Transition to a commercial business

Financial summary – fourth quarter 2024

• Revenue in the period amounted to kSEK 50 (30). 
• EBITDA for the period amounted to kSEK –7,721 (-86,903), and net loss kSEK – 7,106 (-111,545).
• The total cash flow in the fourth quarter amounted to kSEK 2,628 (-6,096).
• Earnings per share before/after dilution for the quarter amounted to SEK -0.12 (-0.17), calculated on weighted average number of shares in the period.

Significant events – fourth quarter 2024

• On 8. November Qlife holds an extraordinary general meeting to resolve on a directed issue to a predetermined circle of investors to increase the share capital with maximum SEK 440,872.74 at a share price of SEK 2.52 determined through negotiations between the company and the external investors.
• On 11. November Qlife announces the outcome of the directed issue of shares and warrants were subscribed for and allocated in accordance with the decision of the extraordinary general meeting.

Significant events after the end of the period

• On 7. January Qlife provides an operational update on progress with its partner in China. The company has achieved: a) Excellent clinical data for Egoo CRP; b) more biomarkers are advancing to the clinical testing phase; and c) a production setup for the Egoo Analyzer is progressing.
• On 14. January Qlife provides a sales and regulatory update. The company has shifted its focus from research and development to becoming a sales-driven organization and has successfully sold its RUO-approved Egoo Phenylalanine (Phe) system in seven countries and is conducting studies in the UK and Denmark to pave the way for full-scale commercialization.
• On 16. January Qlife announces that in collaboration with its strategic partner Hipro Biotechnology, the company has developed a new Egoo Health product platform, which is CE-IVD-marked and sales start immediately in the EU.
• On 28. January Qlife signs a letter of intent with a top-20 global Pharma company to explore a potential commercial collaboration.
• On 29. January announces that it will carry out a rights issue of approximately SEK 11.8 million and will enter into an agreement for a credit facility of SEK 5.6 million.

The full report is attached and can also be found here: https://qlifeholding.com/en/investors/finansiella-rapporter

Letter from the CEO

Transition to a commercial business

It has been a busy quarter for Qlife, with many developments taking place. We are no longer solely an R&D-focused company but are rapidly moving toward commercialization, sales, and marketing.

Our product platforms

Egoo Health offers you the opportunity to gain a deeper understanding of your health. This is especially beneficial if you have already been diagnosed with a condition, as monitoring your blood biomarkers with the Egoo Health platform can provide valuable insights.

Due to our increasingly closer collaboration with our partner Hipro Biotech we now have three highly interesting tech platforms, each focused on a healthcare field:

•   General Health biomarkers

•   Rare Diseases biomarkers

•   Home-Hospital biomarkers

General health

This platform is already CE-marked, and we have launched tests that are typically difficult to access on a routine basis. Initially, these include hormone tests related to women’s health, which we will combine with other biomarkers to provide additional specific health insights. Similarly, we will introduce a focus on men’s health and expand from there.

Rare diseases

We have a strong focus on the PKU disease, where we initially decided to launch the product as a research-use-only product. So far, we have shipped products to customers in seven countries. We are working towards obtaining final approval for the product in the UK first, with an upcoming trial in Birmingham. This will be followed by marketing clearance, at which point we can begin rolling it out in the UK and expanding further into the EU market, and eventually into the USA and the rest of the world.

Home-hospital

This is a professional focus on monitoring of discharged patients within major disease categories such as heart failure, chronic kidney disease and more. When a patient is discharged from the hospital there is always a need to continue to monitor major organs to make sure that the health situation does not deteriorate. This can be done very effectively with blood tests. We expect to be able to partner with some of the major IVD companies that want to expand their product portfolio with in-vitro diagnostics home monitoring.

Egoo.AI

Because Egoo Health is a clinical diagnostic platform, we focus on providing blood data that is typically difficult to access on a routine basis. This is a new approach, and we are developing a specialized Egoo.AI feature that provides precise guidance based on quantitative blood data. By using Egoo Health in combination with Egoo.AI, users can easily access accurate guidance. Particularly when multiple tests are combined, the AI system delivers highly comprehensive insights.

In today’s world, where doctors can sometimes be difficult to access and blood tests are typically only performed when someone is seriously ill, we believe this will revolutionize how people access health information and communicate with healthcare professionals in a more informed manner.

We fully recognize that this is a significant challenge and not something that will change overnight. Every country and culture have its own healthcare infrastructure and varying levels of access to medical services. However, we believe we can gradually introduce new ways for people to access clinical healthcare information, empowering those who are concerned about their health.

Sale and marketing

A significant part of our commercialization strategy will be to develop an efficient marketing approach. As we are still a small company with limited resources, we are focusing on digital marketing through social media, which can be highly effective if you understand your target segment and can capture their attention. Since many of our target segments are often organized into groups on social media, we believe we can build an efficient marketing engine.

Partnering strategy

We signed an LOI with a major pharma company that are interest in our platform. While our discussions are still in the early stages, this could develop into a promising collaboration. Our general strategy is to partner with large IVD, pharma, or consumer health companies in the future. Egoo’s technology and disease focus are highly relevant, especially when combined with their diagnostics, drugs, or health technologies.

China operations

The collaboration with Hipro Biotech is progressing very positively. Our two companies share many commonalities, and by combining our expertise, we have developed an innovative new platform that is already CE-IVD marked. This high-tech platform integrates Egoo optics, Egoo plasma filtration, and Egoo App cloud analytics.

The Egoo consumables production is now fully operational, allowing Hipro Biotech to work independently, while we remain focused on ramping up Egoo Instrument production. Scaling up production for the Egoo Instrument will take time, as it is a highly complex medical device requiring an established sourcing and supply chain.

Today, our China operation is a key part of our strategic plan, with a crucial objective of achieving low production cost that enables us to enter mass consumer markets and establish Qlife as a profitable business.

Finances

Our revenues for Q4 remain modest, although we have shipped the rare disease PHE products to seven countries. We are maintaining a low price while the PHE test is still awaiting approval and have so far chosen to sell only to selected customers who are willing to participate in our trials.

We have already gained valuable insights and are now beginning to expand our customer base. Approval of the PHE rare disease product is targeted for just after the Birmingham study is completed around mid-2025, allowing us to file for registration in the UK. Following this, we will launch a full-scale rollout in the UK and submit for approval in the EU simultaneously.

By the end of this year, we aim to reach a highly motivated PKU self-testing audience of approximately 50,000 people.

If our competitive COGS production is successfully established in China and our regulatory efforts in the UK proceed as planned, we expect to achieve decent sales by mid-Q1 2026 from this category.

With a monthly burn rate below SEK 0.5M, it will not take much for us to become a self-sustaining organization on the path to profitability.

PKU disease is just one category—when we add the CE-marked General Health platform, which we are now launching directly to consumers, along with potential partnerships this year, I believe we can reach our financial goal of becoming a profitable business by Q1 2026.

Rights issue

We have recently launched a rights issue to provide the company with enough capital to operate for the next 12 months. The Company will receive proceeds of maximum SEK 11.8 million before deduction of the issue costs. This goes in line with our plan of reaching self-sustained operations end of the 12-months period. The proceeds from the rights issue will used to create a strong focus on sales, marketing, and general commercialization.

Expectations for the future

We have recently transitioned from being an R&D-focused company to offering a research-use-only product, and now to having three high-tech category platforms—one already at the commercial stage and the others rapidly approaching it. This means we can now start building a sales-driven business, and I am pleased with how far we have come.

Additionally, over this period, we have strengthened our partnership with Hipro Biotech, gaining significant leverage and improving resource efficiency.

Recently, we have also demonstrated interest in our platform from major companies by signing a letter of intent, which we hope will lead to a partnership that can bring our products to the global market. We also anticipate forming additional partnerships with global companies across different disease segments.

I see the next 12 months as a critical opportunity to prove what we have always aimed to demonstrate: that bringing lab-grade, simple-to-use diagnostics into the homes of people living with chronic conditions makes sense and can support better health management. Over this period, we have taken a significant step toward becoming a viable and sustainable business.

Göteborg, 6. February 2024

Thomas Warthoe, CEO

This disclosure contains information that Qlife Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 2025-02-06 09:00 CET.

Qlife is a Swedish company based in Helsingborg, which develops and markets an innovative medical technology platform, Egoo.Health (“Egoo”), with the goal of giving people access to clinical biomarker data when testing at home. The company is listed on the Nasdaq First North Growth Market (ticker: QLIFE). G&W Fondkommission is the Company’s Certified Adviser. For additional information, please visit www.qlifeholding.com.