LUND, Sweden– On May 23, 2023, the world witnessed a remarkable breakthrough engineered from the European nation of Sweden. After years of dedicated research, scientists in Lund proudly announce their exciting news to the global community.
January-March 2023
Our company had great success this quarter, with net sales reaching kSEK 520 (an increase of 188% compared to the previous quarter). Our sales of tests reached kSEK 379 (a 210% increase compared to the previous quarter), and our royalties reached kSEK 141 (a 136% increase compared to the previous quarter). We are thrilled by the success of our business this quarter!
Net earnings were reported as MSEK -51.7 (-44.1) for the period, translating to earnings per share of SEK -2.28 (-1.95) before and after dilution. These figures mark a significant decline compared to previous financial reporting periods.
Cash flow from operating activities experienced a significant decrease, dropping from MSEK -46.1 to -39.7, a decrease of 6.4.
Cash and equivalents increased substantially at the end of the period, reaching a total of MSEK 68.2 compared to the previous figure of MSEK 239.8.
Lara E. Sucheston-Campbell has been welcomed to the company as their newest addition to lead the Clinical and Medical Affairs Team! With the wealth of expertise and experience Lara brings to the table, the Company is thrilled to have her on board and looks forward to seeing what the future holds.
The Company announced on January 19 that it had begun a process to streamline its Swedish operations, with a particular focus on US commercialization of the IMMray™ PanCan-d test. After completing the consultation process on February 8, the Company is well on its way to reaching its strategic goals.
On February 20, the company announced a rights issue of approximately SEK 202.2 million, postponing both the publication of its January-March quarterly report and the annual general meeting until May 23 and 26, respectively. This remarkable decision marks a significant milestone in the company’s history.
On the 20th of February, the Company gave its official notice that an Extraordinary General Meeting will take place on the 16th of March 2023. This is sure to be a significant gathering for all involved, so mark your calendars and be sure to join in on the conversation!
On March 1, the Company announced the exciting appointment of Karl Stone as chief operating officer. Karl will be in charge of driving research and development, as well as overseeing day-to-day operations. With this appointment, the Company looks forward to furthering its goals and mission.
At the extraordinary general meeting of Immunovia AB, a resolution proposed by the board of directors to increase the company’s share capital by a maximum of SEK 1,508,772.00 through the issuance of up to 30,175,440 new shares with preferential rights for existing shareholders was exuberantly approved.
On March 17, the Company unveiled its prospectus, offering its shareholders the chance to take part in a rights issue. Don’t miss out on this opportunity to participate in the growth of the company!
Significant events after the period
Immunovia achieved great success in its recent Rights Issue, with the offering being subscribed to at an impressive 75.1% and resulting in the Company receiving an outstanding SEK 151.8 million before issue costs.
The Company cordially invites you to attend its Annual General Meeting on Friday 26th May 2023! Make sure to mark your calendars now and don’t miss this important event. We look forward to seeing you there.
On April 26, the Company announced a discussion on adoption of IMMray™ PanCan-d with key opinion leaders on May 3, 2023.
On April 29, the Company made a major shift by appointing Jeff Borcherding as its new Global CEO, replacing the outgoing Philipp Matthieu. This changeportends a new era for the company as Mr Borcherding takes the helm and steers it towards continued success.
Philipp von Hugo has taken the extraordinary step of voluntarily resigning from the Board of Immunovia, the innovative in vitro diagnostics company. His departure was announced on May 6th and marks the end of a successful tenure on the Board.
CEO’s comments
As the new global CEO of Immunovia, I am both honored and energized to lead our mission of saving lives by detecting pancreatic cancer earlier. Our groundbreaking IMMray™ PanCan-d test has the potential to drastically improve patient survival by detecting the disease in its early stages, when it can still be treated effectively.
In my first year here, I have been immensely encouraged seeing the response towards our test from gastroenterologists and individuals alike – a response that is only growing and becoming more promising. Together, we are determined to conquer the deadly threat of pancreatic cancer.
In the first quarter of 2023, we saw exciting developments in the commercialization of the IMMray™ PanCan-d test – a milestone advancement in cancer diagnosis and treatment. We began transitioning our breakthrough technology into the medical community, allowing us to transform lives by providing fast and accurate results and potentially saving countless lives.
Nearly five hundred healthcare professionals ordered the test for the first time in this quarter, signaling the test’s growing importance in the medical world.
We are proud to announce that the number of high-risk surveillance centers using IMMray™ PanCan-d has increased to 34 – enabling us to offer more widespread support and visibility for those seeking accurate and timely medical diagnosis.
We’ve seen a huge increase in the number of adopter-centers that have ordered five or more IMMray tests, with the figure now standing at an impressive 21. It’s clear that this is a dependable option for health professionals in need of reliable diagnostics.
In Q1, we achieved a major success: transitioning physicians and patients from free tests to patient-paid tests. More than half of tests were paid for by the patients, showing that our efforts to bolster self-pay have been an unequivocal success.
We had an illuminating quarter of meetings with nine payers, several of them being leading U.S. commercial payers, to demonstrate the significant economic savings and clinical improvements that IMMray™ PanCan-d has to offer.
We are delighted to announce that our rights issue has been a resounding success, raising a net of 122 MSEK after issue costs. This invaluable funding will ensure operations are sustained until at least 2024.
Our monthly burn rate has been typically around 15-20 million SEK, and as of now, it’s trending downwards towards the lower end of this range.
Going forward, we must face three formidable challenges if we are to reach our business and financial ambitions. With determination and dedication, we can overcome these obstacles and secure our desired success.
IMMray™ PanCan-d diagnostic tests have quickly become a go-to test for early detection of pancreatic cancer; however, payers in the U.S. demand extensive clinical evidence before they will agree to cover the test. In order to meet these requirements, the PanFam-1 study was conducted to provide evidence of clinical utility and accuracy.
Unfortunately, due to a surprisingly low number of pancreas cancer cases in the study population, more data is needed to satisfy most payers. Therefore, further clinical evidence must be provided to demonstrate the benefits of IMMray™ PanCan-d.
Proving the clinical utility of an early detection test for pancreas cancer can be a challenging endeavor. It requires considerable planning and investment to conduct the necessary clinical studies, which typically involve hundreds of patients over the course of several years. This presents a significant hurdle in the pursuit of early detection for this disease.
Immunovia faced a difficult financial predicament due to the tight, risk-averse climate that limited capital access. Despite this difficulty, we were able to successfully conclude a rights issue in the first quarter. To make the best of our restricted capital, we must operate in a frugal fashion, and make careful investments in both our clinical and commercial endeavors.
We have a plan to tackle these obstacles and capitalize on the possibilities in the market. By leveraging our innovative technology, enhancing our customer experience, and embracing our corporate culture, we are determined to achieve success and become a leader in the industry. With these strategies, we are confident that we can meet and exceed our goals.
We are collaborating with large multi-center research consortia, researchers with government funding, and institutions with biobanks to validate the accuracy and clinical utility of our IMMray™ PanCan-d test. Our goal is to generate more clinical data, faster, and at a lower cost than traditional proprietary clinical trials. We firmly believe that this strategic partnership will bring great results and will demonstrate the top-level performance of IMMray™ PanCan-d. Our ultimate objective is to provide cost-effective and reliable testing for pancreatic cancer surveillance.
We are taking a two-pronged approach to ensure reimbursement for our test. While most traditional payers, including Medicare, require extensive clinical evidence before agreeing to cover the test, we are excited to be in discussions with a number of different innovative payers who are willing to cover the test with short-term agreements. We expect to announce results from these pilot programs over the next two years. For the remaining payers, our rigorous clinical program aims to secure coverage by 2025.
We’re disciplined when it comes to costs and won’t overspend; only critical R&D, clinical and commercial activities will be funded. To support continued operations prior to profitability, we’re open to exploring all options – such as collaborative research grants – to support a portion of our clinical studies.
With our highly talented and experienced team of sales representatives, we are committed to increasing clinician and patient awareness and adoption of the IMMray™ test in the most cost-efficient way. In the past year, we have enabled our sales professionals to break into the high-risk pancreas cancer surveillance market as they decide on the importance of early detection.
To further amplify this effort, we are actively investing in public relations and digital marketing campaigns to drive consumer demand for our test. Our sales and marketing spending is regulated and monitored to ensure efficiency and success.
Immunovia has taken several huge steps forward in bringing our plan to life. Our strategic collaboration with Proteo-medix, the Swiss diagnostics company, has been hugely successful. We’ve also implemented organizational changes in our Lund facility, reigning in costs and elevating the calibre of our lab and production efforts. In the US we further increased our clinical research power by welcoming the VP of Clinical & Scientific Affairs, creating a thorough clinical plan and solidifying leader partnerships.
Moving forward, our reimbursement expert is ensuring a seamless basis for payer pilots, while our sales & marketing personnel are perfecting our go-to-market approach and updating the abilities of the sales team. All in all, an impressive collection of steps that demonstrates Immunovia’s robust commitment to effective and ambitious execution.
Unprecedented Success: What Investors Can Look Forward To in 2023
With the aim of securing reimbursement for IMMray™ PanCan-d, we are taking a strategic approach and limiting our investment in the field sales force in order to ensure modest volume in 2023.
In 2023, revenue growth will remain modest as we continue to offer our tests at a fair rate. Discounts may be available to those with a lesser ability to pay, but overall, most tests will still be paid directly by the patient.
We’re aiming to make progress in 2023 with innovative payers by introducing initial reimbursement through “coverage with evidence development” pilots. It’s an exciting step forward on the road to making our product available and accessible to more people.
2023 will be a year of possibilities as we announce specific collaborations with leading healthcare systems and research consortia. Two of these studies will be retrospective, giving us the chance to announce results by the end of the year. Other studies will be of a more prospective nature, with results not expected until 2025. This promises to be an exciting year for us and our partners as we unlock the potential of future treatments.
We have an incredible opportunity ahead of us that we couldn’t be more excited about! With 1.8 million people in the U.S. at risk of pancreatic cancer, our mission is to dedicate ourselves to provide them with the best solutions possible.
As we make progress on our plan, we’ll make sure to keep the market updated with our progress and success stories. Together, we will overcome the challenges that stand in the way and we will make an impact that will improve the lives of people all over.