LUND,
Sweden, Nov. 10, 2022 /PRNewswire/ --
July-September 2022
- Net sales amount KSEK 358 (377) divided by sales of tests KSEK
111 and royalties KSEK 247.
- Net earnings amount MSEK -23 (-36) and earnings per share
before and after dilution were SEK – 1.01 (-1.60)
- Cash Flow from operating activities amount MSEK -37 (-38).
- Cash and equivalents at the end of the period amounted to MSEK
159 (339).
- On July 5 the Company informed
that a CPT PLA Code for the IMMray™ PanCan-d test was approved from
the American Medical Association (AMA). The code will be effective
from October 1, 2022.
- On August 11 the Company informed
that the California Department of Public Health had granted
Immunovia, Inc., the American subsidiary of Immunovia AB, a
Clinical and Public Health Laboratory license, allowing physicians
in California to order the IMMray
PanCan-d test for their patients.
- On September 26 the Company
announced, that the Centers for Medicare & Medicaid Services
(CMS) published a preliminary payment determination implying a
price of $897 for the IMMray PanCan-d
test.
Significant events after the period
- On October 12 the Company
announced positive feedback from its physician experience program
for the IMMray™ PanCan-d test in the U.S. The program has included
23 high risk surveillance centers around the U.S. thus far, and
physicians have showed substantial interest in the use of IMMray™
PanCan-d to detect early-stage pancreatic cancer.
- On October 17 the Company
announced that it enters into a strategic partnership with
Proteomedix to leverage the parties joint development experience in
diagnostic technologies for the detection of cancer.
- On October 19 the Company
announced executive management changes to accelerate execution of
strategic priorities.
- On October 20 the Company
announced that the Nomination Committee for the 2023 Annual
General Meeting has been determined to consist of the following
persons who together represent 13.46 percent of the number of
shares and votes in the company: Ranny Davidoff, Carl Borrebaeck,
Peter Lindvall and Mats
Leifland.
CEO's comments
Q3 has been a quarter focussed on commercial execution and
taking further steps towards reimbursement to make our innovative
IMMRay PanCan-d test, the first dedicated test for early detection
of pancreatic cancer, broadly available in the US.
After receiving approval for a Proprietary Laboratory Analyses
(PLA) code from the American Medical Association (AMA) for the
IMMray™ PanCan-d test we entered the process with the Centers of
Medicare & Medicaid Services (CMS) to establish payment for the
test. In September, CMS followed our recommendation and published a
preliminary payment determination implying a price of $897. This rate appropriately values our
innovative test. While this does not represent a coverage
determination to reimburse the IMMray PanCan-d test, it is an
important step in the process of securing reimbursement for our
test. We anticipate CMS to finalize its basis for the payment
decision during November.
The newly obtained Clinical and Public Health Laboratory license
from the California Department of Public Health now allows
physicians in California to order
the IMMray PanCan-d test for their patients and expands the
availability of our test to 49 out of 50 US states. This is another
step towards increasing availability and adoption of our diagnostic
test.
We further expanded our physician experience program for the
IMMray PanCan-d test targeting more than 20 high risk surveillance
centers around the US. Immunovia's physician experience program has
been designed for providers to gain clinical experience using the
IMMray PanCan-d test. Our novel test continues to be broadly
adopted by physicians at those high risk surveillance centers and
has contributed to more patients getting screened for early-stage
pancreatic cancer. We anticipate completion of the initial
physician experience program by year end.
In October, we entered into a strategic partnership with
Proteomedix, a Switzerland-based
proteomics-focused diagnostics company, with the purpose to
leverage both companies´ substantial joint development experience
in diagnostic technologies for the detection of cancer. This
partnership with Proteomedix will combine leading proteomics-based
researchers with state-of-the art capabilities from both companies
to create an outstanding R&D platform and will enable us to
focus on the commercialization of the IMMray™ PanCan-d test in the
US while maximizing our R&D productivity.
On October 19 we announced
executive management team changes to accelerate execution of
strategic priorities.
During Q3 we continued to deliver on our previously communicated
strategic priorities. Our significantly strengthened US team
successfully executes the commercial US launch of IMMRay PanCan-d
test. The positive feedback from physicians and patients is highly
encouraging and further motivates us. We are fully committed to
our mission to increase the number of patients that get diagnosed
early enough to have surgical resection of their tumor and increase
their survival rates.
November 10, 2022
Philipp Mathieu, CEO and
President
Immunovia AB
For more information, please contact:
Philipp Mathieu
CEO and President
philipp.mathieu@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
10, 2022.
Conference call
Immunovia will hold a webcast tele conference at 14:00 pm CET on November
10 with President and CEO Philipp
Mathieu, CEO Immunovia, Inc. 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://link.edgepilot.com/s/5c6b60a2/OaUB5Q9ASkeASYHQ8QIopQ?u=http://creo-live.creomediamanager.com/8c2be08d-5469-401d-bc5f-cb5024ef45d0
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.
The following files are available for download:
https://mb.cision.com/Main/13121/3664402/1660264.pdf
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Immunovia interim
report January-September 2022 (PDF)
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SOURCE Immunovia AB