Bionano Genomics at H.C. Wainwright Event: Mapping the Future of Genomics

On Wednesday, 15 October 2025, Bionano Genomics (NASDAQ:BNGO) participated in the H.C. Wainwright @ Home Event, where its President and CEO, Dr. Eric Humbley, discussed the company’s strategic direction. The conversation highlighted Bionano’s unique position in the genomics market with its optical genome mapping (OGM) technology, addressing both its potential and challenges. The company is focusing on increasing the utilization of its existing instruments rather than expanding its install base, aiming for efficient growth.

Key Takeaways

• Bionano’s optical genome mapping (OGM) technology complements traditional sequencing methods.
• The company is focusing on increasing utilization of existing OGM instruments rather than expanding the install base.
• Bionano expects double-digit growth in consumables revenue, aiming to keep expenses flat.
• Recent financing has extended the company’s financial runway, supporting future growth.
• Bionano is the sole provider of OGM, with strong intellectual property protection.

Financial Results

Bionano reported its Q2 2025 financial results with a detailed breakdown:

• Software revenues ranged between $1.3 million and $1.4 million.
• Instrument and consumables revenues combined reached approximately $5.5 million.
• Services and other revenues were around $1.6 million.
• The company provided a 2025 revenue guidance of $26 million to $30 million.
• Non-GAAP operating expenses are currently between $8.5 million and $9 million, a reduction from the previous quarter’s $11.5 million GAAP expenses.
• Consumables are currently the highest contributor to revenues.

Operational Updates

Bionano’s focus remains on optimizing its current operational capabilities:

• The total OGM instrument install base stands at 378, with 150 used routinely in cytogenetic laboratories across 140 sites.
• The company exceeded its installation plan, raising guidance to 25 to 30 new installations over the year.

Future Outlook

Bionano is targeting growth in specific regions:

• Focus on the US, Western Europe, Nordic countries, and Israel, with a potential market of 2,500 labs.
• China presents significant growth potential, supported by a partner with NMPA registration for the Saphyr system.
• Beyond the initial target, an additional 7,500 laboratories could eventually adopt OGM technology.

Q&A Highlights

Key insights from the Q&A session included:

• OGM is complementary to next-generation sequencing, not a replacement.
• Consumables and software are identified as the primary margin and profit drivers.
• The company aims to achieve EBITDA positivity in the future.
• Two CPT codes are in place for hematologic malignancies and constitutional genetic disorders.

Conclusion

For a deeper understanding of Bionano Genomics’ strategic plans and financial performance, readers are encouraged to refer to the full transcript below.

Full transcript - H.C. Wainwright @ Home Event:

Yi Chen, Equity Research Analyst, HC Wainwright: You for joining the HC Wainwright at home event. My name is Yi Chen, and I’m an equity research analyst at HC Wainwright. Today, we have the privilege, to have a virtual fireside chat with doctor Eric Humbley, president and CEO Welcome. Thanks, Yi.

Eric, 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?

Eric Humbley, President and CEO, BioNano: Yeah. Sure. Thank you, Yi, and thanks to, AT Rainwright 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 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 a thousand 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 SAFIRE system, it’s the SAFIRE chip. On the Stratus system, it’s the Stratus 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, nano channel itself. And inside there, we can then image the DNA molecules. And so the instrument, the Stratus instrument or the Sapphire 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 dataset. 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 has 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 100 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 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 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.

Yi Chen, Equity Research Analyst, HC Wainwright: So if I understand if I understand correctly, OGM, does not replace next generation sequencing, but it’s complementary to NGS. Is that right?

Eric Humbley, President and CEO, BioNano: 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 100 base pairs in size.

But after you get a after you get above, you know, a few 100, 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, 100 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. 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.

Yi Chen, Equity Research Analyst, HC Wainwright: 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 OGN?

Eric Humbley, President and CEO, BioNano: Yes. You know, it’s it’s interesting. We’ve been developing optical genome mapping, for for some time. And, you know, 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. They have relied primarily on three techniques historically, beginning with karyotyping.

Then they use something called FISH, or fluorescence institute hybridization, and then chromosomal microarrays. And these three techniques are used in combination to analyze samples, to 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 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 mid 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 you know, a few big names here in The United States. And then in 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 there are large centers that see a lot of samples coming through, participate in a lot of advanced clinical trials. And then your more medium 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 in in in these, in these labs. And, of course, you know, 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 the numbers that we’re targeting. And, you know, I think 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, you know, cancers of the blood and the bone marrow, so leukemias, lymphomas, myelomas. One of the reasons that, this is such a 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 set, 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. You know, 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 disabilities 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 altogether, 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, 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, you know, for analyzing patient, cells prior to, administering the, the the 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, 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 off 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, the gene editing or 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.

Yi Chen, Equity Research Analyst, HC Wainwright: Yeah. That’s very helpful. It sounds like there’s a really a wide variety of applications where OGM can be used. Eric, you mentioned that, there are two instruments, Saphyr and Stratasys. Can you tell us what are the differences between the two?

Eric Humbley, President and CEO, BioNano: Yes. Sure. So, the Saphyr system was introduced, originally in 02/2017, and it’s really the platform that we took into human genome analysis. Its predecessor had been used in, you know, 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 that are used by the Sapphire system until, you know, as well as modifying the chemistry that’s used in sample preparation and labeling. And the Saphyr really became the main platform, for for genome analysis that we use to finally enter, you know, twenty twenty, twenty twenty one 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. And so we began development of the Stratus system really as a follow on to the Sapphire, and we released the Stratus system. You know, it’s it’s fully commercially available now since, 2023 and, you know, full commercial ramp in 2024.

And the Stratus system has about four times the annual sample throughput of a Sapphire. And, you know, every lab sets up the workflow somewhat differently, but, you know, from a raw spec standpoint, if you used the Sapphire, you know, twenty four seven 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 through it per year per year. That’s the, Sapphire, and Stratus is four times that. So up to 10,000 samples per year on a Stratus system if you’re running it twenty four seven. Now most labs don’t run it at that at that rate, but if they were to do that, they could get that throughput.

And so the the Saphyr system is, you know, sort of an entry model. It’s a lower volume model. It’s it’s not as expensive as Stratus. You know, it’s about a $175,000 for a Saphyr system, whereas the, Stratus system is more. It’s, about 295,000.

And so, you know, high volume labs use that Stratus. What is also interesting about Stratus, though, in contrast to a lot of higher throughput systems out there, you know, in in you know, across the industry, I guess, is that the Stratus 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 Stratus 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 to 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 Stratus can run 15 samples max per run, and, of course, that can be, replicated over the course of of of, you know, days in a week. But a lab can run one sample or 15, and the cost per sample is is the same. So that’s really, beneficial to them. So the Stratus 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.

Yi Chen, Equity Research Analyst, HC Wainwright: Got it. And I guess both systems have their dedicated consumables. Right?

Eric Humbley, President and CEO, BioNano: Yes. That’s right. So, the Sapphire is a Sapphire chip, and the Stratus is a Stratus chip. The Sapphire chip, does have, three flow cells on it. So, you know, you would you would typically wait to accumulate three samples to run on on a Sapphire.

So not quite as flexible as Stratus, but, you know, less expensive.

Yi Chen, Equity Research Analyst, HC Wainwright: Is the software offered independently from Sapphire and Stratasys? Yes.

Eric Humbley, President and CEO, BioNano: Mhmm. Let’s talk about the software a little bit. So the software is called Via, v I a, 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 and 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, you know, 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, you know, we have a total of 378, optical genome mapping systems out there. So, you know, we 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 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, you know, that’s a a meaningful amount of revenues for us.

I think in the, second quarter of, of this year, 2025, we reported, you know, $1.31400000.0 dollars in software revenues. And that’s you know, we we we kind of, average in that in that range, and, somebody wanna verify that that that number. But that’s the typical quarterly software revenues, and 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.

And when you analyze optical genome mapping data, that’s for free. So the the the, via analysis is included in the price that you pay for consumables, which averages around $500 or so. But if you’re also seeking to analyze sequencing and array data alongside your OGM, then a customer would purchase that. And so it’s a very it’s an incredibly valuable, product as a stand alone, for non OGM applications. But then when we start thinking about those users who have adopted it before adopting OGM, this is a pathway for us to, you know, 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, you know, there’s competition in in software. There’s no direct competition really for optical genome mapping.

You know, when when it comes to competition for optical genome mapping, we’re typically you know, 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, and we expect to continue to offer software and mapping as part of our regular offering going forward.

Yi Chen, Equity Research Analyst, HC Wainwright: Between instruments, consumables, and software, which one has the higher has a higher gross margin, and which one is the main driver of top line revenue growth in recent quarters?

Eric Humbley, President and CEO, BioNano: Yeah. Well, yeah, software is overall a higher margin, you know, simply because, you know, the the the process of of of generating the, marginal, version of the software is straightforward. And so it’s 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 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 to, you know, that have already adopted to increase their utilization. This is a way for us to keep customer acquisition costs down. So we have, you know, 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 and, you know, so that’s a revenue driver as well as the the profit driver. And then instrumentations would be, you know, the lowest of the of the gross margins overall. And we continue to, you know, sell and install new systems.

And so at the beginning of the year, we guided to, 15 to 20 new systems installed. And through the end of the second quarter, we had already installed 16, and so we raised that to 25 to 30 over the year. And some of those are rentals. Some of those are sales. And, you know, really, from a strategic perspective, we we we want to, really be as efficient as we can with the capital on hand.

And the way that we think it’s is 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 into new sites while we build this utilization at existing sites. And then we’ll get back to that. We’ll get back to new customer acquisition, new system expansion, but that’s after we really increased the productivity at existing customers.

Yi Chen, Equity Research Analyst, HC Wainwright: Got it. Got it. So, Eric, you mentioned that the current installed base of OGM instruments is 378. Correct?

Eric Humbley, President and CEO, BioNano: Yes. Total.

Yi Chen, Equity Research Analyst, HC Wainwright: Yeah. And your total addressable market is the total number of labs, which is, as you said, 2,500. Is that right?

Eric Humbley, President and CEO, BioNano: Yes. It’s it’s, you know, it’s it’s 2,500 in the regions that we’re focusing on now, US, you know, Western European countries, Nordic countries, and then, you know, 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, you know, optical genome mapping, know, the Saphyr system was available long before our our cytogenetic, workflows were available. And so a lot of that adoption is in basic research.

When we kind of scale back and and just look at the systems that have been adopted for routine use in, cytogenetic laboratories, it’s probably about a 150 to a 175 systems total in about a 140, customer sites. And so, you know, really, I think that the 100 yeah. Let’s just make it simple and call it a 150. It’s it’s really a 150 customers out of a potential 2,500 customers have adopted. Now one last thing I wanna say about the 2,500 is that, you know, somewhat by choice, we have elected to narrow our geographic focus just to these areas, 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 product National Medical Product Administration or NMPA registration for the Saphyr system, and they are working through a process of building up, a commercialization program there. So China has tremendous potential. As you may know, there are a thousand or so tier three hospitals, many of which have very large cytogenetic laboratory capabilities. And, you know, 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, you know, we actually estimate that on top of the 2,500, there’s another 7,500 laboratories that that could one day be using optical genome mapping. We’re not targeting those, you know, those 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.

Yi Chen, Equity Research Analyst, HC Wainwright: I mean, you you currently do or exploring partnership in those international markets. Correct?

Eric Humbley, President and CEO, BioNano: Yes. So we have distribution partners who make optical genome mapping available in those regions. And as I mentioned, we have the the partner in China with the NMPA registration. I I think that it’s important to just emphasize that, you know, we support those partners, but we don’t make a big marketing, or or, you know, other resource commitment to those regions. And this is this is, again, you know, really something that we’ve implemented to be as efficient as we can be with our capital to extend cash runway.

And, you know, so we, you know, we rely on partners in those regions.

Yi Chen, Equity Research Analyst, HC Wainwright: Got it. Got it. Within your current customer base, are there a few customers that contribute to a majority of the company’s revenue?

Eric Humbley, President and CEO, BioNano: I mean, the answer is yes. The well so the answer is no. There isn’t any customer that contributes to the majority. Mhmm. But, you know, like most companies, we have users that that process more than others.

And so, you know, the the the revenue, I I think, is pretty well distributed across these a 140 customers that are using optical genome mapping, a 150 customers using optical genome mapping on a routine basis. What we see is that the utilization or average utilization varies. So, you know, across all of them, you know, rough numbers, and we’re really just starting to dig into this and, you know, getting the data from customers as to how many samples they’ve run. Sometimes we can we can actually tap into their instrument and and see directly. Other times, you know, 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, you know, of which we have, you know, maybe, five to 10 users that are in this category. They’re they’re running almost, you know, 40 per week. And so, you know, the the numbers, you know, can be pretty substantial. And so the way we think about it is that it’s not like these labs which are using, you know, 20 or 30 or 40 per week, running 20 or 30 or four 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 wanna 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 start. 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 over the next, you know, twelve to eighteen months and really, grow revenues through that path.

Yi Chen, Equity Research Analyst, HC Wainwright: Okay. Talk about the retention rates of customers. I mean, are there, any cases where a customer has, you know, spent some time evaluating the OGM solution but then decided not to use it?

Eric Humbley, President and CEO, BioNano: Sure. So let me let me talk about that. It’s a really good question. And, you know, we’ve seen some patterns, and and the answer is yes. We’ve had, some end users adopt OGM.

We have a a program, which is a reagent rental program, so they can make a commitment to a certain number of consumables, and we’ll place the mapping system, for free as part of that program. And and and, right now, if you commit to a rental program, it’s it’s one year. But we had in, twenty twenty one, twenty twenty two, 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 in a cytogenetic laboratory for applications in hematologic malignancies or constitutional genetic disorders, still has the system, and those 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 they can buy the capital, and that kinda relieves them of the burden of maintaining the the the 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, you know, 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 it’s almost entirely in this area of venture backed pharmaceutical companies, biotech companies, which have, you know, had faced severe funding constraints in the last couple of years.

Got it.

Yi Chen, Equity Research Analyst, HC Wainwright: Got it. Apart from funding, do you see I mean, whether there are any any any other potential hurdles that may prevent potential customers from adopting OGEM?

Eric Humbley, President and CEO, BioNano: I I think that that, you know, we’ve really sort of, knocked them down. So so they they have existed. And, you know, in 2021, when we were really starting to penetrate these CytoLabs, they 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 US site with a paper that was published in Europe, they would say, well, this is great, but we need it from a US site. And so, over time, you know, chief medical officer, Alka Chawbe, 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 comparison against the traditional methods. And in 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 we 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, like, 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 in, especially The United States was, well, are there CPT codes for this? And so, you know, 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 laboratories improvement amendments. You know, they they develop an assay, validate it, and then they may offer that clinically.

You know, 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 one, which is the highest, bar. It’s very difficult to get a get a category one CPT code, but they 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 you know, the frequently asked questions of our salespeople, whether a CPT code existed, and now, you know, it exists for both of these main applications. And so, you know, that barrier is behind us. There are many other nuances that go into, you know, laboratories being reimbursed from payers. And so, you know, that continues to be a process that’s underway, but, you know, really the the the door is opened with the CPT code, so that’s good.

The next, I think, yeah. So so I I see these as the major barriers and that they are behind us. Other barriers that exist for laboratories, not so much in, you know, adopting yes or no, but, okay, I’ve adopted, and now I wanna increase my throughput, automation. So, you know, 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 isotachopheresis 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 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, you know, you know, tidbits of guiding information out there, but, you know, is is the, scientific, consortia and and, communities, out there, such as the, college of medical genetics and genetics, genomics, ACMG, You know, will they make a recommendation that optical genome mapping be 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 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 o g findings from OGM. So this is critical. Any any laboratory can pull the I ISCN manual off the shelf and determine how to report OGM findings, it’s completely standardized.

And just over time, we’re gonna 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, you know, proof sources, CPT codes, you know, guidelines, and automation, these are the these are the real drivers of incremental adoption and utilization.

Yi Chen, Equity Research Analyst, HC Wainwright: Yeah. That’s that’s very helpful. Thank you. Are there any, upcoming on the regulatory side in in terms of catalysts and milestones?

Eric Humbley, President and CEO, BioNano: Yeah. I mean, I think that the way that, our product is developed and sold is for research use only. And so I I think that, you know, what we have seen in 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, you know, 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, you know, there was some potential that this FDA reach into the laboratory developed test arena could have an effect, but that that you know, the FDA has has reversed course on that and will not be regulating those. So that’s that’s actually something that’s positive in a, you know, basically, an absence of of regulation.

Yi Chen, Equity Research Analyst, HC Wainwright: Eric, 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?

Eric Humbley, President and CEO, BioNano: No. Bionano is the only, company that provides optical genome mapping. There are, you know, 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, you know, we we see, anywhere significant, across labs that we visit. And almost certainly, methods that do, evolve and develop will be complementary. And any, you know, lab that’s trying to develop optical genome mapping would be going up against, you know, 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.

Yi Chen, Equity Research Analyst, HC Wainwright: Regarding the, financial performance in the ’25, can you provide a breakdown of revenue, and do you expect the revenue mix to remain relatively the same for the coming year?

Eric Humbley, President and CEO, BioNano: Yes. I mean, I I would have to refer everybody to to the, the the 10 q that we filed, and there’s a, you know, there’s a a revenue footnote that really breaks it down in in detail. But, you know, the the you know, we we sort of break out revenues as, you know, instruments, consumables, and then services and other, and the services and other is where our, you know, software is. And so, you know, the the, instruments and consumables combined was probably around, you know, 5 and a half million or so, and then the the services and other, probably around, 1.6 in that range. And, you know, so think of that as products and and and, software.

And I I see that as being, you know, the breakdown going forward, although, you know, we don’t drive software growth so that, you know, the product revenues, the instruments, and consumables will increase while we expect software to be roughly flat, going forward. Got it.

Yi Chen, Equity Research Analyst, HC Wainwright: Okay. I think the company has provided revenue guidance for 2025. Correct? Yes.

Eric Humbley, President and CEO, BioNano: Talk ’26 to 30,000,000.

Yi Chen, Equity Research Analyst, HC Wainwright: Yeah. That’s right. I don’t know if you is free to talk about or provide any color at all for 2026 or 2027 at this point.

Eric Humbley, President and CEO, BioNano: Yeah. I mean, I I I think that, you know, just staying, you know, general, you know, coming into 2025, we really had a pivot in strategy going towards an emphasis of existing customers and their utilization and, you know, really, you know, kind of slowing down the new customer acquisition because of how expensive that proved to be. And so it was you know, we went from a regime of kind of growth at any cost to, you know, efficient growth. And we’ll we’ll see, you know, the 28 to 30,000,000 sorry, 26,000,000 to 30,000,000 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 I think it’s reasonable to expect that pattern to continue, and and maybe even accelerate, into, 2026.

And so, you know, and and and and, you know, we’re we’re hopeful that that kind of growth at existing customer sites can be a driver of even accelerating growth, you know, to to take the company to, let’s say, EBITDA positive, for example. But, you know, 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, you know, our focus internally is trying to do the best we can to keep expenses flat. We’ve brought expenses way down.

You know, in 2023, know, non GAAP OpEx was around 35,000,000 a quarter. Non GAAP OpEx, I think, is, you know, eight and a half to 9,000,000. GAAP OpEx. Last quarter was, like, 11 and a half million. And so, you know, we really have brought the expenses down, and we we wanna keep those roughly flat growing going forward while still growing revenues, hopefully, in that double digit range.

Yi Chen, Equity Research Analyst, HC Wainwright: For investors who look at the, Boundano common stock price performance during the past twelve months, Can you talk about, you know, the the underlying factors that may have contributed to the the common stock performance?

Eric Humbley, President and CEO, BioNano: Yeah. I mean, I think that that we, know, in that twelve month window is important. So, you know, including kind of the fourth quarter of last year. I mean, think we ran into a handful of really challenging setups. I mean, think that the industry as the 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 of price, you know, sensitivity. And then, you know, we in order to really, maintain the the listing, we needed to, execute a reverse stock split, which we did in the first quarter of twenty twenty five. So, you know, a number a number of macro, non idiosyncratic effects weighed on the stock. The the 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, you know, we don’t see, needing to do, you know, any type of financing like we’ve completed recently for quite some time. And so, you know, we’re hopeful that the the stock can breathe a little bit now.

Yi Chen, Equity Research Analyst, HC Wainwright: Does the company currently have sufficient capital to achieve cash flow breakeven?

Eric Humbley, President and CEO, BioNano: You know, I I would suspect we would need to top off the tanks at some point to get there. But, you know, we’re a lot closer to, you know, EBITDA positive, for example, than we’ve ever been. So we can start to really measure what what we need and, you know, achievable quantities without heroic efforts like we’ve gone through in the past. So we we do feel like we have a lot of breathing room there now.

Yi Chen, Equity Research Analyst, HC Wainwright: Got it. Got it. Oh, we are getting to the end of the chat. Eric, do you have any closing remarks for our audience?

Eric Humbley, President and CEO, BioNano: Well, I’m just, you know, 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

Yi Chen, Equity Research Analyst, HC Wainwright: of

Eric Humbley, President and CEO, BioNano: 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.

Yi Chen, Equity Research Analyst, HC Wainwright: Thank you, Eric. We appreciate your time and effort, and we wish BioNano a successful commercial performance in the coming years. Thank you. Thank you.

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