Welcome to the BioVica International Audiocast with Teleconference Q1 2021 to 2022. For the first part of this call, all participants will be in listen only mode and afterwards there will be a question and answer session. Today, I am pleased to present CEO, Anders Rylander and CFO, Cecilia Dreving. Please begin your meeting.
Thank you very much, and hello, everyone. If you move directly to Slide 2, my name is Anders Lilander. And together with me, I have Sreedhar Boring. And we are going to present our interim report for the Q1 As our fiscal year starts, 1st May. And if we move to the next slide, we have the agenda.
I will first go through just a short introduction to Baileyska as a company and Our business plan. Then I'll talk through the highlights for the Q1. And then Cecilia will talk about the financial status before I make a summary and then we open up for questions. So let's move to the next slide. And just A short background about the company, BioVica.
It's an OXXOLLA based company that spans from the academic research That's been going on for many years within this field. And the focus for the company is to develop blood based biomarker assays in the field of cell proliferation. And the purpose for doing so is to improve monitoring of cancer treatments In order for improved patient outcome and also health economics for payers. We're based in Uppsala and have a subsidiary in U. S.
In Boston. The product is currently Sea Mark, and we are working towards developing an FDA approved version of the product for the launch So if we move to the next one, We have an audio of how it works. And as you know, cancer is defined Uncontrolled cell proliferation. And that is also what we are able with our product, Dividend, which stands for dividing tumor, Are able to measure from a blood sample. So we're measuring how the tumor proliferates, How the cancer is growing.
And this is essential and important information for the treatment physician, Both as prognostic before treatment to assess the aggressiveness of the disease, But also during treatment to be able to monitor efficiently get feedback if the treatment is effective or not. The standard method being used today are image diagnostics, where a snapshot of an image of The tumor or tumors in the metastatic setting are taken. And from that, the size of the tumor is measured. And during treatment, additional images are taken and size measured again and Assessment is made if the tumor is growing or not. That requires a couple of months to be able Follow-up and then also Patient Logistics and its innovation.
So we're confident that we have The complementary method that offers advantages, both for patients and for health care providers. That has also been proven in quite significant amount of clinical trials. We have now 24 published clinical trials from collaborating partners, the big academic centers around the world, especially within breast cancer where the majority of the data exists. And that is also Our initial application that we are working to launch in the U. S.
After a regulatory approval. Moving on to the next one. We have a summary of the highlights of this Q1. And one highlight is the budget impact model that was presented in a conference In May, called ISFOR. That conference is targeted against health economics.
And that is, of course, also an important area for us. And it's closely related to getting reimbursement for the product getting paid for the product, which is, of course, essential. And the way we have done this is that We have worked with academic researchers that has taken the Clinical results for the product within the breast cancer area and model, which have economic impact The product dividend can have based on how it will affect Diagnostics and treatment costs within breast cancer. And both diagnostics and treatment costs Our expenses were high in this area, so improvements makes up for a very strong health economic business case as treatments are priced at over $10,000 per month and patient. The result and conclusion On this that was presented was that for every dollar invested in dividend, the payers $3 in return in savings in diagnostics and futile treatment cost.
So that was a very positive start for the next step, which was and is still Payer discussions, which was kicked off with the Payer Advisory Board, where we had a very positive discussion and presented these And that will continue going forward. So that was important highlight. Another highlight is that we presented our plan how to expand outside of the breast Cancer area. And one of the areas that we defined as interesting to expand into based on the analysis that we have done for unmet need And the market potential was the metastatic malignant melanoma area. And at the ASCO meeting in June, we presented our first results from a collaboration with Karolinska within this area, where patients with metastatic malignant melanoma were treated With immunotherapies and were followed monitored with Divitum.
And it was a positive outcome of that trial, and that was also a starting point for expanding into that area as well as lung cancer And metastatic prostate cancer, which are additional areas that we have defined as areas we would like to expand into. After the end of the period, we have continued in strengthening our management team, Within the commercial era. And if you move to the next slide, I have a picture of the Two most recent recruitments, both within the commercial area and the most recent one was Warren Creswell In the U. S, Amor will be present be responsible for the commercialization activities In U. S.
And Americas in general. And he's part of the management team, of course. And he has a really Attractive background with a lot of experience of building successful commercial organization, Organizations within this field of diagnostics and oncology and also in U. S, which means that it's both have a network within the business and an understanding of the somewhat complex reimbursement system. So that's a great addition to the team.
And I also freeze up time for Robert Dan, who now will focus on his core skill, which is marketing on the product. So Very glad for that. And also Helle Fisker, who has the commercial responsibility for Europe, Who also have a similar background with a lot of leadership roles, both within sales and marketing, within diagnostics and within oncology. So also a very important addition to the team and also part of the management team. Very happy with that.
Okay. Moving on to the next one. It's an update of the FDA process. We are looking To get a so called 510 regulatory approval, which will enable us to market and sell the product For clinical use on the important U. S.
Market, this is a product a process that we have been working with for years. We started actually in 2017 when we had our first meeting with the FDA, where we presented our intended use And received feedback both on what type of predicate device the FDA Recommended and also how we should validate the assay, both from an analytical, which is Performance wise and a clinical standpoint. Since then, we have worked hard in order to generate The data according to what we agreed initially with the FDA, we'll have additional meetings as well to drill down To even more into detail within these areas. And in September last year 2020, we Finally, submitted our application with all the data from all the experiments we've done, including a clinical trial also Together with the U. S.
Swab group with almost 400 patients, so Significant data were submitted. And we quickly passed the 2 first milestone in the FDA process and went into the sub However, at that point, the FCA announced that all non COVID applications was put on hold, including ours since the FDA prioritized COVID tests. However, we were lucky that in January this year, our submission was one of the first to be restarted, And the review of it started early February. We came back with Some initial responses to some initial questions and then nothing really happened until end of May. Since the end of May, we've been working intensively with the FDA.
We've seen a lot of feedback, which we methodically have worked through Together with the FDA and the so called SIR process, where the FDA gathers all their different experts and we got Some excellent feedback that we can work with during the summer and now during August. So we have been able to complete all the experiments That we were required to do to generate some additional complementary data. And we're putting this together In an updated response, which we will submit during the beginning here of September, the first half of September, And we expect to see feedback from the FDA a couple of weeks after that submission, which Yes, granted that they are able to follow their normal process, which we hope they will. And the expected outcome from that submission, we can see 2 possible outcomes. One is, of course, which we hope, it's clearance, 510 clearance.
And the other one is that we are required to answer more questions or provide more data. And hopefully, we'll do that, like we've been doing now, in interactive mode. And we'll keep you updated about that. So very happy with how this has progressed over the summer. With that, I was that was my last update slide.
And so I hand it over to Silje, on the next one, the financials.
Thank you, Anders. And now we should focus to the financials on how this is reflected in the financials. And we start with the sales numbers on the left side. And as Anders told you, we are preparing for our commercial launch. The only things we have nowadays is research use only.
And it's actually slightly more For the Q1 this year than last year. And all the efforts are on taking dividends to the clinical market in U. S. And also in And we will see more continuous sales after launch. And then now we'll leave the same chart and look at the cash balance.
And at the end of the Here, the 31st July, we had SEK 131,000,000 in cash, and We are well capitalized ahead of our commercialization in U. S. And Europe. Our run rate is increasing and about EUR 4,000,000 During the Q1, and going forward, this will, of course, increase because we invest in the larger projects. And the Catra Flat assets are sufficient for 2 years of operation at least without factoring in the expected increase in the sales.
And that's about that. Thank you, Mr. Hannan.
And then to the last summary slide. So we have a Product which has a great potential in meeting a very important unmet need, And that's to be able to personalize treatment and monitoring through monitoring of treatments within metastatic breast cancer To the benefit of both payers, healthcare providers and of course, patients. And the foundation for our commercialization activities is the collaborations we have With the leading academic and chief community leaders within this space, breast metastatic breast cancer, Together with them, we have performed several clinical trials with positive outcome. And that clinical data, the documentation It's fully based our commercialization activities. But at this point, one example is the regulatory process, But also the reimbursement and in the end to generate Demand and Clinical Outreach.
So we have a really interesting half 2nd half of twenty twenty one in front of us. As I told you, we're in the late phase of our 510 process, which will be also the starting point for commercial launch on the used market. And Before end of the year, we expect also to have our first reimbursement on the U. S. Market and also to launch the product On the first European country.
And I'm confident that the if we can add value for patients and health care providers, That will also translate the value for our shareholders. Thank you very much. And we are now open for questions. Next slide. Thank you.
Thank The
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The first question comes from Ioann Unidos from Redeye. Please go ahead. Your line is open. No problem. The next question comes from the line of Jakob Lemkin from ABG Sundal Collier.
Please go ahead. Your line is open.
Hi, and good morning, guys. So maybe first, Could you update us or give a bit more flavor on the 5th 10 process and perhaps what was included in the
Yes, sure. Hello, Jacob. Well, I don't know what really what I can say to start with the Impana Juice, What we have communicated is that we have focused in this 510 It's the monitoring of metastatic breast cancer. So the intended use is based on that. And that's also because the clinical validation trial that we're using are on patients Being treated for metastatic breast cancer.
So that's the starting point, and that also determines what type of devices That the FDA has recommended us to use. And so that's just to set The ground for the application as such. And when we received feedback In May, it was very detailed. So it was way past the questions of pedicle device and that it was very A tale on exactly how the performance studies were done, how you should interpret the data And small, small wordsmithing in the intended use and so on. But those small details have a lot of impact When it comes to the entire application, so yes, that's what we've been working with and Updating during summer.
And the risk here in the beginning of the summer, of course, we were a bit nervous Because we needed to, during the summer, do some complementary experiments and trials. And if we wouldn't have received Positive results from those that would have delayed the process. So that's why I'm very happy now that we can look back I see that the experiments we've done have resulted well. And so we're able to keep up with the schedule that we have set out. I hope that gives you a little bit more of a background.
You understand a little bit more of what you we've been up to.
Yes. Thank you. That's great. And then another question. Could you maybe give an update on the partnership discussions and if you have sort of continued since the What you communicated at the CMD?
Yes. So we have Taking one step further in the sense that we are have advanced the discussions into Validation, so with currently one U. S. Lab now we are in validation. So hopefully, we can, after completion of that, communicate What lab and so on?
So we're taking a step further, but we don't have an agreement in place That we can communicate at this point, but we think we're progressing. And also with the addition Warren, with his background and his network and his history as CEO of Lab, we Increase our own capabilities within this space. So that is also progress, I would say.
Okay. And then my final question is a bit on Warr and the commercial organization you're building. I mean, you have expanded a bit already, but do you continue to add More staff, particularly in
the U. S. Now going forward? Yes, we are. We are.
And so now currently, we have 3 key people over there. Warren, responsible for the commercial activities. We have Amy Williams Supporting him as the Scientific Director, which is a bridge to The Uppsala team where we have the scientific competence, Aimia has a very, very solid scientific background. So but he's also contributing in the commercial work and he's an excellent Person in meetings with oncologists and patients and payers and so on can Line the scientific rationale behind things. And then we have Robert as a marketing person.
And we will Add people competence regarding reimbursement and commercial competence as well. So we are looking to build a small but efficient U. S. Organization that can complement our Partners.
Okay. Thank you very much. That was all for me.
Thank you.
Thank you. We have no further questions. So I will pass back for any closing comments.
Thank you very much for your interest and your questions. Much appreciated, and We'll keep you updated about our 5 10 ks processes and also we'll come back With a similar presentation for our next interim report in December. Thank you.
Thank you for attending. You may now disconnect your line.