July-
- Net sales amounted to KSEK 488 (358) divided by sales of tests KSEK 70 (111) and royalties KSEK 418 (247).
-
Net earnings were MSEK -38.6 (-22.9) and earnings per share before and after dilution were
SEK -0.91 (1.01). - Cash Flow from operating activities amount to MSEK -35 (-37).
- Cash and equivalents at the end of the period amounted to MSEK 107 (159).
-
On
July 11 , the Company announced that it will cease commercialization of IMMray(TM) PanCan-d test inthe United States to focus its resources on development of the next-generation pancreatic cancer detection test.
Significant events after the period
- On
October 3 , the Company informed that a Nomination Committee has been appointed to consist of the following persons who together represent 7.52 percent of the number of shares and votes in the company as ofSeptember 30, 2023 :Sara Ek , Carl Borrebaeck andMats Leifland ,Sara Ek being appointed Chair of the nomination Committee. -
On
October 27 , the Company gave notice that an extraordinary general meeting will take place onNovember 21, 2023 . -
On
November 7 the company announced that the discovery phase of next generation test developme- nt is successfully completed.
CEO's comments
During the third quarter we made significant changes to streamline
Our transformation is nearly complete and
Following the July announcement that we would discontinue selling the IMMray(TM) PanCan-d test, we moved quickly to transform
We have transformed
- We discontinued the sale of IMMray(TM) PanCan-d. We notified physicians and patients of the change, taking care to maintain relationships with clinicians and the trust of our patients. It is now clear that this was the right decision. Customers lauded our transparency and have consis- tently expressed their ongoing support for
Immunovia and our mission. -
We transitioned away from the proprietary IMMray testing platform. We shuttered the produc- tion facility in
Lund, Sweden where we previously produced the slides and antibodies to run the IMMray(TM) PanCan-d test. Discontinuing the IMMray platform will enable us to cut fixed costs, decrease cost of goods sold, and scale clinical testing in the future. -
We initiated and carried out significant staff reductions. Discontinuing production in
Lund led to significant staffing cuts. In theU.S. , we laid off our sales, customer service and lab teams. Overall, we reduced the number of employees from 64 a year ago to 25 by the end of the third quarter. Once the remaining terminations are complete by year end, we will have 11 employees, down 82% from the prior year. - We aggressively cut expenses. In the third quarter we still carried costs relating to discontinu- ation of IMMray(TM) PanCan-d and restructuring, but started to see a positive trend for personnel costs, which decreased sequentially and year-over-year. We expect this trend to continue in the fourth quarter and we also expect other operating costs to decrease.
As we near the end of this transformation, the new
Development of our next-generation test is progressing well
As we announced, we have successfully completed the crucial discovery stage of development for our next-generation test. We found more than a dozen proteins circulating in the blood that identified patients with stage I and stage II PDAC (pancreatic ductal adenocarcinoma). Conducted using the
The discovery study was completed quickly thanks to
We have already begun the model building stage of the R&D process. In this phase, we will develop reliable assays to measure the target proteins. These assays will be conducted on an ELISA platform, which will reduce costs and improve scalability.
During the current model building stage, we will also select the final biomarkers to be used in the commercial test. By Q2 2024 we will complete a training and an initial validation study to optimize the test and assess its sensitivity and specificity. Later in 2024,
Our progress in developing the next-generation test has been powered by
The experience, assets, and relationships
We are actively pursuing partnerships
As I noted in our second quarter report, partnerships will be crucial to our success.
To generate sufficient clinical data on our new test to support reimbursement, we will partner with leading academic institutions and research consortia. These groups are conducting large clinical studies in the early detection of pancreatic cancer in high-risk individuals. By partnering with them, we can study our product in more patients, for a longer time, at a much lower cost than conducting our own proprietary studies. Conversations with these groups are progressing well and we expect to announce research partnerships in the first quarter of 2024.
Commercializing our next generation test will require partnership as well. We will seek a partner with existing selling capacity and established relationships with our target clinicians. This will enable us to accelerate test adoption and bring our next-generation test to market without shouldering the full expense of our own sales organization. We can be an attractive partner to a company looking to bolster its product portfolio with an accurate test targeting a large market with significant unmet clinical needs. Securing a strategic partner is the primary focus for the remainder of 2023 and 2024.
We face challenges, but we are fueled by our clinical mission and our desire to serve our stakeholders.
Our transformation into a much more cost-efficient company is nearly complete and we are making excellent progress on our new test. Still, we clearly face challenges, most importantly a difficult financial market. We are working hard to outline a compelling vision for the company and to regain investor trust by delivering on our commitments. We are focused on execution, leveraging our new lean and agile structure to drive development of our next test. We will capitalize on our legacy assets, while collaborating with partners who augment our strengths. Ultimately, we plan to address the significant unmet clinical need for early detection of pancreatic cancer and to reward shareholders for their commitment and support.
For more information, please contact:
CEO and President
jeff.borcherding@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
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