Spermosens AB (publ)INTERIM REPORT JANUARY - SEPTEMBER 2024

 

Strong progress in clinical study

 

1 JANUARY – 30 SEPTEMBER 2024

SIGNIFICANT EVENTS DURING THE QUARTER 
 

• Spermosens next-generation male fertility diagnostic product ready for clinical study
• Spermosens has entered into an agreement with US based ScanMed Partners to identify and attract strategic and commercial partners in North America with special focus on the US market
• Spermosens passes an important milestone receiving approval for significant clinical study

 

 

 

SIGNIFICANT EVENTS AFTER THE END OF THE INTERIM PERIOD

• Kallelse till extra bolagsstämma i Spermosens AB (publ) för beslut om emission
• Spermosens recruits first couple for clinical study on next-generation male fertility diagnostic product
• Spermosens receives notice of allowance for broad US patent covering JUNO-Checked technology
• Spermosens signs memorandum of understanding for commercial partnership in Japan
• Spermosens reports strong progress in clinical study

 

FINANCIAL INFORMATION

CEO COMMENTS

Infertility is a global challenge, with millions of couples struggling to conceive. Male infertility represents growing problem and is often overlooked due to inadequate diagnostic tools. Traditional assessments focus on sperm count, motility and morphology, but fail to evaluate critical functional aspects such as the sperm’s ability to bind to the egg, a key factor in fertilization. Spermosens’ JUNO-Checked technology addresses this unmet need by measuring the sperm’s capacity to bind to the egg, providing fertility specialists with valuable insights that allow for more personalized treatments and increased chance of success.

 

In addition to its relevance for fertility clinics, JUNO-Checked also holds significant potential for sperm banks by helping ensure donors meet the highest quality standards. Moreover, it could become a valuable tool for couples seeking natural conception by identifying when sperm quality is optimal, thus aiding in determining the best time for conception.

 

Since the launch of our revised strategy in June this year, we have achieved notable progress. Key developments include the initiation of our clinical study at the Reproductive Medicine Center (RMC) in Malmö, the next generation Juno-Checked technology, the signing of a Memorandum of Understanding (MoU) with a well-established Japanese partner, the receipt of a Notice of Allowance for our broader US patent and significant cost reductions.

 

In August, we received ethical approval to commence the clinical study at RMC, which is designed to demonstrate the diagnostic value of our JUNO-Checked technology. By October, the first couple had been recruited, and recruitment is since then progressing steadily. Additionally, we have successfully implemented the next-generation JUNO-Checked sensor in the study, which offers enhanced performance and reduced readout time. With the current recruitment pace, we aim to present interim results already by year-end.

 

In line with our strategy of pursuing commercialization through partnerships and license agreements, we have initiated a collaboration with US-based Scan MedPartners to identify the right partners in North America. We have also made significant progress in our dialogue with an established Japanese company, recently signing an MoU with the goal of formalizing a commercial agreement for Japan. This underscores our focus on entering key markets by leveraging regional expertise, allowing us to scale efficiently while managing costs.

 

A further significant milestone is the Notice of Allowance we received from the United States Patent and Trademark Office (USPTO) for our second US patent. This patent broadens our intellectual property coverage for the JUNO-Checked technology, positioning us even stronger for future partnerships and licensing opportunities in the assisted reproductive technology (ART) sector.

 

I am pleased that we have implemented our revised strategy and to see that we are making good progress in unlocking the potential of our technology. Positive results from our ongoing activities present a significant opportunity for value creation. While we have successfully reduced our capital requirements through reprioritization and cost reductions, the need for capital remains critical to continue advancing our journey. We therefore recently announced a rights issue, inviting both new and existing shareholders to participate. This funding will enable us to advance our clinical study, drive business development and seek valuable commercial opportunities.

 

As we continue to advance our clinical study and business development, we stay focused on realizing the full potential of JUNO-Checked and unlocking value for our stakeholders. We remain confident in our ability to execute our strategy and build value.

 

I wish to express my sincere gratitude to our shareholders, partners and team members for the strong progress and continued support.

 

Tore Duvold, CEO of Spermosens AB

Lund, October 2024