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Immunovia Publishes Interim Report for January-June 2023

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LUND, Sweden, Aug. 30, 2023 /PRNewswire/ — 

April-June 2023           

  • Net sales amounted to kSEK 412 (103) divided by sales of tests kSEK 351 (45) and royalties kSEK 61 (58).
  • Net earnings were MSEK -170 (-34) and earnings per share before and after dilution were SEK -4.00 (-1.49).
  • Earnings during the second quarter has been charged with SEK 141 million, which mainly consist of non-cash flow one-off costs such as depreciation and write-downs of intangible assets as a result of the decision to cease commercialization of the IMMray™ PanCan-d test in the US, but also termination and severance pay which will have a cash impact.
  • Cash Flow from operating activities amounted to MSEK -43 (-41).
  • Cash and equivalents at the end of the period amounted to MSEK 144 (197).
  • On April 12, the Company announced the outcome of the rights issue. The Rights Issue was subscribed to 75.1 percent and Immunovia thereby received approximately MSEK 151.8 before issue costs.
  • On April 25, the Company gave notice for the Annual General Meeting on Friday 26th May 2023.
  • On April 26, the Company announced a discussion on adoption of IMMray™ PanCan-d with key opinion leaders held on May 3.
  • On April 29, the Company announced the appointment of Jeff Borcherding as global CEO replacing Philipp Matthieu.
  • On May 6, the Company announced that the board member Philipp von Hugo resigned from Immunovia’s board at his own request.
  • On May 22, the Company informed on changes to the Nomi- nation Committee’s proposal to the Annual General Meeting 2023 and in addition to the previously proposed re-election of Peter Høngaard Andersen, the Nominating Committee proposed re-election of Hans Johansson and Martin Møller and new election of Michael Löfman.
  • On May 26, the Company published the summary of the resolutions made at the Annual General Meeting 2023.
  • On May 31, the Company informed that, as a result of new shares being issued in the rights issue the number of outstanding shares and votes have increased by 22,655,917, from 22,631,581 to 45,287,498.
  • On June 9, the Company informed that Jeff Borcherding, CEO of Immunovia, purchased 350 000 shares for approximately kSEK 670.

 Significant events after the period

  • On July 11, the Company announced that it will cease commercialization of IMMray™ PanCan-d test in the United States to focus resources on development of the next generation pancreatic cancer detection test.

CEO’s comments

As announced in July, we are significantly restructuring Immunovia to focus on our novel next-generation test for detection of pancreatic cancer. These changes are difficult but necessary to improve the company’s runway and strengthen our product offering. We continue to move quickly to streamline our operations, develop our next-generation test, and optimize our cost structure. Development of the next-generation is progressing well, and we expect to conduct clinical studies during 2024.

We are rapidly creating a new Immunovia grounded in our existing strengths. We are true to our vision, we have unique assets, we are cost efficient, and we are focused on our clinical mission: to save lives through early detection of pancreatic cancer.

External and internal challenges required significant action

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Our strategic reset was triggered primarily by three key external challenges. First, private insurers and government payers in the U.S. require extensive clinical evidence supporting the accuracy and clinical utility of diagnostic tests before they are willing to pay for those tests. Second, proving clinical utility in pancreatic cancer detection is difficult, often requiring large studies conducted over many years. To demonstrate clinical utility in a prospective study at a reasonable cost, we must participate in large studies conducted by a consortium of sites. These trials will likely study more than one test, including other commercial assays and CA19-9 alone. We must be confident that our test will succeed in this comparison. Third, overall access to capital has declined significantly, especially for pre-profit companies like Immunovia.

These external dynamics amplified internal product and financial challenges at Immunovia. Our product, the IMMray™ PanCan-d test, was limited by its reliance on CA19-9, one of the biomarkers in the test. CA19-9 is also not produced by about 10% of the general population, preventing the use of the test in these patients. Worse, the inability to produce CA19-9 disproportionately impacts certain people, including those of African ancestry and Hispanic ethnicity. These populations also show a higher prevalence of pancreatic cancer. As a result, we have both a moral and clinical obligation to serve these individuals equally and eliminate healthcare disparities. We could not do so with our first-generation IMMray™ PanCan-d test.

Financially, our prior efforts to reduce operating costs were not sufficient. Commercializing the IMMray™ PanCan-d test required a significant investment in selling and marketing in the U.S. Producing testing supplies for the proprietary IMMray platform also resulted in substantial labor and materials costs in Lund.

These dynamics led the Board and management to conclude that the best and most viable path forward was to discontinue selling the current IMMray test, significantly reduce expenses, and focus resources on developing and testing our next-generation product.

Our next-generation test provides reason for optimism

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Despite these tough decisions, I am excited about the promise of our next-generation test for the early detection of pancreatic cancer. The test will incorporate new biomarkers identified through a discovery study evaluating thousands of proteins circulating in the blood. The new test is being designed to work across racial and ethnic groups without compromising accuracy. It will be conducted on a commercially available lab testing platform, achieving scale, reducing fixed costs, and lowering future cost of goods sold.

We have strong assets moving forward: Development expertise, an extensive sample bank and strong relationships

The experience, assets, and relationships Immunovia has built over the years will enable us to accelerate development of the next generation test. For example, our research and development partnership with Proteomedix is highly productive and gives us access to leading experts in proteomics test development. We have accumulated thousands of blood samples which we will use to develop and test our new product. Relationships with investigators, key opinion leaders and advocacy associations in the U.S. and Europe will enable us to test the assay in clinical studies that these investigators are leading. In summary, Immunovia maintains unique strengths to solve the clinical challenge of early detection of pancreas cancer.

We are dramatically improving our cost structure

In parallel with increasing our focus on the next-generation product, we are optimizing our cost structure in a significant way by reducing staffing and operating expenses. We forecast that our burn rate will be in the range of 25-30 MSEK per quarter beginning in Q1 2024, down 15-20 MSEK vs. Q1/Q2 2023. After accounting for transition costs of approx. 20 MSEK, we expect to have sufficient cash to support operations well into 2024.

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Earnings during the second quarter has been charged with SEK 141 million, which mainly consist of non-cash flow one-off costs such as depreciation and write-downs of intangible assets, but also termination and severance pay which will have a cash impact.

Going forward, we will benefit from lower fixed costs and reduce our cost of goods sold by transitioning from the proprietary IMMray platform, which required in-house production of arrays and other supplies, to a commercially available platform.

We have a clear vision for achieving our mission

Our mission has not changed: We will save lives through early detection of pancreatic cancer. What has changed is how we achieve our mission. Going forward, Immunovia will be leaner and more capital efficient.

Critically, we will partner at nearly every stage of the product life cycle to leverage the expertise of our collaborators and reduce costs. For product development, we will continue to partner with Proteomedix. For clinical research, we will partner with investigators and research consortia who are conducting early detection trials. For production, we will transition from the high-cost, proprietary IMMray testing platform to a widely used approach called ELISA. Finally, we will explore a variety of options to commercialize the new test in order to drive awareness and adoption in a less capital-intensive way.

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We are creating a very different Immunovia-one that is leaner, more agile, more cost-conscious, and more connected to our customers and patients. I realize the journey to this point has been very difficult for our investors, stakeholders, and employees. Please know that we are working hard to create the company that will reward you for your investment in Immunovia.

August 30, 2023
Jeff Borcherding, CEO and President
Immunovia AB

For more information, please contact:
Jeff Borcherding
CEO and President
[email protected]

Karin Almqvist Liwendahl
Chief Financial Officer
[email protected]
+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 August 30, 2023.

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Conference call

Immunovia will hold a webcast tele conference at 15:00 CET on August 30 with President and CEO 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

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United States: +1 631 570 56 13

Link to the webcast: https://link.edgepilot.com/s/55898572/0v6JeODzJ0OaR5rjK1wJ1g?u=https://creo-live.creomediamanager.com/0916b506-5ec6-4678-b83a-ab16e40022e3

Immunovia in brief

Immunovia AB is a diagnostic company whose mission is to increase survival rates for patients with pancreatic cancer through early detection. Immunovia is focused on the development and commercialization of simple blood-based testing to detect proteins and antibodies that indicate a high-risk individual has developed pancreatic cancer.

Immunovia collaborates and engages with healthcare providers, leading experts and patient advocacy groups to make its test available to individuals at increased risk for pancreatic cancer.

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USA is the world’s largest market for detection of pancreatic cancer. The company estimates that in the USA, 1.8 million individuals are at high-risk for pancreatic cancer and could benefit from annual surveillance testing.

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

CONTACT:

The following files are available for download:

 

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Invitation to presentation of EQT AB’s Q1 Announcement 2024

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STOCKHOLM, April 5, 2024 /PRNewswire/ — EQT AB’s Q1 Announcement 2024 will be published on Thursday 18 April 2024 at approximately 07:30 CEST. EQT will host a conference call at 08:30 CEST to present the report, followed by a Q&A session.

The presentation and a video link for the webcast will be available here from the time of the publication of the Q1 Announcement.

To participate by phone and ask questions during the Q&A, please register here in advance. Upon registration, you will receive your personal dial-in details.

The webcast can be followed live here and a recording will be available afterwards.

Information on EQT AB’s financial reporting

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The EQT AB Group has a long-term business model founded on a promise to its fund investors to invest capital, drive value creation and create consistent attractive returns over a 5 to 10-year horizon. The Group’s financial model is primarily affected by the size of its fee-generating assets under management, the performance of the EQT funds and its ability to recruit and retain top talent.

The Group operates in a market driven by long-term trends and thus believes quarterly financial statements are less relevant for investors. However, in order to provide the market with relevant and suitable information about the Group’s development, EQT publishes quarterly announcements with key operating numbers that are relevant for the business performance (taking Nasdaq’s guidance note for preparing interim management statements into consideration). In addition, a half-year report and a year-end report including financial statements and further information relevant for investors is published. Finally, EQT also publishes an annual report including sustainability reporting.

Contact
Olof Svensson, Head of Shareholder Relations, +46 72 989 09 15
EQT Shareholder Relations, [email protected]

Rickard Buch, Head of Corporate Communications, +46 72 989 09 11
EQT Press Office, [email protected], +46 8 506 55 334

This information was brought to you by Cision http://news.cision.com

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https://news.cision.com/eqt/r/invitation-to-presentation-of-eqt-ab-s-q1-announcement-2024,c3956826

The following files are available for download:

https://mb.cision.com/Main/87/3956826/2712771.pdf

Invitation to presentation of EQT AB’s Q1 Announcement 2024

https://news.cision.com/eqt/i/eqt-ab-group,c3285895

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EQT AB Group

 

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Kia presents roadmap to lead global electrification era through EVs, HEVs and PBVs

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  • Kia drives forward transformation into ‘Sustainable Mobility Solutions Provider’
  • Roadmap enables Kia to proactively respond to uncertainties in mobility industry landscape, including changes in EV market
  • Company to expand EV line-up with more models; enhance HEV line-up to manage fluctuation in EV demand
    • Goal to sell 1.6 million EVs annually in 2030, introducing 15 models
    • PBV to play a key role in Kia’s growth, targeting 250,000 PBV sales annually by 2030 with PV5 and PV7 models
  • Kia to invest KRW 38 trillion by 2028, including KRW 15 trillion for future business
  • 2024 business guidance : KRW 101 tln in revenue with KRW 12 tln in operating profit; operating profit margin of 11.9% on sales of 3.2 million units globally
  • CEO reaffirms Kia’s commitment to ESG management

SEOUL, South Korea, April 5, 2024 /PRNewswire/ — Kia Corporation (Kia) today shared an update on its future strategies and financial targets at its CEO Investor Day in Seoul, Korea.

Based on its innovative achievements in the years since the announcement of mid-to-long-term business initiatives, Kia is focusing on updating its 2030 strategy announced last year and further strengthening its business strategy in response to uncertainties across the global mobility industry landscape.

During the event, Kia updated its mid-to-long-term business strategy with a focus on electrification, and its PBV business. Kia reiterated its 2030 annual sales target of 4.3 million units, including 1.6 million units of electric vehicles (EVs). The 2030 4.3 million annual sales target is 34.4 percent higher than the brand’s 2024 annual goal of 3.2 million units.

The company also plans to become a leading EV brand by selling a higher percentage of electrified models among its total sales, including hybrid electric vehicles (HEV), plug-in hybrid (PHEV), and battery EVs, projecting electrified model sales of 2.48 million units annually or 58 percent of Kia’s total sales in 2030.

“Following our successful brand relaunch in 2021, Kia is enhancing its global business strategy to further the establishment of an innovative EV line-up and accelerate the company’s transition to a sustainable mobility solutions provider,” said Ho Sung Song, President and CEO of Kia. “By responding effectively to changes in the mobility market and efficiently implementing mid-to-long-term strategies, Kia is strengthening its brand commitment to the wellbeing of customers, communities, the global society, and the environment.”

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PDF – https://mma.prnewswire.com/media/2380040/Press_Release__2024_Kia_CEO_Investor_Day_240405.pdf

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BioVaxys Technology Corp. Provides Bi-Weekly MCTO Status Update

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VANCOUVER, BC, April 4, 2024 /PRNewswire/ — BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) (the “Company“) is providing this bi-weekly update on the status of the management cease trade order granted on February 29, 2024 (the “MCTO“), by its principal regulator, the Ontario Securities Commission (the “OSC“), under National Policy 12-203 – Management Cease Trade Orders (“NP 12-203“), following the Company’s announcement on February 21, 2024 (the “Default Announcement“), that it was unable to file its audited annual financial statements for the year ended October 31, 2023, its management’s discussion and analysis of financial statements for the year ended October 31, 2023, its annual information form for the year ended October 31, 2023, and related filings (collectively, the “Required Annual Filings“). Under National Instrument 51-102, the Required Annual Filings were required to be made no later than February 28, 2024.

As a result of the delay in filing the Required Annual Filings, the Company was unable to file its interim financial statements for the three months ended January 31, 2024, its management’s discussion and analysis of financial statements for the three months ended January 31, 2024, and related filings (collectively, the “Required Interim Filings“). Under National Instrument 51-102, the Required Interim Filings were required to be made no later than April 1, 2024.

The Company anticipates filing the Required Annual Filings by April 30, 2024. The auditor of the Company requires additional time to complete its audit of the Company, including the Company’s recent acquisition of all intellectual property, immunotherapeutics platform technologies, and clinical stage assets of the former IMV Inc. that closed on February 16, 2024. In addition, the Company anticipates filing the Required Interim Filings immediately after the filing of the Required Annual Filings.

Except as herein disclosed, there are no material changes to the information contained in the Default Announcement. In addition, (i) the Company is satisfying and confirms that it intends to continue to satisfy the provisions of the alternative information guidelines under NP 12-203 and issue bi-weekly default status reports for so long as the delay in filing the Required Annual Filings and/or Required Interim Filings is continuing, each of which will be issued in the form of a press release; (ii) the Company does not have any information at this time regarding any anticipated specified default subsequent to the default in filing the Required Annual Filings and Required Interim Filings; (iii) the Company is not subject to any insolvency proceedings; and (iv) there is no material information concerning the affairs of the Company that has not been generally disclosed.

About BioVaxys Technology Corp.

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BioVaxys Technology Corp. (www.biovaxys.com), a biopharmaceuticals company registered in British Columbia, Canada, is a clinical-stage biopharmaceutical company dedicated to improving patient lives with novel immunotherapies based on the DPX™ immune-educating technology platform and it’s HapTenix© ‘neoantigen’ tumor cell construct platform, for treating cancers, infectious disease, antigen desensitization, and other immunological fields. The Company’s clinical stage pipeline includes maveropepimut-S which is in Phase II clinical development for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL) and platinum resistant ovarian cancer, and BVX-0918, a personalized immunotherapeutic vaccine using it proprietary HapTenix© ‘neoantigen’ tumor cell construct platform which is soon to enter Phase I in Spain for treating refractive late-stage ovarian cancer. The Company is also capitalizing on its tumor immunology know-how and creation of a unique library of T-lymphocytes & other datasets post-vaccination with its personalized immunotherapeutic vaccines to utilize predictive algorithms and other technologies to identify new targetable tumor antigens. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF). For more information, visit www.biovaxys.com and connect with us on X and LinkedIn.

ON BEHALF OF THE BOARD

Signed “James Passin
James Passin, Chief Executive Officer
Phone: +1 646 452 7054

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