Welcome to the OpGen Third Quarter 2021 Earnings Call and Business Update. At this time, all participants are in a listen-only mode. Following management's prepared remarks, there will be a Q&A session. As a reminder, this conference call is being recorded today, November 11, 2021.

Before we begin, I would like to caution you that any comments made during this conference call by management may contain forward-looking statements regarding the operations of and future results of OpGen, including it's subsidiaries, Curetis and Ares Genetics.

I encourage you to review OpGen's filings with the Securities and Exchange Commission, including without limitation, the company's most recent Form 10-K and Form 10-Q for the third quarter of 2021 that will be filed with the SEC which will identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.

Factors that may affect the company's results include but are not limited to, our ability to successfully achieve the expected synergies from the company's completed business combination with Curetis and to implement our commercial strategy, the impact of the continuing global COVID-19 pandemic on our business and operations, our use of proceeds from recent financings, our ability to achieve shareholder approval on the items up for vote at the upcoming December 8, 2021 Special Meeting of Stockholders, the rate of adoption of our products and services by hospitals and other healthcare providers in general, as well as in the current COVID-19 pandemic situation in particular, the success of our commercialization efforts and partnering strategy, the effect on our business of existing and new regulatory requirements and other economic and competitive factors.

The content for this conference call contains time-sensitive information that is accurate only as of the date of this live call, November 11, 2021. The company undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call except as required by law.

Joining the call today will be Oliver Schacht, President and CEO and OpGen's new CFO as of January 1, 2022, Albert Weber. We'll introduce Mr. Weber in further detail later on this call. I'd now like to turn the call over to Oliver Schacht for introductory remarks..

Thank you, operator and thank you, everyone, for joining us this afternoon. As always, we value your continued support of OpGen. We're very pleased with our third quarter progress and the fourth quarter to-date and are well positioned for the rest of 2021 and into 2022.

During this call, we will highlight recent accomplishments in our portfolio of products and provide updates on our new and existing partnerships. OpGen is excited by our achievements and we believe we're poised for continued growth over the coming years.

On today's call, we'd like to begin with a recap of highlights briefly mentioned on the second quarter earnings call, followed by recent updates on our product and R&D pipeline, I will then review the financial highlights from the third quarter and introduce our new CFO.

We'll then wrap up the call with an outlook on the company's upcoming milestones, followed by a Q&A session. As mentioned on our previous earnings call, Curetis successfully completed development and had manufactured by a third-party a batch of 10 final pre-series release Unyvero A30 analyzers in August.

The Unyvero A30 RQ platform is designed to deliver rapid and multiplex testing results for swabs and simple fluids in under 30 and 45 to 90 minutes for more complex native specimen.

The flexible and versatile design of the cartridge technology allows the Unyvero A30 to address various sample license requirements as well as testing for a wide range of DNA and RNA nucleic acid targets.

Additionally, the platform is designed to allow straightforward migration of third-party assays for development and commercialization partners and licensees for their own assay menu and product portfolio. We're currently in active dialog with several parties about licensing and partnering options which we will continue to provide updates.

All of these parties are in active due diligence on the instruments from a hardware, cartridge technology, assay flexibility, manufacturing and software standpoint. And we have recently shipped some A30 product prototypes to some of these parties for in-depth technical discussion.

In parallel, we continue to evaluate our own potential future product development programs on the Unyvero A30 platform which includes rapid test for pathogen identification for viruses, bacteria and fungi and a broad range of antimicrobial resistance marker panels.

September, we announced clinical data from a large investigator-initiated and driven prospective, randomized, controlled multicenter study using the Unyvero HPN Panel for hospitalized patients with a suspicion of pneumonia. The study endpoint was the duration of inappropriate antibiotic therapy which was significantly shorter in the PCR group.

Unyvero decreased the average duration of inappropriate antibiotic therapy from 86 hours to 47 hours in addition to reducing the usage of inappropriate antibiotic therapy by over 45%.

Overall, the study concluded that the results of Unyvero, combined with antibiotic stewardship is efficient and safe in decreasing time on inappropriate antibiotic therapy in hospitalized patients with pneumonia at risk for Gram-negative rods [ph]. The milestone we would like to highlight is the initiation of the prospective multicenter U.S.

clinical trial for OpGen's Unyvero Urinary Tract Infection or UTI Panel. It will allow testing for a broad range of pathogens as well as antimicrobial resistance markers directly from native urine specimen.

The trial is expected to enroll more than 1,500 prospective patient samples and we expect to submit data from that trial to the United States FDA for an eventual clearance and commercial launch of the Unyvero UTI product as a diagnostic test in the U.S. UTIs are amongst the most common infectious diseases.

Therefore, rapid and accurate identification of the pathogens and the correct choice of antibiotics is essential. We believe that Unyvero UTI Panel will be a valuable diagnostic tool to help treat these patient populations.

As we continue into the fourth quarter, we're extremely excited about our progress in 2021 and look forward to our future milestones. We began the fourth quarter on a high note, receiving 510(k) clearance by the FDA to market the Acuitas AMR Gene Panel. We've already initiated the commercial launch in the U.S. which I will touch on soon.

As a reminder, the Acuitas AMR Gene Panel allows testing for a comprehensive panel of 28 genetic AMR markers in isolated bacterial colonies from 26 different pathogens.

The Acuitas AMR Gene Panel expands the diagnostics capability of clinicians to test for select drugs rapidly and simultaneously in nine classes of antibiotics to aid in the identification of potentially antimicrobial resistant organisms that might otherwise escape detection.

The AMR panel can detect antibiotic resistance markers in about 2.5 hours compared to one to four days with classic phenotypic methods. Prior to the FDA clearance, we had prepared the launch plan, marketing collateral, trained the sales team and manufactured several batches of Acuitas AMR kits.

Therefore, once we received FDA clearance, we were immediately able to begin a major marketing and sales campaign, targeting more than 400 institutions and well over 1,000 individual key stakeholders at these institutions directly. We're actively engaged in numerous conversations across the country about the Acuitas AMR Gene Panel.

Recently, we announced and closed a $15 million registered direct offering with a single healthcare-focused institutional investors of 150,000 shares of convertible preferred stock and warrants to purchase up to an aggregate of 7.5 million shares of common stock.

The shares of preferred stock have a stated value of $100 per share and are convertible into an aggregate of 7.5 million shares of common stock at a conversion price of $2 per share at any time after the company has received shareholder approval to increase the number of authorized shares of common stock of the company which we have scheduled for a vote at the December 8, 2021 Special Meeting of Stockholders.

The warrants have an exercise price of $2.05 per share and will become exercisable on the later of the date of shareholder approval and six months following the date of issuance and will expire five years following the initial exercise date.

We intend to use the net proceeds from the offering to further work towards achieving our milestones such as the commercial launch and rollout of Acuitas AMR in the United States.

Also, we plan to continue driving the commercial ramp of our Unyvero business in the United States and abroad in areas such as pneumonia, urinary tract infections and other indications. To that end, we'll be able to fund clinical trials such as the UTI FDA trial and the planned IJI trial in the U.S. as well.

We also intend to bring Ares offerings to the United States which will require dedicated commercial and operational resources in 2022 and beyond. Lastly, the $15 million also provides us with the option to repay certain outstanding debt obligations to the European Investment Bank.

Moreover, we're happy to announce that Ares Genetics has commercially launched it's AREScloud web application. AREScloud is a new commercial web application that fully automates data processing, aimed at accelerating the analysis of sequenced clinical isolates.

The software not only processes the data but also offers insights into epidemiologically and etiologically relevant information, including pathogen identity, genotype, virulence, plasmids and antimicrobial resistance. Ares Genetics is actively engaged in discussions with clinical expert users and is collaborating with two major U.S.

hospitals already on independent studies to evaluate the platform for clinical routine use and for outbreak analysis. On the corporate front, we're thrilled to announce OpGen's new Chief Financial Officer, Albert Weber, effective January 1, 2022. Mr.

Weber is a corporate finance executive with more than 30 years of professional experience, 21 of which were at Epigenomics, a molecular diagnostics company with operations in both the United States and Germany. Mr. Weber served as their Executive Officer, Executive Board Member and Executive Vice President, Finance for the past four years.

Albert has critical capital markets experience from raising hundreds of millions of dollars in capital during his career.

He's been overseeing the finance, accounting, controlling and all other corporate G&A functions and has gathered a wealth of hands-on operations experience in both the United States and Europe as well as in China which was a key factor in our decision to bring Albert to the OpGen -- to OpGen as our CFO.

Albert, will you please take this time to introduce yourself?.

Yes. Thank you, Oliver and nice to meet everyone here. As Oliver mentioned, I previously held roles of increasing responsibilities at Epigenomics AG, most recently as the EVP of Finance and Executive Board member and Executive Officers.

During my time at Epigenomics, I was involved in numerous equity and debt financing transactions, including the listing of American depository receipts in the United States. I also oversaw all the operational and financial aspects of the commercial launches of molecular diagnostic product via direct sales teams in the U.S.

and Europe as well as via partners in China.

I have also been involved in several strategic partnerships, licensing deals with global diagnostic operations and multiple M&A processes over the years, including a public takeover offer by a Chinese investor that was backed by the full board and company and dealt with the company at a significant premium to then prevailing stock prices.

This is an exciting time for OpGen with the receive -- with the recent FDA clearance for the unique Acuitas AMR Gene Panel, the already FDA-cleared Unyvero product and the other product in the pipeline that the company expects to get approvals for in the U.S. as well as China and other parts of the world.

I am very excited to be joining Oliver and the rest of the OpGen team and look forward to working with the team and the Board towards shaping the next phase of our growth story and driving shareholder value.

With a significant part of my overall compensation being equity-based, my personal interest will be definitely aligned with our strong retail shareholder base globally. I will now turn this back to Oliver to discuss the third quarter financials..

Thank you, Albert, for providing a brief background. We look forward to the future ahead with you on the team. I'll now briefly touch on the financial overview of the third quarter, discuss our balance sheet and review underlying growth drivers for the business.

Back in August, we decided to cancel the reconvening of the adjourned portion of our annual meeting of stockholders for consideration of Proposal 2, relating to an increase in the company's authorized shares of common stock due to simply not enough votes being cast overall despite the fact that of all those shares that were voted, around 2/3 have supported the proposal.

The company has called a Special Meeting of Stockholders for December 8, 2021, for the approval of a proposal to reduce the required threshold to amend the certification of incorporation of the company from 66% and two-thirds percent to a majority of the voting power of the outstanding capital stock of the company and a proposal to increase the authorized shares of common stock of the company from $50 million to $100 million.

The preferred stock has voting rights with the common stock equal to 30,000 votes per share of preferred stock on each of these proposals provided that consistent with NASDAQ listing rules, any votes cast by the preferred stock with respect to the proposal to increase the authorized shares of common stock must be counted by the company in the same proportion as the aggregate shares of common stock voted on such proposals.

To be very clear, the preferred stock will simply mirror the votes cast by the common shareholders and would help get this to a decision given the required total number of votes that have to be cast overall. Switching to our revenue.

With $1.24 million in revenue in Q3 2021 which was up 17% from last year's Q3 but was up 53% from the second quarter of 2021, we're now at $2.9 million in revenue year-to-date.

And it is important to remember that we exited the FISH business which had contributed close to $2 million in revenue in 2020 and had the one-time non-recurring R&D collaboration partner revenue for Ares Genetics in 2020. So our products business and service business has been growing nicely and is poised for further growth.

Looking at the operating expenses. We capped our overall Q3 2021 OpEx at $6.3 million compared to $7.2 million in the third quarter of 2020 with this quarter coming in at $2.4 million in R&D, $1 million from sales and marketing and $2.1 million of G&A.

For the nine months in 2021, OpEx was $20.4 million compared to $19.6 million for the same period in 2020, with $8.1 million in R&D, $2.7 million from sales and marketing and $7.4 million G&A.

All of these operating expenses in the third quarter and for the nine months year-to-date are in line with our expectations and track very well against our guidance for quarterly cash consumption. Our net loss for the third quarter of 2021 was $6.1 million or $0.16 per share compared to $7.7 million or $0.40 per share in the third quarter of 2020.

And for the nine months of 2021, net loss stood at $28 million or $0.79 per share versus $19.1 million or $1.36 per share for the same period in 2020.

The increase in net loss is primarily due to a $7.8 million non-cash charge for the warrant inducement and exchange deal in March as well as all three quarters in 2021, including Curetis and Ares numbers, whereas 2020 only included six months of these post-closing of the business combination on April 1. Looking at our cash position.

With $25.4 million in cash as of the end of September and the recent $15 million financing, we had just under $40 million in cash in October. This is the strongest balance sheet that OpGen has had in years.

While we have refrained from providing specific revenue guidance in 2021 due to the COVID-19 situation, with recent developments, we would expect full year 2021 revenues to be in the $3.5 million to $4 million range.

Let's not forget, the almost $2 million in prior year FISH products revenue and the more than $1 million in non-recurring R&D collaboration and partnering revenue that Ares had in 2020 which goes to show that in 2021, our products business on the Unyvero side and services on the Ares Genetics side have been growing nicely and we expect to continue that growth trajectory in 2021 with the added Acuitas AMR product expected to start contributing to revenue generation in 2022 as well.

I'd now like to talk about the company's recent and upcoming milestones.

As discussed earlier on this call, we're thrilled by the recent FDA 510(k) clearance of our Acuitas AMR Gene Panel which we believe to have the potential to aid clinicians in the diagnosis of and treatment decision-making for patients with severe life-threatening infections, who are suffering from multidrug-resistant organisms.

We were proactive in our preparations prior to approval. Therefore, we were able to have a swift commercial launch in the U.S.

We're currently engaged in many conversations across the country as part of our launch campaign, having reached out to over 400 institutions and over 1,000 individuals in those and we look forward to the progress and initial commercial traction in 2022.

While the New York State Department of Health Project was successfully completed at the end of September, we are looking to convert some of these pilot users in the state of New York to the now FDA-cleared IVD kit of the Acuitas AMR Gene Panel.

And we have decided to discontinue the offering of the research use only product as we cannot attach any diagnostic claims to such RUO product.

And it creates significant operational burden and overhead as from a regulatory standpoint, it is a completely separate product with different software and different results reporting from what the FDA has now cleared.

Thus looking forward, the way to think about the New York State Department of Health Project is that the individual sites and users would potentially become users and customers to our Acuitas AMR Gene Panel as FDA-cleared but they will no longer be a state-sponsored research project here.

But that was the intention behind the pilot phase all along, generate the data needed to demonstrate the value and clinical use for such a product which we can now actively promote with confidence based on the data from the FDA trial and the entire package insert to any possible user across the entire country.

We're also in regular dialog with the Chinese NMPA, via our strategic partner, Beijing Clear Bio. The Chinese NMPA has requested supplemental clinical data to be generated and submitted in China. We've defined the details of the clinical study to supplement the submission in China.

We're working out final details on the control concept and logistics and are expecting our partner BCB to place an order for the required pneumonia cartridges in due course. Our partner has already obtained IRB approval from the ethics committee of the first of three hospitals to participate in this small scale study.

To be clear, our partner currently expects such a study to take six months or longer overall and the start date will be driven by the NMPA and our partner signing off on the clinical study design.

Once we have a purchase order in hand, we should be able to deliver cartridges into China within about 8 to 10 weeks from receipt of the purchase order to having products on-site in China. So a regulatory approval and commercial launch in China is expected to be a 2022 milestone.

Also, our partner, Annar, in Colombia, has been successful to gain preliminary registration for Unyvero in Colombia. Just a few weeks ago in October, we have sold the first Unyvero system and kits to them. Vietnam is still very much in lockdown due to COVID and we currently do not have a clear sense of regulatory timelines there.

But we also continue to work on several potential new distribution deals in additional countries and markets for our Unyvero portfolio.

As we previously mentioned, we're also pleased to have successfully completed the search for our new Chief Financial Officer to join the OpGen team and we look forward to the positive impact Albert will add to the OpGen team.

A clear area of business focus and expected revenue growth for OpGen globally is our Ares Genetics' next-gen sequencing and artificial intelligence-powered bioinformatics suite of products. We have integrated the data from the Lighthouse into RSDB and the latter will be our core bioinformatics platform moving forward.

So the Acuitas Lighthouse which was it's own standalone research use only software tool for a research collaboration with the state of New York is not a platform that we plan to continue taking forward.

The AREScloud and RSDB are state of the art and superior, both technically as well as commercially and have seen significant initial customer interest. We anticipate growing the Ares business along it's software and services and longer-term kits and products as well.

To that end, Ares Genetics has recently strengthened it's commercial footprint by hiring an experienced European Business Development Manager and we're looking to add an Ares executive team member for commercial operations in the U.S. for 2022 as well.

Another really exciting way to think about leveraging the RSDB asset is providing access to and commercializing subsets of this data asset. Ares is currently working on finalizing an agreement to do exactly that. And once signed, that deal would, of course, be announced right away.

We believe that this specific deal provides a tremendous opportunity to crystalize the underlying value of the RSDB asset by also putting a value and price tag on a small subset of it's overall content. We currently expect to finalize the deal in the fourth quarter of 2021.

On our Unyvero UTI clinical trial, we expect to do an interim data analysis after the first few hundred UTI samples tested and then proceed with full enrollment with a clear objective of completing the trial and data readout in 2022 in order to prepare the product for our next FDA submission.

On our Unyvero IJI or Invasive Joint Infection trial, while we're ready to go with our clinical trial design and have identified the study sites, we really believe there would be a tremendous benefit in getting some FDA feedback and input in a pre-sub meeting format.

Due to the continued overload from COVID-related submissions, the FDA so far has not been open to such pre-sub requests or push them out into 2022. We have, therefore, decided to postpone the trial start for a few months to see if we can elicit a response from the FDA.

As otherwise, we believe we would take an undue risk with the trial design and might not benefit fully from our large set of already banked patient samples and data already available to us which would be a shame and potentially very costly change in trial design.

We'll provide updates as soon as we hear back from the FDA and our advisers, allowing us to finalize on that IJI trial design. In closing, we're pleased with our R&D advancements and key regulatory milestone achievements over the last few months. We'd like to thank all our employees.

I, along with the rest of the management team, are deeply appreciative of your continued commitment. Your dedication is integral to our success and our mission to fight antimicrobial resistance in any way we can, using all of our platforms and products.

Together, we have defined the core values of OpGen to be ownership, performance, generosity, enthusiasm and a keen sense of urgency in the now. I see our team live and work by these values each and every day and that is hugely gratifying to see.

To our listeners, we're looking forward to updating you as we progress on our partnership strategy, R&D pipeline and continue the swift commercial launch and rollout of Acuitas AMR Gene Panel in the U.S. in parallel to conducting the Unyvero UTI clinical trial during the fourth quarter of 2021.

As always, thank you for your unwavering support and for participating in this afternoon's call. I would now like to turn the call back to the operator for questions.

Operator?.

[Operator Instructions] Our first question is from Max Jacobs with Edison Group..

Hi guys, thanks for taking my question.

So I was just wondering, in terms of the bacterial isolates launch, what metrics should we be focusing on?.

Good question. Look, with the typical sales cycle in our industry in the 6 to 12 months, it will be a 2022 metric of new installations of the Acuitas AMR instrument setup which consists of the QIAGEN EZ1 for sample prep and an OpGen-qualified Thermo Fisher QuantStudio 5.

Over time, during the year, I'd say the metric of installed systems will be to look at average utilization rates and reagent pull-through.

From our past experience in New York state, we would expect a typical account once they go live and go into full clinical and commercial routine to run anywhere from maybe $50,000 to $150,000 worth of tests on an annual basis once fully converted. So that's the sort of metrics I would look at..

Great, that's very helpful.

And I know you probably can't answer this question but since you gave 2021 revenue guidance, I was wondering, could you give us a sense of what revenue and maybe expenses might look like in 2022?.

I wish I could at this point. We're not going to provide guidance. I would say, on the operating expense side, if you look at our last couple of quarters, we've been very consistent with the sort of $5 million to $6 million net cash utilization per quarter. I would say, we'd certainly want to keep that operationally in that ballpark.

And we're clearly anticipating 2022 to be a year of substantial growth. But as there is a lot of moving parts right now.

On the one hand, the ongoing launch, on the other hand, a number of these partnering conversations, I would probably defer to our full year earnings call, at which time, I believe we're going to be in a much better position to provide some meaningful guidance.

But clearly, entering into an exciting phase of both product sales growth as well as services and collaboration revenue streams that we believe will put us on a nice growth trajectory..

Wonderful. Thank you so much. That was very helpful. That's it for me. Thanks for taking my questions..

Thanks, Max..

Our next question is from Ben Haynor with Alliance Global..

Congratulations, gentlemen. Thanks for taking the questions. First off for me, I found it kind of interesting that you came out of the gate in the prepared remarks, addressing the A30 RQ opportunity.

I guess, what should investors take from that? And now that these devices are going out to potential partners, how quickly might you expect proposals to materialize? And what could those potentially look like?.

Yes. I mean, first off, the reason we put this right up front, it is a key part of OpGen's portfolio and strategy looking forward. I mean, as we've met some key development milestones here over the summer. And as we said in the last call, we've since continued the full verification validation testing of the instruments.

They've undergone full lifetime testing. I'll leave the last metric I heard, we've literally run 850,000 PCR cycles on these A30 machines and they're performing as if they were new. So they've kind of done multiple times life expectancy. Very robust, very nice.

And in parallel, we have -- and we've been talking about this for a number of months, we have continued these dialogs. It's still tough because travel has continued to be a challenge.

Now literally this week is the first week where the United States after literally 20 months of lockdown, a lockout of Europeans since March 10 last year, have let people in. This is the first time this week that our Chief Operating Officer has been able to come to the U.S. He was on the first flight out of Germany on Monday. He's been here all week.

And as you can appreciate, some of our partners are in Europe, some of our potential partners are in the United States, some of our potential partners are in Asia. So I believe we certainly have a platform that is ready for partnering. What we have made possible is providing hands-on ability to look and feel and touch product which is always key.

If things work out and stars align, literally, over the course of the next week or two, we'll have the first delegations actually meeting the team and getting a firsthand in-person live experience of the platform at our German facility.

Now with the caveat that if you follow the news and COVID metrics, Germany in the last week has not turned for the better. And the numbers literally today are the highest they've ever been in terms of incidence rates. So it's a moving target. Certainly, our -- we believe the platform is ready for partnering.

The cadence and rhythm of getting a larger, more significant strategic deal done, it's still a multi-month endeavor. But again, these conversations and that's why I specifically pointed to due diligence.

So it's not high-level informal conversations, we're in deep dive diligence right down to the nuts and bolts of what can the platform do? What can the cartridge do? What's the specifics on putting assays on it? What's the manufacturing specifics? Fair to say, so what could a deal look like? I'd say conceptually -- and again, we've talked about this in the past, I would look at a deal and let's look at it in a classic licensing sense, you'd imagine some form of upfront, either license or technology access component under which we would then provide either specific geographic scope or specific indication scope for a partner to develop their own content and potentially even their own brand of this platform and manufacture your product.

So it's not just a kind of service, co-development, it could go all the way to transferring technology and know-how and enabling a potential partner to develop, manufacture and commercialize products on the A30 platform. So again, I would caution that these deals are complex and have a nature of taking a while.

But given where we are, again, we believe that some of these conversations have matured, have gone a lot deeper, have gone a lot more specific. And the rest -- there's always two to the party. We're happy and ready to move as fast as need be.

But if you have much larger corporations on the other side, there's so much you can do to make their timelines move the way you'd like but..

And then, the -- I guess, another question I had on that is the target assays that some of these partners are looking at, is it all human diagnostics? Is there -- are guys looking at it and gals looking at it for veterinary applications or food safety or some other types of testing? Or is it all kind of human infectious disease diagnostics?.

There's two elements to human and infectious disease. So I'd say the primary focus of conversations has certainly been around human and it has been with a heavy focus on infectious disease.

That said, at least some of the parties that we are talking to are actively engaged in diagnostics across the full spectrum from environmental, food safety testing to veterinary to other human disease indications beyond infectious disease, either oncology or other forms of testing.

So our core expertise as OpGen, as Curetis has been and continues to be in human infectious disease testing. But remember, one of the projects that we talked about in the summer, a grant project that we have ongoing is in veterinary applications. It does involve the A30. So even internally, we have certain capabilities on the veterinary side.

If you look at our Ares Genetics team and again, that's -- it's on a different platform but we've also done studies and actually done service work on environmental pathogen identification and testing. So we're certainly open to make this as broad as required by the respective party.

And at least some of the parties that we're talking to, I would clearly believe to be actively looking at a platform from a holistic across the full spectrum of potential applications..

Okay, that's helpful.

So it really runs the gamut?.

Yes..

Okay. So then you kind of mentioned in the press release that you kind of have moved beyond the kind of mainly R&D functions and now are moving towards -- more towards commercialization.

Just wondering if you can share some of the figures on Unyvero installs out there as it stands today, what does utilization look like? How has it been trending? What portion of revenues should we expect from distributor stocking orders, et cetera? Just trying to get a better grasp of what that business looks like now, now that you've kind of ramped that up to replace some of the FISH business and other areas of the business that have declined..

Yes. I mean, I'd say as of the Q, we haven't really split it out into individual products.

But I would say, I mean, one -- as I said, one of the key growth drivers has been the Unyvero business and specifically here in the United States, the key growth driver in recent months and let's call it, the last couple of quarters, has been a lot of interest and new installations of Unyvero UTI.

We now have more than a handful of labs that have gone full-blown commercial routine and that means there is labs that are doing anywhere from, let's call it, 60 tests a month on a month by month by month basis.

So very consistent sort of in that 600, 700, 800 total year -- per year and we have the first larger labs that have gone live and anticipate doing significantly larger volumes. So UTI has grown installed base on the UTI side over the last couple of quarters. We've grown that installed base specifically to somewhere in the 16 to 20 analyzer range.

I know we're actually shipping some additional ones here between now and the end of the year. And then again, it's -- we have grown the team. We've added new members into the sales organization over the summer.

We've got them up to speed and trained and they're now getting to a point where they have the first accounts they're ready to move and put new Unyvero systems in. We'll provide specific updates on kind of where we are with the total installed base but it has grown since the beginning of the year.

Net-net, the growth has essentially come out of the U.S. with the incremental pieces we talked about, Colombia, et cetera. So on the distribution side, that's sort of been the primary -- the key growth driver going forward on the Unyvero outside of the existing distribution business in Europe and the U.S., it's clearly going to China.

And those metrics stand unchanged. It's a question of when the NMPA clears this as the numbers of systems that have been committed to are all in the public domain since early last year and have not changed. So that should be the key driver..

Got it. And then just if you can provide any more color on the early reception on the hundreds of institutions and -- I don't know, I think you said 1,000 folks that you've contacted on Acuitas so far..

It's been generally positive. I mean, a lot of folks that had told us over the course of a year when we were waiting to get FDA clearance that said, Oh, come back when you have FDA clearance. We can only bring in tests once they're FDA-cleared.

So certainly falling on open eyes and ears, the challenge continues and that's just the reality out globally and certainly here in the U.S. as well as COVID cases. And if you go to New York City and you see tents being sprung up left, right and center across the city again for COVID testing.

A lot of labs are once again preoccupied with a lot of COVID testing. That said, outside of New York state, we've actually seen additional states pick up the ball and start looking at ways they could bring the Acuitas AMR into their state labs for sort of epidemiology testing, et cetera. So a lot of fruitful conversations.

But again, it is a one of it's kind, first-in-class product, the broadest ever FDA-cleared panel of genetic AMR markers. So there's a lot of education, there's a lot of clinical conversations and digging deep into the value proposition.

What I expect to be a key element here and we'll make the exact announcement, I expect that early in January, we're going to have data from the Acuitas FDA trial being presented along with some clinical value that folks see.

And again, I think the early reception has been very, very positive but these conversations before you bring in a brand-new system and implement a first-in-class assay, these sales cycles are very traditionally in this space in that 6 to 12 month range with potentially faster, of course, for existing users up in the state of New York but everybody else, it would be a brand new -- net new installation.

That's why I said that's going to be a 2022 story to unfold..

Okay, makes sense. Well, thanks for taking the questions. And welcome aboard, Albert. It sounds like you and Oliver are getting the band back together, so to speak..

Yes, of course. Of course. That's -- it's not the first time that I've heard that comment. Thank you..

Thank you. Our next question is from Yi Chen with H.C. Wainwright..

Hey, how is it going? This is Chait [ph] on behalf of Yi. Just a quick follow-up on the AMR Gene Panel. I know you said -- you spoke about your initial conversations.

Could you perhaps maybe elaborate on the kind of feedback you're receiving from various stakeholders? Any positives? And any red flags that we should keep looking out for?.

At this point, it's basically -- there's a lot of that's kind of like, woah, this is truly broad panel. So by and large, very positive in the sense that the panel's coverage is unparalleled, unrivaled. It is a true one of it's kind.

So you don't run into any obstacle that this is a -- okay, I'm just -- it's not going to come down to, well, what's the price? What's the throughput because I've got three other options that do the exact same thing? But it is a product that will require input from not just the laboratories.

It'll require deep involvement of the microbiology side as well as the clinical and the ID pharmacy and antimicrobial stewardship side. So it's a multi-stakeholder conversation.

Again, I'd say, from that vantage point, there's a lot of people who now start digging into the data which is also why we pushed hard for getting the data from the FDA clinical trial into a mode where it's now slated for hopefully getting published in a peer-reviewed reputable journal.

The paper has been submitted or expecting to hear back from the reviewers. And that's being done through our external principal investigators at these large clinical trial sites.

And that's also why we want to get that clinical data set out there in a public forum right at the beginning of Q1 of next year to make sure that we can broadly share the data and it's clinical value proposition.

So far, I mean, there haven't been any, as you name it, red flags other than, of course -- like always, you've got to bring in a new platform that and you always compete for space, you always compete for retention.

And the COVID -- the ongoing and right now, as we speak, existing COVID situation, it's probably the single biggest obstacle for getting attention and getting people to focus on what they know to be the underlying silent pandemic of antimicrobial resistance.

But I would say that's probably the biggest challenge right now is getting people's attention, sit them down and -- but yes and overall, those conversations have gone -- have happened, they've been very positive. And it creates some momentum and then get it into real-world time.

There's nothing better than real-world clinical users that generate data, publish it and talk about it. And that's really the key objective here right out of the gate. .

Awesome, that makes a lot of sense.

And lastly, I know you spoke about a few upcoming data readouts as it relates to the UTI study and also the gene panel publication but are there any other catalysts that we should look out -- keep an eye out for as we close this year and head into 2022?.

Yes, absolutely. The one that I hopefully emphasized very clearly in the call is the potential partnering deal that we have underway with Ares Genetics and leveraging some of their RSDB database assets. That's a deal that we anticipate will help significantly crystallize the true value that resides in the RSDB data asset.

As I said, as soon as that deal is done, we anticipate issuing a public communication. And as we said, our current expectation is to be able to close and announce that deal here in the fourth quarter. So in terms of near term catalysts, that's probably as close as it gets. There's also -- and we're already actively getting folks in there.

There's a webinar which will present new data from Ares Genetics here on December 9, I believe. That, again, is going to highlight some of the latest new data that Ares Genetics has been putting out there. You'll find in our 10-Q that we'll file tomorrow, I mean, we've grown the Ares database from earlier this year.

We were at 50,000 isolates deep sequenced, we're now at 78,000. So we've substantially grown RSDB as an asset. So anything that we do on that front is going to be key. And then on the UTI, given that, yes, the trial sites -- actually, we have one clinical trial site that literally is being initiated as we speak.

And so we hope to wrap up all site initiations here later this quarter. That first interim data readout should be in the front end of next year. So Q1, I think that's going to be the first glimpse at the data. And again, to remind everybody, we would have liked to have had an FDA pre-sub meeting which didn't happen.

We went forward with the trial design that we had but basically said the way to derisk this is for us to do an interim analysis after the first couple of hundred, so some 200, 300 samples enrolled. We'll do the interim analysis and then assuming that, that data looks favorable, we'll move into full swing to complete the enrollment.

The later readout, so our objective very clearly is to complete the sample enrollment -- patient sample enrollment into the UTI trial and have full data readout from the trial next year and get it ready for FDA submission towards the back end of next year; that's the plan..

Awesome. Thank you so much. And congratulations, once again, on all the amazing work..

Thank you. Appreciate it..

Ladies and gentlemen, we have reached the end of the question-and-answer session. And I would like to turn the call back to Oliver Schacht for closing remarks..

Thank you, everyone, for joining today. Please visit the Investors section of our website or our SEC filings for updates on the company. We really appreciate all the support. And thank you very much..

Thank you. This concludes today's conference. You may disconnect your lines at this time..