January-
- Net sales, which for the quarter only included royalties, amounted to
SEK 156 (520) - Net earnings amounted to KSEK -2,946 (-51,658), where exchange rate effects of KSEK 21 358 (435) had a substantial impact.
-
Earnings per share before and after dilution were
SEK -0.07 (-2.28). - Cash Flow from operating activities amount MSEK -24.4 (39.7).
- Cash and equivalents at the end of the period amounted to MSEK 51.2 (68.2).
-
On
January 31 , the Company announced thatNorma Alonzo Palma had been appointed Vice President of Clinical and Medical Affairs
Significant events after the period
- On
April 9 , the Company announced thatImmunovia had successfully developed accurate and precise assays to measure targeted proteins for its next-generation test. -
On
April 22 , the Company announced positive results from the model-development study for its next-generation pancreatic cancer detection test.
CEO's comments
I am proud to report that we delivered on our promises in transforming
Our next-generation test met the predefined performance criteria and outperforms IMMray(TM) Pan-Can-d
We were thrilled to announce on
Our next-generation test was also significantly more accurate in the study than CA19-9, the biomarker commonly used to detect pancreatic cancer. Outperforming CA19-9 is crucial to securing reimbursement for the new test.
The next-generation test is clearly superior to our first-generation test, IMMray(TM) PanCan-d. First, the new test accurately distinguished pancreatic cancer from a wider range of control samples. Second, the next-generation test does not have a "borderline" category as the IMMray(TM) PanCan-d test did. All patients tested with our new test will receive a "positive" or "negative" result. This will provide patients and clinicians with much greater clarity and appropriately guide next steps, eliminating the indecision of a "borderline" result. Finally, the protein biomarkers in the new test are more accurate, reducing reliance on CA19-9. The IMMray(TM) PanCan-d excluded about 10% of patients because they had a genetic mutation that prevents them from producing CA19-9. This genetic mutation is particularly prevalent in people of African ancestry and Hispanic ethnicity. With our next-generation test we expect to provide a test for the full population of individuals at risk, further expanding the commercial opportunity.
These results confirm we made the right decision in shifting our focus from IMMray(TM) PanCan-d to the new test. We now have a test that includes more accurate biomarkers, outperforms CA19-9, expands the market relative to the IMMray test, and offers a much better chance to secure reimbursement and drive commercial success.
We are moving much faster and are completing promised milestones on time
In
We have transitioned to the lower-cost, more reliable ELISA testing platform
In the first quarter, we largely completed the transition from the proprietary IMMray platform to ELISA. The benefits are clear. Lab results prove the ELISA assays are more accurate and more reproducible than IMMray assays. The new ELISA assays will also reduce turnaround time for the commercial test to 1 or 2 days. Finally, the new platform has much lower fixed costs and will reduce our cost per test.
Our cash burn is in line with expectations and we have a plan to raise capital
First quarter 2024 cash burn averaged 8.7 MSEK per month, in line with our forecast. We have dramatically reduced our staffing costs and operating expenses, as cuts made in 2023 began to deliver the expected savings. 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(TM) Pan-Can-d product. The
Our team is performing at a very high level
Over the past year we reduced staffing by nearly 80% and had only 11 full-time employees as of the end of the first quarter. The team includes top performers from
Our next steps are clear, and we have well-defined plans to bring the next-generation test to market
We will now move to a second phase of the model development study, expected to be completed in June. In the second and third quarters, we will perform several analytical validation steps to verify the accuracy and reproducibility of the protein assays. In the fourth quarter, we will initiate a large clinical validation study to confirm the performance of the next-generation test, which we expect to complete in Q1 2025. We also will partner with leading pancreatic cancer researchers on additional clinical studies starting in early 2025 to support a commercial launch in 2025 as well as future reimbursement.
The market need for an early detection test remains very strong and we are rapidly making progress to meet this need
Market demand for a blood test to detect pancreatic cancer remains very strong. Leading experts in the field confirm the incredible patient desire for a blood test to simplify surveillance. Clinicians who monitor high-risk individuals understand the burdens of annual imaging and are eager to have a blood test to make surveillance faster and more convenient for patients. Meeting this need will enable us to drive volume, revenue, and shareholder value.
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: creo-live.creomediamanager.com/b493ca7a-4f83-40f5-85aa-b9e5e7503b63
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https://news.cision.com/immunovia-ab/r/immunovia-publishes-interim-report-for-january-march-2024,c3969381
https://mb.cision.com/Main/13121/3969381/2765879.pdf
https://mb.cision.com/Public/13121/3969381/9b566cb199fa463c.pdf
https://news.cision.com/immunovia-ab/i/table,c3294846
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