Ladies and gentlemen, welcome to the Immunovia Q4 interim report 2022 conference call. I'm Sasha, the call's call operator. I would like to remind you that all participants will be listen-only mode and the conference is being recorded. The presentation will be followed by a Q&A session. You can register for question at any time by pressing star one on your telephone. For operator assistance, please press star zero. The conference must not be recorded for publication or broadcast. At this time, it is my pleasure to hand over to Karin Almqvist, CFO.
Morning all, most welcome to this conference call following our fourth quarter results. Present here is Philipp Mathieu, CEO, and myself, Karin Almqvist, and I'm the CFO of the company. Before we start, there are, as usual, some practical aspects. This presentation will be followed by a Q&A session, and our operator will guide us through on how to pose the questions. After we have closed today's call, you will find the presentation and recording on our website. With that, I would like to hand over to our CEO, Philipp, please.
Welcome everybody to today's Q4 conference call. I would like to thank you for your interest in Immunovia and in our mission. We are more committed than ever to establish ourselves as the leader in the early detection of pancreatic cancer. With our test, the world's first diagnostic test dedicated to the early detection of pancreatic cancer, we have set out to significantly increase patient survival rates and save lives. During 2022, the first full year that IMMray PanCan-d, our test, was commercially available in the U.S., we reached important milestones in this mission. I'm very proud of sharing with you today what the Immunovia team has achieved in 2022 in delivering on our previously communicated strategic priorities. As an agenda for today's Q4 call, I intend to cover the following topics.
I would like to recap where we are today and what we have achieved in 2022. Of particular focus for me here are what we delivered versus what we had communicated as strategic priorities one year ago. I would also like to provide some detail on the significant advances we've made in building our U.S. business in our U.S. core market and on the substantial progress we made in obtaining reimbursement for our test. I'm going to revisit the operational highlights during Q4, another quarter of tremendous progress. Karin will cover the Q4 financial highlights, as well as details on the rights issue we announced earlier this week. I would like to look ahead and outline the strategic priorities and focus areas for us as a company in 2023.
Today, we are the first company in the world to have launched a diagnostic test dedicated to the early detection of pancreatic cancer. This is a unique position we have. As a company, we want to leverage this position and establish ourselves as the undisputed leader in the early detection of pancreatic cancer. Today, more than ever, I feel that we have everything in place and are on the way to succeed in this. The unmet medical need for our test is significant. In the U.S. alone, 1.8 million individuals per year could benefit from our test across all risk groups. Today, we are just at the beginning of penetrating this huge market opportunity for Immunovia. Offering broad patient access to our test and reimbursement is a prerequisite for as many individuals as possible to benefit from it.
Consequently, the commercial build-out in the U.S. as our core market and the successful execution of our U.S. reimbursement plan are hugely important. I'm looking forward to detailing this presentation, the key milestones we as a new executive management team have realized in 2022. The key for increasing the chances of survival in pancreatic cancer is early diagnosis. Only if diagnosed early enough in stages I or II, patients with the devastating diagnosis of pancreatic cancer have surgery as a treatment option. Only then the five-year survival rates are as high as 42% on average. No other treatment option can deliver that today. Today, we are in the very unfortunate situation that more than 80% of our patients diagnosed with pancreatic cancer have only a 3% five-year survival rate because they're diagnosed too late. There are two main reasons for that.
First of all, traditional standard of care diagnostic methods like MRI or CT have significant challenges in diagnosing pancreatic cancer early enough. Most of the time, they fail. Secondly, overall, there has been limited innovation in both diagnostics and therapeutics, especially compared to other cancers. Now, this is the status quo visualized by the pie chart you see in the middle of this slide, and this is what we wanna change. Moving these less than 20% of individuals with stage I or II diagnosis to a significantly higher percentage is what we have as a mission. This is what keeps us awake at night, and this is what really improves over survival rates.
We have developed our IMMray PanCan-d test to deliver exactly that. At Immunovia, we have taken the strategic decision to focus all our commercial efforts on the U.S. market, the largest and most lucrative diagnostic market in the world. What is the total addressable market for a test like ours for the early detection of pancreatic cancer? Our test is a surveillance test. The key differentiator for a surveillance test is that you're testing a clearly defined group of individuals, as opposed to the general population. Surveillance is done on individuals who have proven increased risk of developing pancreatic cancer. For these individuals, the risk of developing pancreatic cancer is substantially higher than for the general population.
Looking at the risk groups we are targeting, that can be up to 32 x higher, which is very significant and a source of tremendous anxiety if you fall in that risk group. Today, surveillance in these risk groups is largely done via imaging. As mentioned earlier, the total addressable market for our test is 1.8 million patients per year who could benefit from it. Today, we are only at commercial in the risk group of those individuals who have a family or genetic risk factor. With an estimated around 600,000 patients or about 1/3 of the total addressable market, we are only scratching the surface today. New-onset diabetes remains the largest opportunity. In this risk group, we are conducting our PanDIA-1 trial, targeting around 1.8 million patients in the U.S. per year as total addressable market.
The other risk groups include pancreatitis and IPMNs, or cysts of the pancreas. For all those risk groups, we are either conducting or developing further clinical plans. Lastly, there is differential diagnosis, which is not included in the 1.8 million patients. This could provide additional upside. For us as a company, marketing a surveillance test into clearly identified risk groups allows for a very targeted commercialization approach, which is the key advantage. In summary, we see a vast unexplored market opportunity for Immunovia, which will more than triple our initial market. What exactly is our novel test with which we are targeting these risk groups and what is behind it? Our test is today the only blood-based test dedicated to the early detection of pancreatic cancer.
There are other multi-cancer tests, all of these are inferior in terms of performance. The test is based on a proteomics approach, which means we are looking at protein biomarkers. These biomarkers indicate either tumor formation, inflammation, or immune responses. The test looks at a proprietary combination of those biomarkers, and via an algorithm, generates a decision value, which tells the physician if pancreatic cancer is most likely present or not. In our case, we use a biomarker signature of nine biomarkers for which we hold extensive intellectual property and patents. Our test has a clear advantage, both of our standard of care and competing multi-cancer tests, both in terms of performance and convenience for the patient. For the test, we produce a test result within five to seven days, and the test can be taken either at the physician's office or even at home.
It is exclusively analyzed at our proprietary laboratory in Marlborough. Giving as many of those who could benefit from our test rapid access is how we wanna increase overall survival rates for pancreatic cancer. Where are we today on this journey? Especially where are we compared to what we set out to do at the beginning of last year. When I came on board in January last year, I put out five clear strategic priorities. These were priorities for which we as a company have been executing on and against which we wanted to be benchmarked against. I'm very proud to look back at the year 2022, during which the Immunovia team has delivered on all those priorities. I will go in more detail and provide more color on the main ones on the following slides.
In short, we strengthened our U.S. team through key hires in terms of commercial leadership and expertise, and we are now fully set with a full-scale commercial platform to deliver a successful continued launch. We made significant progress on the reimbursement side, having unique coding, CMS Medicare pricing, and state licenses in place. Strategically, we sharpened our focus on pancreatic cancer and commercializing the IMMray PanCan-d test in the U.S. market. Keeping a laser focus and making efficient use of resources is what is key to be successful. Consequently, we deprioritized development programs on all other non-pancreatic cancer indications, and we fully focused all our commercial efforts on the U.S. On the clinical side, PanDIA-1 for new-onset diabetes moved into the next phase to further develop and validate our tests in this large risk group. We announced PanFAM-1 results.
Naturally, additional clinical validation for our IMMray PanCan-d test across risk groups is an ongoing strategic priority for 2023 as well. In summary, 2022 has been a year of delivery on what we said we would do. I would like to spend a bit more time on detailing the progress we made in building our commercial presence in the U.S. Key for delivering a successful commercial launch is having the right commercial platform, the right expertise, and the right team in place. 2022 was the year during which we made sure that this is the case. We made a series of key recruitments over the past year, which brought on board additional expertise. Firstly, we recruited a highly experienced commercial leader as the CEO of our U.S. subsidiary.
Jeff added a wealth of expertise from growing diagnostic businesses in a broad range of commercial leadership roles in the U.S. market. We also added core expertise on the reimbursement side with a new head of market access who is the key point of contact for all our ongoing dialogues with insurances and is driving that reimbursement plan. We added a national sales director to realize the full potential of our sales team and drive our launch. Lastly, more recently in January, we announced the addition of a new head of clinical medical, which is a key hire with broad expertise in study design and execution, as well as in working with key opinion leader, all of which will help bolstering our clinical evidence package.
We have been consistently building out our U.S. presence since 2017. With these key additions, we have now a highly experienced U.S. commercial team in place. With our U.S. business today, I'm fully convinced that we will deliver the complete commercial potential of our test and generate rapid future growth. We have a detailed commercial plan, which we've previously talked about, in which we are executing as we speak. This plan is based on the market insights and experience of our U.S. team. This plan is pursued by us in phases to ensure that we are highly targeted and get the go-to-market approach 100% right before moving to the next phase. This also ensures that we are capital efficient and allocate resources who are best used to achieve the maximum impact.
Today, we are still in the launch phase of commercializing our tests. Only once we see that message, tactics, and results are the right ones are we going to move to the growth phase. The growth phase is characterized by moving from a geographic-focused approach, in our case, on regions or 18 states, to a national coverage approach. Timing-wise, we foresee that to be an event for the second half of this year. The move towards the expansion phase will happen only once we're moving into new-onset diabetes risk group. For all risk groups, but in particular for the new-onset diabetes risk groups, we are opportunistic when it comes to commercialization partnerships. For new-onset diabetes, which would be less targeted than the other more gastro-focused call points, we will likely pursue a partnership with somebody who has a presence in primary care.
All in all, we today are pursuing a highly targeted and highly capital efficient go-to-market approach. Positioning towards being an early commercial company not only changes the requirements for the commercial setup, but also the requirements for the R&D team. Bringing additional R&D expertise from other commercial diagnostics companies on board is needed to increase the R&D efficiency and productivity for that new phase. Our partnership with Proteomedix, another expert in proteomics-based oncology diagnostics, is aimed at delivering exactly that. With this partnership, we are leveraging complementary R&D capabilities of two companies to advance our R&D efforts. Both companies have a proven track record of successfully developing and launching novel tests in our space. With this alliance, we've increased the momentum of our R&D efforts, and we are further developing and validating our tests in the previously outlined risk groups.
Key benefits of this collaboration are increased R&D productivity and efficiency, creating a more flexible R&D organization as it is needed for a commercial company, and focus our internal resources on the commercial build-out and roll-out of our tests in the U.S. This more flexible R&D setup also enables the realignment of internal resources and our R&D organization in Lund, which we announced during January of this year. We are focused on ensuring as many patients as possible can benefit from our test. Securing reimbursement is key to make this happen and to make our test affordable on an at least annual basis for everybody who can benefit from it. We are actively pursuing reimbursement for our tests with both private commercial insurances, which is our initial focus, as well as public healthcare insurance schemes in the U.S.
The US reimbursement process is complex and requires regulatory steps, physician advocacy, price setting with insurances, as well as detailed ongoing discussions with individual payers to obtain coverage. We have made significant progress during 2022, for which I would like to highlight the following. We obtained a PLA code. A PLA code is a unique code which allows physicians and providers to report services such as the laboratory tests to insurances. We also launched a physician experience program to drive adoption and familiarity with IMMray PanCan-d among physicians. Ultimately, we want those physicians to be our advocates for our tests with insurances, and we are highly satisfied by the feedback they are giving our tests and how they adopt it.
Active since January 1st, 2023, we also obtained a CMS rate, which is the price Immunovia can expect once Medicare adopts coverage. At the received $897 price, the CMS payment demonstration, this not only appropriately values our test, it also serves as a price reference point in future pricing discussions with other commercial payers. This is very positive news for the commercial potential of our test. We saw significant progress in 2022 and are relentlessly executing on our refined reimbursement plan. We are aiming as next milestones in 2023 to sign the first payer demonstration project and recognizing initial commercial reimbursement. We are currently in advanced reimbursement discussions with various health assurances on this. Q4 as the most recent quarter was one full of delivery and progress.
I'm not going to touch again on all those operational highlights mentioned before in this presentation, but want to mention a couple of additional ones. During Q4, we also implemented a leaner executive management team to ensure that the team remains focused on executing our strategic plan and on delivering. At the beginning of 2023, after Q4, we announced the appointment of a new head of clinical and medical affairs, as well as in January, also announced the realignment of our Swedish operation, which saw a reduction of our staff in Sweden by about a third. This is a pro-process which we concluded during this month. With this, I would like to hand over to Karin for the financial highlights and details on the rights issue, which we announced earlier this week.
Thank you. As I said, being an early commercial company, revenues still have to pick up. That's why our focus from a financial perspective is on the cost side, and that we spend our money in a wise way. When comparing our cost side this year versus last year, we can see, or 2022, I should say, versus 2021, we can see that we are on a steady level. With our DA on a full year level, we are that also for the fourth quarter. Our cash burn continues to be around SEK 15 million-SEK 20 million per month, which is also what we have guided the market. We can see that we currently are trending towards the lower range of that.
Cash end 2022 amounted to SEK 106 million, and that in combination with the proceeds from the rights issue we announced earlier this week, we do have a solid foundation to execute on our strategy in 2023. The rights issue that was announced Monday this week is of approximately SEK 200 million and guaranteed at 75%. With the proceeds from the rights issue, we will see that we will use approximately 50% of that to continuously build out our commercial presence and the rollout of IMMray PanCan-d on the U.S. market. The remainder will be relatively evenly split between R&D efforts, which means clinical studies and validation of additional risk groups and general running costs of the company.
All in all, as said, the proceeds from this rights issue gives us a very good platform to enable us to execute on our strategy. On this slide, you can see some of the critical dates, but all details around the issue is available in the press release, which you can find on our webpage. By that, I hand over back to Philipp again.
Thank you, Karin. Earlier, I talked about the strategic priorities in our delivery on those during 2022. 2022 paved the way for a successful 2023. 2023, we are going to focus on the following strategic priorities. We are going to further increase adoption of our test through heightened awareness. We are going to see the results of repeat orders following our successful physician experience programs. We're also going to deliver initial successes in obtaining reimbursement for our tests. On the clinical side, we are focused on broadening the clinical validation of our test across all risk groups. In particular, we want to deliver on onset diabetes and unlock this vast market opportunity for Immunovia. As we go along in executing our previously outlined commercial plan, we will also further strengthen and expand our commercial team.
With that, we will make sure that we maximize patient access and maximize commercial opportunity for our test. In summary, after the achievements of the past year, today we are all set to capture the full potential of our novel test and save lives from one of the deadliest cancers. With that, I would like to remind you of the upcoming events of the financial calendar and open the floor for questions.
We now begin the question- and- answer session. Anyone who wishes to ask a question may press star and one on the touchtone telephone. You will hear a tone to confirm that you have entered the queue. If you wish to remove yourself from the question queue, you may press star and two. Participants are requested to use only handsets while asking questions. Anyone with a question may press star one at this time. So far, there are no questions. As a reminder, if you wish to register for a question, please press star and one on your telephone. There are no questions on the telephone at this time.
Unless there are any further questions, we are happy to conclude this call. As always, both on the Investor Relations side with Karin as well as myself, we are happy to take any questions on a bilateral basis. With that, thank you very much for your interest in Immunovia. Thank you very much for your interest in our journey, and we are looking forward to report on what we will achieve in 2023.
Ladies and gentlemen, the conference is now over. Thank you and for participating in the conference. You may now disconnect your line.