Clinical dermatology company, Botanix Pharmaceuticals Limited (ASX: BOT) has received firm commitments from new and existing institutional and sophisticated investors to raise up to $7.5m in gross proceeds in an oversubscribed placement.
Commitments for A$7.5 million worth of new shares were received from investors who will also receive a free-attaching unlisted option for every two new shares issued to them under the Placement.
All Botanix directors committed to participate in the Placement, with the Directors subscribing for a total of $0.5 million of Ordinary Shares as part of the Placement, which is subject to shareholder approval. Directors are not being issued New Options as part of their participation in the Placement.
The proceeds from the Placement will be used to progress Botanix’s lead development programme, Sofpironium Bromide gel (15%), including costs associated with filing for FDA approval, preparing for commercial launch in the United States, enhancing quality and manufacturing capabilities, as well as general working capital purposes.
Euroz Hartleys were the sole lead manager and book runner for the Placement.
We are delighted by the response of our investors in supporting our plans to file for FDA approval this quarter and commercialise Sofpironium Bromide, for the treatment of axillary hyperhidrosis,” Botanix President and Executive Chair Vince Ippolito said.
“With positive Phase 3 data in hand and a multi-billion market opportunity for Sofpironium Bromide, Botanix is in a strong position to transform itself from a small research and development focused company into a leading commercial dermatology company in the US.”
Sofprionium Bromide filing for FDA approval
Sofpironium Bromide is a topically applied gel which has successfully completed Phase 3 studies with very high statistical significance for the treatment of primary axillary hyperhidrosis (a medical condition which causes excessive underarm sweating).
The company is in the final stages of preparing a New Drug Application (NDA) which is expected to be filed with the FDA this quarter, with an anticipated approval in 2023 (assuming the usual 12-month review process).
Positive results from Phase 3 clinical studies demonstrated that 60% of patients had a greater than 2- point improvement on the 4-point Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) scale and greater than 138mg reduction of sweat on average.
In addition, secondary endpoints showed that approximately 85% of patients using the gel, experienced a clinically meaningful improvement in their condition.
More than 700 patients were enrolled in the two Phase 3 studies and approximately 300 patients participated in a separate 48-week safety study of Sofpironium Bromide. There were no treatment related serious adverse events in any of the studies and adverse events were transient and mild to moderate in nature.
Based on these studies, the company believes that Sofpironium Bromide has the potential to be the best-in-class treatment for axillary hyperhidrosis, as existing therapies are less than ideal, either because of the lack of sweat control, an unfavourable side effect profile, or pain from invasive injection procedures or severing of the nerves through surgery.
Sofpironium Bromide is a de-risked asset as the drug has already been approved in Japan by the Japanese equivalent of the FDA and was recently launched by Botanix’s partner, Kaken Pharmaceutical Co., Ltd (Ecclock Sofpironium Bromide 5%). Kaken’s most recent reported quarterly sales show a significant increase in prescriptions and revenue quarter-on-quarter, and provide a significant indication of the unmet need for new treatments for hyperhidrosis and the potential for the products commercialisation in the US and other international markets.
In the US alone, there are approximately 16 million subjects who suffer from hyperhidrosis, with approximately 7.3 million severe axillary subjects, which is the patient population in which the successful Phase 3 studies were conducted. Of the severe axillary patient population, approximately 3.7 million subjects are actively seeking treatment.
