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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

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.

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.

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.

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:

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Arcadis supports “The Chief Executive’s 2024 Policy Address” in Hong Kong

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HONG KONG, Oct. 22, 2024 /PRNewswire/ — Arcadis, the leading global Design & Consultancy organization for natural and built assets, welcomes the initiatives recently outlined in “The Chief Executive’s 2024 Policy Address”, which aim to sustain efforts in land creation and boosting housing supply by simplifying procedures and reducing construction costs. Arcadis will fully support the implementation of these initiatives.

 

Create Land for New Developments and Streamline Procedures

The Government will continue to expedite land production to solve the land supply conundrum, not only for housing but for other uses. Land development procedures will be streamlined.

The Government will expedite the implementation of economic and housing-related projects in the Northern Metropolis. This year, land will be reserved for developing the Northern Metropolis University Town, the third medical school, and an integrated teaching hospital.

The Government will release four quality logistics sites in the Hung Shui Kiu/ha Tsuen NDA to expand high value-added logistics services. The Hong Kong-Shenzhen I&T Park in the Loop will be developed in two phases, starting at the end of this year. The Government will seek funding for the first-stage of San Tin Technopoles’ infrastructure and begin construction works this year. The target is to deliver 20 hectares of new I&T sites in phases, beginning in 2026-27, for the Hong Kong Science and Technology Parks Corporation’s development and operation.

Adopting a Multi-Pronged Approach to Lower Construction Costs

The Project Strategy and Governance Office under the Development Bureau has been entrusted with leading a strategic study to identify major factors contributing to high construction costs and to devise improvement measures by drawing on experiences from Mainland China and internationally. Arcadis appreciates the study as an important step toward optimizing the use of public resources for infrastructure development and enhancing long-term competitiveness.

In response, William Fong, Head of Cost and Commercial Management for Hong Kong & Macau at Arcadis, said:

“The Government has been examining the factors influencing project costs while also assessing the respective impact of each factor. The dedicated efforts invested in this study demonstrate the Government’s commitment to improving the efficiency of project delivery.

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“In addition to streamlining land development procedures, we recognize the importance of promoting the adoption of innovative construction technologies and materials, implementing smart procurement strategies, and reassessing building design standards to enhance speed and efficiency. The effective execution of these measures will require collaboration from the Government, developers, consultants, contractors, and suppliers.”

Align Hong Kong Building Design Standards with Guobiao

As Hong Kong reviews and potentially updates its building standards, we should consider aligning them with best practices and industry standards in Mainland China (Guobiao) and other prominent international cities. Hong Kong can play a key role in establishing unified construction design standards for the Greater Bay Area and promoting the use of high-quality and cost-effective construction materials. Leveraging its robust business presence, Arcadis is prepared to engage in this initiative and support to Building Technology Research Institute.

Enhancing Transport Infrastructure in the Northern Metropolis

With construction of Hung Shui Kiu Station and the Northern Link Main Line commencing, Arcadis is eager to advance to the next phase of preparations for the Hong Kong-Shenzhen Western Rail Link (Hung Shui Kiu-Qianhai) and initiate the detailed planning and design of the Northern Link Spur Line.

William Fong added: “As we witness progress of the Northern Metropolis Development Strategy and the enhanced connectivity between Hong Kong and Shenzhen, the industry can seize opportunities in areas such as cost and project management, sustainability, and business advisory.”

Continue to Promote Waste Reduction and Recycling

In 2025, Hong Kong will inaugurate the commissioning of I•PARK1, the city’s first waste-to-energy facility with the capacity to process 3,000 tons of municipal solid waste daily.

The I•PARK1 project not only contributes to achieving the “Zero Landfill” goal but also spreadheads the adoption of innovative construction methods, including Modular Integrated Construction and the prefabrication of main electrical and mechanical equipment modules in Zhuhai.

William Fong concluded: “This construction approach has elevated both the quality and efficiency standards, setting a new benchmark in excellence and operational effectiveness.”

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About Arcadis

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Finastra reveals Loan IQ Simplified Servicing solution for bilateral and SME loans

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Move will enable financial institutions that lend to smaller businesses to access the same loan servicing technology used by the world’s leading banks

BEIJING, Oct. 22, 2024 /PRNewswire/ — Finastra today announced its Loan IQ Simplified Servicing solution at Sibos 2024. The solution takes the rich functionality available in Finastra’s Loan IQ and combines it with a streamlined user interface that’s optimized for servicing high volume bilateral and SME loan portfolios. As a result, Finastra is bringing together the functionality that financial institutions need to service their entire loan portfolios in one integrated system.

Finastra Logo

Financial institutions adopting Simplified Servicing will benefit from unified portfolio management with a single, efficient modern lending platform that simplifies the user experience and improves the speed and transparency of loan servicing to customers of all sizes. By automating previously manual and disjointed lending processes, the solution delivers crucial efficiencies, resulting in improved data accuracy and shorter lead times. This integrated lending journey functionality breaks down silos and reduces operational risk.

“Historically the loan market has been slow to innovate, making the loan servicing function reliant on manual processes that are inefficient and error-prone – particularly when it comes to servicing high volumes of smaller loans,” said Veena Rao, Head of Corporate Lending at Finastra. “The Simplified Servicing solution provides a way to service SME loans within Loan IQ, opening more routes to finance for small and medium-sized businesses. The move reflects our commitment to Open Finance and helping smaller businesses access the banking services they need to prosper.”

“Corporate and commercial lenders often face challenges in managing their loan portfolios due to siloed operations, a lack of digitization, outdated and fragmented technology, with isolated systems supporting different product types and offering little integration. This can lead to operational inefficiencies, risk exposure, difficulties in attracting and retaining the best staff and the prospect of losing customers to competitors,” explained Patricia Hines, Head of Corporate Banking at Celent. “The ideal lending platform creates an integrated end-to-end customer journey, with seamless integration from origination to servicing.”

To learn more about Simplified Servicing, visit Finastra at Sibos 2024 on stand G30.

About Finastra
Finastra is a global provider of financial services software applications across Lending, Payments, Treasury and Capital Markets, and Universal (retail and digital) Banking. Committed to unlocking the potential of people, businesses and communities everywhere, its vision is to accelerate the future of Open Finance through technology and collaboration, and its pioneering approach is why it is trusted by ~8,100 financial institutions, including 45 of the world’s top 50 banks. For more information, visit finastra.com.

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Fintech Pulse: Your Daily Industry Brief – Market Moves, Platform Innovations, and Strategic Shifts

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Here’s a detailed op-ed-style summary for “Fintech Pulse: Your Daily Industry Brief” based on the provided news articles. This piece will integrate the key insights into a cohesive analysis, aiming for around 7,000 words while maintaining a focus on SEO optimization.

In today’s rapidly evolving fintech ecosystem, market listings, new platform rollouts, and strategic business shifts are driving the industry. As we explore key developments, it’s clear that companies are navigating challenges and opportunities in unique ways. From stock market listings and fintech events to the emergence of new payment solutions and unexpected closures, this briefing will analyze what these movements mean for the broader fintech landscape.

The Payments Group Goes Public: What It Means for the Market

The Payments Group, a notable player in the fintech space, recently made headlines by listing on a major stock exchange. The move marks a strategic step in its growth trajectory, providing an avenue to access broader investment opportunities and improve liquidity for existing shareholders. With this listing, The Payments Group aims to accelerate its expansion plans and invest in innovative payment solutions, thus reinforcing its position in an increasingly competitive market. Source: Finextra

This public debut comes amidst a market environment where investor interest in payment solutions remains strong. The Payments Group’s decision to go public is a strategic response to the rising demand for transparency and growth potential among fintech companies. By leveraging the public market, the firm is positioned to fund new initiatives that could shape the future of digital transactions. This could include investments in cross-border payment solutions, real-time transaction processing, and enhanced customer experience.

However, with this move, the company also faces the challenge of maintaining market expectations while managing regulatory scrutiny that comes with being publicly listed. As investors keep a close eye on quarterly performances, The Payments Group’s ability to deliver on its growth promises will be crucial in determining its long-term market standing.

Hamburg’s Fintech Day: Building Momentum in Europe’s Financial Hub

The first-ever Hamburg Fintech Day 2024 has underscored the city’s ambition to become a major fintech hub in Europe. Industry leaders, startups, and investors gathered to discuss emerging trends, challenges, and collaborative opportunities in the fintech space. This event not only highlighted Hamburg’s growing importance in the fintech ecosystem but also offered a platform for startups to showcase their innovations and attract potential investors. Source: Hamburg Business

Hamburg’s focus on building a strong fintech community is part of a broader trend seen across Europe, where cities are competing to attract talent and capital in the post-Brexit era. The success of the inaugural Fintech Day signals a bright future for the city’s fintech scene. The event also emphasized the importance of partnerships between financial institutions and technology providers, with a focus on fostering an environment conducive to growth and innovation.

For startups, Hamburg’s commitment to nurturing fintech initiatives offers a fertile ground to scale new solutions, especially in areas like digital banking, payment innovations, and sustainable finance. As the fintech ecosystem grows, it could attract more global players, turning Hamburg into a pivotal point for cross-border fintech collaboration in Europe.

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Blip Pay: Fintechio’s Bold Move into A2A Payments

Fintechio has introduced a new A2A (Account-to-Account) payments platform called Blip Pay, designed to offer seamless, low-cost transactions for businesses and consumers alike. This new platform aims to simplify the payment process by enabling direct bank transfers without the need for traditional intermediaries like credit card networks. Source: Fintech Futures

Blip Pay’s focus on efficiency and cost-effectiveness positions it as a potential disruptor in the payments space. As businesses increasingly seek to minimize transaction costs, A2A payments have gained traction as a viable alternative. By offering direct transfers, Fintechio can attract businesses looking to streamline their payment processes and improve cash flow management.

In a market saturated with digital wallets and peer-to-peer payment platforms, Blip Pay’s value proposition hinges on its ability to provide faster and more affordable transactions. However, the success of this platform will largely depend on its ability to scale and integrate with various banking infrastructures. As the A2A market expands, competition is likely to intensify, with other fintechs and traditional banks developing similar solutions. Fintechio’s challenge will be to differentiate Blip Pay through superior user experience, security, and strategic partnerships with banks.

SoFi Technologies: Staying Resilient Amid Industry Turbulence

SoFi Technologies, Inc., a key player in the digital banking and financial services space, continues to navigate the challenges of the evolving fintech market. Recently, the company has been focusing on expanding its offerings, including the introduction of new products that cater to diverse financial needs. Source: Yahoo Finance

SoFi’s strategy is centered around becoming a one-stop-shop for financial services, offering products ranging from personal loans and mortgages to investment opportunities and banking services. This diversified approach has helped SoFi build a strong user base, with a significant portion of its revenue coming from its lending products.

However, the competitive nature of the digital banking space means that SoFi must constantly innovate to maintain its edge. The company faces pressure from both established banks adapting to digital trends and new fintech entrants offering niche solutions. Additionally, regulatory changes, particularly those related to digital lending and data privacy, pose potential challenges to SoFi’s growth plans.

Despite these challenges, SoFi’s adaptability and focus on customer-centric services have allowed it to maintain resilience. Its ability to anticipate market shifts and respond with tailored solutions will be key to sustaining growth in the long term.

CapWay’s Closure: A Reflection on the Tough Road for Fintech Startups

In a surprising turn of events, CapWay, a Y Combinator-backed fintech company, has shut down its operations. CapWay aimed to provide financial services to underserved communities, focusing on bridging gaps in access to banking and financial education. The closure reflects the broader challenges faced by fintech startups, especially those targeting niche markets. Source: TechCrunch

CapWay’s downfall highlights the complexities of building a sustainable business model in the competitive fintech sector. While its mission to serve unbanked and underbanked populations was laudable, the company faced difficulties in scaling its services and attracting enough users to achieve profitability. Additionally, competition from larger players offering similar financial inclusion solutions likely added pressure.

The shutdown serves as a reminder that the fintech landscape is unforgiving, even for companies with strong backing and a clear mission. For startups in this space, the ability to rapidly scale and adapt to changing market conditions is essential for survival. As the industry continues to evolve, we may see more consolidation and exits as companies grapple with operational and financial challenges.

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Navigating the Future: What’s Next for the Fintech Ecosystem?

As we digest these developments, it’s clear that the fintech industry remains in a state of flux. Companies like The Payments Group and SoFi are adapting to market dynamics through public listings and product diversification, while events like Hamburg’s Fintech Day emphasize the importance of building regional hubs of innovation. At the same time, new solutions like Blip Pay show the continued drive toward payment efficiency, while the closure of companies like CapWay underscores the harsh realities of the startup world.

The future of fintech will be shaped by several key trends:

  • Regulatory Adaptation: As fintechs move into new areas like A2A payments and digital lending, regulatory frameworks will evolve. Companies that proactively engage with regulators to ensure compliance will have a competitive advantage.
  • Partnerships and Ecosystems: The importance of partnerships between fintech startups and traditional financial institutions will grow. These collaborations can drive innovation while offering stability and access to larger customer bases.
  • Focus on User Experience: As competition intensifies, user experience will become a key differentiator. Fintechs that invest in intuitive interfaces, customer support, and seamless integrations will be better positioned to attract and retain users.
  • Financial Inclusion as a Market Driver: Despite the challenges, financial inclusion remains a major focus for the industry. The success of initiatives targeting underserved communities could redefine market dynamics, especially in emerging markets.

As these trends unfold, stakeholders across the fintech ecosystem must stay agile and open to change. While the road ahead is uncertain, the potential for growth and innovation remains immense. For those who can adapt to the shifting landscape, the rewards will be substantial.

Conclusion: The Evolving Dynamics of Fintech

The fintech sector’s latest moves reveal a dynamic industry where innovation, competition, and adaptation define success. Whether it’s The Payments Group’s stock market debut, SoFi’s strategic diversification, or the promising launch of Blip Pay, each story contributes to the ongoing narrative of a market in transformation. Even the closure of CapWay serves as a crucial reminder of the risks inherent in the industry. By understanding these shifts and anticipating future trends, businesses and investors can better navigate the complexities of the fintech world.

This article offers a comprehensive look into the latest developments, emphasizing key industry trends and the strategic moves by major players. By focusing on these elements, it serves as an in-depth analysis tailored for your daily news briefing.

 

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