Bifogade filer
Beskrivning
Land | Sverige |
---|---|
Lista | First North Stockholm |
Sektor | Hälsovård |
Industri | Medicinteknik |
Finally there
- Revenue in the period amounted to kSEK 0 (45).
- EBITDA for the period amounted to kSEK -27,151 (-6,660), and net loss kSEK - 28,087 (-8,926).
- The total cash flow in the third quarter amounted to kSEK 2,979 (-3,631).
- Earnings per share before/after dilution for the quarter amounted to SEK -0.12 (-0.01), calculated on weighted average number of shares in the period.
- On 2. July Qlife announces that it has participated a research trial in the USA for people living with PKU (phenylketonuria) and achieved positive data.
- On 17. July Qlife updates that the reverse split approved at the 26. June general meeting takes effect from 31. July. The spilt consist of a merger where thousand (2,000) existing shares shall be merged into one (1) share.
- On 29. August Qlife acquires the assets of Qlife ApS, carries out directed issues of a total of approx. MSEK 6.90 and a proposal of directed issues of approx. MSEK 5.05
- On 29. August Qlife provides strategic business update focused on fully leveraging the collaboration with stratetic partner Hipro Biotechnology, who is focused on the transition of blood testing from hospitals to people's homes, offering significant market potential for high-volume sales.
- On 4. September Qlife announces that production of Egoo consumables is now established in China to support on-going clinical trials and future sales.
- On 6. September Qlife announces that it publishes a second balance sheet showing that the Company's total equity exceeds the registered share capital.
- On 10. September Qlife announces that Peter Warthoe will return to the management group as Chief Scientific Officer focused on bringing the Egoo Health platform to the market in the near term.
- On 1. October announces that it will start to sell its PHE rare disease test targetted at people with PKU (phenylketonuria) addressing an unmet need in the at-home testing market estimated worth SEK 2.5 billion.
- On 7. October 2024 Qlife calls for an extra ordinary general meeting to implement proposal and aktivities as announced on 29 August.
The full report is attached and can also be found here: https://qlifeholding.com/en/investors/finansiella-rapporter
Letter from the CEO
Finally there
I have been waiting for this moment for 10 years - to bring a clinical-grade diagnostic tool into the hands of the layperson. This has always been Qlife's vision, and we have finally begun that journey.
Egoo Phe roll-out
In October, we began shipping the Egoo Phe (Phenylalanine) product to individuals with the rare condition PKU (Phenylketonuria). Typically, they send a blood card to a central laboratory every week and wait for the result for days or up to a week. The biggest challenge for these individuals is that they need to know immediately if their phenylalanine (Phe) level is high, as they must avoid protein in such cases. It is a constant struggle to keep their diet balanced and avoid consuming too much protein, which is difficult. They rely on specialized, low-protein foods for life. The condition affects approximately 1/10.000 and it is most severe for children and young people.
For years, they have wished for an easier way to obtain their blood data, but the Phe assay is quite challenging, and no one has managed to create it. Until now.
Qlife was built on the promise to bring this Phe test forward. It proved to be much harder than we initially anticipated, but our brilliant scientists have worked diligently over the years and have finally cracked the code. Now, we can begin enhancing the quality of life for individuals with PKU by providing them with a high-quality diagnostic tool that delivers results in just 30 minutes.
The global PKU market consists of approximately 150,000 individuals who require weekly Phe level testing. The total addressable market is estimated to be approximately SEK 2.5 billion. To take a significant chunk of that market will require regulatory clearances in multiple countries and an efficient global distribution network, which will take some time to establish. However, given the clearly defined need for a home blood test, it seems like an ideal place for us to start.
The Egoo Analyzer is CE-marked, but the Phe test is not fully CE-marked yet - we have ongoing trials in Copenhagen and Birmingham. We must also gather real-life usability data before submitting in the UK/EU and eventually in the USA and other regions. Therefore, our short-term focus within the PKU market is to document and learn from dealing directly with customers who have purchased the product. As of now, we have shipped products to seven countries, with requests coming in from all over the world. We will thus be holding back on full scale rollout until we have completed all necessary filings.
As Egoo Health is a complete IoT system, data can be accessed from anywhere or simply stored on the phone. Furthermore, once we apply AI to the data, users will be able to predict their own trends and plan their food intake accordingly. This allows us to evolve our business model toward a lifelong subscription service that will benefit all parties by continuously improving data and deepening individuals understanding of their optimal health.
All that lies in the future, but at this moment, Qlife is the only company in the world offering a high-tech immuno-diagnostics platform for at-home self-testing of various types of biomarkers. We intend to
capitalize on our first-mover advantage.
China operations
In China, we are progressing as planned with our partner Hipro Biotechnology ("Hipro"). During the summer, some of our team members traveled to China to help setup production of Egoo consumables (EgooCapsules and EgooCollect). This setup is now fully operational, allowing Hipro to work more independently.
Scaling production of the Egoo Analyzer will take some time, as it is a highly complex medical device. However, eventually, it will also be manufactured in China, allowing for a more competitive cost structure.
Hipro is focused on key areas, including inflammation (C-Reactive Protein), diabetes (HbA1c), heart failure (NT-proBNP), and more biomarkers in the pipeline. Access to Hipro's commercially available reagents greatly simplifies integration into Egoo, enabling us to build a significant portfolio of biomarkers on Egoo Health in the short to medium term.
Our China operation is a key part of our strategic plan, which is; 1) to address the Chinese professional home-hospital market through our partnership with Hipro, 2) to source supplies from Hipro to serve the home-hospital segment outside of China in collaboration with other partners, and 3) to leverage our focus on the rare disease PKU as a first-mover advantage into a high-need, consumer-based segment. All of this supports our goal of achieving a cost structure that makes Qlife a profitable business and will eventually enable us to sell to mass consumer markets.
Finances
Following a complete restructuring of the company, we are now operating with a burn rate below SEK 0.5 million per month, which makes us a highly agile company. This is only possible due to the substantial Investments in our product platform over the past five years, resulting in a product that is ready for commercialization.
Additionally, we have a Chinese partner committed to investing in the platform, who believes that Egoo Health is the future of decentralized critical biomarker testing and believe in allowing more people to access quality diagnostics. Although Qlife's organization is quite small today, we operate with the capabilities of a much larger company, thanks to our Chinese partner's hard work and focus on launching
Egoo Health in the Chinese market. We are very much looking forward to that launch happening, and we are at the same time happy that we now can get our consumables supply from China and sell in EU and
other markets.
Expectations for the future
We have successfully launched our Phe product for families living with PKU, giving us a head start in this high-need segment. This allows us not only to begin generating revenue but also to gather critical user
feedback, providing valuable insights.
We expect our partner Hipro to begin the launch of Egoo Health in 2025 in China, and we expect to see a significant impact from that. At the same time, we will continue to develop the home-hospital market outside of China and seek strategic partnerships to enable efficient distribution. Overall, I am very optimistic about the future. Our primary focus now is to continue executing our strategy and to get the product into the hands of the layperson, contributing to making their life a little easier.
Helsingborg, 7. November 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 07-11-2024 08:30 CET