Gedea Biotech raises 1.5 MEUR (16.5 MSEK) in oversubscribed rights issue as registration CL3-2 trial begins

Lund, Sweden, November 15, 2023: Gedea Biotech today announced that it has raised 1.5 MEUR (16,5 MSEK) to initiate and accelerate clinical trial activities supporting pHyph™ applicable for antibiotic free treatment of vaginal infections. The funds will be used to:

• Initiate patient recruitment in the recently approved registration CL3-2-study.
• Reach upcoming data readout from the CL4 -study to obtain pHyph proof-of-concept for treating vaginal fungal infections.
• Perform microbiome analysis from the CL3-study.

Vaginal infections affect at least 400 million women worldwide every year, but with current treatments, the risk of recurrence is substantial and antimicrobial resistance also rapidly increases. pHyph has shown a clinical cure rate for bacterial vaginosis on par with antibiotics on the market, with a superior safety profile and without causing secondary fungal infections, contrary when using antibiotics.

Annette Säfholm, Gedea Biotech’s CEO comments: “We are of course delighted to complete an oversubscribed funding round in the current climate, and I would like to thank our investors both new and old for their tremendous support. It comes just as we have received approval to initiate our registration CL3-2 study, which is vital for receiving European approval for pHyph in treating and preventing bacterial vaginosis recurrence. It also allows us to support the preparations for pivotal phase 3 studies for FDA drug approval.”

Chairman of the board Ton Berkien adds: “The oversubscription has the additional benefit of enabling us to extend the runway for the CL3-2 study and thus prepare us for the next funding stage which could lead us through pHyph approval. 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.”

S.A.B Corporate Finance and Jensen Corporate Finance supported the capital raise which attracted several new strong international investors whereas we received continued support from existing investors; family offices and high net-worth individuals with track records in the life sciences.

For more information please contact:

Annette Säfholm, CEO Gedea Biotech
Telephone: +46 708 - 91 86 81
Email: annette.safholm@gedeabiotech.com 
 

Ton Berkien, Chairman, Gedea Biotech

Telephone: +46 70- 791 49 54

Email: ton.berkien@gedeabiotech.com   

About pHyph

The vaginal tablet, pHyph will treat bacterial vaginosis (BV) and prevent recurrence by promoting a healthy vaginal microbiome, restoring the vaginal pH to its normal level of pH 4,0 - 4,5 and by breaking down the biofilm formed during BV under which the infectious bacteria thrive. pHyph is also expected to treat and prevent vaginal fungal infection by preventing present candida from causing infection. These mechanisms of actions together provide a beneficial environment for the healthy vaginal microbiome. The naturally occurring active ingredient GDA 001 in pHyph is well documented and is already approved as a food additive. A clinical cure rate for BV on par with antibiotics on the market, has been shown in two phase 2 trials, with a superior safety profile and without causing secondary fungal infections as antibiotics do.

About Gedea Biotech
Gedea Biotech is a Swedish, innovative women’s health company developing pHyph, the first antibiotic free treatment that will both treat and prevent bacterial vaginosis as well as vaginal fungal infections. Vaginal infections affect at least 400 million women every year worldwide and the market is worth over $ 1.5 billion.  Gedea Biotech was founded in 2015 in Lund, Sweden. https://gedeabiotech.com/