0G8X Immunovia Ab (publ)

LUND, Sweden, Feb. 23, 2023 /PRNewswire/ -- 

October-December 2022           

• Net sales amount kSEK 502 (305) divided by sales of tests kSEK 190 (278) and royalties kSEK 312 (27).
• Net earnings amount MSEK -67 (-47) and earnings per share before and after dilution were SEK -2.97 (-2.08).
• Cash Flow from operating activities amount MSEK -51 (-50).
• Cash and equivalents at the end of the period amounted to MSEK 106 (287).
• On October 12, the Company announced a positive update on its physician experience program with IMMray™ PanCan-d. Thus far 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 a strategic partnership with Proteomedix to leverage the joint R&D efforts skills of both companies allowing for increased focus on commercialization within Immunovia.
• On October 19, the Company announced executive management team changes to accelerate the execution of strategic priorities.
• On October 20, the Company announced that the Nomination Committee had been appointed for the 2023 Annual General Meeting and consist of Ranny Davidoff, Carl Borrebaeck, Peter Lindvall and Mats Leifland, who together represent 13.46 percent of the number of shares and votes in the company as of September 30, 2022.
• On November 16, it was announced that CEO, Philipp Mathieu, had purchased 150,000 warrants of the 2022/2026 scheme for approximately 297 kSEK.
• On November 30, the Company announced that Centers for Medicare & Medicaid Services finalized its payment determination and had set a rate of $897 for Immunovia's IMMray™ Pan- Can-d test.
• On December 5, the Company announced that its U.S. subsidiary, Immunovia Inc., had appointed Jon Hager as new National Sales Director.

Significant events after the period

• On January 17, the Company appointed Lara E. Sucheston-Campbell as Head of Clinical and Medical Affairs to Accelerate Commercial strategy of IMMray™ PanCan-d test in the US market.
• On January 19, the Company informed about the realignment of the Swedish operations and that a union consultation process had been initiated with the aim of reducing the number of employees within R&D and Operations in Lund.
• On February 8, the Company announced that the consultation process regarding realigning its Swedish operations, announced on 19 January 2023, has been completed.
• On February 20, the Company announced a rights issue of approximately SEK 202.2 million and postponed the publication of the quarterly report for the first quarter and the annual general meeting.

CEO's comments

In Q4, Immunovia continued to execute on its unique position as a leader in innovative early detection of pancreatic cancer. Immunovia's IMMray™ PanCan-d test is the first ever blood test dedicated to early detection of pancreatic cancer, addressing a significant unmet medical need. We reached important milestones in 2022: the first full year that IMMray™ PanCan-d was commercially available in the US, significant progress in driving adoption and important advancements in pursuing reimbursement for our test.

We remain committed to changing the paradigm for early diagnosis of pancreatic cancer by further advancing and improving our commercial and operational capabilities in the US market to ultimately increase the survival rates for one of the deadliest types of cancer.

Looking back at 2022, our team delivered on all our strategic priorities and built out the commercial team supporting a successful product launch in the US, which is our core market. Our commercial teams' expansion included the addition of Jeff Borcherding, who joined Immunovia in April as the CEO of our US business and brings extensive experience in growing diagnostic businesses from a broad range of commercial leadership roles in the US market. We made additional key recruitments including a new Head of Market Access as well as a Head of Clinical and Medical Affairs more recently. Our expanding commercial team will broaden the market access to IMMray™ PanCan-d and ensure its affordability for as many individuals as possible.

We are focused on ensuring as many patients as possible can benefit from our test. Enabling patient access to our test by broadly rolling it out and securing reimbursement are key in this mission. We are actively pursuing reimbursement for our test with both private, commercial insurances as well as public healthcare insurance schemes in the US. Attaining reimbursement for our test requires both regulatory steps (such as obtaining the required approvals for our laboratory, a unique identifier code etc.) as well as technology validation, demonstrating clinical utility and ensuring physician advocacy for our test with insurances. We have made significant progress on all those aspects over the last year and are currently in advanced reimbursement discussions with various health insurances.

Progress over the past year included receiving Clinical and Public Health Laboratory licenses in all except one state in the US. As of today, only the license in New York state is outstanding, which we are aiming to secure. Licenses enable physicians in a particular state to order the IMMray™ PanCan-d test for their patients and are an important step towards increasing the availability and adoption of our test.

In March, our laboratory in Marlborough, Massachusetts, received accreditation from the College of American Pathologists. In June, we received approval for a Current Procedural Terminology (CPT) Proprietary Laboratory Analyses (PLA) code from the American Medical Association (AMA) for the IMMray™ PanCan-d test. The PLA code became effective on October 1, 2022. CPT codes are the most widely accepted medical nomenclature used in the US to report physician and healthcare professional services, including laboratory tests under public and private health insurance programs and are a necessary and important step on the path towards reimbursement.

Following the approval of the PLA code, we entered the process with the Centers for Medicare & Medicaid Services (CMS) to obtain a payment determination for our test. In November, we received the final payment determination at a rate of $897 from CMS for our IMMray™ PanCan-d test which brings us one step closer to reimbursement. CMS' payment determination not only appropriately values our test at an attractive rate for Immunovia but also serves as a price reference point in future pricing discussions with commercial payers. Our test has now been included in the 2023 CMS Clinical Lab Fee Schedule at that price, which became active at the beginning of 2023. This price level highlights the value of the market niche Immunovia is targeting and was a welcome approval.

In our mission to drive patient access and physician advocacy for our test during 2022 Immunovia also continued to drive adoption and familiarity with IMMray™ PanCan-d amongst physicians by conducting a physician experience program. The program was designed for providers to gain clinical experience using the IMMray™ PanCan-d test and to collect additional data supporting clinical utility of our test. Feedback from participating physicians suggests IMMray™ PanCan-d is an important test for the early detection of pancreatic cancer that could be integrated into regular patient care. The program included twenty-three high risk surveillance centers around the U.S.

We reported updates from our clinical programs, including results from our PanFAM-1 study and our PanDIA-1 study. The PanFAM-1 study was a prospective, multi center, investigational study, designed to assess the performance of the IMMray™ PanCan-d test in early detection of pancreatic ductal adenocarcinoma (PDAC) in high-risk populations. The IMMray™ PanCan-d test met its primary endpoint of test specificity comparable to imaging in the study. Sensitivity, however, could not be evaluated due to the low number of PDACs among study participants. We also provided an update on the PanDIA-1 study which moved into its next phase using one of the largest, comprehensive prospective sample collections for early detection of pancreatic cancer in new onset type 2 diabetics to further develop and validate our test for this large risk group.

In the current phase of being an early commercial company it is critical for Immunovia to focus internal resources on strengthening its commercial development in the US and accelerate the rollout of IMMray™ PanCan-d while maximizing R&D productivity. For this reason we launched a strategic partnership with Proteomedix, a Switzerland-based proteomics company and an expert in proteomics-based oncology diagnostics. This collaboration leverages the substantial joint development experience in diagnostic technologies for the detection of cancer and provides Immunovia with a more flexible and efficient R&D organization.

To summarize 2022, we sharpened our focus on pancreatic cancer and commercializing the IMMray™ PanCan-d test in the US market and I am very proud of what the Immunovia team has achieved, delivering on our strategic priorities by:

• Substantially strengthening our US organization to enable rapid commercial growth
• Receiving a Clinical Laboratory License in all US states but one
• Receiving a CPT PLA code for our test
• Receiving a final payment determination of $897 from Centers for Medicare & Medicaid Services, which appropriately values our innovative test
• Launching a strategic R&D partnership with Proteomedix

All of the above are critical and very promising milestones in the US market development for our test paving the way for rapid, future growth.

Looking into 2023, I am very confident that the continued execution of our strategy will result in further increasing adoption of our test through heightened awareness and initial successes in obtaining reimbursement as well as a broadening of the clinical validation of our test for the current and additional risk groups within pancreatic cancer.

I want to thank our stakeholders for their continued support and look forward to a new year with further major milestones in improving pancreatic cancer survival rates.

February 23, 2023
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 February 23, 2023.

Conference call

Immunovia will hold a webcast tele conference at 11:00 pm CET on February 23 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/94d445d8/kGg7TnRc0kW8IMCMe-92zw?u=http://creo-live.creomediamanager.com/d1d6a3da-b961-48c9-beb8-3d4026f05d6f

About Immunovia 
Immunovia 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, addressable market size of 1.8 million individuals per year who could benefit from our test.

Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com.

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