Botanix is joining the biotech investment community at the 17th Bioshares Biotech Summit in Hobart this week.
This year’s theme is ‘partnering and financing’, and Botanix Executive Director, Matt Callahan, will be sharing insights into the Company’s progress navigating towards FDA approval for Sofpironium Bromide.
Botanix has announced it has secured firm commitments for A$12.5 million via an institutional placement.
Proceeds from this raise will be used to extinguish future milestone and royalty payments linked to Botanix’s lead product, Sofpironium Bromide (SB) – in a move that could save up to $160 million and prime the Company for potential M&A or partnership activity.
Botanix has today announced that our partner Kaken Pharmaceutical Co Ltd, has secured a new sublicense and distribution agreement for Sofpironium Bromide in Korea.
The deal with Dong Wha Pharmaceuticals, Korea’s oldest pharmaceutical company, will see the expansion of Sofpironium Bromide into the Korean market. Sofpironium Bromide has been successfully marketed as ECCLOCK® by sublicensee Kaken in Japan since November 2020.
Under the terms of this agreement, Botanix will be entitled to a share of the upfront, milestone and royalty payments based on net sales of the products.
Botanix Executive Chairman, Vince Ippolito, said:
“We are very pleased with the progress being made by our partner Kaken in expanding the territories for Sofpironium Bromide commercialisation globally.
“Given the global incidence of primary axillary hyperhidrosis and the relative lack of effective solutions for patients, the opportunities for Sofpironium Bromide continue to expand beyond Botanix’s primary focus of the USA with our existing partner Kaken and new partners to come.”
Botanix lifted a trading halt this morning, sharing news that it has secured commitments of
A$10.0million via institutional investors to accelerate the marketing and launch activities for
Sofpironium Bromide.
Proceeds from the Placement will be used to progress Botanix’s lead development
program, Sofpironium Bromide gel (15%), including costs associated with completing
FDA review, manufacturing, satisfying milestone payments and preparing for commercial
launch in the United States, as well as general working capital purposes and costs of the offer.
Botanix Executive Chairman, Vince Ippolito, commented:
“We are very pleased to announce this placement to institutional investors who have
actively researched and engaged with Botanix and are prepared to invest at this pivotal point in
the Company’s development.
“We are particularly pleased by the support from new institutional investors as they take
the opportunity to join Botanix on its journey towards FDA approval and
commercialisation of our lead product, Sofpironium Bromide for primary axillary
hyperhidrosis.”
Botanix has today released an update regarding the progress of its lead product, Sofpironium Bromide, for the treatment of primary axillary hyperhidrosis – a medical condition where excessive sweating occurs beyond what is needed to maintain normal body temperature.
The U.S. Food and Drug Administration (FDA) has now conducted the mid-cycle review meeting for Sofpironium Bromide, and no significant issues have been identified, as a result of the review. This includes no major clinical safety issues, no risk management issues, or advisory board requirements.
The Company has also announced a capital raise to support the next stage of our New Drug Application (NDA) filing.
Botanix (ASX:BOT) has today published its Quarterly Activities Report and 4C Quarterly Cash Flow Report, for the period ended 31 December 2022.
Key highlights from this period include:
Botanix will be attending the JP Morgan Healthcare Conference in San Francisco this week. The conference attracts more than 50,000 attendees from around the world, bringing together global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community.
As part of the conference, Botanix will be discussing the significant commercial potential of Sofpironium Bromide and sharing some of the independent market research recently completed by Triangle Insights.
With the formal filing of the Sofpironium Bromide NDA now accepted by FDA and a standard review period confirmed, we are pleased to report that the mid-cycle review remains on track for this quarter.
Botanix has today announced that it has received formal written communication from the FDA, confirming that the New Drug Application (NDA) for Sofpironium Bromide is suitable for substantive review, and that no issues have been identified.
With the NDA now formally under review, and a standard review period confirmed, Sofpironium Bromide remains on track for approval in 3Q, 2023.
Botanix President and Executive Chair, Vince Ippolito, said:
“We are very pleased that the NDA for Sofprionium Bromide has been accepted for substantive review by the FDA. Our team has worked diligently to file a comprehensive application and we look forward to the anticipated mid-cycle review in 1Q 2023 and the ultimate approval of Sofprionium Bromide.”
Botanix’s recently announced Share Purchase Plan (SPP) to raise up to A$3 million is now open for eligible AU/NZ shareholders.
The SPP opens today, 9 November 2022 and will remain open until 8:00pm AEDT on Wednesday, 23 November 2022 (unless extended or withdrawn).
As the SPP is only open for two weeks, eligible shareholders are encouraged to apply for new shares as soon as possible.
Botanix (ASX:BOT) has today lifted its trading halt, sharing news that it has secured a commitment of A$5.0million from a highly respected institutional investor, Antares Capital. The Company will also offer a limited Share Purchase Plan (SPP) for eligible AU and NZ shareholders to raise up to A$3 million.
