LUND, Sweden, Aug. 24, 2022 /PRNewswire/ --
April-June 2022
- 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™ PanCan-d test
- The Annual General Meeting on April 7th elected Eric Krafft and Philipp
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
from Rhode Island Dept of Health
from IMMray™ PanCan-d test
- In May Immunovia, Inc. achieved Clinical Laboratory Permits
from Pennsylvania and Maryland
Departments of health for IMMray™ PanCan-d test
- On June 2, Philipp Mathieu
was appointed Chief Executive Officer and President since
January 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™
PanCan-d test approved
- In August Immunovia, Inc. issued Clinical and Public Health
Laboratory License from California Dept of Public Health for
IMMray™ PanCan-d test
CEO's comments
During Q2 Immunovia built on our front-runner position in early
detection of pancreatic cancer to ensure the execution of a
successful commercial US launch by significantly strengthening our
US team through the addition of new highly experienced hires. We
have also broadened market access to IMMray™ PanCan-d for patients
in additional US states and obtained a unique CPT PLA code for our
test on the way to reimbursement.
During the second quarter, Immunovia continued to execute on the
previously communicated strategic priorities for 2022.
Immunovia is currently in the scale-up phase of its US
commercial organisation to facilitate a successful launch of
IMMray™ PanCan-d. Our US team was significantly strengthened
through Jeff Borcherding, previously
Chief Marketing Officer at Myriad Genetics, joining in April to
lead our US business and the US commercialization efforts, as well
as the hire of Natalie Carfora as
Head of Market Access US. Having Jeff and Natalie on board with
their combined industrial experience, I feel that we have a solid
platform enabling us to grow our brand and diagnostic business in
the US market.
In the pursuit of additional clinical validation of IMMray™
PanCan-d we announced PanFAM-1 results and provided and update on
PanDIA-1. During PanFAM-1, IMMray™ 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™ 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™
PanCan-d test to the American Medical Association, which was
approved at the beginning of July. The physician experience
program, continued collaborations with key opinion leaders and
having attained the PLA code, are all important steps in executing
our US reimbursement plan.
During the quarter Immunovia has firmly continued the journey to
penetrate the US market and generate significant growth. We have a
clear path forward and an industry leading team in place focused on
our mission to enable broad access to early detection. Improving
pancreatic cancer survival rates is hugely motivating and
continuously driving us forward.
August 24, 2022
Philipp Mathieu, CEO and
President
Immunovia AB
For more information, please contact:
Philipp Mathieu
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 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 August 24,
2022.
Conference call
Immunovia will hold a webcast tele conference at 13:00 pm CET on August
24 with President and CEO Philipp
Mathieu 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://link.edgepilot.com/s/9134565d/n4saifQXgEG99MipSw3ORw?u=http://creo-live.creomediamanager.com/6074dc43-43a2-4f11-9bff-9647548664fd
About Immunovia
Immunovia AB is a diagnostic company with the vision to
revolutionize blood-based diagnostics and increase survival rates
for patients with cancer.
Our first product, IMMray™ PanCan-d is the only blood test
currently available for early detection of pancreatic cancer. The
test has unmatched clinical performance. Commercialization of
IMMray™ PanCan-d started in August
2021 in the USA and IMMray™
PanCan-d is offered as a laboratory developed test (LDT)
exclusively through Immunovia, Inc. For more information
see: www.immunoviainc.com.
Immunovia collaborates and engages with healthcare providers,
leading experts and patient advocacy groups globally to make this
test available to all high-risk pancreatic cancer groups.
The USA, the first market in
which IMMray™ PanCan-d is commercially available, is the world's
largest market for the detection of pancreatic cancer with an
estimated value of more than USD 4
billion annually.
Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For
more information, please visit www.immunovia.com.
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/immunovia-ab/r/immunovia-publishes-interim-report-jan-june-2022,c3618560
The following files are available for download:
https://mb.cision.com/Main/13121/3618560/1617967.pdf
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Immunovia Interim
Report January-June 2022
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https://mb.cision.com/Public/13121/3618560/a9d9bc74886ab9ae.pdf
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Press release
(PDF)
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