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spk06: Welcome to the Optin third quarter 2022 earnings call and business update. Today, Optin management will provide an update on the company's current business and outlook for the future. Following Optin's prepared remarks, there will be a live Q&A session. As a reminder, this conference call is being recorded today, November 10th, 2022, and all participants are in a listen-only mode. At this time, we will turn the call over to Alyssa Factor, Optin's IR representative, to provide the opening statement.
spk00: Good afternoon, everyone, and thank you, operator, for the introduction. Before we begin, I would like to note that any comments made by management during this conference call may contain forward-looking statements regarding the operations and future results of OpGen, including its subsidiaries, Curatus, and RS 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 2022 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, the success of the company's commercialization efforts and partnering strategy, its ability to successfully, timely, and cost-effectively develop, seek, and obtain regulatory clearance for and commercialize its products and service offerings, the company's ability to continue to successfully achieve the expected synergies from the company's completed business combination with Curatus and to implement its commercial strategy, the impact of the continuing global COVID-19 pandemic on the company's business and operations, and on capital markets and general economic conditions, the company's use of proceeds from recent financings, as well as its ability to access additional financing in the future, the company's ability to satisfy its debt obligations under its loan with the European Investment Bank, the rate of adoption of its products and services by hospitals and other healthcare providers in general, as well as during the COVID-19 pandemic and geopolitical situation in particular, the effect of the military action in Russia and Ukraine on its distributors, collaborators, and service providers, the effects of the company's 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 of the date of this call, November 10, 2022. 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 are Oliver Schacht, OpGen's President and CEO, and Albert Weber, its CFO. Now we will turn the call over to Oliver for introductory remarks.
spk04: Thank you, Alyssa, and thank you, everyone, for joining us this afternoon. On today's call, I will begin with a recap of previous highlights discussed on the second quarter earnings call, followed by recent updates on our products and R&D pipeline. Albert will review the financial highlights from the third quarter and offer an update to our guidance. I will then provide an outlook on options ongoing and upcoming milestones and business development, followed by a Q&A session. At the beginning of this quarter, options subsidiary, Aris Genetics, signed a research collaboration agreement with the Belgian National Reference Center for Invasive Streptococcus Pneumoniae at the University Hospital, Leuven. The US Center for Disease Control, CDC, has classified drug-resistant streptococcus pneumoniae as a serious antimicrobial resistance, or AMR, threat. And AMR is one of the top 10 global public threats. This presents an unmet need for effective diagnostics. Under the agreement, the partners aim to employ machine learning tools for antibiotic susceptibility testing. In August, we launched the RS-ISS isolate sequencing services from our Rockville, Maryland lab at Optum. We're now able to serve U.S. customers directly in the U.S., providing easy access to our RS technologies from Optum's commercial lab. By expanding our services and offerings in the United States, we're continuing on the path to generating revenue-producing opportunities. Our U.S. lab facilities will also enable an expedited turnaround on the next-generation sequencing, or NGS, work related to the Univero Urinary Tract Infection, or UTI, clinical trial. In October, we announced completion of enrollment of our major prospective multicenter clinical trial in the U.S. on the Univero 850 platform for the Univero UTI panel. We enrolled over 1,800 patient samples and exceeded our goal of 1,500 prospective samples. We expect to conclude reference testing in the next few weeks and anticipate the unblinding of data in December this year, which we will discuss in more detail later in this call. Following the Univero 850 UTI product, we'll be looking to develop our first products on the Univero 830 platform. These will include bringing into clinical trials an invasive joint infection, or IJI panel, as well as working on a panel focused on AMR markers from blood cultures for low- and middle-income countries, or LMICs, under our FIND collaboration, which began in September. The initial feasibility phase of the collaboration with FIND is expected to be completed at the end of March 2023 and is forecast to deliver six proof-of-concept deliverables, such as panel definition for an AMR-focused cartridge, certain assay development work, prototype definition, and development towards an A30 touchscreen cockpit. The FIND program will focus on detecting pathogens and AMR markers from common blood culture bottles. The €700,000 in co-funding by FIND and German KfW Bank will also allow us to develop prototypes of a dedicated A30 touchscreen cockpit that will be suitable for use in LMIC settings. Optin signed its second commercial customer contract for the Acutis AMR gene panel in the third quarter. Additionally, we have several ongoing contract negotiations in the final stages undergoing legal and commercial review. We recently announced a collaboration agreement between Bioversus AG from Switzerland and Curatus for the development and use of the Univero platform in Bioversus' upcoming phase two clinical trial of novel drug candidate BV100. BV100 is used to treat serious infections in patients with mortality rate of around 50% with little to no effective and safe treatment options. In the phase two clinical trial, all hospital sites will be using our Univero hospitalized pneumonia or HPN cartridge as a rapid diagnostic test to help optimize enrollment. We estimate that the first trial sites will start coming online early next year and estimate at least 18 months for a trial at somewhere around 10 to 20 trial sites across different European countries. We anticipate revenues of a couple hundred thousand dollars over the duration of the trial for Univero systems that will be rented, cartridges sold, support as well as training delivered to Bioversus and their clinical research organization. This week, Optin's board elected Yvonne Schleppi as a new independent non-executive member of the company's board of directors. Ms. Schleppi brings legal governance, life sciences, and international experience to the board. Since 2011, Ms. Schleppi has served as a managing partner of Strativise LLC, an international strategic advisory firm that she co-founded. Prior to founding Strativise, Ms. Schleppi served as general counsel at Global Enterprise Technologies, passport and ID, a high-security document printing solutions provider, and systems integrator from 2007 to 2011. and as Executive Vice President, General Counsel, and Corporate IP Officer at Organon Biosciences, a global pharmaceutical, animal health, and biotech group based in the Netherlands, from 2006 until its sale in 2007. Prior to that, Ms. Schleppi was a partner at the Boston-based law firm of Palmer & Dodge LLP, where she served as chairperson of that firm's international practice group. Ms. Schleppi has been recognized by the National Association of Corporate Directors as directorship certified, has served on the board of directors of several public companies, and currently is a member of the board of Astronova Inc. I will now turn the call over to Albert Weber, Options Chief Financial Officer. He will review financial results for the third quarter and recent financial developments. Albert.
spk02: Thank you, Oliver, and welcome to everyone on the call. I will briefly discuss the third quarter 2022 highlights our balance sheet position and underlying growth drivers for the business and conclude with some thoughts on guidance. Our revenue for the third quarter 2022 was $0.4 million. This time last year, we ended the quarter with $1.2 million. The decrease in revenue is largely attributed to the contribution of the New York State Department of Health project in the third quarter of 2021 with no comparable project in the reporting quarter, as well as lower universal systems revenue internationally, which by their nature fluctuates significantly quarter by quarter. Our third quarter 2022 revenue does not yet reflect the impact from the fund collaboration, which is expected to be recognized over the term of the agreement into the first half of 2023. Additionally, the Acquita sales did not contribute at a material level since the first customer sites did not become operational until October of this year. Therefore, those sales will be reflected going forward in the upcoming quarters. Later in the call, Oliver will discuss our expanding pipeline for increasing sales within the U.S. and internationally. In the third quarter of 2022, we had to recognize a goodwill impairment charge of $7 million due to the sharp decrease of options share price over the last month and the corresponding drop in our company's market capitalization. Thus, our operating expenses for the three months ending September 30, 2022 increased notably to $14 million compared to nearly $6.3 million in the third quarter of 2021. Leaving the special one-off effect aside, operating expenses would have been $7 million in this reporting period, and the increase would have been 11.1% due to a $1.4 million reserve charge for our inventory built up in anticipation of a faster progress with the market approval process for Univero in China. For the first nine months of 2022, we saw an increase of 29.9% in operating expenses. from $20.4 million in the nine months of 2021 to $26.5 million in the comparable period this year, but operating expenses would have decreased more than 4% if the goodwill impairment charge was excluded. In fact, we have reduced regular operating expenses in 2022 by means of strict cost management even more. which is not apparent at first glance in the nine months figure due to the aforementioned inventory reserve charge. Our third quarter 2022 R&D expenses were $2.0 million compared to $2.4 million in Q3 of 2021, a 16.7% reduction. R&D expenses in the first nine months of 2022 were $6.6 million, down by 18.5% from $8.2 million in the nine months of 2021. The decreases were primarily due to lower personal costs. Our focus towards smaller and more efficient R&D teams has proven to be as so, in addition to our focus shifting increasingly towards commercial efforts and our future NGS lab services. Third quarter 2022 G&A expenses were $2.0 million, down by over 3% from our Q3 2021 G&A expenses of $2.1 million. In the first nine months of 2022, G&A expenses amounted to $6.8 million, which corresponds to a decrease of about 8% from $7.4 million in the first nine months of the previous year. Leveraging of synergies following the completion of our business integration have allowed us to reduce G&A expenses. Third quarter and nine months of 2022 sales and marketing expenses were $1 million flat and $3.3 million respectively compared to $1.0 million during the third quarter of 2021 and $2.7 million in the first nine months of 2021. We are convinced that our sales and business development team will be crucial in expanding our partnerships and driving overall revenue. We have also seen the return of live in-person conferences and exhibitions internationally, as well as here in the US, which has also contributed to increased marketing spend in return for much improved customer access and interactions. Turning to our operating loss, it has also been impacted by the goodwill impairment charge and increased in the third quarter of 2022 to $13.5 million compared to $5.1 million in the same time last year. Our net loss available to common stockholders in the third quarter of 2022 was 14.1 million or 30 cents per share as compared to $6.1 million or 16 cents per share in the third quarter of 2021. Nevertheless, the nine months net loss available to common stockholders decreased to $26.7 million or 57 cents per share in the current year compared to $28 million or 79 cents per share in 2021. This was positively impacted by much lower interest expenses from our loan from the European Investment Bank or EIB, which has been partially repaid in the second and third quarter of 2022. Finishing off with our cash provision, we ended the nine months of 2022 with approximately $10.3 million, a decrease compared to our cash position at the end of 2021 of $36.1 million. We continue to closely monitor our cash downgrade. The successful financing that closed on October 3, 2022 meant that as of the date, we had $13.3 million in cash available to options. As mentioned on our last earnings call, our subsidiary Curatus and the ERB have agreed to amortize the debt trench originally due in April 2022 over a 12-month period until April 2023. We repaid 5 million euros in April 2022 and in May began monthly installment payments for the remainder of the debt trench of approximately 8.4 million euros over the 12-month period until April 2023. So, as of today, we have about 4.2 million euros in debt repayment obligations left from the first tranche. There are two additional tranches of 3 million and 5 million euros, principal plus accumulated and deferred interest, as well as the PPI that becomes due in June 2023 and June 2024, respectively. At this point, these tranches remain unchanged by the agreement with EIB. Additionally, the company currently may sell up to $3.5 million of its shares of common stock under the company's ATM agreement with HC Wainwright. In October, we close the register for direct offering for gross proceeds of about $3.4 million. We plan to use net proceeds from the offering to continue commercialization of the FDA-cleared Acuitous AMR gene panel test for isolates in the U.S., focus on commercializing the Univory platform and diagnostic tests, support further development and commercialization of the IRIS database, support directed sales and marketing efforts to the customers and collaborators for our products and services, invest in manufacturing and operations infrastructure to support sales of products, and repay certain outstanding indebtedness of the company. We intend to use the remaining net proceeds for working capital and other general corporate purposes. The company will continue to explore additional strategic and tactical equity and debt financing opportunities, as well as potential strategic alternative options throughout the remainder of the year and into 2023 to possibly further strengthen its cash positions. As mentioned on our previous earnings calls, our operating expenses remain in line with our expectations and track well against our guidance for yearly net year consumption. We anticipate continuing that track record this year at an expected net cash consumption of around $5 to $6 million per quarter from our operations. Following the restructuring of our EIB debt, we continue to see an additional cash outflow of approximately $700,000 dollars per month until April 2023. We are continuing to see growth opportunities, especially with product sales and with our ARIS services here in the US. We believe ARIS Genetics has a strong business development and collaboration opportunity funnel, which we remain optimistic about with potential partnering deals that each could begin to contributing to revenue growth from 2023 onwards. As a result of our progress in the third quarter of 2022 and here to date, we expect future growth in the commercial rollout of Univero products and the Acutis AMR gene panel. We are focused on expanding and progressing our commercial pipeline for the AMR gene panel, as well as Univero, LRT, and UTI, with several ongoing discussions with hospitals. This year, we have signed the first two commercial Acuitas agreements in Q2 and Q3 and also added a new Univero UTI lab customer contract in Q3. We expect these numbers to increase in the weeks and months ahead. There are several new commercial contracts with US customer accounts across Univero and Acuitas products with a combined seven-figure dollar value annually that we believe are currently in final review and we believe this indicates a significant revenue growth potential for ARPGEN. We are looking forward to our final UTI clinical trial data and readout and a subsequent regulatory submission for Univaro UTI to the FDA. Our goals for the longer term include expanding our ARIS services business as well as collaborations and partnerships. We have multiple ongoing conversations with potential U.S. accounts and leading organizations in NGS, diagnostics, and pharma. Our newly opened U.S. Next Generation Sequencing Services Lab here in Rockville, Maryland, is currently processing hundreds of samples for NGS sequencing for the UTI clinical trial. With a slower than anticipated 2022 signing of new contracts and ramp up of revenue on the signed contract and collaboration agreements, we now expect revenue from our products and services and collaborations globally for 2022 to be in a range of somewhere around $2.5 to $3 million. While this is lower than expected, we still have a strong pipeline of opportunities with significant revenue growth expected in 2023. Our income statement will soon reflect the proceeds from the fine collaboration which will be recognized in Q4 and into 2023. Also, we expect revenue recognition from the new BioVersus collaboration to begin in early 2023. In August, NASDAQ granted options request for 180-day extension to regain compliance with NASDAQ's minimum bid price requirement under NASDAQ listing rule. We have until the end of February 2023 to regain compliance with the minimum bid price rule, which we are confident about. There will be a special meeting of stockholders on November 30, 2022, to vote upon a proposal to authorize a board to implement a reverse stock split at a ratio not less than 5 to 1 and not more than 20 to 1. With that, I'll turn back the call to Oliver to discuss the company's achievements and upcoming milestones. Oliver?
spk04: Thank you, Albert. I will now focus on upcoming milestones and how we plan to execute on our upcoming plans. After many months, Optin has recently received an update from Beijing Clear Biotech regulatory advisors about feedback from China's National Medical Products Administration, NMPA, at new regulatory procedures that NMPA has recently implemented in China. We've been informed that they have a new electronic filing regime that we need to resubmit our filing for market approval for our pneumonia product. We're in conversations with them to determine the exact impact on timelines and processes. Initial indications are that with the restart of the new submission, we could be looking at a 24 to 30-month overall process, and within that, BCB and their advisors estimate the duration for the clinical study to be around 10 to 12 months. We see this as a positive because there is now a much clearer path and well-defined process that we, like everyone else with new or pending submissions in China, must follow. We're looking forward to progressing with the clinical study and working towards a final NMPA submission and review and eventual clearance. Following an NMPA approval, there is still an unchanged commercial contract worth potentially up to $180 million to option already in place over an eight-year period. We hope to have more information in the near future and proceed with moving this forward. We have many milestones to look forward to regarding our Univero platform. Earlier this quarter, we completed clinical trial enrollment for the Univero UTI panel in the U.S. Due to the complexity and comprehensive nature of the data sets, We expect to conclude reference testing in the next few weeks and then anticipate unblinding the study results in December of this year. Following final data readout, we will prepare the submission package for the FDA in early 2023 and target a submission by the end of the first quarter of 2023. The FDA usually takes about six to 12 months for its review and clearance decision, and we will have better visibility on timing, and an update once we receive their initial feedback in 2023. Also on the clinical front, we're on track with our Univero 830 platform on an IJI panel from Synovial Fluids. We're currently finalizing the development of the IJI panel cartridge, as well as working on the AMR test from Blood Culture under the FIND collaboration. Our goal is to initiate a prospective multicenter clinical trial for the IJI product in the United States on the Univero A30 platform in the second quarter of 2023, i.e. after completion of the FIND R&D collaboration project in preparation of a subsequent FDA submission of the IJI product. Our FIND R&D collaboration involves a feasibility study that is expected to conclude in the first half of 2023. The FIND collaboration agreement already envisages a potential additional contract in order to develop any products through the required clinical trials and regulatory submissions towards a commercial arrangement for a number of selected LMICs. Both parties, GERATUS and FIND, would require a separate contract to address those aspects, and we would expect to begin talking about such additional contract in the first half of 23, and would then finalize it once the feasibility data is available. This initial FIND contract is an exciting milestone for options. and our subsidiary curators because FIND has a track record of doing deals that range from low to mid single digit millions, all the way up to several tens of millions of dollars of funding in individual strategic collaborations. Therefore, following successful feasibility data, there is potential for future collaboration opportunities here. In closing, we're looking forward to several key catalysts and milestones upcoming for options. We plan to continue our progress throughout the end of this year and into 2023, on both the commercial and R&D front with collaborations. We look forward to updating everybody on our developments. Thank you for your continued support and for participating in this afternoon's call. I would now like to turn the call back to the operator for questions.
spk06: Thank you. We will now begin the question and answer session. If you have a question, please press star 1 now to be placed in the queue. Please ask one question and allow the presenters to respond before asking a follow-up. One moment, please, while we poll for questions. Our first question comes from Yi Qin with HC Wainwright.
spk07: Please proceed with your question. I think you might be on mute.
spk03: Oh, sorry. Sorry about that. Thank you for taking my question. My first question is just for clarification. You mentioned the new installations of Q-DIS EMR gene panel. So does that mean the customers will have new instruments installed? And can you tell us whether the customers are obligated to purchase a certain amount of the panel within a certain period?
spk04: Sure. Good question. Yes. So each of the contracts has a clearly defined minimum number of cartridges. In fact, we have seen purchase orders for the consumable cartridge, or kits, I should rather say, not cartridges, Acuitous AMR gene panel kits come through. We have actually supplied those kits to the customers. But in order for them to begin testing, we first had to install the systems. If you remember, the Acuitous AMR gene panel does not run on our Univero system. It runs on a Kyogen EZ-1 for the sample prep. and the Thermo Fisher Quant Studio 5 for the PCR. Those instruments, both the QIAGEN EZ-1 and the Thermo Fisher QS5, first have to be, you know, taken through IQOQ testing by the respective QIAGEN and Thermo Fisher field service engineering representatives. That happens during the month of October at both sites. Only then can we, at Options, upload the FDA-cleared software, and basically turn these systems into option-qualified systems for the ACUDA's AMR gene panel testing, which basically means from contract signature to beginning to recognize revenues, there is a certain time lag to anticipate for the installation, the IQOQ by external third parties, and then basically ordering shipping kits until the site begins testing. But both of them have received consumables. And, yes, the contracts have clearly defined numbers for each of the contracts.
spk03: Got it, got it. And regarding ARIS genetics, ARIS is Isolate Sequencing Services that has been launched in the U.S. Is it generating revenue starting in the current quarter?
spk04: It's hard to predict. Right now, the first quarter, although, you know, that's not going to, going to be recognized as revenue, although it's done at arm's length as a commercial service. We're processing the Univero UTI samples really as a service by the RS Genetics US team for Curatus that is preparing that data set. Again, you're looking at, in fact, that's over 1,000 isolates that are being deep sequenced. If you look at sort of standard market pricing, it would be a couple hundred grand in actual services. Sales cycles for the isolate sequencing service, hard to predict, you know, between now and the holidays. I wouldn't speculate on whether we see revenue recognition begin in the fourth quarter or maybe early, early 23. But again, the sales funnel for our isolate sequencing services in the U.S. as well as in Europe is growing, expanding, and there are some very attractive and very significant opportunities that are currently being pursued.
spk03: Got it, got it. And finally, regarding the collaboration agreements with BNRC, FIMB, and BioVersus, are these collaborations expected to generate revenue for the company?
spk04: Yes. So we'll start with the BioVersus. We anticipate that their clinical trial for their drug should get underway, and that's a Phase II clinical trial, should get underway here in the first quarter of next year. And we will begin recognizing revenue as soon as we basically start with initial trainings. They start renting a defined number of Univero systems, essentially a system for each of the trial sites. And then we supply each of the trial sites via their CRO with cartridges at essentially full price for these Univero cartridges. So again, we expect that revenue recognition As I said, it's over the total clinical trial duration, which, again, for typical Phase II and infectious disease, you're likely going to look at at least 18 months overall trial duration, but that's going to be a couple hundred thousand from that. Fine, the $700,000, you know, again, we haven't recognized anything in terms of revenue here in the third quarter. Now that the project is on the way, in the fourth quarter and then into Q1 and maybe into the early parts of Q2 next year, we anticipate the impact on the P&L to get recognized. Again, that $700,000 over those couple of months will show up in the P&L being recognized.
spk03: Got it.
spk04: Thank you. Which was the other collaboration?
spk03: The first one was BRNC. The Belgian National Reference Center?
spk04: Belgian National Reference Center. Yeah. So that one is actually a true R&D collaboration. That will not be revenue generating. But both of the other, the BioVersus and the FIND, clearly have top line growth potential.
spk07: Okay. Thank you.
spk06: Our next question comes from Sue Romanoff with the Edison Group. Please proceed with your question.
spk05: Hi, Oliver. Hi, Albert. Thank you for taking my call.
spk01: Sure. Hi, Sue.
spk05: Quick question. Hi. Can we talk a little bit about maybe the pipeline? I recognize install base is a little lower, but, you know, can we talk about what we're seeing now and maybe like the anticipate drivers of growth?
spk04: Sure. I mean, when you look at, you know, when you look at ARAS, let's start with ARAS, the feedback we've gathered from various sort of voice of customer sounding market analysis, as well as key opinion leader roundtable discussions on the specific ARAS offerings, we believe that we're definitely addressing an unmet need and have a unique and differentiated product and service offering. What we're seeing, I guess, is that sales cycle in this emerging market and still very early stage market in next-gen sequencing and AI-based bioinformatics tend to also be longer than we had originally expected. And on the partnering and collaboration side of things, that's always hard or almost next to impossible to predict exact timelines for these deals to emerge. In the third quarter, we've seen some of those collaboration opportunities being pushed out into 2023. A couple of others fall out of the funnel due to corporate reorganizations, reprioritizations at some parties. And at the same time, we've seen several new opportunities emerge and come into the funnel of partnering discussions, which is why we're very optimistic about the future growth in the RS business. When you look at the sequencing side, again, we've seen the launch happening in the third quarter. The sales cycle for the isolate sequencing service and RS-based bioinformatics are likely also going to be in the six- to nine-month range. At least we would not expect the material impact on the fourth quarter revenues, but rather view this as a strategic growth opportunity for 2023. As I said, the team right now is processing hundreds, in fact, north of a thousand isolates from the UTI clinical trial, which both from a volume and workflow perspective is an excellent pilot. What the IRS team is delivering at arm's length at commercial terms, and hence it will have a well-trained, well-established team and workflow set up for future commercial projects. And we're already working on a number of early adopter leads that have some rather significant opportunities with potential strategic key accounts in the funnel.
spk05: Okay, that's really helpful. How about China? It's nice to hear that we actually have more clarity. I mean, did I understand that right? Is that like three to four years before we can launch there? Or did I misunderstand that?
spk04: Yeah, so not three, of course, 24 to 30 months. And again, this is not our expectation or our estimate. This is what we've been told by the regulatory advisors to Beijing Clear. And I'll remember, this is something that the Chinese NMPA has implemented here in recent months and weeks. And we've been going back and forth, you know, week by week. There's not a lot of precedent. This is a brand new procedure for an electronic filing system in the previous submission. for the univiral pneumonia cartridge had gone in paper-based, essentially notarized paper documents. They've now changed that and require a resubmission, which kind of will restart the clock, but current anticipation, 24 to 30 months for that full procedure. It looks very much, if you read it and kind of interpret it, it very much looks like what the US FDA does in terms of its interactive review procedures. And within that 24 to 30 months timeframe, that's where the clinical study is also gonna get executed. And so that's not adding, that's not additive, that 10 to 12 months that the regulatory advisors anticipate, but that's within that 24 to 30 months of that time period, roughly 10 to 12 months is anticipated for the full execution of the clinical study.
spk05: Okay, that's helpful. And my last question, I wanted to understand, you know, Do we think that the commercialization strategy, you know, there's any changes or anything like that? I know we have a lot of international partners, and then we do a lot of that commercialization in the U.S. ourselves. Any kind of updates on that, if possible? Thank you.
spk04: Sure. I mean, so strategically, I think, you know, As you point out, rightfully, we're selling direct in the United States, and we're selling through distribution partners, collaborators anywhere else, Europe, Asia Pacific, Latin America, Middle East, et cetera. Fundamentally, that strategy will remain unchanged. Now, whether at some point in the future there may be opportunities to add a strategic complementary strategy sales channel in the United States with potential distribution partners. That's certainly something that we're actively looking into, and there are options and ways of doing that. But that's not going to be us abandoning, you know, the direct selling of the Univero and Acutis products in the U.S., but it would rather be additive and complementary in terms of channel.
spk07: Thank you so much.
spk06: That's all the time we have today. I will now turn the call back over to Options CEO Oliver Schacht for closing remarks.
spk04: Well, thank you everyone for joining today and please visit the investor section of our website or our SEC filings for updates on the company. Thank you very much and have a great day.
spk06: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
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