July-September 2023
Significant events after the period
CEO’s comments
During the third quarter we made significant changes to streamline Immunovia and made important progress in developing our next-generation test. As we move forward, we are focused on the rapid execution of our plan to develop and validate the new product. Additionally, we are exploring strategic partnerships that will allow us to succeed in 2024 and beyond.
Our transformation is nearly complete and Immunovia is now leaner and stronger
Following the July announcement that we would discontinue selling the IMMray™ PanCan-d test, we moved quickly to transform Immunovia. This transformation has been significant and multi-faceted, touching nearly every part of the company. The restructuring was intended to significantly decrease spending, while focusing the company’s resources on our next-generation test.
We have transformed Immunovia in important ways:
As we near the end of this transformation, the new Immunovia is a much more agile, much leaner, and more focused company. We remain true to our vision, we have unique assets, we are now cost efficient, and we are focused on our clinical mission: to save lives through early detection of pancreatic cancer with our next generation test.
Development of our next-generation test is progressing well
As we announced, we have successfully completed the crucial discovery stage of development for our next-generation test. We found more than a dozen proteins circulating in the blood that identified patients with stage I and stage II PDAC (pancreatic ductal adenocarcinoma). Conducted using the Olink platform, the study is the most comprehensive proteomics study to date in pancreatic cancer, exploring more than 3,000 protein biomarkers.
The discovery study was completed quickly thanks to Immunovia’s extensive repository of in-house blood samples from pancreatic cancer patients and controls. Immunovia’s R&D partnership with Proteomedix has also proven instrumental in rapidly developing the new test.
We have already begun the model building stage of the R&D process. In this phase, we will develop reliable assays to measure the target proteins. These assays will be conducted on an ELISA platform, which will reduce costs and improve scalability.
During the current model building stage, we will also select the final biomarkers to be used in the commercial test. By Q2 2024 we will complete a training and an initial validation study to optimize the test and assess its sensitivity and specificity. Later in 2024, Immunovia will confirm the analytical validity of the test and conduct a larger clinical validation study.
Our progress in developing the next-generation test has been powered by Immunovia’s strengths and assets The experience, assets, and relationships Immunovia has built over the years are enabling us to develop the next generation test successfully and quickly. Our development efforts are being guided by a deep roster of expert advisors, with many of the top thought leaders in pancreatic cancer providing counsel. We have built deep realtionships with these advisors over several years and they are incredibly supportive of our efforts. We are also reaping the benefits of our industry-leading repository of pancreatic cancer blood samples. Accumulated through collaborations with pancreatic centers throughout Europe and U.S. these samples enabled us to quickly evaluate thousands of potential biomarkers in a wide range of patient types using samples we already had.
We are actively pursuing partnerships
As I noted in our second quarter report, partnerships will be crucial to our success. Proteomedix continue to demonstrate their deep expertise in discovering novel biomarkers, building accurate tests, and developing commercial assays. Our collaboration strategy has enabled us to accelerate our time to market and reduce our development costs.
To generate sufficient clinical data on our new test to support reimbursement, we will partner with leading academic institutions and research consortia. These groups are conducting large clinical studies in the early detection of pancreatic cancer in high-risk individuals. By partnering with them, we can study our product in more patients, for a longer time, at a much lower cost than conducting our own proprietary studies. Conversations with these groups are progressing well and we expect to announce research partnerships in the first quarter of 2024.
Commercializing our next generation test will require partnership as well. We will seek a partner with existing selling capacity and established relationships with our target clinicians. This will enable us to accelerate test adoption and bring our next-generation test to market without shouldering the full expense of our own sales organization. We can be an attractive partner to a company looking to bolster its product portfolio with an accurate test targeting a large market with significant unmet clinical needs. Securing a strategic partner is the primary focus for the remainder of 2023 and 2024.
We face challenges, but we are fueled by our clinical mission and our desire to serve our stakeholders. Our transformation into a much more cost-efficient company is nearly complete and we are making excellent progress on our new test. Still, we clearly face challenges, most importantly a difficult financial market. We are working hard to outline a compelling vision for the company and to regain investor trust by delivering on our commitments. We are focused on execution, leveraging our new lean and agile structure to drive development of our next test. We will capitalize on our legacy assets, while collaborating with partners who augment our strengths. Ultimately, we plan to address the significant unmet clinical need for early detection of pancreatic cancer and to reward shareholders for their commitment and support.
November 9, 2023 Jeff Borcherding, CEO and President Immunovia AB
For more information, please contact: Jeff Borcherding CEO and President jeff.borcherding@immunovia.com
Karin Almqvist Liwendahl Chief Financial Officer karin.almqvist.liwendahl@immunovia.com +46 70 911 56 08
The information in this report is information that Immunovia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:30 am CET on November 9, 2023.
Conference call
Immunovia will hold a webcast tele conference at 15:00 pm CET on November 9 with President and CEO Jeff Borcherding and CFO Karin Almqwist Liwendahl.
To take part of the presentation, please dial one of the numbers or watch via the web link below.
Sweden: +46 8 5051 0031
United Kingdom: +44 207 107 06 13
United States: +1 631 570 56 13
Link to the webcast: https://access.creomediamanager.com/registration/10534c57-ff26-4cd2-8e58-91ffc103b244?ref=https%3A%2F%2Fcreo-live.creomediamanager.com%2F10534c57-ff26-4cd2-8e58-91ffc103b244
Immunovia in brief
Immunovia AB is a diagnostic company whose mission is to increase survival rates for patients with pancreatic cancer through early detection. Immunovia is focused on the development and commercialization of simple blood-based testing to detect proteins and antibodies that indicate a high-risk individual has developed pancreatic cancer.
Immunovia collaborates and engages with healthcare providers, leading experts and patient advocacy groups to make its test available to individuals at increased risk for pancreatic cancer.
USA is the world’s largest market for detection of pancreatic cancer. The company estimates that in the USA, 1.8 million individuals are at high-risk for pancreatic cancer and could benefit from annual surveillance testing.
Immunovia’s shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com
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Interim Report Q3 2023 (PDF)