VÄSENTLIGA HÄNDELSER UNDER OCH EFTER PERIODENS UTGÅNG AegirBio sluter avtal med Salofa för veterinärmarknaden och får en första order på c:a 2 miljoner kronor. • Den fortsatta årsstämman I AegirBio AB (publ) hölls den 25 augusti 2023. • AegirBio AB har erhållit ett fas 1-pris från National Institutes of Health (NIH) för ett tillgänglighetsprojekt (RADx). Utmärkelsen ger AegirBio 1,2 MUSD från NIH, varav ca 240 KUSD blev utbetalda i oktober 2023. • AegirBio fortsätter att stärka upp sin organisation genom Dr. Vasiliki Fragkou som COO från 1 november 2023. Dr. Fragkou´s ledarskap som COO kommer att stärka företagets position som branschledare och driva innovation som i slutändan gynnar både patienter och vårdgivare. Dr. Fragkou kommer att ersätta Dr. Nils Paulsson. • AegirBio fokuserar på RADx projektet och beslutar därför att inte längre upprätthålla CE-märkningen för MagniaReader therapeutic drug monitoring (TDM) testning.  • AegirBio utser Christel Dahlberg till CFO med tillträde den 1 februari 2024. Christel Dahlberg har agerat som interim CFO för AegirBio sedan april 2023.

SAMMANFATTNING AV DELÅRSRAPPORTEN

Med bolaget eller AegirBio AB avses AegirBio AB

Tredje kvartalet i koncernen jämfört med samma period 2022

• Totala intäkter uppgick till 0 (0,31) MSEK
• Resultatet före skatt uppgick till -18,3 (-13,8) MSEK.
• Kassabehållningen var vid slutet av kvartalet 23,4 (28,1) MSEK efter erhållen likvid om totalt 46,3 MSEK i första kvartalet till följd av utnyttjande av teckningsoptioner och konvertibellånet från Atlas.

Årets första nio månader i koncernen 2023 jämfört med 2022

• Totala intäkter uppgick till 0 (1,7) MSEK
• Resultatet före skatt uppgick till -50,2 (-46,0)
• Resultat per aktie* uppgick till -2,04 (-2,35)
• Soliditeten** uppgick till 12% (93%)

Marco Witteveen - CEO

Presenting the Q3 report, a reflection of our progress during the holiday season

I initiated a well-prepared transformation at AegirBio, shifting focus from science to market orientation. Our primary goal was to identify intersections between AegirBio’s science and the market to generate commercial value. This led to the establishment of the company's mission and vision.

Our mission is to simplify diagnostic testing and develop accessible biomarker assay technologies that empower people to monitor their health and enhance treatment in their homes.

Our vision is to create an integrated, user-friendly diagnostic and monitoring platform that enables individuals to manage their health through non-invasive testing.

Here is an overview of our subsequent steps:

Organizational Restructuring

We streamlined our organization, making it leaner and more efficient for future growth by centralizing Quality Assurance-, Human Resources- and administration functions to create a global team.

We moved Magnasense R&D and Quality management from Finland to the UK, centralizing all R&D operations.

Dr. Vasiliki Fragkou was promoted to COO, recognizing her extensive experience in test development. Two scientists were added to her team in UK.

Additional lab space was acquired in the UK to support the RADx project.

Throughout the year, our primary emphasis has been on cost management. Despite facing elevated expenditures in the Finance Department, including heightened consultant fees, increased financial audit costs, and escalated legal fees, we have significantly reduced other costs notably in Sales and Administration. This achievement has allowed us to channel resources towards the RADx project, allowing us to meet the project's milestones. Consequently, Research & Development costs experienced a SEK 6 million increase in the third quarter compared to the corresponding period last year. Our strategic focus has also resulted in securing an upfront payment from the NIH in October 2023.”

RADx Agreement

During the past quarter, our Research & Development (R&D) activities were focused on moving the RADx project forward. As a reminder, the NIH RADx® Tech program is a project driven by the US National Institute of Health (NIH) aiming to develop a digital multiplex self-test platform designed to provide essential assistance to individuals with disabilities. While that effort led to increased R&D costs of SEK 6 million vs the same period last year, in October 2023 we were awarded $1.2 million in funding for the development of a digital multiplex self-test platform.

Cloud-Based Saliva Testing Strategy

We've formulated a forward-looking strategy for our forthcoming cloud-based saliva testing platform, with a deliberate focus on addressing clinical gaps in the market related to Anti TNF and Oral Health testing. These gaps stem from the current challenges associated with obtaining comprehensive insights into Anti TNF efficacy and oral health diagnostics.

By leveraging the non-invasive nature of saliva as a sample type, our platform aims to provide a more accessible and streamlined alternative to traditional blood-based testing methods. This approach addresses the specific clinical voids in the market by offering a convenient and efficient means of obtaining critical diagnostic information for Anti TNF effectiveness and oral health status.

Market Research and Patient-Centric Focus

Extensive market research has reinforced our position in saliva-based Anti-TNF testing. We are prioritizing therapeutic drug monitoring (TDM) home testing for patients dealing with autoimmune disease such as Crohn's disease and Multiple Sclerosis, reflecting our commitment to evolving healthcare needs.

Oral Health Expansion

We are entering the field of oral health, recognizing its intricate connections to various disease domains. This move opens new growth and innovation opportunities, not only for chronically ill patients but also for disease prevention. Maintaining good oral health prevents systemic diseases but also safeguards against the potential adverse effects of bad oral health, including increased risk of cardiovascular disease, cancer, and diabetes due to the entry of oral bacteria and inflammation into the bloodstream. Biomarker testing provides a valuable advantage in oral health by accurately detecting elevated levels of that biomarker, aiding in the early identification of periodontal disease, and allowing for timely intervention to prevent further oral health complications.

Salofa Veterinary Agreement

We finalized an agreement with Salofa for the sale of 150 Magnia Readers, amounting to 195,000 euros. This highlights the strength of our offering and benefits for the veterinary market.

Natalizumab Testing

Our entry into the intact natalizumab testing arena presents a potential business opportunity, opening doors with pharmaceutical and diagnostic companies, as well as key opinion leaders in the Multiple Sclerosis space.

In Conclusion

Since assuming my role, we've made substantial progress. It has been an honor to collaborate with such a skilled team whose contributions were pivotal in reaching these milestones. Together, we are poised for even greater achievements in the future.

Denna information är sådan som AegirBio är skyldigt att offentliggöra enligt EU:s marknadsmissbruksförordning (EU nr 596/2014). Informationen lämnades, genom angiven kontaktpersons försorg, för offentliggörande 2023-11-24 08:19 CET.

AegirBio i korthet

AegirBio är ett svenskt diagnostikföretag som grundades 2019 för att erbjuda tester för att övervaka och optimera doseringen av biologiska läkemedel via sin unika patenterade teknologiplattform. I juni 2020 noterades AegirBio på Nasdaq First North Growth Market. Bolagets ambition är, förutom att föra ut innovativ diagnostisk teknologi till marknaden, att göra diagnostik mer tillgänglig, enklare att använda och att ge korrekta och lätt överförbara resultat. För mer information, se Aegirbios hemsida www.aegirbio.com

Bolagets Certified Adviser är Eminova Fondkommission AB, adviser@eminova.se

Related links:
Q3 report AegirBio
Cision