Spermosens is preparing for an upcoming clinical study conducted at RMC in Malmö with Dr. Ingela Soltic as principal investigator. Based on power-analysis the study is set up to involve an estimated 250 couples with so-called unexplained infertility undergoing IVF treatment. An application to the ethical committee with the study protocol has been submitted. The extensive study planned to start in Q3 2024 is anticipated to generate regular interim results contingent on the expected recruitment rate. The purpose of the study is to investigate the male fertility related to a molecular recognition between sperm cells and oocyte via binding of two important proteins. The focus will be on the JUNO-score, which measures the binding between the IZUMO1 and the JUNO proteins. A strong correlation between the binding of these key proteins and successful fertilization of the egg, will enable clinicians to assess the fertilization potential of sperm cells more accurately, leading to a personalized and more efficient IVF treatment. A positive outcome from this study can enhance IVF treatments, become a valuable diagnostic tool for sperm banks and as well to help couples experiencing fertility challenges prior to IVF treatment.

Spermosens is attracting interest from several companies in the field of assisted reproductive treatments (ART) and are actively pursuing strategic partnerships through licensing deals in several attractive markets, including the US and Japan. The aim is to identify capable partners with robust distribution channels. Business development and out-licensing efforts will advance in parallel with the clinical study. We will leverage regional specialists with a strong presence in these relevant markets to execute our business development strategy effectively.

Spermosens has implemented measures to optimize operations, ensuring efficient execution of both the clinical study and business development. All resources will be reallocated to these two focus areas, while other exploratory activities will be temporarily suspended. This strategic shift enhance efficiency, reduce costs, and position Spermosens optimally for success.

Dr. Tore Duvold, CEO of Spermosens, comments: "I am genuinely excited about the opportunity to help people struggling to have their own children. Our technology stands out as it may offer a personalized and improved fertility treatment, potentially leading to better fertility rates and a simpler treatment process. After thoroughly analysing our technology, strategic options, organization, and R&D partners, it is clear that we must now focus all our efforts on demonstrating the diagnostic value of our product and seeking the right commercial partners to successfully bring it to the market. This requires us at Spermosens to be both efficient and cost-conscious. A positive outcome from the clinical study will be immensely valuable to both patients and our shareholders."

About Spermosens AB. Spermosens is a pioneering biotechnology company dedicated to advancing fertility treatments through innovative diagnostic solutions. Based in Sweden, Spermosens specializes in developing cutting-edge technologies that improve fertility outcomes and simplify the treatment process for individuals and couples facing infertility challenges. The proprietary JUNO-Checked product aims to enhance the precision and effectiveness of fertility diagnostics, ultimately helping more people achieve their dream of parenthood. Committed to scientific excellence and patient care, Spermosens collaborates with leading research institutions and commercial partners to bring transformative solutions to the market.

About Reproductive Medicine Center (RMC) in Malmö. RMC is a leading fertility clinic located in Malmö, Sweden, renowned for its comprehensive and advanced reproductive healthcare services. The center specializes in offering a wide range of fertility treatments, including in vitro fertilization (IVF), Intra Cytoplasmic Sperm Injection (ICSI) and other assisted reproductive technologies . With a dedicated team of experienced medical professionals, state-of-the-art facilities, and a patient-centered approach, RMC is committed to providing personalized care and achieving the best possible outcomes for individuals and couples seeking to overcome infertility. The center also actively engages in cutting-edge research to continually improve and innovate in the field of reproductive medicine.

About JUNO-Checked. Spermosens' product, JUNO-Checked, is an innovative diagnostic technology designed to enhance fertility treatment outcomes. This unique product focuses on evaluating sperm quality by providing precise diagnostic information, which can potentially aid in personalized fertility treatments. JUNO-Checked aims to increase fertility rates and streamline treatment processes, offering hope to individuals and couples struggling with infertility. By leveraging advanced scientific research and cutting-edge technology, Spermosens AB is committed to making a meaningful impact in the field of reproductive medicine through JUNO-Checked.

About the ART market. Globally, 3-4 million IVF treatments are performed annually, with fewer than 1 in 5 being successful. According to the latest data from 2019, more than 1 million treatment cycles were reported in Europe. Japan, one of the largest markets with a 10 percent growth rate, reported over 498,000 treatment cycles in 2021. In the USA, over 413,776 cycles of assisted reproductive technology (ART) were conducted at 453 reporting clinics in 2021. The global market for IVF is estimated to be worth approximately USD 25 billion in 2023, with an annual growth rate of about 6% projected until 2030. Spermosens estimates the sales potential for JUNO-Checked to be approximately USD 600 million, based on 3 million annual IVF treatments and an assumed average price of USD 200 per cassette. The primary market for the Company's assisted reproductive technology (ART) is the world's IVF clinics, which collectively perform over 3 million IVF treatments each year. Additionally, Spermosens is exploring additional adjacent market opportunities beyond IVF clinics, including sperm banks, assessing sperm quality prior to IVF treatment, and for veterinary applications.

For more information, please contact 

Tore Duvold, CEO

info@spermosens.com

This disclosure contains information that Spermosens 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 25-06-2024 15:59 CET.