Botanix Pharmaceuticals : Appendix 4C - Quarterly

For personal use only

28 January 2022

Botanix Pharmaceuticals Quarterly Activity Report

and 4C Quarterly Cash Flow Report

Key highlights

• Botanix's canine atopic dermatitis program, BTX 1204A, is progressing well and on track to finish enrolment this quarter
• BTX 1702 Phase 1b/2a Rosacea Study continues to progress well with enrolment on target to be completed mid-year
• Pre-clinicalwork to support the initiation of a Phase 2 human study for its BTX 1801 antimicrobial program is complete with the clinical study planned to initiate at the end of this quarter
• Strong balance sheet with $16.8 million in cash at closing of 4Q 2021 with R&D tax return expected 1Q 2022

Philadelphia PA and Perth Australia, 28 January 2022: Clinical dermatology company, Botanix

Pharmaceuticals Limited (ASX: BOT, "Botanix" or "the Company"), is pleased to release its Quarterly Activity Report and Appendix 4C Quarterly Cash Flow report for the period ended 31 December 2021.

Clinical Studies and Drug Development

Rosacea: BTX 1702 Phase 1b/2a study is advancing

As previously announced, the Company is currently undertaking a Phase 1b/2a randomised, double blind, vehicle-controlled clinical study in patients with moderate to severe papulopustular rosacea.

The study commenced in late June 2021 and the study is on track to complete enrolment in mid-2022. As part of the 8-week study, which is taking place at 15 dermatology sites across Australia and New Zealand, 40 patients will receive a high dose, 40 patients will receive a low dose and the remaining 40 patients will receive the vehicle (placebo). All patients will be dosed twice daily.

The study will investigate the safety and tolerability of BTX 1702, and examine the change in inflammatory lesion counts from baseline at days 15, 29 and 57, the proportion of patients with Investigator's Global Assessment (IGA) treatment success, the change in Clinician's Erythema Assessment (CEA) scale as well as a number of other imaging and patient reported outcomes

Botanix's rosacea study represents research of strategic importance for the Company's wider clinical development as the results will provide key safety and efficacy data, as well as validate the implementation of centralized review of each clinical investigator's ratings and some endpoint assessments for consistency and quality control.

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Dermatology: BTX 1204A canine atopic dermatitis program on track

In September 2021, the Company announced the launch of the canine atopic dermatitis program (BTX 1204A proof of concept study with receipt of ethics approval and the initiation of sites across Australia and New Zealand. Recruitment remained strong despite Christmas closures and the study is on track to complete enrolment this quarter, with data expected in early 2Q 2022.

BTX 1204A is based on a higher dose formulation of synthetic cannabidiol (CBD) in a novel PermetrexTM formulation, which has been demonstrating strong efficacy in killing bacteria over the last months. Given the similarity in disease between humans and canines, successful outcomes from the POC study will drive licensing programs for animal health and also support progression to a late-stage Phase 2b clinical study in humans with atopic dermatitis.

Antimicrobial: BTX 1801 clinical development moving forward

Following the success of its Phase 2a study reported in 2021, Botanix's antimicrobial clinical development program, BTX 1801, is moving forward with a Phase 2 study planned to initiate in late 1Q 2022. Botanix has recently completed a further round of animal studies and other preclinical work to enable a longer term, repeat dose study to be conducted in humans with confirmed bacterial colonisation.

The BTX 1801 program is designed to target nasal decolonisation of Staph aureus and MRSA in patients undergoing haemodialysis with a view to reducing the incidence of life-threatening blood stream infections. Infections frequently occur due to the placement of the central venous catheter in the chest directly below the nose, with direct access into the bloodstream adjacent to the heart. There are no approved products to decolonise the nasal passages of patients undergoing haemodialysis and commercial work undertaken by Botanix, demonstrates a significant market opportunity for such a therapy.

The Company also intends to leverage a range of existing US FDA programs, including, Qualified Infection Disease Product (QIDP), Fast Track and the grant of Limited Population Pathway for Antimicrobial and Antifungal Drugs (LPAD) status to accelerate the development of BTX 1801, reduce clinical costs and increase the FDA exclusivity period for the product.

Financial overview

During the quarter, Botanix had net cash outflows of A$2.7m, with A$1.9m invested in R&D activities. At the end of the quarter, Botanix held A$16.8m in cash and remains in a strong financial position. Botanix expects receipt of its R&D tax return in 1Q 2022 which will further strengthen its cash reserves.

Payments to related parties as detailed in Section 6.1 of the Appendix 4C relate to salaries, fees and superannuation (or equivalent) entitlements paid pursuant to agreements with Directors or associates.

Upcoming milestones and outlook

Botanix continues to progress its pipeline of dermatology and infection focused products and is excited to be working towards a number of important clinical and other milestones in 2022 including:

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• Antimicrobial BTX 1801: filing of ethics approval in Q1 2022 and commencement of Phase 2 study in Australia treating subjects over a 9 week period intermittently to show xtended effect of BTX 1801;
• Rosacea BTX 1702: Phase 1b/2a study recruitment targeted for completion by mid-2022;
• Acne BTX 1503: planning for Phase 3 clinical studies, informed by the successful completion of the BTX 1702 Phase 1b/2 study;
• Dermatitis BTX 1204A: canine proof of concept study targeting completion of enrolment 1Q 2022 with data early in 2Q 2022. Success to drive licensing programs for animal health and support progression to a late-stage Phase 2b clinical study in humans with atopic dermatitis; and
• New indications and PermetrexTM opportunities and business development: Activity to acquire new opportunities that either leverage the PermetrexTMtechnology platform and/or can be progressed rapidly through clinical development towards approval.

Release authorised by

Vince Ippolito

President and Executive Chairman

About Botanix Pharmaceuticals

Botanix Pharmaceuticals Limited (ASX:BOT) is a clinical stage dermatology Company based in Perth (Australia) and Philadelphia (USA) committed to the development of pharmaceutical products that are underpinned by science and supported by well-controlled randomised clinical trials. The Company has two complimentary development platforms - dermatology and antimicrobial products - both of which currently leverage the unique anti-inflammatory, immune modulating and antimicrobial properties of cannabinoids, particularly synthetic cannabidiol or CBD. Botanix has an exclusive license to use a proprietary drug delivery system (PermetrexTM) for direct skin delivery of active pharmaceuticals in all skin diseases, which it utilises in its existing development programs and is being explored with a view to being utilized in a number of other product opportunities.

The Company is developing a pipeline of product candidates with recent positive data from its BTX 1801 Phase 2a antimicrobial study and its Phase 1b/2a rosacea clinical study is currently enrolling patients. Following a successful meeting with the FDA, the Company has also confirmed a drug development plan for the BTX 1503 acne Phase 3 program to support registration. In addition, Botanix plans to advance its BTX 1204A atop dermatitis program to a proof of concept canine study in Q3 CY2021 following encouraging early data from a recent pilot study. To learn more please visit: http://www.botanixpharma.com/

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For more information, please contact:

General enquiries	Investor enquiries	Media enquiries
Corporate Communications	Hannah Howlett	Haley Chartres
Botanix Pharmaceuticals	WE Communications	H^CK
P: [phone]	P: [phone]	P: [phone]
[e-mail]	[e-mail]	[e-mail]

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, 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 ability to successfully develop its product candidates and timely complete its planned clinical programs and the Company's 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.

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Rule 4.7B

Appendix 4C

Quarterly cash flow report for entities subject to Listing Rule 4.7B

Name of entity

Botanix Pharmaceuticals Limited
ABN	Quarter ended ("current quarter")
70 009 109 755	December 2021

Consolidated statement of cash flows	Current quarter	Year to date
			$A'000	(6 months)
				$A'000
1.	Cash flows from operating activities
1.1	Receipts from customers	-	-
1.2	Payments for
	(a)	research and development	(1,911)	(3,259)
	(b) product manufacturing and operating	-	-
		costs
	(c)	advertising and marketing	-	-
	(d)	leased assets	-	-
	(e)	staff costs	(200)	(415)
	(f) administration and corporate costs	(573)	(960)
1.3	Dividends received (see note 3)	-	-
1.4	Interest received	6	24
1.5	Interest and other costs of finance paid	(9)	(20)
1.6	Income taxes paid	-	-
1.7	Government grants and tax incentives	-	-
1.8	Other (provide details if material)	-	-
1.9	Net cash from / (used in) operating	(2,687)	(4,630)
	activities
2.	Cash flows from investing activities
2.1	Payments to acquire or for:
	(a)	entities	-	-
	(b)	businesses	-	-
	(c) property, plant and equipment	-	(7)
	(d)	investments	-	-
	(e)	intellectual property	-	-
	(f)	other non-current assets	-	-

ASX Listing Rules Appendix 4C (17/07/20)	Page 1
+ See chapter 19 of the ASX Listing Rules for defined terms.