PRESS RELEASE Lund, Sweden, March 12, 2025 Gedea Biotech has completed a clinical study, the NEFERTITI-2 study, for the treatment of bacterial vaginosis, showing significantly better treatment outcomes with the company's vaginal tablet pHyph compared to the control group. This result forms the basis for the company’s application for CE marking of pHyph in Europe.

• Both primary and secondary endpoints were met

• Significantly better cure rate with pHyph treatment compared to the control group
• Patients experienced rapid symptom relief that was sustained over time
• Long-term positive effect on the vaginal microbiome

The primary aim of the study was to evaluate the effect of pHyph compared to an untreated control group. The study was designed for 92 patients, with the possibility of an interim analysis when two-thirds of the patients had completed the treatment. Already at the interim analysis of 61 patients, a statistically significant result was observed, allowing  the study to be completed earlier than planned. Clinical Results Provide Long-Term Symptom Relief The percentage of patients cured of bacterial vaginosis increased from day 7 to day 25, showing that maintenance treatment with pHyph twice a week after the first week is effective. Maintenance treatment continued for another 9 weeks, and at follow-up via mobile app on day 35, all patients reported remaining symptom-free, which is substantially better than with antibiotic treatment. Antibiotic treatment causes secondary vaginal yeast infections in up to 5-17% of patients, whereas no yeast infections were reported in patients treated with pHyph. Bacterial vaginosis is caused by an imbalance in the vaginal microbiome (dysbiosis). Already after 7 days of treatment with pHyph, a significant reduction in dysbiosis was observed, from 94% to 56%. For patients whose microbiome had normalized by day 25, the normal microbiome was maintained throughout the study. The responsible investigator for the NEFERTITI-2 study was Aino Fianu Jonasson MD, PhD, former urogynecology specialist at the Women’s Research Unit, Karolinska University Hospital, Huddinge, Sweden:

• Treatment with pHyph shows significantly better results than the control group at day 7. A large portion of the patients become symptom-free, and this persists over time, which is the most important thing for the patient. In the end, the microbiome is decisive. When the patient's microbiome has normalized, the underlying cause of BV is gone.

Annette Säfholm, CEO of Gedea, is pleased and excited:

• The results of the study are significant for both the primary endpoint and for important clinical parameters such as the patient's perceived symptom relief and long-term symptom freedom. We have now applied for CE marking for pHyph and look forward to partnerships for sales in Europe and Phase 3 studies in the United States.