Biovica International AB (publ)

be live. Thank you. Start. Hello everyone and welcome

to the earnings call for the second quarter of Bavik as broken fiscal year for 2023 and 2024. The presenters for today will be first it will be me Anders Rulander followed by Warren Creswell, Henrik Winter and Anders Morén. And the agenda for the call is a short introduction for me and then I'll talk about the highlights. Then we'll dive into a US update with Warren Creswell and Henrik Winter will provide an update about our pharma services development. Anders Morén will provide an update about the financial status before we have a summary by me and the Q&A session. And you can all post questions using the function in Teams and if you want to remain anonymous you can do that as well by checking that checkbox and at the start of the session we will let the equity researchers from Red Eye, Pareto and Kempen. So they also had the opportunity to ask questions, follow up by questions that we received from other participants. So I will start by talking a few words about our product. So we are all on the same page here. So the product is called Divitum, stands for dividing tumour and with Divitum we can from a simple blood test from the patient measure cell proliferation. And in the cancer that is essential and important information as cancer grows through uncontrolled cell proliferation. So Divitum can provide important information both before and during treatment. Information about the aggressiveness of the disease and also provide quick response if the treatment is effective or not. We have in clinical trials shown that we can provide such information if the treatment is effective or not only two weeks into treatment. That is a significant improvement versus imaging which is the standard method being used today which requires three four months before evaluation of progression is typically done. We've also in another clinical trial shown that we on average can provide feedback about progression around three months on average quicker than with imaging. So we have a very convenient tool for monitoring of cancer therapies in the metastatic setting. We've shown several clinical trials. Talking about clinical trials here's a summary of the clinical trials that we have published so far together with our partners or to be correct it is the partners that has used our assay and used it in clinical trials that have made the publications. Before that they'd be peer reviewed and published in scientific journals. This is of course essential for us having data proving the value of the product. These trials have shown that the Divitum is strongly prognostic both in local setting of cancer but also in the metastatic setting where it's been shown to be prognostic both for progression and overall survival. And it's also been shown to be an excellent monitoring tool where we've been able to follow patients and taking repeated samples over time. Our focus area is the breast cancer area where we have the majority of the data 14 studies and over 3000 patients. We also want to highlight the collaborating partners. We have really strong key opinion leaders some of the leading ones in this area especially within the breast cancer area that has performed these trials at some of the most well-renowned academic institutions in the world such as Mayo Clinic and Johns Hopkins and then Dana-Farber etc. This is of course important because these people and these institutions they have impact when they reach out to others and present the results of the clinical trials. When it comes to our -to-market plan and the market potential we'll talk a little bit about the plan and the different areas. Our focus is initially now to commercialize the product for use as a monitoring tool within metastatic breast cancer both in on the US market where we have an clearance since last year and we're now in the ramp up of the commercialization phase which Warren will talk more about. In Europe we also have a very good start where we have signed several agreements with partners that is providing analysis services and also has a sales force working against oncologists on these certain European markets. Another area with great potential is the pharma services area where we serve pharma companies using our product when they develop new therapies within the cancer area something that Henrik will dive into and explain a little bit more where we stand we've made great progress there as well. Looking further ahead we have also great opportunity and potential to widen the use outside of the breast cancer area into new indications. We already have data on metastatic malignant melanoma and in combination with immunotherapies we also see potential within lung cancer and prostate cancer. So there's a great potential for the product and we have also made great progress during the last quarter where we are in the early phase of our commercial journey of commercializing the product. If we dive into the second quarter of our fiscal year and the highlights that we've had it's been quite a few actually that many that we have now been forced to categorize them. If we start with the US and clinical Warren will cover these a little bit more in detail but we made progress when it comes to direct bill agreements directly with US hospital or hospital networks you might say because we are now covering around 50 hospitals with these three agreements in three states in the US. We also made a PR about the preliminary decision with the gap fill process for CMS and then after the end of the period we made a new PR that in the end we concluded or CMS concluded that we'll go with a quicker method called crosswalk which means we'll have a price or be included on the Medicare price list from start of 1st of January next year which is great news. Warren will also explain a little more what that means. We're making progress when it comes to the lab we got the cap accreditation that opens up opportunity in certain geographical areas and at certain also private insurers etc which Warren will talk about and we are continuing to strengthen our clinical data by initiating new clinical trials so a lot of progress on the US area this quarter. Looking into pharma we have now a portfolio of projects and we can see that they are growing and we can see that revenues are keep growing. Henrik will give you some little more guidance around what we've done there and also how we've been able to within which areas we've been able to grow our business there. And also when it comes to the more administrative PRs that we've issued we've communicated that we will do a rights issue that's partially guaranteed and we're progressing with that we've also carried out an EGM in that process. And then the last news before end of or sorry after the fiscal the Q2 ended during November we announced that we signed a commercial agreement for Europe and if I move into that slide specifically it is with a Danish company called Axelab a company is growing very fast and is focusing on diagnostic or sales of diagnostic products and they have a facing team of 25 reps within sales and marketing and they are planning to expand that when they're bringing in a dividend to their assortment. So this aligns very well to the kind of partners that we would like to team with that is successful fast growing within oncology has a sales force has the competence and the drive to make us both successful. And we've said aggressive targets to within three years is realized 15 percent of the market potential on this market and I think also we have some some really strong partners when it comes to the clinical setting with Karolinska and we have ongoing trials also with Krista hospital in Manchester that Swedish hospitals like the one in Shipping also is part of. So this is a great news also for European area. Alright then I'll let Warren on stage and Warren if you please can take us through the US status and walk us through what happened during the last quarter.

Great thanks a lot Anders I really appreciate it you can there you go. So we have we continue to execute our US strategy and I think this quarter has been not only productive but I think very exciting for the organization as well. Throughout the presentation I'm going to talk about a number of different topics. I'm going to talk about Medicare pricing that was recently established. I'm going to talk about the three hospital contracts that Anders alluded to. I'm going to talk about regulatory progress we've made it with our CLIA lab laboratory. I'm going to talk about clinical trials that are ongoing in the US and then I'm going to finish with some feedback that we've received from medical oncologists that's been very positive that I wanted to share.

Next slide please. So Medicare pricing this has really

been part of our overarching reimbursement strategy is to work with both the AMA and CMS to be able to establish a price for and we started this process early in the year we worked with the AMA. AMA is really the gatekeeper of all coding in the US you need to have a code to be able to provide essentially an invoice or a bill to Medicare or to private insurance and we did establish a proprietary laboratory analysis code. That code is actually specific to both DIVITUM and DIVITUM being run in our San Diego based laboratory. So what that means is with this very unique code if there is a competitor that decides to develop a TKA assay they're not able to use our code nor are they able to use our price. They themselves would really have to start from scratch so it's really unique to us our product and our laboratory. We also were working with CMS. CMS is the one that actually is a part of the organization that determines the price for a particular product so we worked with the CMS subcommittee and during that discussion there's really two paths that we could take. One is called crosswalk where we compare our product with similar technology to establish a price or there's another payment methodology called gap fill where you really have to start from scratch and prove the value of your product. That's a two-year process. In September CMS issued a preliminary payment determination where even though the subcommittee voted in favor of crosswalk CMS ended up deciding after further evaluation that it would be best for us to follow the gap fill payment methodology. After they indicated that there is a timetable where we can provide some additional information and ask for reconsideration is what we did in October and after they took a look at the information that we provided and the argument we provided. This month in fact last week they did reverse their decision. They made a final payment determination and they indicated that we could pursue crosswalk and what that means is January 1st, 2024 so just over one month away Dividend will have a price of $322 per test for Medicare patients and that is really a huge milestone for us here in the U.S. Now I know Anders has given guidance in the past in regards to having an average test price of $400 a test and this works perfectly in our equation because we had calculated $322 per test when we add in private insurance and when we add in hospital agreements the net is $400 and maybe even a little bit more so I think we're doing a

really great in regards. Next slide please.

In the quarter we did sign execute three separate contracts. Now these three separate contracts aren't necessarily for three hospitals as Anders had indicated just a few minutes ago. This really encompasses about 50 hospitals because these hospitals really act as networks. The first one that we signed is based in Arizona but they really do cover the southwest region and they're one of the one of the largest health care providers. They themselves have about 30 hospitals in their network and we're just starting to see samples come in through some of those hospital institutions now. The second agreement is with the largest health care provider in Missouri. This is a NCI designated cancer center. They have 18 hospital laboratories and they're working through really kind of the final details in regards to logistics, internal logistics before they start sending samples in but the contract is in place and executed. Thirdly is a contract with a with really world-renowned cancer center. They're an NCI designated center. They're located in Florida. They serve patients from all 50 states and we are actively receiving samples from that particular institution. The target that we have in the U.S. for this fiscal year is to be able to sign 10 hospital contracts. We do have a pipeline of institutions that we're working with and one of the things I want to mention as well is that the real takeaway with these contracts is we've pre-negotiated a price so that is in place but also the fact that each one of these institutions has indicated that there is clinical utility with divotum which enables their oncologists to order the products and that's a huge win

from our perspective. Next slide. From a regulatory progression

perspective, back in February we worked very hard to get our lab CLIA certified. We achieved that the following month. We were credentialed by Medicare which means that we could receive samples, test those samples and invoice them to Medicare. Then in October we're very pleased to be able to earn our cap accreditation and so this is a lot of very hard work that's gone out on within the laboratory over the last year to be able to get CLIA certification, being credentialed by Medicare and being cap accredited. Today what we're able to do is we're able to conduct business in 48 of the 50 states and we anticipate the 49th state that we can do business in is in Maryland and we anticipate that being happening getting a license anyways in the next month or two and we're working closely with the state of New York. New York is a bit of a longer process. They do require cap accreditation before you can apply for a license so we're working with them. The time frame there is a bit longer but we anticipate kind of late H1 early H2 to be able to get a New York state license and be able to then serve their 20 million people that

are in the state of New York.

We

are

also actively engaged in prospective interventional clinical trials and really in no particular order we are working with Yale University and with Yale the clinical trial that's open and recruiting patients. It's for both drug to drug interaction so they're looking for patients that are taking a therapy specifically CDK46 inhibitors and where we see a high TKA value where maybe the patient isn't responding to the therapy and one of the things that physicians are looking at is the drug to drug interaction. What's that impact to the efficacy of the drug? The other side of this is also looking at dose reduction so when you have a patient response incredibly well to a therapy is there an option to actually dose reduce that patient so that the is up and running. The second one I want to talk about is with Washington University in St. Louis. This trial is called TK Impact and this is a trial that looks at real-time biomarkers of tumor response and again this is patients that are on CDK46 inhibitors that are hormone positive that are meds like breast cancer patients. In this particular trial they're looking at not only our product Femidikinus but they're also taking a look at other biomarkers as well and seeing how a physician may act differently if they had a TKA value that was elevated or declining versus other biomarkers. This clinical trial is open and recruiting patients and in fact there's an abstract that was submitted to San Antonio Breast Cancer Symposium and that will take place next week. The third one is another clinical trial through Washington University and it's called the Better Trial and with this particular trial it's biomarkers driven early therapeutic selection so when a patient goes on a therapy we look at the Femidikinase level at baseline and then we look at it at cycle one day 15 and based on the results of those two tests the clinician will make a decision whether they keep the patient on a particular therapy or they make a decision to change the therapeutic selection that made for that patient. So that trial is opening in early H1 of next year so we're really excited about this. The real takeaway from these clinical trials is that one it gives us data where we can understand where we can potentially expand the label of our product. It also provides clinical utility and it also helps from a reimbursement perspective as well. And then

lastly

I'd like to end with feedback we received from medical oncologists and the feedback has really been overwhelmingly positive. There's three particular comments I want to review real quick one of which is doctors indicating that the test really provides confidence not only to the physicians but also to the patients so one oncologist located in the southeast indicated receiving a divotum tka value of less than 250 gives me the confidence that my patients have a low likelihood of disease progression and that's really exactly on label what we want both physicians and patients to experience. The middle one is really early determination so we have physicians this one particularly the northeast that from the baseline test to the cycle one day 15 result a reduction in tka value suggests that my patients are responding to therapy so it really gives them an early understanding like Anders mentioned before that we can see things in a couple weeks results. And thirdly is really this personalized therapy approach which is providing patients with the lowest effective dose rather than the highest tolerable dose personalizes therapy for my patients and this is really in line with project optimus that the FDA has been talking about where they're looking at dosing patients not based on maximum tolerability but minimum effective dose so it feels like we're exactly in line with where the market is shifting there as well and with that being said I'm going to hand the presentation over to my colleague Henrik Winther and he's going to give an update on pharma services.

Super thank you very much Warren yes so I'll provide you with an update on what we have achieved during Q2 within our pharma services and collaboration business. So for those of you that have actually seen our presentations before this slide might seem familiar it really shows the step-wise approach we use when we onboard pharma. So typically they start out by evaluating our technology through an agreement or T-Stand we call it when they have actually realized the potential of the assay they typically move into step two where we sign a master service agreement with them allowing to actually run several projects with that pharma partner and then at some point of time when we have run a couple of quite a few perhaps of these projects pharma will start the discussion about what is you know the potential of actually customizing your assay towards our drug so that's you know the third step the CDX collaboration and then finally you know it should lead to you know products bio-vika products brought to the market and that's really the goal of this business is you know getting new products to the market. So if you look at the status on the slide here in lower part what we achieved during Q2 was a great continuation of you know what we actually also or the positive trend we saw in Q1. So totally you know you can see we have now 21 projects and in parentheses here you can see you know how it looked in Q1. So we went up you know three projects even better is actually that if you look a little bit now above and look at the T-SATs and the MSA we managed to go from 12 MSA projects to actually 19 projects now in Q2 and that's really because you know some of the T-SATs they turned into master service projects and then you know we also signed you know two new T-SATs with pharma. So totally Q2 we have 21 projects. We also signed one new master service agreement during the quarter so very very positive progression. If we dive a little bit you know deeper into you know what happened during Q2 I have you know a few highlights here. So financially we actually grow 35 percent from Q1 to Q2 and you know if we compare to last year's Q2 we had you know 130 percent growth. So really a strong Q2 in this part of our business. Another a couple of other highlights is that we saw an increased interest from tier one oncology pharma companies and you know I have a quote here from one of these companies saying you know they really said you know I can't understand why we haven't used your biomarker before. And the thing about tier one pharma companies is that these are the companies that will really pursue the companion assay development and therefore it's super important for BioVica to have these interactions with tier one oncology pharma companies. Another trend we saw was that for many of these projects we have they're now we now have activities not only within the CDK46 inhibitors and also the second generation of those drugs. We actually also see activities within CIRMS, CIRTS and not the least immune checkpoint inhibitors the ISIS. And if you can if you take a look at you know the slide here you can see that this is really broadening our total addressable market because we're moving outside risk cancer into two other indications as well. So also super positive. And then you know the final point I bring up here is the fact that we had one company actually reactivating their project. This company is about to enter into phase two and this is again you know super positive to BioVica because phase two is exactly where we want to be. This is going to again you know increase the likelihood of us being part of a CDX development activity. So overall very very positive to you too on the pharma services business. So by that I'll hand over

to our finance. Thank you Henrik. So a

few slides on the financials. If I can get this to move. Yes so net sales for the second quarter was 2.6 million. Previous same time the second quarter last year was 1 million so we had a significant growth year over the second quarter. Also net sales here to date for Q2 or for the first six months of our fiscal year 4.3 million in sales. You can see here the dark blue bars are current fiscal year and the light blue bars are previous fiscal year. So we sold 4.3 million this year and accumulated 1.5 million. You can see also graphically that we sold more this first six months than the full year for last fiscal year and sales is mainly coming from the pharma services business. That's the pharma service in terms of test services to pharma companies but also kit sales to pharma companies. A little bit on the cash flow. Cash is extremely expensive so we are watching our cash very very diligently. Operating cash flow before changing working capital was minus 24.5 million. Previous quarter it was 30 million so we have a significant improvement there. Changing working capital this quarter was minus 3.9 million so all in all it was 28.3 million. Q1 this fiscal year was minus 38.5 so it's quite a positive trend there. Cash balance for second quarter 46.9 million. That's basically in line with what we had last year. Last year we had a rights issue of 150 million I think and this year we have projected 120 million. Total headcount for the end of October was 37. Last year it was 27. You can see here that we have 24 out of these 37 in Sweden and 13 in the US. Last year same time in Q2 we had five in the US so the main increase is coming from the US and that's the sales team that was employed first of December last year. So with that I'll hand it back over to Anders for summary and Q&A. Thank

you very much. Let me sum it up. So we have Davidton,

a very important product that meets an important currently unmet clinical need which is the ability to improve monitoring of cancer treatments. And we have together with the key opinion leaders and from some of the leading institutions made scientific collaboration and clinical trials that has laid a foundation for our commercial journey which we are taking now the first steps now a few quarters in and still relatively low volume but we see a very positive trend and progress both yeah in all three areas US, Europe and pharma services. And if you look forward our targets for the fiscal year that we currently in 23-24 that ends in by end of April we have the ambition to sign an additional seven of those agreements in total 10 and another agreement in Europe and in total sales more than double digits in Swedish crowns so more than 10 million. And our long-term goal is to break even mid 2025 to become cash flow positive and in order to do that our sales projection is to have revenues of 50 million Swedish per quarter. And I think we're taking some important steps into that direction it feels really positive. In order to take us to cash flow positive we're now doing a capital injection a rights issue where the subscription period starts tomorrow so later today the prospectus will be published or on our website. The purpose is yes I said to take us to become cash flow positive it is 120 millions which is partially guaranteed in the rights issue and then an additional 54 million in warrants that is effective in during September next year. The subscription price is 261 and I am myself looking very positive on on our future so I'll be participating with 10 million Swedish kronor in this rights issue so very very good quarter for us and and we look positive for the future so with that I'd like to open up for the Q&A session see if we can get our some of the equity researchers in. I can see that we had at least for a while Chen Sun Li from Paretoin I don't know if we can yes I can see that he's now on YouTube. Hey perfect.

Hey can you hear me?

Yes I hear you

well. Perfect yeah good afternoon and yeah congrats with the process so yeah my first question will be what would you think about the process or timeline so when the hospital contract is signed until you start receiving orders do you need to clear anything? Yeah yes

all right so the question I guess is related to the US market where we sign contracts with hospital or hospital networks and we have a process in order to get those going so maybe Warren if we move focus to Warren Warren could elaborate a little bit on on those steps and also timing.

Yeah absolutely and thank you so much for the question I think with regards to getting a contract signed and then getting samples coming in it is there's a process that takes place you know initially when we engage a hospital we talk to kind of a champion a person that's very very interested in in using the product we go from there to really meeting with the formulary committee with the formulary committee they really make the decision whether or individuals of the hospital can order the test if there's clinical utility from that point we go through a contracting phase where we contract with the institution negotiate pricing terms of service things of that nature the fourth step is really the logistic side of things because internally when an oncologist wants to order a product they need to know how is it built into their EMR system is it a paper order or what that may be and then finally would be receiving the from the institution so in some cases you know this process can take can happen incredibly quick and in some cases it can take a bit of time our commitment is always to be able to move as fast as we can so we're really reliant upon our partner to move quickly so in some cases we can contract and see orders in a couple months and sometimes it can take us you know six months to get a contract signed and get orders coming in but there's there's no real standard I think each institution is a bit different we do see the contract that we signed in Florida they are very active in sending samples in every week whereas the contract that we signed in Missouri it's taking them a little bit of time to get systems in place I hope that answered your question

okay perfect thanks and for those 10 hospital contracts that you aim for for the fiscal year to which extent do you think they will be able to cover the the US hospital chain would they be able to cover the majority or yeah what kind of portion that you are thinking about

yeah so the hospitals those particular 10 hospital contracts will will cover will not cover the entire the US the US is enormous obviously but it will certainly align with the revenue forecasts and the you know the financial commitments Anders has made so in regards to that I think that's how we we tend to look at it you know at some point in time I think when we as we progress the business then we reassessed and we take a look at you know other institutions we do have a deep pipeline of institutions that we want to sign contracts with there's also a balance kind of from a resourcing perspective as well but I think those 10 contracts and the the goals that we've put in place align with the revenue projections that Anders has shared with the market

okay thank you and maybe just a last question so how do you expect the the sales development or the the distribution between a direct bill hospital hospital contract and the medicare related sales over the coming years so I guess the hospital contract will start first and the medicare sales will will come in later maybe in a couple years is that correct

the there's three channels that we will get paid from one will be the hospital contracts one will be directly through medicare and one will be through private insurance

and

all three of those avenues or those payment channels are open today so we've submitted claims to private insurance and we've been paid we're submitting claims through medicare and we anticipate being paid by them and through the through the contracts themselves our core focus is really working with hospitals to to contract with them directly so I would foresee there being greater revenue most likely through hospital contracts but it'll really depend on the mix and how it moves forward but certainly as well one point I want to I want to make is that the medicare patients those patients you know certainly as we contract with these institutions those institutions will be responsible for the billing of those particular patients when we receive a sample oftentimes that information is blinded from us so we we run the sample we report the sample results back it could be a medicare patient it might not be a medicare patient but we'll get paid the contract at price so most likely the revenue stream will be the greatest through through the through the individual contracts okay

perfect thanks for taking my questions

great thank you very much John I'm asking

Hala here who's helping us with the production see if we have if we can get the one who nears also into the call see that you're working on that

yes I have him here on the phone and I'll just put the loudspeaker on so let's see yes

okay

let's

have a go

yeah no you want

excellent okay excellent yeah issue or question regarding the u.s sales and also that's regarding the cost initially uh some of the opex cost came in slightly lower in this uh quarter is that a level that is representative going and moving ahead or is this sort of a lower quarter for some reason

well I don't know if if it's um should do cost andres opex

hi uh you on uh the we since we have agreed now with the u.s team and and the rest of the team regarding our cash out bonus to have that on on rather equity based bonus we released that uh accrual that we had which was about 3.8 million swedish kronor that we had accrued in q1 we have released now in q2 so you have that uh variance between the quarters uh and we haven't initiated and we hadn't the time to initiate the long the new equity bonus program yet so we haven't started to accrue any i offer i rfs to cost associated to that equity program yet so there is a but from a cash flow perspective i think we are definitely on a better trajectory than we were before we had this agreement with changing cash out bonus to to equity bonus but there will be coming in an equity bonus accounting cost if that makes sense going forward when we have this program in place and that will be probably somewhere in january if that makes sense was that answer yeah

yeah thank you yes that's useful so cash wise you're on a sort of more modest level and we also noticed that anders intended to defend a reasonable stake interest in in in the ongoing right issues

yes absolutely

yeah and also to warn and it's clear that the direct bill will be very important especially initially presumably that we should expect a higher average price and also what sort of issues sorry what sort of support will be necessary to drive the sales channels presumably you need to encourage failed direct bill

all right so direct bill questions see if i can repeat it see if i understood

it correctly and i see the focus is on warn so that's good because it's a us question so you can keep it on warn so the question was direct bill what kind of support do you need in order to execute and if you can elaborate a little bit on price levels on direct bill versus medicare i guess then warn yeah absolutely so

with to execute these contracts you know there there's different pieces of this as i just described where we go through and we find the champion and work with formulary contract work with internal logistics so where we're at now is where we we spend a lot of time in the institutions talking to oncologists and driving interest and utilization of the product in these particular institutions so that's real our real focus with these hospitals that have been contracted once you know as these contracts get signed and the logistics are in place it's actually much much easier for us to do business with contracted entities than it is for us to bill on our own actually the cost is much less to do business with hospitals that are contracted versus us having to to bill private insurance and medicare and things of that nature so it's actually a bit easier for us once we get those contracts in place but still you still have to spend a significant amount of time in those institutions driving demand these hospitals you know they don't require oncologists to use the product but what it does it us the opportunity to to build interest in the product and and it really smooths the way for oncologists to order the products then so that's really where we're spending the core of our time in regards to pricing you know all the contracts that we sign are highly confidential i can't share those with you but but certainly the price point is greater than the medicare pricing i just shared so the net net again will be somewhere around when we add in private insurance reimbursement and medicare and the hospital contracts that will be at four hundred dollars or

more on average

Thank you and earlier you

alluded to that for the current calendar not calendar year but the year and April you expect higher ongoing folios towards the end of this period and presumably most of that will be related to direct bill is that how we should understand it

I'm not sure I

think I understood your question about where our efforts are going to be placed if that was essentially the question our efforts are are certainly around driving you know interest and adoption of the products our team is very focused on working with hospitals to to not only drive utilization within those institutions that are contracted but also we have quite a pipeline of institutions that we are working with to contract so that will be focus you know not only throughout this into this fiscal year but also moving forward for quite some time did i did i answer your question correctly

yeah i think you did thank you and yeah i think that's all for me perhaps a bit more color to your pharma projects and the prospects of promoting a project to the gdx state what about the outlook for the rest of the this period or is that

something we should expect later in 24

yeah excuse me yeah i mean what i can say is that i mean we're doing all we can you know to really progress on that front you know we're having these discussions as i described you know kind of the third step there it is only natural for some of these pharma partners you know that they really want to try you know customize our assay to make an even better fit to their drug so we have the discussions that being said i mean it is of course in control of the pharma partner so i i can't say you know more than that it's but it is certainly our goal you know to to have a couple of these agreements signed as soon as possible as we can

okay thank you all right okay and thank you

we have louisa or or do you have any additional questions uh one no yeah we

have louisa from from fan campin on the chat

on the chat okay

uh all right so let's see i have to put my glasses on to be able to read these all right so um the first one i think is is uh i'll publish it also you all can read uh i think the first one is really interesting um that is project optimus i think warren mentioned that briefly and uh maybe you can elaborate a little bit uh the project optimus is is what the fda has launched i think it was during 23 this year and you can see on the conferences there's a lot of focus and as the the objective is to go from maximum tolerated dosing to minimal effective and then of course you need of an effectiveness biomarker assay like ours and maybe you you if you can give some more background of flavor how that has been met from the oncologists you're talking with

warren yeah absolutely and i think how you describe it is is absolutely perfect anders is that this is something that the fda wants to look at is how do they essentially go to this minimal effective dose and they're doing it obviously for a couple of reasons one of which is has to do with tolerability of the drug and managing side effects so as we've talked to physicians you know that have patients on these you know whether it's cdk46 inhibitors or chemotherapy drugs or or you know io therapies or things of that nature um you know with all of them they do have their own unique set of side effects and tolerability issues and physicians really believe that that if they can keep patients on a drug for a longer duration of time with it being effective then then the patient will have a better outcome and you know certainly with with some of these drugs there's a kind of a litany of different side effects and oftentimes patients will there'll be compliance issues where patients are not taking the drug because of some of these side effects so i think it's a really good a really good thing that the fda is doing here is is taking a look at how can we do how can patients be dose this minimal effective dose because most likely tolerability will be better managed and there should be better outcomes and in the physicians that we've talked to the medical oncologists we've talked to have been very aligned with this and there's really been a lack of markers that could help them out and when we've talked to them about divotum this is something where most automatically refer to project optimists and and are excited that this is a this is a great opportunity for them to manage the tka value to determine whether or not a patient's responding to a therapy so i think this is a great opportunity for us where we really feel like we're at the right place at the right time with this particular

product all right

thank

you warren i continue

with louisa's questions will you provide any guidance what we can expect for 23 24 sales we just did that more than 10 million we said could you provide more details on the progress uh giving applying divotum in other indications our focus right now where we put the resources is primarily within breast cancer so uh we that's where we're driving demand and and are are focusing our efforts the three clinical trials that we talked about how many patients and the timelines about around these studies so um it was impact it was a yale trial and it was the better trial that we talked about here which we also have been pr in previously and in various trial by trial but the impact trial was started i think it was announced is it one half two years ago uh and uh it's um as warren said in the presentation we'll be able to uh we at least have submitted uh the or we the wash wash you that washington uristad that performs the trial has submitted the interim results to san antonio so that's what you can expect around two years from start to interim results uh so hopefully they will be presented at the san antonio breast cancer conference and in that case we'll pr that as well and uh the number of patients uh in that trial i think it's said uh between 50 and and 100 it's uh we have an option it's not fixed number but it is in that range and the others are pretty similar in terms of size and timeline although as jay started this year and we pr that and patients are are being enrolled and the better will start early next year so give you uh some feeling for how we're progressing yeah um and then there's a a question follow-on question how much uh does the cdx collaboration negation negotiations depend on these trials uh does it depend highly if it's okay hand it just answer and say no it will not i think the data that we've generated so far is what has been driving the uh demand and the project portfolio that we have now with the 21 projects ongoing on the pharma area so this is more targeted towards the u.s market getting into the reimbursement and guidelines proving clinical utility or strengthen our already proven clinical utility so uh different purpose there and yeah uh in regards to those trials and project openness i guess you can spin a bit that's also a way that you can tell uh the interest from project optimist that the dose uh dosing question comes up uh in these discussions so as warren said both the yale and the better trial has a dosing component and as you know we had the palma dosing in washington university that was published or presented at least at the conference like a year ago or so so we are already into this area in terms of clinical trials um yeah see if i can continue reading yeah europe are you you mentioned that you're in a negotiations that in case that you'll be having agree another agreement signed this is a european question and yeah it's difficult of course to disclose uh when you're negotiating but yes we're working the same way in europe as we're doing with within u.s when we say that we are goal is in u.s to have 10 hospital agreements closed we of course already have a sales pipeline where we have progressed pretty far with enough of them so that we believe there's a great likelihood to meet that target and it's the same thing with europe we have several ongoing discussions and negotiations which make us pretty confident that we'll meet that target as well and it will be also on those markets that you are mentioning here the bigger ones like spain germany uk or france uk or france are a little bit more difficult markets when it comes to pricing and biomarkers so yes we have looked at those as well but we are prioritizing markets where we can get well paid reflecting the value of the product and there's where the strongest demand and support is so yeah so how will we continue doing that as well so thank you for all those questions and there's actually additional there's a lot of questions appreciate that someone regarding the capital injection can you give us a timetable yes we can we will publish the prospectus later today the subscription period will start tomorrow it will run until the 13th of december and then for the warrants they will be opened to be able to convert uh during september i don't know the dates but september 24 and in the meantime i understand they will also be tradable on the stock exchange until then until they are effective um yes uh see if you have more here the management is the management team uh uh participating in the clinical trial yes most of of the management team members and also the board of directors members are participating i think the details will be in the prospectus i'm participating with 10 million i know larc is participating with a million and uh yeah um several other ones as well so i'm very happy to see that and you could say also that the biggest investment of all is done collectively by management in in sweden and the us team because they are indirectly participating by giving up some of their or all of their uh cash out bonus for this fiscal year in order to uh to get a bigger stake in equity and so that's that's a huge commitment which i'm very grateful for and was very important for my decision um i think yeah how we will implement the hospitals we have answered can you expect similar revenue growth in next quarter yes we expect this trend to continue we see we expect to see effect of all those projects that we have agreed within a pharma services area and also the client bill contract that have we have received some few samples but we expect to to receive a lot more now that we have that contract in place so yes um all right here we have marcus who is not happy with the share performance that has lost a lot of value over the last 10 years well um he's partly correct i'm also not happy with i'm very happy with the development of our company and i think the way we progress we've met the milestones from 510k clearance and onwards i think it's a huge achievement both yeah on all three markets really the us milestones we talked about the portfolio of pharma companies the contracts we are making agreeing on on the european market all those i think is is huge achievements by the team i think we have not been rewarded as well marcus says that we have not have a share price development positive during the latest 10 years that's not 100 correct we had a great share price development until starting of 2022 when the financial climate changed quite significantly and despite our progress with 510k clearance we were more affected i think with those external factors and the question i guess is what are we to do about it yes we are going to make sure that we become less dependent on the financial market and generate revenue enough to be cash flow positive and this that's why we laid out this this plan which includes cost savings in order to get to that milestone with as little capital as possible as the price for capital is very expensive right now so that's a short answer to that one all right i think we need to be a little bit selective here because we're running out of time

and

two identical yeah

there's a lot of identical the scandinavian market can talk about the opportunity yes i don't want would you want to elaborate heli it's it's it's a market which has no reimbursement system really for diagnostics so but it's important to get into the guideline we have strong support from key peony leaders that we would like to benefit on and the price levels are are compared to european levels on the higher side isn't that a good summary

yes and i think you know the commercial partnership that we're entering we we are very strong in sweden with key opinion leader network and this will broaden it to denmark norway and and eventually also finland and iceland so it is a very strong agreement with a company rooted in scandinavia

all right i think you that has to be the last one we're two minutes over time i think appreciate it was a lot of questions appreciated a lot thank you for all the interest and we have just closed a quarter which we believe has been great progress for us and we're looking forward to continue on that journey thank you very much for all the interest in our company thank you bye