Ladies and gentlemen, welcome to the Immunovia Q4 Interim Report 2024 conference call. I am Yusuf, the Chorus call operator. I would like to remind you that all participants will be in listen-only mode and that the conference is being recorded. The presentation will be followed by a Q&A session. You can register for questions at any time by pressing star and one on your telephone. For operator assistance, please press star and zero. The conference must not be recorded for publication or for broadcast. At this time, it's my pleasure to hand over to Karin Almqvist-Liwendahl, CFO. Please go ahead.
Thank you so much. A good morning, and a good afternoon, and a warm welcome to all of you joining Immunovia's conference call following the fourth quarter results for 2024. Presenting in the call is our CEO, Jeff Borcherding, and myself, Karin Almqvist-Liwendahl, CFO of the company. As you already heard, this presentation will be followed by a Q&A session, which will be guided by our operator. After we have closed today's call, you will find the presentation and the recording on our website. With that, I'd like to hand over to Jeff. Please go ahead.
Thank you, Karin. I'm very excited to be with you today to share the progress that we've made as we close out 2024 and transition to 2025. We have excellent results that we have shown with our next-generation test. We completed the clinical validation of that test in the fourth quarter, and I'm very excited to share those results with you today and also talk about what will come next in 2025 as we move forward to commercializing the test in the back half of 2025. Our agenda will start with a review of that next-generation test and its performance in the clinical validation study. Karin will then review our financials from the fourth quarter and our cash position.
I'll cover our 2025 priorities before we open the call for questions, which we very much would like to have the opportunity to answer your questions as part of that session. It has been just over two years since we made the decision to remove our test from the market and focus our efforts on our next-generation test. During that time, we've made tremendous progress. We've moved very rapidly through the stages of research and development, and we've been able to, over that two-year period, develop a very high-performance test. It started with our discovery study, then it moved on to the model development efforts. We did the analytical validation, which we finished at the beginning of Q4 2024, and then we moved on to the clinical validation.
That analytical validation, we won't talk a lot about today, but it is important, and we did complete that in the fourth quarter of 2024. Excuse me. That analytical validation was a series of experiments that really showed that we have the ability to very precisely measure the five protein biomarkers that are part of our test and gave us confidence as we headed into the clinical validation. The purpose of that clinical validation was really to look at the performance and the accuracy of our test. Before we share those results, though, I thought it might be helpful to talk about what were our goals when we started development of the next-generation test and were we successful in achieving those goals.
I'm very excited to share with you that we've made significant improvements in our test when you compare our next-generation test to the earlier IMMray PanCan-d test. First, we were able to identify higher-performing biomarkers. By adding those new biomarkers to the test, we reduced the test's reliance on CA19-9, and we can now provide results for all patients. With IMMray, we were limited, and about 10% of the time, we could not provide results because the patient didn't produce enough CA19-9. That was such an important biomarker in the first-generation test that we knew we needed new, stronger biomarkers. In the IMMray test, we had nine biomarkers. In the new test, we have five biomarkers. The only one which is consistent is CA19-9, so we've really, really strengthened the other biomarkers that are part of the test.
This also allows us to be able to use the test effectively in patients of all races and ethnicities. One of the challenges with a test that was so reliant on CA19-9, like IMMray, was the fact that people who do not produce CA19-9 are more likely to be Black or Hispanic. As a result of that, about 20-25% of individuals in those populations could not use the IMMray test. The new next-generation test can be used across all races and across all ethnicities. One of the pieces of feedback that we heard about the original IMMray test was that people were confused by the borderline result. When we gave an IMMray test result, about 10% of the time, we returned a result of borderline, which essentially meant that that patient was kind of in the gray zone between a positive and a negative result.
That created confusion and anxiety for patients. It also left clinicians uncertain about what to do next. With our next-generation test, we have eliminated that borderline category by increasing the precision of our test. We are now able to either give a clear positive or negative result, and that really helps clinicians to know what to do next following the test result. When we made the transition to the next-generation test, one of the things that we did was to move away from the proprietary IMMray platform. By doing that and by adopting a widely used industry standard, ELISA platform, we were able to really reduce our costs. We reduced our costs in two ways. First, the cost per test when we launched the new next-generation test will be much lower than what our cost per test was with the IMMray test.
The second thing, and this is very important for a company like ours where we're at that stage where we're doing everything we can to preserve cash and not spend capital, is the fact that the new testing platform has very, very minimal fixed costs. With the IMMray platform, we had a large production facility in Sweden that required a decent amount of staffing and also quite a lot of space and equipment. With the new testing platform, our costs are almost all variable, which really allows us to match our expenses to testing when we're performing it. We are very excited about sort of the attributes of the next-generation test. Let's talk about really the most important attribute, which is accuracy. Just as a little bit of background, we'll be talking about two terms in this presentation: sensitivity and specificity.
Sensitivity is the percentage of cancer cases that are successfully detected. If you imagine a study to test the clinical validity of a product like ours, imagine that there are 100 cancer cases and 100 non-cancer controls in that study. If a test had 60% sensitivity, that means that the test would correctly identify 60 out of the 100 cancer cases, but the other 40 cancer cases would be missed. Sensitivity is really about defining cancer when it's present. Specificity is sort of the opposite of that. It's essentially the percentage of controls that are correctly categorized as not cancer. Imagine a test that had 80% specificity. If you gave that test to this clinical validity study, you'd see a negative result for 80 of the 100 controls, but 20 of those control cases would be incorrectly identified as cancer.
That would lead to unnecessary follow-up and imaging for that patient. Obviously, we want to have very high numbers for both sensitivity and specificity. Looking at what's the current standard of care in the market, this is results from a meta-analysis that looked at the three imaging approaches that are used today to identify pancreatic cancer in high-risk individuals. These are the results for sensitivity and specificity in detecting stage one and two pancreatic cancer. You can see that endoscopic ultrasound has excellent sensitivity and pretty good specificity at 82%. The challenge with endoscopic ultrasound is that it's quite invasive. Patients have to be fully sedated under anesthesia. Because of the risks of that procedure, it must be done in a hospital, and it must be done by a physician who is very skilled in that technique.
Because the challenges of endoscopic ultrasound, or EUS, MRI and CT are often used as a substitute to try to identify early-stage cancer. The challenge with MRI and CT, though, as you can see on this chart, is that about 50% of the time, it's unable to pick up that stage one and two cancer. That's because stage one and two cancer tumors tend to be small, and they tend to hide within the pancreas. We need a better option than these imaging approaches, not only from an accuracy standpoint, but also from a convenience standpoint as well. We undertook the CLARITY study to look at the sensitivity and the specificity of our next-generation test, both to see its performance alone as well as to compare its performance to CA19-9.
This was the largest clinical validation of a pancreatic cancer test ever completed in a high-risk population. That's really important. Sometimes you'll see cancer detection tests tested against normal people. Essentially, you're comparing people who have a specific type of cancer to healthy individuals. When you do that, you have the risk that you overestimate how accurate your test is. We wanted to make sure that we were using control cases that were essentially the same as what they would be in the real world when the test is used. To complete this study, we leveraged our existing relationships with key opinion leaders and experts in pancreatic cancer around the world. You can see here some of the sites where we collected blood samples from. We were able to obtain 1,066 rare blood samples. Of those, 202 of them were stage one and two pancreatic cancer cases.
These are really rare samples to find. Unfortunately, the vast majority of the time, over 80% of the time, pancreatic cancer is detected at stage three and four. It is hard to get these stage one and two pancreatic cancer samples, but we were able to do so because of the strength of our relationships with these pancreatic cancer center experts. We also leveraged our relationship with the PRECEDE Consortium, which is a group of institutions that is focusing on early detection in pancreatic cancer to help us get that really high number of high-risk controls at 864. Here are the results. We were very excited to show sensitivity of 78% and specificity of 94% in the CLARITY study. What that means is that for every five patients with stage one and two PDAC, we would detect cancer in four of those patients.
With a specificity of 94%, if you imagine looking at 20 individuals who would be tested, if none of them had pancreatic cancer, we would only return a false positive result one out of those 20 times. We also performed very well against CA19-9. The Immunovia test was 14 percentage points more sensitive than CA19-9, so 78% sensitive compared to 64%. To put that into context, what that means is that in this study, with our next-generation test, we were able to identify 28 cancer cases that were missed by CA19-9, which is often used as a way to conduct surveillance in these high-risk individuals. This chart really brings the data together. On the right hand, you see that sensitivity and specificity data for the imaging approaches that we talked about earlier.
On the left side of the slide, you see the accuracy for the next-generation test that we saw in the CLARITY study. We were very, very pleased by the sensitivity. You can see here that that sensitivity significantly exceeds the sensitivity that you see with MRI and with CT. In addition, the specificity of our test was better than the specificity of all of those imaging approaches. This is not a head-to-head comparison, but it is a very good indication about the superior accuracy of our test. Remember, this is a simple blood test. Not only is it showing excellent accuracy, but it's much more convenient than doing imaging, and it's less costly to the patient and to the healthcare system.
One of the things that we looked at was the performance of our test as a function of the age of the samples that were in the study. I mentioned that these pancreatic cancer samples are very hard to get your hands on. Some of the samples that we had in the study were quite old. Some of them were 7, 8, 10 years old. What we did was an analysis to look at what happens when you separate the samples into four groups based on how old the samples are, meaning how long ago was that blood sample collected. What you can see in this chart is that the performance of the test is much, much higher in those samples that are newer, those samples that were collected within the last two and a half years.
As you get further and further out and as the samples get older, the sensitivity and the specificity drop significantly. We think this is critically important, and we're very excited about these results because what we know is that when we test blood samples clinically, when we launch the test, we're going to be testing those samples within a day or two days of when that blood sample was collected. You are not going to see any degradation in the proteins that are part of our test. As a result, if you look at the sensitivity and the specificity that we saw in this study within those newer blood samples, you can see 83% sensitivity and 96% specificity. Even better results than what we saw overall. Just in conclusion, we were very, very pleased with the performance and the accuracy of our next-generation test.
We showed high sensitivity and specificity. The test was significantly more sensitive than CA19-9. When we looked at those samples that were more recently collected, the ones that are much more like what we'll see when we launch the test commercially, we saw even better performance: 83% sensitivity and 96% specificity. Our two-year journey to develop the next-generation test is now complete. We will continue to do additional clinical studies, but we have transitioned from that R&D phase. We'll talk about what's coming next in just a moment. Before we do that, let's continue the review of the fourth quarter by looking at our financial results. For that, I'll turn it over to Karin.
Thank you. Looking at the financials, one can conclude that the company continues to deliver on the financial plan, bringing down OpEx, bringing down cash burn, and maintaining it at a low level. OpEx for the fourth quarter amounted to SEK 30 million, which is relatively flat compared to last quarter, but an increase with SEK 7 million compared to the fourth quarter 2023. Here one can note two trends when it comes to OpEx for the quarter. One is that headcount costs are declining while costs for clinical studies are increasing. Cash burn for the quarter averaged just over SEK 9 million per month, and total for the quarter was SEK 28 million, which is in line with what we have given to the market.
Looking ahead into 2025, the expectation is that we should see a monthly cash burn of around SEK 8-10 million, and we should continue to see OpEx shifting from R&D more over to clinical studies leading the way to commercialization. Moving to the next slide. A few words on the rights issue and the warrants that were exercised now in January. As we reported in the Q3 report, the company executed a rights issue during the autumn that truly exceeded our expectations. The issue was subscribed to 91%, and the company was able to raise a net of SEK 53 million. With that issue followed two series of warrants. In January 2025, the first series, the TO2 warrants, were exercised with the participation of 74% and bringing net proceeds of SEK 37 million.
It is worth noting that in both cases, participation in both the rights issue and for the TO2 warrants, participation exceeded the guaranteed level, truly demonstrating investor interest. To move over to the next slide, summing up the quarter, the company closed the quarter with a cash balance of SEK 25 million, delivered on the financial plan, reduced OpEx, and reduced cash burn. As I said before, what we will see now moving into 2025 is a shift in OpEx from R&D more over to clinical studies preparing for commercialization in the second half of 2025. Also, as I mentioned before, we expect to see cash burn to be around SEK 8-10 million per month. That is in line with previous guidance.
As I also have mentioned before, we should, though, be prepared for some volatility between the quarters depending on sort of timing of studies that we are conducting. With the cash balance end Q3 of SEK 25 million, and adding to that the proceeds from the TO2 warrants that we received in January, which amounted to SEK 37 million, and in combination with a not overly aggressive estimate relating to what we think we can get in net proceeds from the TO3 warrants, which are due in April this year, the expectation from management and the board is that the company should be able to fund the need of operational capital into the second half of 2025. With that, I'd like to hand over to Jeff again.
Thanks, Karin. As we look forward to the rest of 2025 following the successful completion of the CLARITY study, we'll be moving forward with our strategic plan. If 2023 and 2024 were focused on research and development of the next-generation tests, 2025 and beyond will really be focused on commercialization and making the most of the opportunities that we have to drive adoption of the new tests, to drive revenue behind the new tests, and to do that in a way that builds shareholder value. We really focused on three priorities this year. The first is that we will begin selling our next-generation tests in the third quarter of 2025. That selling effort will be highly focused initially. Our plan is not to significantly build out our own commercialization effort.
Our goal in 2025 is to do a very targeted, very cost-effective launch so that we can demonstrate the market demand for the tests and give experience in using the tests to the key opinion leaders and pancreatic cancer experts that practice in the U.S. at these large pancreatic cancer surveillance centers that really see a lot of these high-risk individuals who need to be in surveillance for pancreatic cancer. As we think about that launch, we will be focused on driving adoption in those high-risk surveillance centers. Our goal is not to have broad adoption across hundreds of physicians. Our goal is to focus on those high-risk surveillance centers that have a very high number of patients, and we want to drive deep penetration of our tests within those pancreatic cancer centers.
As we think about the commercialization of our tests, I mentioned that the initial effort will be very focused, very targeted, and very cost-effective. The reason for that is that we see an opportunity to really capitalize on the potential of this test by bringing in a commercialization partner. As we've discussed previously, we see this strategic partner as a diagnostics company that would have the commercial resources to really bolster the effort in selling this test across the United States in order to drive that breadth that we really won't be able to accomplish with our own internal resources. By having a strategic partner with an existing sales team that's calling on the right physicians, we'll be able to drive more adoption, we'll drive that adoption faster, and we'll do it at a much lower cost than if we were trying to build out our own internal sales organization.
That will really help us to minimize our capital outlays relative to what they would be if we were trying to do this alone. In terms of the discussions that we've had with strategic partners, as you can imagine, I can't share a lot of details, but what I can tell you is that we have spoken with dozens of potential partners. We have narrowed our focus to a smaller number of potential strategic partners that have a strong presence in the market commercially. They have the financial resources to provide support and to really invest behind commercializing our tests. They have the ability to bring other resources to the table that will help us. For example, regulatory expertise that at this point within Immunovia is pretty limited, so it's helpful to have some of that expertise from a strategic partner.
We will share information as we can about these discussions. As you can imagine, it's difficult to predict when an agreement will be signed. What we want to do is sign an agreement at the right time, and that really makes sure that we will get the right terms. We have a very strong, valuable asset in our next-generation tests. When we sign that agreement, we want to make sure that we're capturing the full value of that in the agreement with that strategic partner so that we can reward our shareholders. Finally, as we think about our third priority for the year beyond the initial launch of the tests and continuing pursuit of a strategic partner, our third focus will be on additional clinical studies. We will leverage what we learned in the CLARITY study to do additional clinical studies.
Those clinical studies are really helpful for three reasons. They will help us to secure reimbursement. Government payers, private payers in the United States want to make sure that we have multiple clinical studies that show that our test is accurate and that it's useful for physicians and can lead to better outcomes for patients. The first reason to do those additional clinical studies is to secure reimbursement. The second reason to do them is to help drive adoption among physicians. As you can imagine, physicians who are monitoring high-risk individuals who have a risk of pancreatic cancer, they want to be very sure that the test that they are using is reliable and that it's accurate and that they can use that either in conjunction with or in place of doing the imaging studies that they're doing today.
Having the additional clinical studies and publishing those will really help us drive physician adoption of the tests. The third reason to do these additional clinical studies beyond reimbursement, beyond physician adoption, is really about regulatory approval. We will launch our tests in the third quarter of 2025 using an approach called a lab-developed test, which does not require FDA approval. FDA is the Food and Drug Administration, and that's the primary health regulator in the US. FDA approval is not needed for us to launch the test, but there have been regulations that have been passed that will require us to have FDA approval over the next few years. We will go ahead and work on that now. The clinical studies that we're doing are really going to be critical for supporting that.
This just gives you a sense of the timeline of what that commercialization phase will look like in 2025. We are already conducting additional studies to support reimbursement, and one of those studies should read out by April. We are also continuing to work on securing a commercial partner. Again, it's difficult to predict when that will happen, but we're optimistic that we can make that happen in the middle of this year. Finally, as I mentioned earlier in the call, we plan to launch the new test and to begin selling it in the third quarter of 2025. In closing, I just want to highlight the tremendous work that has been done by the Immunovia team to achieve our product development milestones on time and on budget in 2023 and 2024.
In 2025, we'll take that same diligence, that same effort, and that same expertise to deliver on our clinical and commercial milestones in the coming year. As I close and talking about the team, one of the things that I'd love to do is to say a huge thank you to Karin Almqvist-Liendahl, who is our CFO and who will be stepping down at March 31 of 2025. Karin has been instrumental in leading this transformation of Immunovia, helping us get through this development phase. As we transition to the commercial phase, I just want to let her know how much I've appreciated working with her, how much I've appreciated her expertise, her steady approach, and all of the things that she's implemented to put us in a good position going forward. Thank you to Karin.
With that, I would love to transition to questions from all of you.
Ladies and gentlemen, we will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on their 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. Questioners on the phone are requested to disable the loudspeaker mode while asking a question. Anyone who has a question may press star and one at this time. The first question comes from the line of Nikl as Elmhammer from Carls quare. Please go ahead.
Yes. Hello, Jeff. Good morning. Thank you for taking my questions. Just a little bit of clarification. In the report, you mentioned that you will announce results from the second clinical validation study in Q1. Could you elaborate on that?
Yes. We are conducting a second clinical validation study that will, again, look at high-risk individuals. This will be in individuals that have both family history or a genetic risk of pancreatic cancer. In addition, we will also add in this study those individuals that are high risk for pancreatic cancer because they have cysts in the pancreas. We are conducting that study now and expect to announce those results by the end of the first quarter. We are very excited about the study for a few reasons. One is that we will be looking at those pancreatic cyst patients who have been part of some of our studies, but this will include a larger number of them. The second reason that we are excited about this study is that we will apply some of the things that we saw in the CLARITY study to this study.
Probably the biggest example of that is that we will limit the age of samples in this study to those that have been collected within the last five years. I think that'll give us a clearer read on what the actual performance of the tests will be. The other thing that we're excited about is we're going to make some adjustments in the age and the gender of the samples to address some questions that we've gotten around the use of the tests and how does it compare across different age groups and genders. We'll be able to do that with this test. We're very excited about that. Having two clinical validation studies is really important because you need those two clinical validation studies in order to get reimbursement in the US.
Okay. Great. Just regarding also the guidance for the cash burn, are you including expanding the sales team and also the initial sales from the launch in this guidance? Is it correct to assume that?
Yes. Yes. That is included in here. Admittedly, the expansion of our commercial team will be pretty limited in 2025. We, as I mentioned, want to do a very targeted launch. Our initial focus will be on the high-risk surveillance centers where we already have established relationships because of the research that we've done, as well as those centers that used the IMMray PanCan-d test in the past. Our effort will be pretty targeted, and therefore our investment in the sales team will be pretty limited in 2025. Again, we expect that to increase in 2026 and also be bolstered substantially by a partner. Those costs are included in the guidance that we've given. As Karin said, it really reflects the fact that we're shifting expenses from R&D to commercialization as well as the clinical studies.
Okay. Thank you. Going back to the introduction about the next-generation test, one of the reasons for developing the next-generation test was to reduce the dependency of CA19-9. Can you confirm that in the clinical validation you have sort of lowered the rate of non-performing tests? Is that something you can confirm or?
Yes. Yes. Absolutely. We are able to detect pancreatic cancer even if the patient does not secrete CA19-9. In the past, we were not able to do that with the IMMray test, and we are absolutely able to do it now. As you can imagine, the test is more sensitive for those patients who do create CA19-9, but we can absolutely identify cancers even in those patients who do not produce CA19-9.
Great to hear that. I noticed that there are some other blood tests in development, and they sort of claim some interesting results on their own, and then they sort of use CA19-9 to boost the accuracy. How feasible is that? Do not they face the same problem that you faced with the previous test?
They do. They do. I think as you look at the competitive tests that are in the market, they are a little bit different from our tests or quite a bit different technically, I should say. Most of the other tests that are in the market are looking for circulating tumor DNA. What we have seen is that that is a difficult way to identify early-stage pancreatic cancer because pancreatic cancer does not tend to shed a lot of cancer cells into the bloodstream. If that is what you are looking for, it is tough to pick up the cancer at an early stage. That is why at least one of these companies and probably a couple of them have incorporated CA19-9 in addition to looking for that DNA in the bloodstream.
I think we feel very good about the accuracy of our test and the fact that we can produce results in the absence of CA19-9 because we're looking at proteins. And because we're looking at proteins, that gives us an ability to detect the cancer earlier.
Okay. Thank you.
Thank you.
Colleague Herman here from Cold Square as well. Just a question on the CLARITY study. You talk about the high-risk population being comprised of both genetic and familial. Is there a split there that you can talk about? What percentage was genetic? What percentage was familial? In case of the genetic population, what genes specifically did you look at there? Was there some statistics on that, or is that not public information?
It's a great question. We haven't released that information yet, and I probably need to keep that confidential in order to support the publication of that data. One of the things that, as you know and investors may know, we can release top-line results, but we try not to release too much so that we can publish those data in a peer-reviewed journal. We will be sharing information about that. In addition to that, we also have some plans to look at additional studies in that familial risk group and the genetic high-risk group, including one study where we're going to be looking at one specific group that only has genetic mutations. They may have family history or they may not, but it's focused on one genetic mutation.
I think that combined with the CLARITY results as well as the second clinical validation that we're doing should really be helpful.
Okay. Thank you.
As a reminder, if you wish to register for a question, please press star and one. There are no further questions from the phone line.
It looks like we have some that were submitted via the online site. The first one is for you, Karin. Can you explain why Immunovia was profitable in the fourth quarter?
Yes, of course. That relates actually strictly to the way we are required to handle our accounting. To try not to be too technical about it, it relates to an intercompany loan or an intercompany transaction between the Swedish parent company and our subsidiary in the U.S., sorry, in the U.S. From an accounting perspective, that's treated as an intercompany loan. Since we then have the issue with two different currencies, i.e., U.S. dollars and Swedish kronor, any fluctuation between the currencies needs to be recognized in the income statement as an unrealized exchange effect. It's not a real profit in that sense, but it's more following and applying to the accounting rules that we are obliged to follow. It's an unrealized accounting effect.
Thanks, Karin. Another question. The clinical study plan sounds expensive. How can you afford these studies? I think one of the things that we are very excited about is the fact that we can conduct these studies at a low cost for a few different reasons. First is that some of these studies will use samples that we already have in the Immunovia biobank, so there is not incremental cost for those samples. The second reason that we can do it is that some of the studies are funded by the National Institutes of Health, which is the largest U.S. government funding organization for scientific and biological research. Three of the studies will be largely funded by the government. Our cost at Immunovia will be limited to just the cost to run our tests.
The third thing is that because we have such strong relationships with the key opinion leaders and with researchers in this space, they are very excited to work with us. Now that they've seen the results of the CLARITY study, those researchers are often asking us whether they can incorporate our tests into clinical studies that they are already conducting. Rather than having to bear the whole cost of those studies ourselves, we're essentially just participating in a piece of the study and doing so at a pretty low cost. We certainly will have one or two studies where we have significant expenditures. Those are all built into the budget, but we are able to conduct a large number of studies at a very, very reasonable cost because of those three factors.
One question that we've received both today in the chat as well as previously is, how do the actions of U.S. President Trump impact Immunovia? The short answer is, I think we're still sorting through that, and I think there's a lot of uncertainty about what will happen in the U.S. and how that will impact healthcare in the U.S. We do know a few things. The Trump administration has issued a large number of executive orders, and some of those executive orders relate to healthcare, and a couple of them could impact Immunovia. One of the things that President Trump did was paused funding for projects from the National Institutes of Health or the NIH. That's that government group that I just mentioned that is slated to fund three of the studies that we have planned.
The good news for us is that the funds for 2025 were already provided to the researchers who are conducting those studies, and we expect that the funds for future years will come as needed as the government sorts out the different priorities that they have. There have been indications that cancer is going to continue to be a top priority, and we don't expect any changes there. There's just a little bit of uncertainty in the near term. The second thing that could impact us over time is that the Trump administration has reduced staffing at the Food and Drug Administration or the FDA. FDA is the group that reviews applications for the approval of tests like ours.
I suspect that because of those staffing reductions, you may see some increase in the length of time that it takes to review submissions from companies like ours. Fortunately for us, we have multiple years in order to comply with the rule that says we need to get FDA approval. That delay would not impact the company and does not impact our ability to launch the test in the second half of this year, as we outlined earlier. A good question here. What is your take on these great results not reflected in the share price? I think it is a really good question, and it is always dangerous, I think, as a CEO to comment on the share price. I think that there are probably a variety of things happening, but a couple of things that I think stand out.
One is just the general uncertainty in the market for small-cap companies, which has created challenges. I think one other thing in our case is the fact that because we had the rights issue followed by the two warrants, there is a little bit of an or there is an impact, I think, on the share price because of that that gets created. What we plan to do at Immunovia is to just continue hitting our milestones, continue delivering results, and certainly are optimistic that that will be reflected in the share price. I do not see any other questions in the chat. If there are any other additional questions, please include those now.
No, there are no further questions.
Okay. I want to thank you all for joining. We really appreciate your participation. We really appreciate your interest in Immunovia and are excited that you are with us as we transition from the development of our next-generation test to the commercialization of that test this year. We look forward to driving the growth and success of our next-generation test and having that deliver shareholder value along the way. Thanks very much.
Ladies and gentlemen, the conference is now over. Thank you for choosing Cold Square, and thank you for participating in the conference. You may now disconnect your lines. Goodbye.