt it even if they have lower volumes because it will scale with them, but both of those exist and are available for sale today in the market.
Got it. And I guess both systems have their dedicated consumables, right?
Yes, that's right. So the Saphyr is a Saphyr Chip. And the Stratys is a Stratys Chip. The Saphyr Chip does have three flow cells on it. So you would typically wait to accumulate three samples to run on a Saphyr. So not quite as flexible as Stratys, but less expensive.
Is the software offered independently from Saphyr and Stratys?
Yes. Let's talk about the software a little bit. So the software is called VIA, VIA, which is an acronym, and it stands for Variant Intelligence Applications. And it's a very powerful software. It had been in the market, developed originally for analysis of next-generation sequencing data and microarray data. And we acquired that product and adapted it to optical genome mapping. And so right away with VIA, it's possible for the end users to visualize, analyze, interpret, classify, and report variants that are optical genome mapping, chromosomal microarray, next-generation sequencing. And then within NGS, the visualization capabilities include large structural variations, such as copy number variations, as well as sequence variants. And so VIA is an incredibly powerful platform that really is kind of a central consolidator for digital pathology data types across the market.
And if a customer wants to adopt and use VIA, they really have two paths. The one path is that maybe they're not yet an optical genome mapping user. And so if there's 2,500 labs out there, I can tell you that we have a total of 378 optical genome mapping systems out there. So we still have a lot of customers that aren't yet optical genome mapping users, which is great. That's our future growth potential. But if a customer wants VIA and they're not yet an optical genome mapping user, they adopt VIA. And they purchase it for analysis of NGS or chromosomal microarray. And they pay a per-sample processing fee. And that's a meaningful amount of revenues for us. I think in the second quarter of this year, 2025, we reported $1.3 million-$1.4 million in software revenues. And we kind of average in that range.
Somebody wants to verify that number. That's the typical quarterly software revenues. That's for analysis of the chromosomal array and NGS data. If you're an OGM customer, you get the VIA software for free. It comes with your OGM system. When you analyze optical genome mapping data, that's for free. The VIA analysis is included in the price that you pay for consumables, which averages around $500 or so. If you're also seeking to analyze sequencing and array data alongside your OGM, then a customer would purchase that. It's an incredibly valuable product as a standalone for non-OGM applications. When we start thinking about those users who have adopted it before adopting OGM, this is a pathway for us to land with the software and then expand with other offerings that we have, such as OGM, the core offering.
And then the flip side is true. So some lab that adopts for OGM, we can encourage them to start analyzing their array and NGS data using VIA. And so we really have expansion opportunities per account based on selling these two products. And there's competition in software. There's no direct competition really for optical genome mapping. When it comes to competition for optical genome mapping, where typically a lab is considering buying the next microscope, for example, for FISH analysis or for karyotyping analysis. And so they're choosing between microscopes and mappers. In software, there's quite a bit more software platforms that are available. But our VIA is recognized as the leading platform for analysis of structural variations, which is the area that we're so incredibly steeped in expertise in. And so it really fits nicely with the customer base that we're developing.
We expect to continue to offer software and mapping as part of our regular offering going forward.
Between instruments, consumables, and software, which one has a higher gross margin? And which one is the main driver of top-line revenue growth in recent quarters?
Yeah. Well, software is overall a higher margin simply because the process of generating the marginal version of the software is straightforward, and so it's the highest margin of the overall product suite, but as a contributor to revenues right now, the highest contributor to revenues is the consumables, OGM consumables, and they are also high margin, so OGM consumables and software are really the margin and profit drivers. OGM consumables are really the growth drivers right now. That's where we're putting all of our attention is to really encourage labs that have already adopted to increase their utilization. This is a way for us to keep customer acquisition costs down, so we have quite an array of what we call routine users. These are labs that have an existing sample flow, and so OGM consumables are what we sell to these labs. They already have their instrumentation in place.
And so that's a revenue driver as well as the profit driver. And then instrumentations would be the lowest of the gross margins overall. And we continue to sell and install new systems. And so at the beginning of the year, we guided to 15-20 new systems installed. And through the end of the second quarter, we had already installed 16. And so we raised that to 25-30 over the year. And some of those are rentals. Some of those are sales. And really, from a strategic perspective, we want to really be as efficient as we can with the capital on hand. And the way that we think it's best to do that is to focus on driving growth of OGM consumables utilization.
And this idea that we're sort of exceeding our plan with regard to new systems installation is just a reflection of the existing demand that's out there because we're really not driving hard OGM into new sites while we build this utilization at existing sites. And we'll get back to that. We'll get back to new customer acquisition, new system expansion. But that's after we really increase the productivity at existing customers.
Got it. Got it. So Erik, you mentioned that the current installed base of OGM instruments is 378, correct?
Yes, total.
Your total addressable market is the total number of labs, which is, as you said, 2,500, is that right?
Yes. It's 2,500 in the regions that we're focusing on now: U.S., Western European countries, Nordic countries, and then Israel is a big user of optical genome mapping, and something that's important for me to clarify is that the total installed base of systems is this 378, but keep in mind that optical genome mapping, the Saphyr system was available long before our cytogenetic workflows were available, and so a lot of that adoption is in basic research. When we kind of scale back and just look at the systems that have been adopted for routine use in cytogenetic laboratories, it's probably about 150-175 systems total in about 140 customer sites, and so really, I think that the 100, let's just make it simple and call it 150. It's really 150 customers out of a potential 2,500 customers have adopted.
Now, one last thing I want to say about the 2,500 is that somewhat by choice, we have elected to narrow our geographic focus just to these areas: the United States, Canada, Western Europe, Israel, as I mentioned. There's your 2,500. But China, we have a partner in China, which has received National Medical Products Administration or NMPA registration for the Saphyr system. And they're working through a process of building up a commercialization program there. So China has tremendous potential. As you may know, there are 1,000 or so tier three hospitals, many of which have very large cytogenetic laboratory capabilities. And karyotyping, when you think about it, is the global standard. There's much, much more karyotyping that happens every year than sequencing. And optical genome mapping is a replacement for that.
And so we actually estimate that on top of the 2,500, there's another 7,500 laboratories that could one day be using optical genome mapping. We're not targeting those international markets at the current time, but we will. And so there's tremendous runway for growth of optical genome mapping on a global scale.
I mean, you currently do or explore in partnership in those international markets, correct?
Yes. So we have distribution partners who make optical genome mapping available in those regions. And as I mentioned, we have the partner in China with the NMPA registration. I think that it's important to just emphasize that we support those partners, but we don't make a big marketing or other resource commitment to those regions. And this is, again, really something that we've implemented to be as efficient as we can be with our capital to extend cash runway. And so we rely on partners in those regions.
Got it. Got it. Within your current customer base, are there a few customers that contribute to a majority of the company's revenue?
I mean, the answer is yes. Well, so the answer is no. There isn't any customer that contributes to the majority. But like most companies, we have users that process more than others. And so the revenue, I think, is pretty well distributed across these 140 customers that are using optical genome mapping, 150 customers using optical genome mapping on a routine basis. What we see is that the utilization or average utilization varies. So across all of them, rough numbers, and we're really just starting to dig into this and getting the data from customers as to how many samples they've run. Sometimes we can actually tap into their instrument and see directly. Other times, we need to rely on their reporting. So these are just estimates. But I think our estimates are around four or so samples on average per week.
But when we look at the highest volume users, of which we have maybe five to 10 users that are in this category, they're running almost 40 per week. And so the numbers can be pretty substantial. And so the way we think about it is that it's not like these labs, which are using 20 or 30 or 40 per week, running 20 or 30 or 40 per week. It's not like they are so much bigger than the average lab. It's that the average lab has just started. And so our focus is to work with them for them to increase their utilization on a weekly or monthly basis, however you want to measure it. And the path to them increasing their utilization is relatively straightforward.
So they may be using optical genome mapping initially for one type of blood or bone marrow cancer, for example, acute lymphocytic leukemia, ALL, or acute myelogenous leukemia, AML, they may develop an assay for AML, and that's something that they may make available within their institution, but then after AML, they'll add ALL, CLL, CML, and so this is a way of increasing the menu and driving more and more samples through OGM, and keep in mind, it's not just the leukemias, but then they can also add the constitutional genetic disorders, and so this is why we believe that we'll take this average of four and just march that up over the next 12-18 months and really grow revenues through that path.
Can you talk about the retention rates of customers? I mean, are there any cases where a customer has spent some time evaluating the OGM solution, but then decided not to use it?
Sure, so let me talk about that. It's a really good question, and we've seen some patterns, and the answer is yes. We've had some end users adopt OGM. We have a program, which is a reagent rental program, so they can make a commitment to a certain number of consumables and will place the mapping system for free as part of that program, and right now, if you commit to a rental program, it's one year, but we had in 2021, 2022, some programs where laboratories could make just a six-month commitment, and what we saw during that period was that just about every single laboratory that adopted in a cytogenetic laboratory for applications in hematologic malignancies or constitutional genetic disorders still has the system, and they've renewed the commitments and continue to purchase on a regular basis. Many of those sites have bought out the system.
So that's a feature of the rental program. They can buy the capital. And that kind of relieves them of the burden of maintaining the volume commitment on consumables, but they keep OGM in-house. Where we did see some returns was in the cell and gene therapy arena. And interestingly, almost exclusively in small venture-backed biotech companies, some publicly traded biotech companies. And this process of them doing the evaluation, completing it, and intending to not go forward was almost entirely driven by a lack of funding in those laboratories. And many of them have switched to a different model. So instead of having optical genome mapping in-house, they send their samples out to a CRO. We actually offer services for processing samples. And so they're able to still get OGM data but don't have the system. And so the answer is yes.
There's been some evaluations that have resulted in somebody sending the system back. It's almost entirely in this area of venture-backed pharmaceutical companies, biotech companies, which have faced severe funding constraints in the last couple of years.
Got it. Got it. Apart from funding, do you see, I mean, whether there are any other potential hurdles that may prevent potential customers from adopting OGM?
I think that we've really sort of knocked them down. So they have existed. And in 2021, when we were really starting to penetrate these Cyto Labs, they wanted publications. They wanted evidence that really demonstrated that OGM was comparable or superior to existing methods. And we had a few papers, but there weren't a lot. And one of the things that we found was that if we went to a U.S. site with a paper that was published in Europe, they would say, "Well, this is great, but we need it from a U.S. site." And so over time, our Chief Medical Officer, Alka Chaubey, really built an amazing team of clinical affairs scientists to coordinate a number of studies and clinical trials to really demonstrate the incremental value and utility of optical genome mapping, including side-by-side comparisons against the traditional methods.
And in every case, optical genome mapping performed incredibly well. And now there are just hundreds of publications that demonstrate this performance. In addition to those publications, we track the number of what we call clinical research genomes. So like a clinical sample that comes in, of course, is used for analysis and research and then published. And the cumulative number of unique samples that has been analyzed and published in one publication or another exceeded 10,000 in the second quarter of this year for the first time. And that's a critical mass. So that barrier around whether optical genome mapping works or not, I think we've overcome that. The next question that we got a lot, especially the United States, was, "Well, are there CPT codes for this?" And so optical genome mapping and our products are sold for research use only.
And laboratories, we're aware that laboratories adopt it under their regulatory framework of CLIA, for example, Clinical Laboratory Improvement Amendments. They develop an assay, validate it, and then they may offer that clinically. They're interested in whether they can get reimbursed from third-party payers, insurance companies, Medicare, Medicaid, and so forth. And one of the mechanisms they would leverage to do that would be a CPT code. They would bill against that code to these third-party payers. Well, in 2024, the American Medical Association established a CPT code Category 1, which is the highest bar. It's very difficult to get a Category 1 CPT code. But they established one for hematologic malignancies. And then this year, they established one for constitutional genetic disorders. And so that was one of the most frequently asked questions of our salespeople, whether a CPT code existed.
And now it exists for both of these main applications. And so that barrier is behind us. There are many other nuances that go into laboratories being reimbursed from payers. And so that continues to be a process that's underway. But really, the door is opened with the CPT code. So that's good. The next, I think, so I see these as the major barriers and that they are behind us. Other barriers that exist for laboratories, not so much in adopting yes or no, but, "Okay, I've adopted it, and now I want to increase my throughput," include automation. So VIA automates the data analysis and reporting part of the workflow. It makes it incredibly efficient. But the DNA isolation step, this is very unique.
Some of our customers have felt that the best technicians to use for optical genome mapping are those technicians that don't have any experience with sequencing because mapping is just a different approach, isolating these ultra-high molecular weight DNA molecules, and so labs are looking for that step to be automated, and we actually have an automation solution. We acquired something called isotachophoresis through a company we acquired called Purigen Biosystems, and we sell the Ionic system for DNA isolation. It's also used for RNA isolation from formalin-fixed, paraffin-embedded tissues, and we are releasing, we have adapted the isotachophoresis process to optical genome mapping, and we are releasing that into the market early next year, and that will automate the front end, or at least the DNA isolation step for OGM, and that will allow labs to increase their throughput.
So what I see is that there are now catalysts. It's not so much barriers to adoption, but now there are catalysts that will increase throughput. Another really significant catalyst, and we've started to see some tidbits of guiding information out there, but is the scientific consortia and communities out there, such as the American College of Medical Genetics and Genomics, ACMG, will they make a recommendation that optical genome mapping be used? Other examples include NCCN, or National Comprehensive Cancer Network. Will NCCN make a reference to optical genome mapping being useful? And so these are where optical genome mapping starts to appear in guidelines. We've seen a little bit of optical genome mapping being standardized. The International System of Cytogenetic Nomenclature, ISCN, has developed a specific way of reporting findings from OGM. So this is critical.
Any laboratory can pull the ISCN manual off the shelf and determine how to report OGM findings, so it's completely standardized, and just over time, we're going to see optical genome mapping appearing in more of these critical guidelines, and so it's not a barrier to adoption that we are there, but it's a huge catalyst to expansion of utilization the more optical genome mapping is incorporated into that, so proof sources, CPT codes, guidelines, and automation. These are the real drivers of incremental adoption and utilization.
Yeah. That's very helpful. Thank you. Are there any upcoming on the regulatory side in terms of catalysts and milestones?
Yeah. I mean, I think that the way that our product is developed and sold is for research use only, and so I think that what we have seen in the space is that laboratories do adopt the technique. They do validate it as what's called a laboratory-developed test, and we had seen that the FDA was seeking to regulate labs that had LDTs, and maybe that might have had some impact on us. Again, we're research use only, and so the intended use is up to the customer when they adopt it, but there was some potential that this FDA reach into the laboratory-developed test arena could have an effect, but the FDA has reversed course on that and will not be regulating those, so that's actually something that's positive in basically an absence of regulation.
Erik, I think you briefly touched on competition before, but can you clarify again, are there any other companies that provide OGM products offerings on the market currently?
No. Bionano is the only company that provides optical genome mapping. There are a few other companies that have been seeking to develop methods to look at structural variation. That's clearly an unmet need, and so companies have been trying to develop sequencing methods, for example, to go after it. Nothing has really risen to a level of adoption that we see anywhere significant across labs that we visit, and almost certainly, whatever methods that do evolve and develop will be complementary, and any lab that's trying to develop optical genome mapping would be going up against our very extensive intellectual property patent portfolio. It's incredibly solid and well protected in the United States and around the world in the geographies in which we're commercial, so I think we have a good protection against incoming competitors.
Regarding the financial performance in the second quarter of 2025, can you provide a breakdown of revenue, and do you expect the revenue mix to remain relatively the same for the coming year?
Yes. I mean, I would have to refer everybody to the 10-Q that we filed. And there's a revenue footnote that really breaks it down in detail. But we sort of break out revenues as instruments, consumables, and then services and other. And the services and other is where our software is. And so the instruments and consumables combined was probably around $5.5 million or so. And then the services and other probably around $1.6 in that range. And so think of that as products and software. And I see that as being the breakdown going forward, although we don't drive software growth. So the product revenues, the instruments, and consumables will increase while we expect software to be roughly flat going forward.
Got it. Okay. I think the company has provided revenue guidance for 2025, correct?
Yes. $26 million-$30 million.
Yeah. That's right. I don't know if you're free to talk about. I'll provide any color at all for 2026 or 2027 at this point.
Yeah. I mean, I think that just staying general, coming into 2025, we really had a pivot in strategy going towards an emphasis of existing customers and their utilization and really kind of slowing down the new customer acquisition because of how expensive that proved to be. And so we went from a regime of kind of growth at any cost to efficient growth. And we'll see the $28 million-$30 million or sorry, $26 million-$30 million, if we hit the midpoint of that, for example, our core revenues, consumables will have grown right around double digits if all the patterns from the first half hold here in the second half. So I think it's reasonable to expect that pattern to continue and maybe even accelerate into 2026.
And so we're hopeful that that kind of growth at existing customer sites can be a driver of even accelerating growth to take the company to, let's say, EBITDA positive, for example. But we really do need to get through 2025. It's such a critical year for us, kind of like setting this new strategy. And that will help us really formulate what we think 2026 and 2027 hold. Having said that, our focus internally is trying to do the best we can to keep expenses flat. We've brought expenses way down. In 2023, non-GAAP OpEx was around $35 million a quarter. Non-GAAP OpEx, I think, is $8.5 million-$9 million. GAAP OpEx last quarter was like $11.5 million. And so we really have brought the expenses down. And we want to keep those roughly flat going forward while still growing revenues, hopefully in that double-digit range.
For investors who look at the Bionano common stock price performance during the past 12 months, can you talk about the underlying factors that may have contributed to the common stock performance?
Yeah. I mean, I think that in that 12-month window is important. So including kind of the fourth quarter of last year, I mean, I think we ran into a handful of really challenging setups. I mean, I think that the industry as a whole, our peers have all experienced a lot of contraction in stock price. And then Bionano, in particular, has really had a financing overhang, which has been a driver of price sensitivity. And then in order to really maintain the listing, we needed to execute a reverse stock split, which we did in the first quarter of 2025. So a number of macro non-idiosyncratic effects weighed on the stock. The idiosyncratic financing overhang coupled with the reverse split, I think, set up a lot of that performance that we saw. That is largely behind us.
We completed a financing very recently that really gives us a lot of runway extension. And so we don't see needing to do any type of financing like we've completed recently for quite some time. And so we're hopeful that the stock can breathe a little bit now.
Does the company currently have sufficient capital to achieve cash flow break-even?
I would suspect we would need to top off the tanks at some point to get there. But we're a lot closer to EBITDA positive, for example, than we've ever been. So we can start to really measure what we need and achievable quantities without heroic efforts like we've gone through in the past. So we do feel like we have a lot of breathing room there now.
Got it. Got it. We are getting to the end of the chat. Erik, do you have any closing remarks for our audience?
Well, I'm just really excited to be able to talk about optical genome mapping, about Bionano and really highlight for folks that this whole area of cytogenetics, which is part of pathology, is an area where the techniques and the procedures and so forth that have been used have been there for decades. And so it's really ripe for companies like Bionano to come in and completely digitize these workflows. And so we think of ourselves as a digital pathology company with an enormous opportunity out there for us to capitalize on. So I really appreciate the opportunity to talk about that, Yi.
Thank you, Erik. We appreciate your time and effort, and we wish Bionano a successful commercial performance in the coming years.
Thank you.
Thank you.