For personal use only

27 July 2022

Euroz Hartleys Healthcare Conference Presentation

Key highlights

  • Release of updated corporate presentation to be delivered at Euroz Hartleys Healthcare Conference being held today in Perth including a number of other leading ASX listed companies
  • The presentation includes:
  1. an update on the accelerated FDA submission timetable of the New Drug Approval (NDA) for Sofpironium Bromide which is now planned for this quarter;
  1. insights into the market opportunity for Sofpironium Bromide; and
  1. confirmation of timetable for completion of rosacea (BTX 1702) Phase 1/2 clinical study and the canine dermatitis pilot study (BTX 1204A in Q3 CY2022

Philadelphia PA and Phoenix USA, 27 July 2022: Clinical dermatology company, Botanix

Pharmaceuticals Limited (ASX: BOT, "Botanix" or "the Company"), is pleased to release a corporate presentation being used for the Euroz Hartleys Healthcare Conference being held today in Perth.

Botanix's Chief Commercial Officer, Howie McKibbon, will be presenting an update on Sofpironium Bromide for which the FDA filing has been accelerated and is now planned for this quarter, further insights into the market opportunity for Sofpironium Bromide, as well as an update on the Company's BTX 1702 Phase 1b/2 rosacea study and the BTX 1204A Phase 1b canine dermatitis study, which are on target for completion in Q3 CY2022.

Executive Director Matt Callahan will also be presenting some thoughts on the FDA drug development and approval processes and how companies (and investors) can mitigate risk in development.

Release authorised by

Vince Ippolito

President and Executive Chairman

About Botanix Pharmaceuticals

Botanix Pharmaceuticals Limited (ASX:BOT) is a dermatology company based in Philadelphia and Phoenix (USA) which is committed to the development of novel treatments for a range of common skin diseases. The Company has a mature dermatology pipeline with its first product, Sofpironium Bromide, for the treatment of primary axillary hyperhidrosis, planned to be filed for FDA in Q3 CY2022. The Company also has a pipeline of other products in late-stage clinical studies for the treatment of moderate to severe rosacea, dermatitis and acne respectively. Botanix is also developing a topical

For personal use only

antimicrobial product for the eradication of bacteria on the skin surface, initially in patients who are undergoing hemodialysis.

Botanix leverages its proprietary drug delivery system (PermetrexTM) for direct skin delivery of active pharmaceuticals in all skin diseases, which is utilised in its existing development programs and is being explored with a view to being utilized in a number of other product opportunities. To learn more please visit: http://www.botanixpharma.com/

For more information, please contact:

General enquiries

Investor enquiries

Media enquiries

Corporate Communications

Hannah Howlett

Haley Chartres

Botanix Pharmaceuticals

WE Communications

H^CK

P: +61 8 6555 2945

P: +61 450 648 064

P: +61 423 139 163

investors@botanixpharma.com

hhowlett@we-worldwide.com

haley@hck.digital

Cautionary Note on Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, the Company's strategy, future operations, the expected timing and/or results of regulatory approvals and prospects of commercialising product candidates or research collaborations with its partners, including in Japan, the outcome and effects of Sofpironium Bromide and the market for Sofpironium Bromide and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the Company's or its partners' ability to successfully develop its product candidates and timely complete its planned clinical programs and the Company's or its partners' ability to obtain marketing approvals for is product candidates. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

For personal use only

Euroz Hartleys

Healthcare

Conference

July 2022

Preparing to file first dermatology product for FDA approval in Q3 2022

1

onlyuse

personalBotanix:a leaderin topical drug development

For

Preparing to file for FDAapproval offirst productin a $1.6 billion market

Pharmaceutical focus

New treatments for common skin diseases - such as excessive sweating (hyperhidrosis), rosacea and acne

Topically driven

Targeting key indications with topical treatments that are safe, well tolerated and validated with clinical efficacy

World class team

US based team that have been responsible for more than 30 dermatology drug developments and launches

Sofpironium Bromide

First and only new drug for "primary axillary hyperhidrosis" (excessive underarm sweating) already approved in Japan1

Near-term catalysts

Upcoming filing for FDA approval for Sofpironium Bromide and data readouts from other pipeline products in 3Q CY2022

Source 1 : ASX release May 4 2022

2

For personal use only

Corporate

Overview

ASX: BOT TRADING INFORMATION

Share price

A$0.081

6-month low / high

A$0.052/0.095

Shares outstanding

979,233,384

Market Capitalisation

A$79.3m

Cash (31 Mar 2022)

A$ 16.4m

Debt (31 Mar 2022)

Nil

Enterprise value

A$62.9m

SUBSTANTIAL SHAREHOLDERS

Shareholder

%

Board and Management

8.29%

Caperi Pty Ltd, Co-Founder

5.4%

Positioned to transition to commercial dermatology company

SHARE PRICE PERFORMANCE

0.081

3

This is an excerpt of the original content. To continue reading it, access the original document here.

Attachments

  • Original Link
  • Original Document
  • Permalink

Disclaimer

Botanix Pharmaceuticals Ltd. published this content on 27 July 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 27 July 2022 00:41:01 UTC.