Q1 2021 OpGen Inc Earnings Call
Good morning, and thank you for joining us today I would now like to hand, the call over to Meghan, Paul of and Investor Relations Megan the floor is yours.
Welcome to the option and first 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 May 13 2021.
Before we begin I would like to caution you that comments made during this conference call by management may contain forward looking statements regarding the operations and future results of Bob Jones, including its subsidiaries cure this and Aries genetics and.
And I encourage you to review options filings with Securities and Exchange Commission, including without limitation. The company's most recent form 10-K and form 10-Q for the first quarter of 2020, one and may be filed with the SEC and will be filed with SEC.
Which will identify specific factors that may cause actual results or events to differ materially from those described and a forward looking statement.
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 curative and to implement the combined company strategy and the impact of the continuing global COVID-19 pandemic on our business and operations.
Our use of proceeds from the aftermarket offering that we commenced in February 2020 as well as the proceeds from recent warrant exercises and financing such as the November 2020 pipe and February 2020 'twenty, one registered direct pursuit of FDA clearance for the acuity and Mark gene panel for use in fact.
Oh I see.
And for other products and services the rate of adoption of our products and services by hospitals and other health care providers in general as well as and the current COVID-19 pandemic situation and particular, the success and our commercialization efforts and partnering strategy P effects on our business and existing.
Of new regulatory requirements and other economic and competitive factors.
Context for this conference call contains time sensitive information and is accurate only as of the date of this live call may 13th 'twenty 2020 one.
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 Tim Dec CFO of Upjohn.
I'd now like to turn the call over to Oliver shocked for introductory remarks.
Thank you operator, and thank you everyone for joining us this morning.
We're very pleased with our first quarter performance and our undoubtedly off to a strong start to 2021.
We have and exciting diversified portfolio of products and a strong cash position that supports and attractive combination of product revenue and partnership grows.
We anticipate a robust pipeline of activity and the months ahead and look forward to establishing ourselves as industry leaders and the molecular diagnostics and buying from attic space and believe we're well on the way.
On today's call, we will begin by discussing our recent business highlights as they relate to the company's core capabilities and top line growth prospects.
I will then pass the call over to Tim to review financial highlights from the first quarter as well as recent financing activities.
We will then wrap up the call with an update on the company's strategic initiatives and pipeline and outlook.
I wanted to start by providing an update on one of the product portfolios option as previously highlighted with and improved focus for the company.
Our proprietary universal platform and unique bioinformatics capabilities.
This focuses on expanding the platform to include complicated urinary tract infections, and invasive joint infections, and the United States with two upcoming prospective multicenter clinical trials for future FDA submission.
Both clinical trials are anticipated to start and the second half of 2021 with a UTI trial and the summer and the Iga I trial late and mid year.
We have submitted materials for a potential pre submission meeting with the FDA for you.
Unit, URL UTI product and the first quarter of 2021.
Not too surprising the FDA at this time has declined to host pre submission meetings due to the ongoing pandemic and option will be proceeding without such a voluntary meeting and FDA had indicated that they would require a resubmission of such a request and then would take many months before being able to review materials and preparation of such a meeting opportunity.
Given that similar products and both clinical indications using identical corresponding sample types have been successfully developed on the universal platform and CE IBD, Mark and are commercially available in Europe and other markets today option does not consider the fda's and ability to conduct such a pre sub meeting to be immaterial.
At this time.
Most excitingly as it relates to our Universal platform, we announced earlier this year that we received regulatory approval from the Chinese and M. P. A COVID-19 curated unit Aero system as an IBD instrument system.
Options subsidiary, <unk>, and its Chinese partner beige and clear biotech continue to closely interact with the N M. P E. As it continues its review of the <unk> 815 ammonia cartridge.
The product is the first unit URL based diagnostic application from Chinese market.
And the dossier for review and potential future approval and pneumonia cartridge was also provided.
This dossier includes comprehensive data from various clinical trials and regulatory submissions of the universe L. R. T and L. R. T B a L products, both of which are FDA cleared here and the U S and begin a barrow H P. M cartridge for hospitalized pneumonia patients, which is the IBD marked and Europe.
The startup commercialization by our partner BCB remains subject to approval of the pneumonia cartridge, which is still pending.
We hope to and be able to provide updates on the Chinese regulatory approval process and subsequently planned commercial launch in the coming quarters in 2021.
At this point and time, however, the N P. Eight does not provide any specific guidance or timelines for their reviews.
As mentioned before the commercial side of the contract with Beijing clear bio has been negotiated and the deal was signed several years ago.
To reemphasize there was no need to negotiate a commercial deal and China anymore. It's already in place and it contains minimum commitments of 360 unit Arrow system, and 1.5 million cartridges over an eight year period cumulatively, adding to about $180 million and revenue to option at carne transfer prices in the agreement and.
And at current Euro dollar exchange rates.
On the topic of partnerships and January we announced that option subsidiary courageous and entered into a distribution partnership with and our health technologies and Columbia.
And are headquartered in Bogota, as Columbia's leading diagnostics distributor and is already working with numerous we're now global IBD and manufacturers.
Under the distribution agreement and our has the exclusive rights to commercialize the greatest unit Arrow, a 50 instrument system and its full suite of unit Arrow infectious disease diagnostic application cartridges and Columbia.
The distribution agreement has an initial term of three years and it can be extended and one year increments.
And return and ours committed to significant minimum purchases op unit Barrow instruments and application cartridges over the initial three year term amounting to a total of at least 10 unit Aero systems, plus significant numbers of unilateral cartridges.
And ours responsible for product registration, which has progressed nicely for the unilateral platform and the entire portfolio of unit Arrow cartridges and during the first quarter and year to date and 2021.
And they are actually working on and accelerated preliminary registration for the unit Arrow system.
And ours committed to introduce the unilateral product line to the Colombian market. We continue to be encouraged by this partnership as it strengthens our commercial presence in Latin America and is in alignment with our core commercialization and revenue growth strategy.
And early 2020, one as part of the launch preparation a highly successful pre marketing event was held at the international symposium on bacterial resistance diagnostics stewardship and infection control from February 24th to 26, 2021 and Columbia.
Options session within this program, where one of our key opinion leaders presented was titled detecting antimicrobial resistance genes to guide patient care on February 25th.
And March we announced the final data from the Carlin and Institute study following publication and a peer reviewed journal.
This paper highlights options unilateral H P and products for hospitalized patients with pneumonia.
Demonstrating a higher diagnostic yield than bacterial culture with a high negative predictive value of 99, 8% for pathogen detection.
This strong performance data comprehensive coverage and turnaround time of less than five hours from sample to result provides clinicians earlier data to inform antimicrobial decisions, especially and critically ill COVID-19 patients.
As it relates to the Universal product line I wanted to highlight the outcome of our very successful and highly attended webinar titled pneumonia diagnosis bacterial superinfection and COVID-19 patients that took place in April.
Professor Christian Guiscard at the Department of Laboratory Medicine, Karolinska Institute in Stockholm, Sweden.
And drew Bell and medical and public Health Microbiology Fellow at Indiana University School of Medicine, Indianapolis presented their independent study results from the Universal hospitalized pneumonia H P M and your deferral lower respiratory LRT B a L panels.
Their studies demonstrated that syndromic testing of lower respiratory specimens with unit Barrow H P M and L. G. B a L panels can indeed improve patient care and time to appropriate targeted antibiotic therapy, and COVID-19, pneumonia patients as well as and non of COVID-19 population with a suspicion of pneumonia.
The webinar highlighted that unit vero detected bacterial pathogens up to seven days earlier and would've been able prompted appropriate targeted antibiotics and 41, 3% of cases and reduce time to appropriate therapy by 25.7 hours.
Now shifting gears I would like to discuss options subsidiary Ares genetics activity contributing to top line growth this quarter.
We were excited to announce that art genetics and Sandoz the number one global supplier of generic antibiotics not only extended their collaboration within its pharma partnering program, but sandoz also edit and procured another joint project in the first quarter of 2021 to.
To assess the potential of molecular surveillance for better informed therapeutic guidance and antibiotic stewardship.
The overall goal of this partnership is to develop a digital and infectious platform combining established microbiology laboratory methods with advanced bioinformatics and artificial intelligence methods to support drug development and lifecycle management.
And as it relates to Irish genetics and February we announced a peer reviewed study highlighting best practice techniques for accurate antimicrobial resistance prediction.
This study focused on whole genome sequencing data that supports harmonization of the development of good machine learning practices.
This study adds to Ares genetics publication record further validating our approach to becoming a globally recognized leader in the development of AI powered next generation sequencing solutions for infectious disease testing.
Addressing the U S. FDA action plan by developing good machine learning practice and robust algorithms will be key to moving our AI powered solutions into clinical practice.
Applying the proposed best practice techniques to Iris DB allowed us to further improve predictive performance of whole genome sequencing based a.
A S T.
In this context. We're currently also working with several leading clinical centers and the United States to further demonstrate the potential of accurate whole genome sequencing based a S T and.
And independent validation studies.
We also received great news this quarter relating to all work with the New York State Department of Health.
Opt and announced that our collaboration using a state of the art solution to detect track and manage antimicrobial resistant infection statewide has expanded and extended beyond the second tier expansion phase by another six months through September 30 of 2021.
The six month extension and expansion contract is valued up to an additional $540000, which includes a quarterly retainer based project fee as well as volume dependent per test fees.
We're providing our acuity AMR gene panel for isolates for rapid detection of multi drug resistant bacterial pathogens, along with our <unk> lighthouse software for high resolution pathogen tracking.
We anticipate that with our innovative solutions will be able to proactively identify such pathogens, leading to early intervention and potentially life saving treatment.
This six month extension period gives us time to also discuss and evaluate potential future forms of collaboration with the New York State Department of health across the state.
As of today for testing centers that run the acute is a AMR gene panel test on isolate are up and running servicing more than 30 affiliated hospitals.
We've seen significant ramp up and testing volumes and the first quarter and into the second quarter of 2021.
I will now turn the call over to our Chief Financial Officer, Tim Dec will review financial results for the first quarter and discuss recent financial developments for the business Tim.
Thank you Oliver on today's call I will briefly touch on the highlights of the first quarter discuss our balance sheet position and the real underlying growth drivers for the business.
Please keep in mind that the business combination closed on April one 2020, therefore, Q1 'twenty one 'twenty 'twenty. One results include the full quarter as a combined company, whereas Q1, 2020 numbers are for Upjohn stand alone only.
Revenue for the first quarter of 2021 was $830000 up 34, 5% from 617000 and for the prior year period.
The increase was largely due to the business combination of option with curators offset in part by lower collaboration revenue related to our New York State project and lower fish product revenue with final orders processed and delivered in Q1 and 2021 we.
We have now closed out the fish business entirely and then.
Not generate any further revenue and from this product line and Q2 2021 and beyond.
Operating expenses for options for the first quarter of 2021 were $7 $1 million.
Compared with $4 $6 million and the first quarter of 2020.
Since the business combination of our Opex by line them has been consistent and right on budget.
R&D was $2 $8 million essentially flat over the last four quarters.
G&A was $2 7 million also flat over the last four quarters and sales and marketing was $900000 Likewise flat over the last four quarters.
One item one item I would like to point out is and the other expense category.
We reported a onetime noncash accounting charge of $7 $8 million associated with the warrant inducement, which raised gross proceeds of approximately $10 million.
Net loss for the first quarter of 2021 was $14 9 million or <unk> 50 per share compared with $3 $9 million or <unk> 53 per share and the first quarter of 2020.
Our story has continued to resonate very well with investors throughout the beginning of 2021.
We have strategically move the company forward by continuing to strengthen our balance sheet this quarter by raising $34 $7 million.
Bringing our cash position to $39 4 million as of March 31, 2021.
The increase in cash this quarter was attributable to a $25 million registered direct offering in February and a strong price point.
And the warrant exercise and exchange of $9 7 million and March.
Both the registered direct offering and the warrant exercise and exchange carry warrants and a strong strike price of $3 55, and $3 56, respectively.
These warrants along with the company's remaining capacity under its existing shelf could generate additional proceeds of up to $37 9 million for the company. If all were exercised in full.
Total shares outstanding as of today, our approximately 38 3 million shares and the fully diluted number of shares would be $49 8 million shares.
I would like I would like to make a brief comment on proposal two and the proxy statement requesting stockholder approval to increase our authorized shares from 50 million to $100 million.
The board and management thinks is very important that this proposal be approved.
Our fully diluted share count is bumping up against the current maximum action from number of shares authorized.
We certainly realize and we might be able to access and additional 30 plus million of cash via the warrants that I mentioned, a moment ago. However, the additional authorized shares would be beneficial for a number of reasons, including strategic business development efforts corporate expansion and potential future M&A activity.
I mentioned in March that would be considered I would be considering providing additional guidance on the company.
I think due to the continued challenges presented by COVID-19, pandemic, we will refrain from any specific revenue guidance today.
However, I will re touch on a few things I previously stated.
I will echo my comments and March the company continues to see growth and its universal LRT LRT.
Al and UTI product lines with 11, additional univar analyzers placements during the quarter we.
We continue to be very optimistic on the traction we are seeing from these products.
I also mentioned and Oliver touched on a moment ago that one of the company's most significant long term growth drivers would be China.
Currently the timeline for and NPA approval of the company's unit Vera.
Pneumonia cartridge remains unclear.
Once approved though our partner Peking clear buyer as committed to a minimum purchase of 360 unit and our systems and $1 5 million cartridges cumulatively over an eight year from time period with total revenue of up to $180 million.
And I also previously and discuss potential areas licensing and partner deals and we remain actively involved on those fronts, but given the stage of negotiations it would be prudent to assume that and material deal would not happen until later in the year.
And finally cash burn.
The company took strategic and operational measures and late 2020 with the discontinuation of its fish product line and cancellation of its.
Acuity Ahmar Euro and trial.
As well as move to a smaller and tailored new headquarters facility and lab and warehouse space to reduce its cash burn.
We expect to utilize these savings and the form of prospective trials for a unit very UTI and Iga products in the U S as well as expand our investment and our Ares genetics and <unk> technologies.
We expect the additional cost to offset the savings from late 2020 and to have a similar cash burn pattern during 2021 of $5 million to $6 million per quarter.
With that I'll turn the call back to Oliver to discuss additional key milestones.
Thank you Tim.
I would now like to briefly highlight some of options key upcoming milestones and our development programs and commercial activities.
As stated earlier and on previous calls option has remained and constant dialogue with the FDA regarding the status of the acuity AMR gene panel for isolates five 10-K submission. Despite the ongoing delays and the review of non COVID-19 related submissions.
Last October option had issued our formal response to the agency's additional information request, which we had received earlier in 2020.
Following the submission and November 2020, we received notice from the FDA, indicating they would be reallocating CRH staff from open submissions to prioritize emergency use authorization or EUA request for in vitro diagnostics intended to address the COVID-19 pandemic.
While the staffing focus on COVID-19 related E ways within the FDA continues and we were pleased to report that at the end of January the FDA had informed option that they have formally resumed the review of our submission.
Option had anticipated that this reallocation of FDA staff towards the review of its submission should have allowed for a near term clearance decision for the acute is a AMR gene panel. Although the FDA has recently reiterated two option that is still not able to commit to any madhu for timelines.
Recently and the last couple of days the FDA provided further written updates to option on their timelines and stated that they know and I quote.
Expect to provide substantive feedback review feedback within 120 days off the 29th January 2021 restart of the formal review.
I eat by the end of May of 2021.
And yes, we can confirm that most of such substantive feedback has already been received to date and option has already responded to such FDA feedback without revise documents.
Comments to the few remaining open items are expected in the coming days in May.
The FDA also stated that they and again I quote expect to complete the review within 210 days and quote off the review restart I that would be on or before 27th of August of 2021.
However, the FDA caution that the and again I quote review completion timelines can be affected by submission complexity as well as other income workload and public health priorities.
And quote.
So again to reiterate this would suggest that all substantive feedback should be and by the end of May and the Fda's completion of review and subsequent clearance decision should come on or around late August.
We're confident that option has addressed all of the agency's comments and suggested at its two key documents.
And as the intended use statement the instructions for use or package insert electronic user guide and operating manual for Thermo Fisher Quant studio five already.
FDA feedback and comments to the 500 10-K summary are still pending nonetheless, we anticipate a clearance decision at the Fda's earliest opportunity in line with the aforementioned timeline, which according to the FDA could now extend into Q3 of 2021.
While the FDA is working towards their final clearance decision. We've continued full steam ahead with commercial launch readiness activities. We've already manufactured several batches of acuity AMR gene panel for isolates product and preparation for commercial release.
In other words, our commercial team is poised for launch.
Yes.
We've also made further excellent progress during the first quarter and year to date and the final development phases of our Universal <unk> RQ platform.
We reiterate our expectation that by mid 2021, we should have a series of 10 instrument systems readily available for final verification and validation testing.
We've already established several assays on the 830 cartridges, including one for Sars COVID-19, two flu and flu B and RSV and one assay for several EMR markers.
As previously mentioned, we can confirm that option continues its dialogue with several potential partners for such a platform.
We have received specifications for several potential products that could be developed onto such type of a system and we believe that a partnering opportunity for option around the 830 platform assets may present itself and the next several quarters.
In closing, we're very pleased with our results for the first quarter of 2021 and head into the second quarter with a much stronger balance sheet and cash position and a robust pipeline of activities and a corporate strategy that supports growth across the entire portfolio.
We believe options and a strong position to pursue value, creating opportunities to meet our growth and profitability targets.
We're well on the way with exciting announcements such as the extended partnership with New York State.
Evaluating peer reviewed publications and a prospective pipeline that includes the pending FDA clearance decision per the guidance that the FDA provided which we outlined during this call and a swift subsequent commercial launch of the acuity Ahmad pick gene panel for isolates in the U S.
As always thank you for your unwavering support and for participating in this mornings call I would now like to turn the call back to the operator for questions.
Thank you we will now begin the question and answer session. If you do have a question. Please press star one now to be placed into the queue.
A confirmation tone will indicate you are and the Q. If you would like to remove yourself. Please press star two one moment. Please while we poll for your questions.
Okay.
Thank you. Our first question is come from the line of E. Chen with H C. Wainwright. Please proceed with your questions.
Thank you for taking my questions are free.
First question is you mentioned that there are skus, some remaining items that need to be addressed.
As requested by the FDA.
Is that correct.
That is correct.
The one that I, specifically called out was the 500 10-K summary, now as the name suggests the five 10-K summary is the overall.
Summary of all of the other documents, including the intended use the instructions for use the E U.
Our guide et cetera, so what we've already done given that we have already received and incorporated all of the other feedbacks, we have proactively already put into this 500 10-K summary, all of the items that we logically you would anticipate the FDA to request since they have asked for those added wording chain.
<unk> et cetera to be made and other documents. So once we do get their feedback on that we should be able to turn that around very swiftly and get it back into the fda's hands.
Got it got it and then assuming you obtain market and Clarence.
At the end of August.
What would be the potential market uptake during the remainder of this year.
After launch.
Well, so we're obviously not providing any specific revenue guidance at this point, but the way to think about this launch.
And frankly any other similar platform launches and the rapid molecular diagnostics space.
We're targeting large academic centers and public health institutions of which there are several hundred across the U S will likely see a wide range of annual testing volumes.
Start as low as a couple of hundred tests, a year and up to well over 1000 tests per year per per installation. So given our initial list price for this first in class and first to market broad genetic AMR gene panel of $175 a test.
And then typical volume based discounting and commercial model and will likely rely on reagent rental you can anticipate that per installation annuities.
Once these sites go live and to clinical and commercial routine could be somewhere in the 50 to $150000 per installation.
Got it and.
And with respect to the collaboration with New York State Dupont and move to quantum and Douglas Hills. So after September 'twenty, 'twenty, one and what could.
Oh like clean pattern.
In terms of smaller.
Another extension.
Well and when you look back originally we had entered into the New York State Department of Health project back in 2019, and it was designed to develop the platform for rapid and effective infection prevention outbreak tracing and tracking and monitoring.
The year, two which started on April one last year was designed to deliver the testing volume and the data for the New York State Department of Health.
Sort of assess the impact and how to best think about the potential statewide rollout across more hospitals and more labs in New York State.
Since we saw that sort of during our during 2020 and due to COVID-19 testing was suspended for a couple of course and only restarted and fall.
That's why we did the six month extension and we've seen great uptake and uptick and testing volumes across all of the site. Since then.
And <unk>.
And when he would suggest.
Yes, Sir.
Well when you sort of think about a year three and beyond there is multiple potential components. So one thing obviously, we would want to see the sites moving from using the research use only or are you all labeled Q and it's a market over to the IBD cleared kits once they are FDA cleared.
The next thing, we'd anticipate adding more sites across the state of New York and.
So to really get it ultimately stayed white right now we have four centers Wadsworth as the New York State Lab and then.
A large central lab at North well, one way at NYU with these 30, plus affiliated hospitals and spending sending samples and for testing one.
One thing we've already seen here in recent weeks and months.
Having added additional sites that are sending samples either to wadsworth or to some of these new York City based labs, but again, so additional installations for additional testing sites and expanding the hospitals that are in the network, sending and specimen and then ultimately once this has been proven to work as a model in the state and New York.
Clearly also looking at ways of potentially rolling this out to other states across the country.
So does that suggest that by the end of this year there could be a.
Potentially.
A formal commercial contract between option and New York State.
I mean, they're already is the contract we have with New York State is a is a commercial contract.
Pesify as the.
The dollar amount that they are guaranteeing as a retainer, but could there be another extension, yes, absolutely I mean, our objective and we've done that with with the year to which.
Which was seamless right after the end of year one.
We have that second year contract start April 1st without missing a beat we did the same thing for this six month extension the year to formally ended March 31, and as of April 1st of this year. We now have that extension in place. So our objective would be to <unk>.
Continue that that relationship seamlessly beginning with the fourth quarter of this year.
Got it.
And finally do you have any visibility at this time.
And when.
Chinese and N P and approve the unit per cartridge for new book.
And <unk>.
As we stated and the call we do not have any visibility.
And we're fortunate enough debt for the first time in the year, the United States FDA has finally come back with a timeline, which is robust and very specific and clear the Chinese and NPA has so far not come back with any timelines, but again they haven't done this for the instrument either when there were questions that we.
Had have received and responded to back and the fourth quarter and late fall of 2020.
And then went radio silent and then in Q1 and sent across the approval. So.
So far we have responded to all of the request for additional data and the Das day on the cartridge.
We've provided frankly all of the data that exists from clinical studies and trials.
Within the option group be it from U S FDA.
And a barrel pneumonia tests or from the European versions as well as a number of external third party studies. So we believe we've provided everything there is but we do not have visibility on their timeline.
Similar so there is very similar to the United States they have timelines.
Timelines and general that are similar to Madhu for timelines, but like here, they've essentially suspended those those timelines.
Got it thank you.
Thank you our next questions come from the line of Maxim Jacobs with Edison Group. Please proceed with your questions.
Hi, guys I just have one question, which you may or may not be able to answer.
I was just wondering so you mentioned that Oh and one of the reason for the increase and authorized shares is potential M&A activity. So I didn't know if you can just give us a.
A broad sense of like if if there were M&A activity, what would a potential acquisition look like.
Good question, Max and so obviously at this point there is nothing concrete or specific so we're not at this point working on any transaction or any specific acquisition nor have we publicly.
<unk> guided to any particular point that if you look at the history of option, though option today is the results not only off the M&A transaction between option and curators and and Ares genetics, but option historically itself had been the product of a merger between option and advantaged. So we have a history of.
Looking at complementary products that can be added into the portfolio that could be a good commercial fit so.
We clearly strategically and tend to remain focused on our core theme of fighting antimicrobial resistance. So anything that's within infectious disease with a clear focus on EMR.
And that is a synergistic fit to the product portfolio and pipeline.
Looking at.
Potentially areas sub to strengthen the bioinformatics.
And Ares genetics based <unk>.
Service and product offerings, both might certainly be areas to look at further future growth.
And.
Some of the acquisitions historically, you look back at the acquisition of what is now will become Ares genetics from Siemens was cash based deal. So it wasn't actually a share based deal similar for the <unk> hundred 30 platform. When we originally acquired it was a cash deal for the asset acquisition.
So it's really more of a creating the flexibility and the means to potentially.
Potentially raise additional capital and or strategic.
Strategic gum.
Potential portfolio and round out some expansions.
Okay, great and that was very helpful. Thanks for taking my question.
Thank you. Our next question is coming from the line of Ben Hayner with Alliance Global. Please proceed with your questions.
Good morning, gentlemen, thanks for taking the questions.
First off for me on the the RUC Universal pathogen assay.
And I think this is the first time, you guys have disclosed or at least that I've seen that it covers over 6000 genetic markers for EMR.
<unk>.
You know that seems like I guess.
Particularly several orders of magnitude above most currently available task can you kind of give us a little bit more color on that.
Assay and and you know kind of some of the.
And finer point to that.
Good good good spot there indeed it is the first time that we have disclosed that.
And as the name Upa stands for Universal Paso genome assay. So the goal here is really using next gen sequencing and the full power of.
And next Gen sequencing to bring you know a very broad panel that allows you to identify these genetic markers now the way to think about this from a commercial rollout. This will initially be a research use only provided as a service.
In Europe that.
Certainly be a.
Send and service into into the Iris lab or out of Vienna, Austria here and the United States of.
Of course people can always sent isolates across the pond, but.
We're likely also going to be looking at channels of bringing bringing that assay here.
And then you can imagine over time from from.
And that universe of 6000 markers.
For specific questions clinical questions.
You could imagine having a targeted subsets.
I would say it is prudent to assume that youre not likely never going to take I think I shouldn't say never but not anywhere in the near future would you take a panel as broadest this through and FDA process simply because it would be a daunting task from our clinical validation standpoint.
And the reason why essentially all next gen sequencing providers and platforms have opted for a CLIA lab route.
Rather than going the IBD kits and and FDA clearance route.
But it also sets sets a benchmark for the type of depth and breadth of what we're able to get out of our database and launch commercially as a service offering and <unk>.
And to remind you I mean this is in fact the.
The panel that we have first pilot customers from the.
Austrian equivalent to the Austrian FDA and.
By now a handful of.
Commercial customer sites across Europe. So.
So, it's definitely gaining and gaining quite some interest and they will be in the coming earnings calls, we will be mapping out a very clear roadmap for the way to think about hours genetics launching and deploying its various south services, starting with isolate sequencing service and going to the universal path or geno and more broadly as.
Well, it's some of it's buyouts bio informatics software specific offerings. Some so this is the first step and a series of launches that we anticipate making here commercially over the coming months.
Okay. That's.
And that's very helpful color.
I guess on the Fda's written responses to the Universal U T I a.
And many requests application and you know were there any surprises in there and then you know just I know, it's commercialized outside of the U S. But is there anything with that that kind of hinges on the acuity. This decision and I know that's for isolates and not.
Youre and base, but.
Just anything to be thinking about on that front.
No. So for the unit very UTI, we had submitted what's called a request for a pre sub meeting. These are entirely voluntary it's always an opportunity when.
When you have and a pre sub meeting to get in front of the FDA, usually its a one hour meeting and we even proposed to win this virtually and saying here's a handful a question that might have incrementally helped.
Shaping the clinical trial now.
Given their priorities and and given that their backlogs.
It was absolutely no surprise that they said and all they said is look at this point, we're not hosting any precept meetings. It's just not on our priority list I was no substantive feedback whatsoever I'm not even sure. They they read the document and our questions. They basically said you can resubmit, but then it's going to take several months for us to review the request and it's likely going to be.
And <unk>.
Many months before before we even begin starting thinking about scheduling so we said well unbalanced opt.
Option had previously had a number of these pre sub meetings around the acute as euro and trial. So we've actually got the benefit of quite some color and feedback from the FDA already and that frankly will be sufficient.
And again given that until last summer that was an ongoing prospective multicenter euro and trial, yes on a different platform, but ultimately from a pathogen and EMR marker coverage extremely similar.
So no surprises there also just to expand on the FDA feedback we did receive.
And writing on all of these documents for the acuity Ahmar non.
Not a single surprise not a single new question. These are what I would characterize us let's call them clean up at it.
Footnote wordsmith thing.
Table format, Inc, where the FDA had come back and said look.
We'd like you to combine three.
Three different genetic EMR markers that are all from the same family into one.
And your and your results reported and after we've done that they sort of said yeah. And then now you should kind of combine those three lines and that table into one it gives you a sense of.
They're trying to clean up the documents format the bullet point format the tables.
And you get the sense that they're getting ready to get this this off their their workload there so.
Again, we're confident that.
And there has not been any any substantive surprise or again no new question no new issue raised its a question of time for the agency to work through the process and worked with motions.
Okay. That's helpful and then.
On the New York State you know obviously, the there are plenty busy and thanks for the color earlier on on you know one and extension could potentially look like but you also mentioned that is you know moving this into two additional state department of health type.
Situations and my recollection is a a while back and that you guys might have had.
And some conversations with folks.
Folks are not formally it doesn't sound like it and you know.
And the other state department of health and such.
Is there anything that is kind of ongoing.
And and discussions with other.
Entities within other states right now or.
And as everyone's still kind of too busy with COVID-19.
Focus too much on it.
I would say and general folks are probably still still coming to grips with the hopeful as hopefully the tail end of the COVID-19 situation.
Now, we've certainly identified across the United States a significant number of.
State and local health authorities and institutions that might very well be a inter.
Interesting.
Partners and to have these types of conversations but at this point our focus for the acuity AMR gene panel and number one is the FDA clearance and number two is then converting the New York State sites that are using it to the FDA cleared kit and <unk>.
Number three is to get the New York State extension and.
And based on the learnings all of the lessons learned we're actually working very closely with all of the stakeholders across all of the sites and New York State.
Also think of ways, we can publish the data that's been generated throughout that two year collaboration project, it's going to be a blueprint and a role model showing the benefits.
And the power that this type of solution can have and then having that data in hand, and having the clear.
Here's what we found here is how it benefited here's why we're continuing rolling this out more broadly and in New York State that has a much stronger pitch and then going to any any of these other states at this point and.
And the first question and get a great wall. So how is New York State.
And with a broader rollout and and you know where are you on the FDA clearance. So it's got to be a question of timing. So at this point would be premature to speculate on any specific conversations there.
Okay that makes sense regarding kind of the sequencing of.
Other institution and and then finally this is kind of open ended but you know just.
Just curious on the you know the reactions you've gotten from some of the study results and Webinars that you've hosted.
And the the co infection study with H P. M panel you had the pneumonia webinar.
And anything of note that our investors might be interested and are you now with regard to the reaction you've gotten from some of these things.
And again for the for the pneumonia a webinar, we hosted we had well over 1000 and pre registered participants and was really global from a stable probably roughly 50 50 between the U S and.
Around the world.
A lot of a lot of positive data I mean, you look at a negative predictive value of 99, 8% I mean, I see and the molecular diagnostics for almost 25 years, you don't often get to see this type of data it mathematically doesn't get much stronger than that.
So lot of positive feedback obviously number of.
As you always get you know you're always attract a competitive crowd listening into these things.
And as you are publishing data, but also a lot of potential.
Potential customers and leads and.
And you know stakeholders within those sites.
So it certainly helps strengthen our broadened the funnel of commercial sales opportunity. So we obviously have a number of ongoing conversations.
As these types of studies since they were independently done independently analyzed and presented.
It's clearly validation of the <unk>.
Performance and a clinical value potential of the platform, so very positive and D from feedback perspective.
Okay, great. Thanks for all the color gentlemen, that's it that's all I had.
That's on the progress.
Thanks benefit.
Thank you that's all the time, we have today for questions I would now like to turn the call back over to Mr. Shaffer for any closing comments.
Well really thanks, everyone for joining us today. Please visit the investors section of our website and our SEC filings for updates on the company. Thank you very much and look forward to keeping everybody apprised of the exciting news coming out.
Thank you. This does conclude today's teleconference. You may disconnect. Your lines at this time. Thank you for your participation.
Have a great day.