Gedea´s share issue oversubscribed by 54%
Gedea Biotech AB carried out a rights issue of SEK 24.3 million during October. The interest from both existing owners and new investors exceeded the board’s mandate, and an extraordinary general meeting resolved a directed issue to include the oversubscription of SEK 13 million. In total, Gedea has after issue costs received SEK 34.8 million.
Earlier this year, Gedea received a €2.5 million grant from the Horizon 2020 EIC program, which provided a EU quality stamp to our program efforts. Strengthened by this EU support, the company is now finalizing the CE marking process according to the Medical Device Regulation (MDR) for getting European approval for pHyph. Supporting the approval in Europe we will launch project activities to transfer our technology to commercial-scale production, as well as advancing partnership efforts for the development and commercialization of pHyph.
Based on clinical results from the European registration study for bacterial vaginosis together with a strong financial situation and a runway exceeding 24 months, Gedea´s position in the partnering process is strengthened.
Annette Säfholm, CEO of Gedea Biotech comments: “Gedea is making progress, and we are delighted by the support from both current owners and new investors. We are excited about the next steps in our journey and the potential impact pHyph can have on the lives of millions of women.”
Chairman of the board Ton Berkien adds: “We have extended our runway beyond the CE-marking process, technology transfer and partnering process which gives us a very strong position to commercialize pHyph with the support of a partner. I congratulate Annette and her team for the tremendous efforts made and I would like to thank our present and new investors for their strong support in Gedea.”
For further information, please contact:
Annette Säfholm, CEO Gedea Biotech
Phone: +46 708 - 91 86 81
Email: annette.safholm@gedeabiotech.com
Ton Berkien, Chairman of the Board, Gedea Biotech
Phone: +46 70- 791 49 54
Email: ton.berkien@gedeabiotech.com
S.A.B Corporate Finance and Jensen Corporate Finance supported the capital raise which attracted several new strong investors, whereas we received continued support from existing investors; family offices and high net-worth individuals with track records in the life sciences.
About Gedea Biotech
Gedea Biotech develops pHyph, an antibiotic free vaginal tablet for the treatment and prevention of bacterial vaginosis, estimated to reach EU approval in 2025. Further development towards US approval as an Rx-treatment is planned to be initiated in partnership. Gedea also has a pipeline with indications for vulvovaginal candidiasis and prevention of pre-term birth.
Globally, over 300 million women experience an episode of bacterial vaginosis, every year. The prevalence is estimated to 23% to 29% in the female population in reproductive age. The most bothersome symptom is excessive discharge with fishy odour, which is extremely stressful and affects all aspects of life. Today, patients are treated with antibiotics which have a fairly high short-term cure rate but leads to recurrence for 23-46% of patients within 35 days from start of treatment. Treatment with antibiotics also leads to a secondary vaginal fungal infection for up to 17% of the patients within 30 days.
Gedea Biotech was founded in 2015 in Lund, Sweden, by four researchers from Lund University and Skåne University Hospital.
About pHyph
pHyph is a vaginal tablet for treatment of bacterial vaginosis. Treatment with pHyph has shown significant results in cure rate and symptom relief. The safety profile is excellent and the recurrence rate is much lower than for standard of care. As a modern treatment for bacterial vaginosis, pHyph strengthens the microbiome to treat the infection and to boost resilience to recurrent infections. Conventional antibiotic treatment for bacterial vaginosis (BV) negatively affects the vaginal microbiome, which reduces resilience to new infections. Two clinical trials have verified that pHyph meets pressing medical needs for women with BV; rapid relief of fishy smell, long-term effect with low risk of recurrence and no risk of secondary fungal vaginal infection.
This project is supported by the European Innovation Council
The European Innovation Council is Europe’s flagship innovation programme to identify, develop and scale up breakthrough technologies and game changing innovations The EIC has been established under the EU Horizon Europe programme. It has a budget of €10.1 billion to support game changing innovations throughout the lifecycle from early stage research, to proof of concept, technology transfer, and the financing and scale up of start-ups and SMEs.
