Immunovia AB: Immunovia Publishes Interim Report Jan-Sep 2022

2022-11-10 08:30:00
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.

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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 70911 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 visitwww.immunovia.com.

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