Welcome to the Immunovia audiocast with teleconference Q3 2021. For the first part of this call, all participants will be in listen-only mode, and afterwards, there'll be a question and answer session. Today, I am pleased to present CEO Patrik Dahlen. Please begin your meeting.
Good afternoon, everyone. Thank you for joining us today, and thank you for your continued interest in Immunovia. My name is Patrik Dahlen. I am the CEO of Immunovia, and I will be presenting the Q3 2021 results for Immunovia. We have now passed a pivotal milestone in the company's history. Immunovia, Inc. has launched IMMray PanCan-d as a laboratory developed test in the United States, and we have tested the first commercial patient samples with IMMray PanCan-d in our laboratory in Marlborough, Massachusetts, U.S. This is a major achievement for all of us here at Immunovia and provides an opportunity for persons in the high-risk group or familiar hereditary risk group to access the first blood test for early detection of pancreatic cancer. Next page, please. Page two. Here you can read our disclaimers and forward-looking statements, and I encourage you to read these at your leisure.
Next page, please. Page three. Today's agenda is as follows: I will start by giving you a summary of the Q3 highlights and updates on post-period events. Obviously, the launch of IMMray PanCan-d in the U.S. is the key event this time and marks a significant milestone for Immunovia. Then I will give you an update on the initial phase of commercialization of the IMMray PanCan-d test in the U.S. Next, I will discuss milestones going forward. I will then move on financials for Q3 2021, and following financials, we will go to a Q&A session. Next page, please. Page four. Now I will move on to discuss Q3 2021 highlights. Next page, please. Page five. The third quarter of 2021 was a historical quarter for Immunovia. Following the receipt of the CLIA certificate of registration late June, Immunovia, Inc.
received a license to operate a clinical laboratory from the Massachusetts Department of Public Health on the third of August 2021. We are extremely proud to have achieved this pivotal milestone. It means a lot to us as a company, it means a lot to the people working in the field of pancreatic cancer, and it means a lot to people who have a family history of pancreatic cancer or have a genetic predisposition and therefore are at risk of pancreatic cancer. We provided an update, actually two updates regarding IMMray PanCan-d test. First, the test is launched at the list price of $995 per test.
Based on feedback from the payer study, we saw a clear chance to adjust the price, and there seems to be a relatively large price elasticity among the payers for a blood-based test for early detection of pancreatic cancer in the U.S. In comparison, the price for MRI and endoscopic ultrasound scans are in the range of $5,000-$6,000. Second, the test is launched for those individuals with CA19-9 levels greater than 2.5 units per ml. The overall sensitivity of the test then improves to 89% in stages one and two, and 92% in all stages of pancreatic cancer. The specificity of the test is 99%. We also announced in the quarter that we've signed a license deal for two biomarkers with JW Holdings from South Korea. The license further strengthens our patent portfolio of biomarkers around IMMray PanCan-d.
We have discovered these biomarkers in our own studies. However, JW Holdings patent had priority to our discovery. Furthermore, we are excited to have JW Holdings as a future commercial partner in South Korea. In the quarter, also, the National Pancreas Foundation and Pancreatic Cancer Action Network, or PANCAN, informed their constituents about Immunovia, Inc.'s blood test IMMray PanCan-d on their website, in social media, and through direct email contacts. We are very proud and pleased for this support as it is an important step for Immunovia, Inc., in terms of spreading the word and creating valuable awareness about the test. All in all, the reception of the medical community in the U.S. for IMMray PanCan-d has been overwhelmingly positive. Next page, please. Page six.
After the close of the quarter, we announced the appointment of our renowned Karin Almqvist Liwendahl as new Chief Financial Officer. Karin will join the company at the latest by April 1, 2022. Karin has a very strong background in investor relations and as a finance leader, both from the international telecom industry and Swedish biotech. We are very excited that Karin will join us in the new year. Dr. King, our Medical Director at Immunovia, Inc., received the Presidential Poster Award for our poster on the blind validation study at the American College of Gastroenterology Annual Scientific Meeting. Furthermore, Dr. King was invited to present at the U.S. National Cancer Institute, or NCI, Pancreatic Cancer Detection Consortium, or PCDC, as a keynote speaker at their upcoming steering committee meeting, taking place virtually on December 13-14, 2021.
The main objective of the PCDC is to develop and test new biomarkers to improve the detection of early-stage PDAC and its precursor lesions, and identify individuals who are at high risk of developing PDAC and are candidates for early intervention. Next page seven, please. Now I will focus on the U.S. market. Next page, please. Page eight. We have decided to focus our efforts on establishment of IMMray PanCan-d on the U.S. market. The U.S. is the biggest singular market opportunity for Immunovia, and we have decided to follow the footsteps of all other companies that have commercialized tests for early detection of cancer. This means a very clear focus on the U.S. The full market potential for IMMray PanCan-d in the U.S. represents an opportunity exceeding $4 billion annually.
To support our efforts in the U.S., we have initiated a search for a CEO for Immunovia, Inc. We have a very ambitious specification for the person, and we look for an individual who has specific experience in selling, marketing, and developing a CLIA/CAP laboratory service for early detection of cancer in the U.S. In our budget for the next year, we are planning to more than double our efforts in sales and marketing in the U.S. in 2022. Especially the second half of 2022 will be important as we anticipate having the first payer coverage agreements in place in Q4. As we focus on the U.S., we will continue our efforts in Europe based on key opinion leader collaborations and clinical studies.
We are very close with the pancreatic cancer key opinion leaders in Europe, and we will continue to collaborate with them on important clinical studies in Europe going forward. Next slide nine, please. With the CLIA certification and a license to operate the clinical laboratory, we can now commercialize our test in 45 of the states in the U.S. To reach the rest of the states, we have filed for a so-called CAP accreditation. The inspection is expected in Q1 2022. This will enable us to initiate and broaden our commercial efforts in the remaining five states. We are very pleased with the sales starts of IMMray PanCan-d in the U.S. We are proud to be the first company to launch a blood-based test for early detection of pancreatic cancer, and pleased to have received such a great support from patient advocacy groups and the medical community.
It should be noted that our test is sold out of pocket or as self-pay test, which means that the individuals pay for their own testing. We have noted that it takes several weeks, four to eight weeks, for individuals to make up their minds about taking the test. A part of that time is driven by the fact that all individuals that take the test shall have proper consultation with their doctor. COVID-19 has made it slow to make appointments with clinics, and several clinics across the U.S. do not allow salespeople to enter the clinic. This is a fact that many other companies have reported on as well. We have now submitted the manuscript for blind validation study to a peer review journal and are hoping to see the article published before year-end 2021. This is another critical step in providing independent peer-reviewed data supporting IMMray PanCan-d.
For many doctors and surveillance centers, having a peer-reviewed article available is important for their decision-making and patient consultation. This continued support from the National Pancreas Foundation and PanCAN are, of course, important to us, and it is a very effective channel to reach individuals at risk for pancreatic cancer. Next slide, please. Slide ten. We have received very positive feedback from the patient advocacy groups and the medical community. Some of this feedback I share on this slide. As you can see, the feedback is very much focused on improved patient care. I quote Julie Fleshman, President and CEO of the Pancreatic Cancer Action Network, "The early diagnosis of pancreatic cancer is key to improving patient outcomes and survival rates.
We are encouraged by the results presented by Immunovia's IMMray PanCan-d blood test and the company's progress toward an early detection strategy for this disease." End of quote. Next slide 11, please. Important next steps in our commercialization includes the peer-reviewed article on the data from our blind validation study. As I mentioned, we expect to see the article published by year-end. This will certainly help sales going forward. We continue to run the PanFAM study samples. We anticipate completing the testing of all samples by year-end and reporting results from the study in Q1 2022. We have initiated a study together with one of our key opinion leaders in the U.S. on symptomatic patients with pancreatitis. We are roughly halfway in the study and anticipate completion before year-end 2021.
The initial results are promising, and if the study comes through as expected, we should be able to commercialize IMMray PanCan-d for the symptomatic patients with pancreatitis in the U.S. by year-end. Next slide 12, please. We have a very busy schedule with scientific conferences. As mentioned before, Dr. King will be speaking at many of the conferences, and also independent scientists are speaking about IMMray PanCan-d at clinical and scientific conferences. It's truly an extremely busy second half of the year for Immunovia, Inc. Next slide, please. Slide 13. We obviously continue our commercial launch plan activities of IMMray PanCan-d with a high pace, with lots of activities. On the World Pancreatic Cancer Day on November 18, we hold a grand opening of our laboratory in Marlborough.
We will continue to be extremely active on social media and other platforms and media platforms. Next slide 14, please. Next, I want to say a few words about our milestones for IMMray PanCan-d going forward. Next slide 15, please. The CAP accreditation should follow the inspection, which is scheduled to Q1 2022. As mentioned before, the CAP accreditation is an important step for the commercialization in the remaining five states. The PanFAM study should be ready by Q1 with the study readout. A peer-reviewed article or publication will follow most likely in Q3 2022. The dossiers with documentation of clinical utility and test performance will be compiled to enable us to start payer engagements and coverage negotiations in Q4 2022, with subsequent reimbursement in place from the most advanced payers in Q4 2022. Next slide 16.
Briefly, a few words on financials Q3 2021. Next slide, please. Slide 17. Our net sales in Q3 2021 was SEK 377,000 . This is sales from IMMray PanCan-d tests in the U.S. and royalty payments. Net earnings was minus SEK 36 million in the quarter. Cash flow in the quarter was negative. We had a negative cash flow of SEK 42.5 million. In the quarter. Cash and cash equivalents at the end of the period was SEK 340 million. Based on current burn rate, we have a run rate over one and a half years at current full year levels. These projections do not include cash contributions from sales in Q4 nor in year 2022.
As we present Q4 results for 2021, we will give sales guidance for the first time on a forward-looking basis for full year, 2022. With this, I want to turn to the next page 18, and open up the call for Q&A. Operator, please.
Thank you. If you wish to ask a question, please dial zero one on your telephone keypads now to enter the queue. Once your name has been announced, you can ask your question. If you find your question has been answered before it's your turn to speak, you can dial zero two to cancel. Once again, that's zero one to ask a question or zero two if you need to cancel. There'll be a brief pause now while we register any questions. Okay. We've just had one question come through so far. That's from the line of Mikael Löfman, private investor. Please go ahead. Your line is open.
Thank you very much. I was just wondering about the pipeline. What's the status of the lung test and the RA test?
We have decided that, different from earlier quarterly reports where we have stated that we've gone through the pipeline, and we've stated that we will update when there is news to update, it's better for us to actually inform the market when there is truly an update in the discovery pipeline. We will focus our updates with regards to the pipeline on projects that are in clinical studies and in development phase.
Thank you for that. A follow-up question. New-onset diabetes, what's the status of that?
As you know, we have collected a set of samples from three different Swedish hospitals for new-onset diabetics. We are planning a pilot study on a subset of that collection and that cohort here shortly. Again, we are in the process of getting the samples to Lund and getting them into the lab. Whether we are able to get the first results before the end of this quarter four, 2021, or whether it will go into quarter one, 2022 is a little bit early to say, but it's our ambition to be able to report on that within the next minimum six months.
Thank you so much.
Thank you, Mikael.
Thank you. Once again, if there are any further questions, please dial zero one on your telephone keypads now. Okay, there seems to be no further questions on the line at this time, so I'll hand back to Patrik for the closing comments. Oh, actually, we've had a follow-up from Mikael Löfman, so please go ahead. Your line is open.
Yes. I was just wondering about the sales development in October and the beginning of November. Have you seen a pickup in sales after a hesitant start, or is it still long lag times or? How do you see the difficulties of getting into the hereditary groups already ongoing screening programs?
There's definitely been a pickup because you should in fact think of our sales in Q3 while we got the clearance and approval to go ahead and commercialize the test in the first few days of August. As I mentioned, there is a time lag from the time when an individual makes a decision to take the test until we have the test in our lab and can perform a test for the individual. That time lag, as I said, is between four and eight weeks. Effective sales time and effective testing time in quarter three was, in that sense, extremely limited, in fact, just down to a few weeks.
Definitely, when we are now in quarter four, the testing has now a much more regular feel to it. Again, we will, of course, report on the sales numbers when we report in February 2022 in our quarter four and full year report, but there's a definite pickup. Obviously we are working very closely in terms of getting into the surveillance centers, and we definitely see a clear pickup. There is a movement for increased volumes definitely in the quarter.
Thank you.
Thank you. There seems to be no further questions on the line now, so I'll hand back to Patrik for the closing comments.
Great. Thank you. Thank you so much for that. We obviously are extremely proud here at Immunovia for the launch of IMMray PanCan-d in the U.S. We recognize that this is a big step for people at risk for pancreatic cancer, be that for familial or hereditary reasons. We're overwhelmed by the very positive feedback from the community, the patient advocacy groups, the medical community, for supporting us in our efforts to help people with regards to early detection of this devastating disease. To the investors and analysts, I just want to say thank you very much for your continued interest and continued support of Immunovia. Thank you so much. This concludes our quarter three 2021 report.