Immunovia Publishes Full Year Report for 2023
October-
- Net sales, which for the quarter only included royal- ties, amounted to kSEK 155 (502).
- Net earnings were MSEK -49 (-67) and earnings per share before and after dilution were
SEK -1.08 (-2.97). - Cash Flow from operating activities amount MSEK -28 (-51).
- Cash and equivalents at the end of the period amounted to MSEK 77 (106).
- On
October 3 , the Company announced that the Nomination Committee had been appointed to consist of the following persons who together represent 7,52 percent of the total number of outstanding shares and votes in the company as ofSeptember 30, 2023 :Sara Ek , Carl Borrebaeck andMats Leifland . - On
October 27 , the Company gave notice that an extraordinary general meeting was to take place onNovember 21 . - On
November 7 , the Company announced that the discovery phase of next generation test was successfully completed. - On
November 21 , the Company announced thatMelissa Farina andValerie Bogdan-Powers had been elected as new board members at the extraordinary general meeting. An adoption of an equity incentive program for the Company's management and key personnel along with an equity incentive program for the Company's board of directors were resolved.
Significant events after the period
- On
January 31 , the Company announced thatNorma Alonzo Palma had been appointed as the new Vice President of Clinical and Medical Affairs.
CEO's comments
I am proud to report on the transformation
In 2024 our key priorities are to finalize development of our new test, prove its value in clinical studies, and secure the resources and commercial partnerships to bring our test to the market in 2025. The size of the pancreatic cancer surveillance market, the growing need for early detection and the promise of our R&D efforts fuel optimism as we confront the realities of our resource challenges.
The market for early detection of pancreatic cancer in high-risk individuals is large and growing, and there is proven market demand for a simple blood test
The market for pancreatic cancer surveillance is growing and pancreatic cancer cases are rising, putting more family members at risk. Growth in genetic testing is identifying more people with hereditary mutations at risk for pancreatic cancer. A blood test for pancreatic cancer is a scalable solution to meet the increasing need for surveillance.
Our experience in recent years makes it clear that there is a large and significant unmet need in early detection of pancreatic cancer. We have long believed in this potential based on our deep collaborations with key opinion leaders in pancreatic cancer. The adoption of the IMMray™ PanCan-d test at leading academic institutions and high-risk surveillance centers reinforced our conviction that people at risk for pancreatic cancer—and their clinicians—have a strong desire for a simple, accurate blood test for early detection. The IMMray™ PanCan-d test paved the way for our next-generation test.
Our access to leading scientists
Once our test is ready for launch, these key opinion leaders will be important voices to educate other physicians about the test. These relationships with KOLs are a unique asset that
Our unique sample bank
Through our extensive research, we have accumulated a large and valuable biobank of nearly 8,500 blood samples. We have over 850 blood samples from patients with pancreatic cancer; of these, nearly 400 samples are rare stage 1 and 2 PDAC cases. The biobank includes a rich assortment of individuals with a family history of pancreatic cancer, genetic mutations, diabetes, pancreatitis, and other risk factors. This expansive biobank is driving rapid development of the next-generation test. It will also enable
Our development partner
Finally, our development partnership with Onconetix (formerly Proteomedix) continues to pay dividends. The expertise of the Onconetix team in developing and refining protein-based assays has been a strong complement to
We have leveraged our legacy assets and strong partnerships to develop our next-generation test in a fraction of the time it took to develop IMMray™ PanCan-d
We have made tremendous advancements over the last 9 months in the development of
Once we have completed test development, an analytical validation study will follow to confirm that we are accurately measuring the target proteins. Finally, we will complete a clinical validation study by year-end 2024 to confirm the sensitivity and specificity of our new test. In parallel, we are designing and preparing for additional clinical studies in 2025 to support reimbursement.
The new
Starting in
Importantly, we completed these significant changes without impacting the rapid progress of developing our new test. Further, we were able to maintain and even enhance our relationships with key researchers, clinicians, and advocacy groups despite the changes.
We are focused on the efforts required to achieve our milestones and bring the new test to market
We have reduced our burn rate to below 10 MSEK per month and are focused on the development and clinical study of our exciting next-generation test. In parallel, it is critical that we secure the resources to fuel R&D, clinical studies, and future commercial efforts. The company is currently funded into the fourth quarter of 2024. We are also negotiating to reduce or eliminate long-term financial commitments linked to the now-discontinued IMMray™ PanCan-d product. The
The new
Since I became CEO in
For more information, please contact:
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
Conference call
To take part of the presentation, please dial one of the numbers or watch via the web link below.
Link to the webcast: https://access.creomediamanager.com/registration/cff0b72c-e4f5-48b2-8bc0-47467df18f1b?ref=https%3A%2F%2Fcreo-live.creomediamanager.com%2Fcff0b72c-e4f5-48b2-8bc0-47467df18f1b
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CONTACT:
The following files are available for download:
Full Year Report 2023 |
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https://mb.cision.com/Public/13121/3932536/9b7fb633f888f4f7.pdf |
Press release (PDF) |
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