April-
- Net sales amounted to kSEK 103 (38) divided between sales of tests kSEK 45 and royalties kSEK 58
-
Net earnings amounted to MSEK -33 (-49) and earnings per share before and after dilution were
SEK -1.49 (-2.18) - Cash flow from operating activities amounted to MSEK -41 (-34)
- Cash and cash equivalents at the end of the period amounted to MSEK 197 (382)
- In April Immunovia submitted the application for CPT PLA Code for the IMMray(TM) PanCan-d test
-
The Annual General Meeting on
April 7th electedEric Krafft andPhilipp von Hugo as new board members.Ann-Christine Sundell ,Mimmi Ekberg and Christofer Sjögren had declined re-election. The other board members were re-elected. -
On
May 16 ,Natalie Carfora was appointed as Head of Market Access,Immunovia, Inc. -
In
May Immunovia, Inc. achieved Clinical Laboratory Licensure fromRhode Island Dept of Health from IMMray(TM) PanCan-d test -
In
May Immunovia, Inc. achieved Clinical Laboratory Permits fromPennsylvania and Maryland Departments of health for IMMray(TM) PanCan-d test -
On
June 2 ,Philipp Mathieu was appointed Chief Executive Officer and President sinceJanuary 2022 - In June partly inconclusive results from the Pan-FAM-1 study were announced
- In June Immunovia announced that the PanDIA-1 study for early detection of pancreatic cancer in newly onset diabetes moved into the next phase
Significant events after the period
- In
June Immunovia, Inc. had CPT PLA code for the IMMray(TM) PanCan-d test approved -
In
August Immunovia, Inc. issued Clinical and Public Health Laboratory License fromCalifornia Dept of Public Health for IMMray(TM) PanCan-d test
CEO's comments
During Q2
During the second quarter,
In the pursuit of additional clinical validation of IMMray(TM) PanCan-d we announced PanFAM-1 results and provided and update on PanDIA-1. During PanFAM-1, IMMray(TM) PanCan-d met its primary endpoint of test specificity comparable to imaging in the study. The study, however, was partly inconclusive since sensitivity could not be evaluated due to the low number of PDACs among study participants. We certainly had aimed for more tangible results of the study, but have gained important learnings from PanFAM-1, which together with our ongoing discussions with payers will inform the way forward in establishing further clinical validation in this risk group.
We also provided an update on PanDIA-1, one the largest studies for the early detection of pancreatic cancer in newly onset type 2 diabetics. The study aims to give another substantial risk group for pancreatic cancer access to early detection. The prevalence of diabetes is dramatically increasing worldwide, and newly diagnosed diabetics have up to 8 times higher risk of getting pancreatic cancer. PanDIA-1 is now moving into a decisive next phase and during the second half of 2022 we will initiate the analysis of samples from the included patients.
To continue our mission making IMMray(TM) PanCan-d broadly available on the US market, we initiated a physician experience program in the US, which is now almost fully enrolled at selected pancreatic cancer high-risk-surveillance centers. The program commenced in May and has enrolled more than 20 established surveillance centers. It aims to drive familiarity and adoption amongst physicians who together with other key opinion leaders is expected to play a critical role as advocates for our test with payers.
In April we submitted a CPT PLA Code application for the IMMray(TM) PanCan-d test to the
During the quarter
For more information, please contact:
CEO and President
Email: philipp.mathieu@immunovia.com
Karin Almqvist Liwendahl
Chief Financial Officer
Email: karin.almqvist.liwendahl@immunovia.com
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://link.edgepilot.com/s/9134565d/n4saifQXgEG99MipSw3ORw?u=http://creo-live.creomediamanager.com/6074dc43-43a2-4f11-9bff-9647548664fd
About
Our first product, IMMray(TM) PanCan-d is the only blood test currently available for early detection of pancreatic cancer. The test has unmatched clinical performance. Commercialization of IMMray(TM) PanCan-d started in
The
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