Q3 2022 OpGen Inc Earnings Call
Welcome to the option third quarter 2022 earnings call and business update today option management will provide an update on the company's current business and outlook for the future. Following options prepared remarks, there'll be a live Q&A session. As a reminder, this conference call is being recorded today November 10 2020.
Two and all participants are in a listen only mode. At this time, we will turn the call over to Elissa factor options IR representative to provide statement.
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 <unk>, Inc.
Its subsidiaries curated.
Ares genetics I encourage you to review options 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 F. D C, which will identify specific fab.
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 services.
Operating the.
The company's ability to continue to successfully achieve the expected synergies from the company's completed business combination with carried us and to implement its commercial strategy.
The continuing global COVID-19 pandemic on the company's business and operations.
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.
Company's ability to satisfy its obligation under its loan with the European investment Bank.
Of adoption of its products and services by hospitals and other health care providers in general as well as during the COVID-19, pandemic and geopolitical situation in particular.
Effect of the military action in Russia, and Ukraine, honest distributors collaborators and service providers.
The effect 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.
The date of this call November cat in 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, Upjohn, President and CEO and Albert we burn it CFO now.
Now I will turn the call over to Oliver for introductory remarks.
Thank you Melissa and thank you everyone for joining us this afternoon.
Today's call I'll begin with a recap of previous highlights discussed on our second quarter earnings call followed by recent updates on all products and R&D pipeline.
Albert will review the financial highlights from the third quarter and offer and updates to our guidance I will then provide an outlook on options ongoing and upcoming milestones and business development followed by Q&A session.
At the beginning of this quarter option subsidiary Ares Genetics signed a research collaboration agreement with the Belgian National reference center for invasive Streptococcus pneumonia at the University Hospital.
The U S Center for disease control C. D. C is classify its drug resistant streptococcus pneumonia as a serious antimicrobial resistance or EMR threat and <unk> is one of the top 10 global public threats.
This presents an unmet need for effective diagnostics under the agreement partners aimed to employ machine learning tools for antibiotics susceptibility testing.
In August we launched the Rsi SaaS isolate sequencing services for my Rockville, Maryland lab at auction.
We're now able to serve U S customers directly in the U S, providing easy access to our RF technologies from options commercial lab.
By expanding our services and offerings in the United States.
Continuing on the path to generating revenue producing opportunities.
Our U S lab facility, which will also enable an expedited turnaround on the next generation sequencing, where Ngls work related to the unit arrow urinary tract infections or UTI clinical trial.
In October we announced completion of enrollment.
Of our major prospective multicenter clinical trial in the U S on the unilateral he 50 platform.
The unit Barrow UTI panel.
We enrolled over 1800 patient samples and exceeded our goal of 1500 prospective samples.
We expect to conclude reference testing in the next two weeks and anticipate the UN blinding of data in December this year, which we will discuss in more detail later in this call.
Following the unilateral 850, UTI product, we'll be looking to develop our first products on a unit of Arrow a 30 platform.
These will include bringing into clinical trials and invasive joint infection or Iga high panel as well as working on a panel focused on EMR markers from blood cultures for low and middle income countries, where LMI fees under our find collaboration which began in September .
The initial feasibility phase of the collaboration with fine is expected to be completed at the end of March 2023, and is forecasted to deliver six proof of concept deliverables such as panel definition for an EMR focused cartridge certain assay development work prototype definition and development towards an 830 touch screen cockpit.
The final program will focus on detecting pathogens and EMR markers from common blood culture bottles.
The 700000 euros and co funding by fines and German K F. W. Bank will also allow us to develop prototypes of a dedicated 830 touchscreen cockpit that will be suitable for use in LMR settings.
<unk> signed its second commercial customer contract for the acute as EMR gene panel in the third quarter editions.
Additionally, we have several ongoing contract negotiations in the final stages undergoing legal and commercial review.
We recently announced a collaboration agreement between bio versus AG from Switzerland, and curated for the development and use of the unit arrow platform and bio versus upcoming phase II clinical trial of novel Drug candidate VB 100, VB 100 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 II clinical trial, all hospital sites will be using our unit barrel hospitalized pneumonia or H P. M cartridge, because a rapid diagnostic tests to help optimize enrollment.
We estimate that the first trial sites will start coming online early next year, an estimate at least 18 months for a trial at somewhere around 10 to 20 trials sites across different European countries.
We anticipate revenues of a couple of hundred thousand dollars over the duration of the trial for a unit URL systems that will be rented cartridges sold support as well as training delivered to bio versus and their clinical research organization.
This week options board elected you won't Schleppy as a new independent non executive member of the company's board of directors.
The slightly brings legal governance, lifesciences and international experience to the board.
Since 2011, the Schleppy has served as a managing partner of <unk>, LLC and international strategic advisory firm that she cofounded.
Prior to founding Stradivari.
Slappey served as general counsel at Global Enterprise technologies passport and I E 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 and animal health and biotech group based in the Netherlands.
From 2006 until its sale in 2007.
Prior to that the slab he was a partner at the Boston based law firm of Palmer and Dodge LLP, where she served as chair person or that firms international practice groups.
Subtracting 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 as a member of the board of astronauts Inc.
I will now turn the call over to Albert flavor options, Chief Financial Officer, who will review financial results for the third quarter and recent financial developments Albert.
Thank you Oliver and welcome to everyone on the call.
I will briefly discuss the third quarter 'twenty is going to highlight our balance sheet position and underlying growth drive us towards the business and conclude with some thoughts on guidance.
Our revenue for the third quarter 2022 was zero point $4 million.
This time last year, we ended the quarter with $1 2 million.
The decrease in revenue floor for you attributed to the contribution of the New York State Department of Health to project in the third quarter of 2021 with no comparable project in the reporting quarter as well as lower unit system revenue internationally, which by their nature.
Fluctuate significantly quarter by quarter.
Our third quarter 2022 revenues does not yet reflect the impact from the final critical ratio, which is expected to be recognized over the term of the agreement. It was the first half of 2020 and story.
Additionally, the accused of sales did not contribute.
Material level since the first customer sites did not become operational until October .
Therefore, those sales will be reflected going forward in the upcoming quarters.
Later in the calls Oliver who will discuss our expanding pipeline pool, increasing sales within the U S and internationally.
In the third quarter of 2020, two we have to recognize.
A goodwill impairment charge of $7 million due to the sharp decrease of options share price over the last months and a corresponding drop in our company's market capitalization.
Thus our operating expenses for the three months ending September 32022 increased notably to $14 million compared from nearly $6 3 million in the third quarter of 2021.
Leaving with a special one off effect aside operating expenses would have been $7 million in this reporting period and the increase would've been 11, 1% due to a $1 $4 million reserve charge for inventory buildup in anticipation of a fast progress with the market approval process.
Only available in China.
For the first nine months of 2022, we saw an increase of 29, 4% and operating expenses of 24 million in the nine months of 'twenty or 'twenty, one to $26 5 million.
The comparable.
This year, but operating expenses would have been 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. The nine months. They go too because they get aforementioned inventory reserve charge.
Okay.
Our third quarter 'twenty to 'twenty, two R&D expenses with too.
$2.0 million compared to $2 4 million in Q3 of 'twenty, 'twenty 116, growing 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.
Okay.
It's smaller and more efficient R&D teams has proven to be successful. In addition to our focus shifting increasingly towards commercial efforts and all future Engie S Lab services.
Third quarter 2022, G&A expenses were 2.0 or $1 million down by over 3% from our Q3 2021 G&A expenses of coupons.
Yeah.
And 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 all business integration has allowed us to reduce G&A expenses.
Third quarter, and nine months of 2020, two sales and marketing expenses were $1 million flat and $3 3 million, respectively compared to 1.0 a million during the third quarter of 2021 and $2 $7 million in the first nine months of 2020 one.
We are convinced that our sales and business development team will be crucial in extending our partnerships and driving overall revenue.
We have also seen the return of life in person conferences and exhibitions internationally as well as here in the U S. Which has also contributed to increased marketing spend in return for a much improved customer access and interact.
Turning to our operating loss. It has also been impacted by the goodwill impairment charge and increased in the third quarter of 'twenty to 'twenty, two 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 <unk> 57 per share in the current year compared to $28 million or 17 nine cents per share in 2021.
This was positively impacted by much lower interest expense from a loan from the European investment bank or EIB, which has been partially we paid in the second and third quarter of 2022.
Finishing off with our cash and cash position. We ended the nine months of 2022 was approximately $10 $3 million a decrease compared to our cash position at the end of 2021.
$36 $1 billion.
We continue to closely monitor our cash burn rate.
A successful financing that closed on October three 2022 meant that as of this date, we had $13 $3 million in cash available to auction.
As mentioned on our last earnings call our subsidiary Greatness N E M. B, a greeter empathize with best friends originally view in April 'twenty or 'twenty two over a 12 month period until the April 'twenty two 'twenty three.
We repaid 5 million euros in April 2022, and it may began monthly installment payments for the remainder of the best trends.
<unk> $8 4 million euros over those 12 months period until April 2024.
So as of today, we have about $4 2 million and debt repayment obligations left from the first box.
There are two additional tranches of 3 million and 5 million euros principal plus accumulators and deferred interest as well as the P. P. I that becomes due in June 2023, and June 'twenty 'twenty four respectively.
At this point these branches remained unchanged by the agreement with EIB.
Additionally, the company currently you may sell up to $3 $5 million of its shares of common stock under the company's ATM agreement with H C. Wainwright.
In October we closed the retro style for direct offering for gross proceeds of about $3 $4 million.
We plan to use the net proceeds from the offering to continue from a stabilization of the F. D. A T O acuity ammo gene panel test well I slipped.
Yes.
Focus on commercializing the only global platform and diagnostic tests.
Further the development and commercialization of the Irish database.
Support direct sales and marketing efforts to the customers and collaborators for our products and services.
Invest in manufacturing and operations infrastructure to support sales of product entry pay so it's an 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 position.
As mentioned on our previous opening schools are operating expenses remain in line with our expectations in fact, well against our guidance for yearly net.
We anticipate continuing that track with Carpathia I didn't expect that net consumption of around $5 million 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 $700000 for months until April 20th 23.
We are continuing to see growth opportunities, especially with pollak sales and with all of our services here in the U S.
We believe our genetics has a strong business development and collaboration opportunity funnel, which we remain optimistic about with potential partnering deals that each could begin to contribute to revenue growth from 'twenty to 'twenty three onwards.
As a result of our progress in the third quarter of 2020, two and here to date, we expect future growth in the commercial rollout of Union.
And the acute is a M O gene panel.
We are focused on expanding and progressing our commercial pipeline for the M. R gene panel as well as the railroads I Love T N Q T R with several ongoing discussions with hospitals.
This year, we have signed the first two commercial acuity disagreements in Q2 and Q3 and also added a new Union Railroad 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 U S customer accounts across the only variable in our queue at this product with a combined seven figure the dollar value of annually that we believe are currently in final review and we believe this indicates a significant revenue growth potential for option.
We are looking forward to a final deal with your all your clinical trial data readout and a subsequent regulatory submission for you on a go you'll see eye to the F D. A.
Our goals for the longer term include expanding our our services business as well as collaborations and partnerships.
We have multiple ongoing conversations with potential U S accounts and leading organizations in N J S diagnostics and pharma.
Our newly opened its U S. Next generation sequencing service will slap here in Rockville, Maryland is currently processing Hungered Sop samples for Engie S sequencing for the youth Y'all I clinical trial.
With a slower than anticipated 2020 to signing of new contracts and ramp up of revenue under signed contract and collaboration agreements. We now expect revenue from our products and services and Kona brewery collaborations globally for 2022 to be in a range of somewhere around two five.
$3 million.
Well this is slower 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 collaborations which will be recognized in Q4 and into 'twenty two 'twenty three.
Also we expect revenue recognition from the new buyer versus collaboration to begin in early twenties 20 for Ya.
In August NASDAQ granted options request for 100 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 32022 to vote. Upon a proposal to authorize the board to implement a reverse stock split at a ratio of not less than five to one and not more than 21.
With that I'll turn back the call to Oliver to discuss the company's achievements and upcoming milestones.
All of them.
Thank you Albert and I will now focus on upcoming milestones and how we plan to execute on our upcoming plans.
After many months option has recently received an update from Beijing clear biotech ECB.
Regulatory advisors about feedback from China's National Medical products Administration M. P. A.
New regulatory procedures that N M. P. Eight 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 time lines and processes.
Initial indications are that with the restart of the new submission we could be looking at a 24 to 30 months overall process and within that the ECB 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.
Looking forward to progressing with the clinical study and working towards a final M. P. A submission and review and eventual clearance.
Following an M. P. A approval there was still an unchanged commercial contract worth potentially up to $180 million to auction already in place over an eight year period.
We hope to have more information in the near future and proceed with moving this forward.
With many milestones to look forward to regarding our universal platform.
Earlier this quarter, we completed clinical trial enrollment for the Universal UTI panel in the U S.
Due to the complexity and comprehensive nature of the data since we expect to conclude reference testing in the next few weeks and then anticipate on blinding. The study results in December of this year.
Following final data readout, we will prepare the submission package for the F. D. A early 2023 and targets a submission by the end of the first quarter of 2023.
The FDA usually it takes about six to 12 months for its review and clearance decision and.
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 unit barrel 830 platform on an agi panel from Synovia fluids.
Currently finalizing the development off the Iga I panel cartridge as well as working on the AOR tests from blood culture under the find collaboration.
Our goal is to initiate a prospective multicenter clinical trial for the Iga only product in the United States only gonna viral 830 platform in the second quarter of 2023 I E. After completion of the find R&D collaboration project <unk>.
In preparation of a subsequent FDA submission of the <unk> product.
Our find R&D collaboration involves a feasibility study that is expected to conclude in the first half of 'twenty three.
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 LMI sees both parties greatest 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 'twenty three and would then finalize it once the feasibility data is available.
This initial find contract is an exciting milestone for auction and our subsidiary courageous because fine as 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 and individual strategic collaborations there.
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 auction.
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 afternoons 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 have a question. Please press star one now to be placed in the queue. Please.
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 <unk> Chen with H C. Wainwright. Please proceed with your question.
Okay.
I think he might be on mute.
Sorry.
Sorry about that thank you for taking my questions. My first question is just for clarification, you mentioned, the new installations of computers and their margin I don't know so does that mean.
The customers, we don't have a new instruments installed and whether it's and tell us whether the customers are obligated to purchase a certain amount of the AR at the panel within a certain period.
Sure. He good good question, yes, so each of the contracts has a clearly defined.
Minimum number of cartridges and.
In fact, we have seen purchase orders for the consumable cartridges are Kent I should drive the same I'll cartridges acute as EMR gene panel kits come through we have actually supply those kits to the customers.
But in order for them to begin testing, we first had to install the systems. If you remember the acute is a AMR gene panel does not drawn on our universal plus the system. It runs on a qiagen easy one sort of sample prep.
And the thermal Fisher Quant studio five for the P. C R.
Those instruments, both the Qiagen easy one and the Thermo Fisher <unk> five first half to be got taken through IQ O Q testing by the respective Qiagen and Thermo Fisher our field service Engineering Representatives that happens during the month of October .
At both sites are only then can we at option upload the FDA cleared software and basically turn these systems into option qualified systems for the acute is a more gene panel testing with.
Basically means from contract signature to beginning to recognize revenues there is a certain time lag.
To anticipate for the installation the IQ O Q by external third parties.
And then basically ordering shipping kits until to the site began testing, but both of them have received consumables and yes. The contracts have clearly defined numbers for each of the contracts.
Got it got it.
And regarding Oh genetics.
I was just isolate sequencing services that is that has been launched in the U S is it generating revenue starting in the current quarter.
It's hard to predict but right now the first quarter. Although you know that that's not going to go to be recognized as revenue. Although it's done at arms length as a as a commercial service we're processing the <unk>.
Universal UTI samples really as a service by by the Ares Genetics U S team.
For <unk> that is preparing that dataset again youre looking at in fact, that's over 1000 isolates that are being deep sequenced.
Look at sort of stand up market pricing that'd be a couple of hundred grand in and actual services.
Sales cycles for the isolate sequencing service are 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 'twenty three.
But again the sales funnel for ours isolate sequencing services in the U S as well as in Europe is growing expanding and there are some very attractive.
And a very significant opportunities there.
Currently being pursued.
Got it got it.
And finally regarding the collaboration agreements with a B C and D and a bowel versus these collaborations expected to generate revenue for the company.
Yes so.
Let's start with the bio versus 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 you.
We basically start with our initial training so they start renting a defined number of unit barrels systems essentially a system for each of the trial sites.
And then we supply Egypt, Egypt, the trial sites via their CLO with cartridges at a you know.
Essentially full full price for these you know their old cartridges. So again, we expect that revenue recognition as I said, it's over the total clinical trial duration, which again for typical phase two in infectious disease, you're likely going to look at at least 18 months overall trial duration, but that's going to be a couple of hundred thousand from from that.
Find the 700000.
You know again, we haven't recognized anything in terms of revenue here in the third quarter now that the project is underway in.
In the fourth quarter, and then into Q1.
Maybe into the early parts of Q2 next year, we anticipate the impact on the on the P&L to get recognized and getting that 700000 over those couple of months.
Well it will show up.
In the P&L being being recognized.
Got it and then what was the other which was the other two I believe.
First one was the B M P. R I N C.
Oh, sorry, that's the argument.
Pardon me.
The Belgium for instance, national referencing that that is that's so that one is actually a true R&D collaboration wet that that will not be revenue generating but both of the other the bio versus and defined a clearly have topline topline growth potential.
Okay. Thank you.
Our next question comes from Soo Romanoff without Bateson group. Please proceed with your question.
Hi, Oliver.
Albert Thank you for taking my call.
Sure Hey, two quick questions.
Can you can we talk a little bit about maybe the pipeline I recognize install bases a little lower.
But you know could we talk about what we're seeing now and maybe like the anticipated drivers of growth.
Sure I mean, when you look at you know when you look at the Arris, let's start with hours their pipeline the feedback gathered from various sort of voice of customer sounding market analysis as well as.
Key opinion leader Roundtable discussions on the specific hours offerings, we believe that we're definitely addressing an.
And unmet needs and have a unique and differentiated product and service offering.
What we're seeing I guess is that sales cycle in this emerging and still very early stage market in next gen sequencing and AI based bioinfomatics tend to also be longer than we had originally expected.
The partnering and collaboration side of things.
That's always harder almost next to impossible to predict exact timelines for these deals to emerge in the third quarter. We've seen some some of those sort of collaboration opportunities being pushed out into 2023.
A couple of others fall out of the funnel.
Due to corporate reorganizations re prioritization at some parties and at the same time, we've seen several new opportunities emerge and come into the funnel partnering discussions which is why we're very optimistic about the future growth of the <unk> business.
Okay.
When you look at the sequencing side.
You know it.
Again, we've got you know we've seen the launch happening in the third quarter.
Sales cycles for the isolate sequencing service in our space Bioinfomatics are likely also going be in the six to nine month range.
We would not expect a material impact on the fourth quarter revenues.
But rather view this as a strategic growth opportunity for 2020 three.
I sent a 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 pilots what they are seems delivering at arm's length at commercial terms and hence we will have a well trained well established team in workflow setup for future commercial projects.
I'm already working on a number of early adopter leads that have some rather significant opportunities with potential strategic key accounts in the fall.
Okay. That's really helpful. How about how about China, it's nice to hear that we actually.
More clarity I mean is it did I understand that right is that like three to four years before we can launch there or is there.
Did I understand that.
Yeah, Yeah, so not $3 24 to 30 months is the car and again this is not our expectation or our estimate this is what we've been told by.
By the regulatory advisors to Beijing clear and I'll remember this is something that the Chinese N. M. P. A has implemented here in recent the recent months and weeks and we've been going back and forth. So you know a week by week Theres not a lot of precedent. This is a brand new procedure for an electronic filing system into the previous <unk>.
Mission for the unit barrel.
Pneumonia cartridge had gone in paper base.
Okay. So she notarized paper documents like now changed that and require a resubmission.
Which kind of if you will restart the clock, but current anticipation 24 to 30 months for that full a full procedure. It looks very much if you read it and kind of interpret it very much looks like a a what the U S. 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 it's not additive that 10 to 12 months that are 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.
Okay. That's helpful.
And my last question I wanted to understand you know.
Do we think that the commercial side.
Eddie you know theres any changes or anything like that I know, we we have a lot of our international partners and then we do a lot of that commercialization in the U S right now.
Kind of update on that if possible. Thank you.
Sure I mean, so strategically I think you know as you point out rightfully were selling direct in the United States and we're selling through distribution partners, our collaborators anywhere else Europe Asia Pacific Latin America, Middle East et cetera are fundamentally that strategy will remain unchanged.
<unk> now.
Whether at some point in the future there maybe opportunities to add a.
It's called a strategic complementary 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 abandoning our you know.
The direct selling off the unit Aronie Cumulus products in the U S, but I'd, rather be additive and complementary in terms of channel.
Thank you so much.
That's all the time, we have today I will now turn the call back over to option CEO Oliver Schacht with closing remarks.
Well. Thank you everyone for joining today and please visit the investors section of our website or our SEC filings for updates on the company.
Thank you very much and have a great day.
This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
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