BOTANIX PHARMACEUTICALS LTD — Investor Presentation 2021

Feb 18, 2021

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19 February 2021

Botanix attends 2[nd] Dermatology Drug

Development Summit Europe

Philadelphia PA and Sydney Australia, 19 February 2021: Clinical stage cannabinoid company Botanix Pharmaceuticals Limited (ASX:BOT, “Botanix” or “the Company”) is pleased to announce Matt Callahan, Executive Director, will be presenting at the 2[nd] Dermatology Drug Development Conference Europe, held virtually this year.

The Company will provide an update on the progress of the key clinical programs, including the BTX 1801 Phase 2a results and the implications of this data on the broader dermatology platform. The conference attracts industry experts focused on therapeutic innovation in the dermatology space and features company presentations, thematic panel discussions, workshops and one-on-one discussions. The conference presentation is attached to this release.

Release authorised by

Vince Ippolito

President and Executive Chairman

About Botanix Pharmaceuticals

Botanix Pharmaceuticals Limited (ASX:BOT) is a clinical stage synthetic cannabinoid 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 separate cannabinoid development platforms, dermatology and antimicrobial products, both of which leverage the unique anti-inflammatory, immune modulating and antimicrobial properties of cannabinoids, particularly synthetic cannabidiol. Botanix has an exclusive license to use a proprietary drug delivery system (Permetrex) for direct skin delivery of active pharmaceuticals in all skin diseases.

The Company is developing a pipeline of product candidates that leverages the antimicrobial properties of cannabinoids with the BTX 1801 Phase 2a study nasal decolonization study announcing positive data in early February CY 2021. For the dermatology platform, the Company has confirmed a drug development plan for the BTX 1503 acne program to support registration and plans to initiate its Phase 1b rosacea study in 1H CY2021. To learn more please visit: https://www.botanixpharma.com/

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For more information, please contact:

General enquiries Investor enquiries Media enquiries Corporate Communications Joel Seah Haley Chartres Botanix Pharmaceuticals Vesparum Capital H^CK P: +61 8 6555 2945 P: +61 3 8582 4800 P: +61 423 139 163 investors@botanixpharma.com botanixpharma@vesparum.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, 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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Unlocking the potential of synthetic cannabinoids
2 [nd] Dermatology
Drug Development
Summit Europe
February 2021
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www.botanixpharma.com

Overview of Botanix

Pharma focused

Leading pharmaceutical company leveraging unique properties of synthetic cannabinoids, including cannabidiol (CBD)

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Antimicrobial opportunities

Dermatology opportunities

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Novel antimicrobial platform with positive Phase 2a results that underpin potential to combat antimicrobial resistance

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

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Near-term catalysts

World-class team

Multiple upcoming key catalysts including progression of antimicrobial platform, launch of Phase 1b rosacea study and planning for Phase 3 acne study

World-class and experienced team with significant cannabinoid, dermatology and antimicrobial drug development expertise

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www.botanixpharma.com

Pharma focused

Synthetic Cannabinoids Advanced Clinical Pipeline

BTX 1503 Acne

BTX 1801 Antimicrobial

BTX 1702 Rosacea

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Ph 1

Ph 1b

Ph 2

Ph 3

Status

Planning underway for Phase 3 clinical studies

Positive Phase 2a study outcome

Targeting initiation of Phase 1b study in 1H CY2021

www.botanixpharma.com

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Pharma focused
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Synthetic Cannabinoids are well suited to treat Skin Diseases and Infections

Botanix’s studies show synthetic cannabinoids:

• Safe and well tolerated

• Broad anti-inflammatory properties relevant to infections

• Strong and consistent impact on inflammatory lesions

• Kill S. aureus and resistant S. aureus (MSRA - “Superbugs”)

• MRSA bacteria are not prone to develop resistance[1]

• Potential for widespread use across human and animal health

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1. See ASX announcement “Antimicrobial Platform Update and Launch of BTX 1801 Study” (13 March 2020)

www.botanixpharma.com

Background Anti-microbial resistance and cannabinoids

ANTIMICROBIAL

No new antibiotics have been discovered in over three decades

No new approved class of antibiotics has been discovered since 1984 and no new class of antibiotics has been discovered to treat Gram-negative bacteria since 1962

Number of antibiotic classes discovered or patented[1]

Cannabinoids

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9
55+ year gap
No new approved classes of
antibiotics discovered since 1962 for
7 the most dangerous types of
bacteria (Gram-negatives)
5 5 35+ year gap
No new classes of
antibiotics discovered
at all since 1984.
Nearly every antibiotic
2 in use today is based
on Daptomycin
1 1 1 discovered in 1984
0 0 0 0 0 0
1890 1900 1910 1920 1930 1940 1950 1960 1970 1980 1990 2000 2010 2018
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New class of antibiotics
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Structural activity characterized by Botanix (IP Position secured) Examples Cannabidiol (CBD), Cannabigerol (CBG), CBD analogs

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1. Pew Charitable Trusts; Deak et al. Progress in the Fight Against Multidrug Resistant Bacteria?; A Review of FDA Approved Antibiotics 2010-2015. 31 May 2016. DOI: 10.7326/M16-0291

www.botanixpharma.com

CBD is a broad-spectrum Gram-positive antibiotic CBD is a powerful new antibiotic that is effective against a range of problematic Gram-positive bacteria at MICs comparable to currently approved antibiotics[1,2,3]

100 Gram-Negative Fungi Gram-Negative Anaerobes Acinetobacter baumannii Proteus mirabilis Candida albicans Bacteroides ovatus Burkholderia cepacian Providencia stuartii Cryptococcus neoformans Veillonela parvula Campylobacter jejuni Pseudomonas aeruginosa Fusobacetrium nucleatum Citrobacter freundii Salmonella typhimurium Enterobacter cloacae Serratia marcescens Mycobacteria Escherichia coli Shigella dysenteriaev 10 Haemophilus influenzae Shigella sonnei M. smegmatis M. tuberculosis Klebsiella pneumoniae Stenotrophomans Morganella morganii maltophila Gram-Positive Staphylococcus Gram-Negative Streptococcus 1 S. aureus MSSA Other Gram-Positive Gram-Positive Anaerobes N. Gonorrhoeae S. aureus MRSA S. pneumoniae Neisseria meningitidis S. aureus VISA S. pneumoniae MDR Bacillus cereus Acidpropionibacterium Legionella pneumophila S. canis S. aureus VRSA Bacillus megaterium acidipropionici S. capitis S. intermedius Bacillus subtilis Cutibacterium granulosum S. epidermis S. pyrogenes Corynebacterium minutissimum Cutibacterium acne4 S. epidermis VISE S. saprophyticus Enterococcus faecium Clostridium difficile S. haemolyticans Enterococcus faecalis S. aureus MRSA S. warneri Enterococcus gallinarum 0.1 Kocuria rosea

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1. Based on testing conducted by the University of Queensland – BOT data on file

2. Based on testing conducted by the Micromyx – BOT data on file

3. Based on testing conducted by Monash University –BOT data on file 4. Formerly known as Propionbacteria acnes

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www.botanixpharma.com

Remarkable activity against MRSA without inducing resistance CBD shows remarkable activity against 132 isolates of S. aureus and MRSA[1]

Antibiotic Minimum Inhibitory Concentration (MIC) comparison[1]

Antibiotic	S. aureus all isolates(mg/mL)	S. aureus all isolates(mg/mL)	S. aureus all isolates(mg/mL)	MRSA(mg/mL)	MRSA(mg/mL)	MSSA(mg/mL)	MSSA(mg/mL)
	MIC50	MIC90	Range	MIC50	MIC90	MIC50	MIC90
CBD	2	4	0.25 - 8	2	2	2	4
Mupirocin	0.5	0.5	0.125 – 64	0.5	0.5	0.5	0.5
Vancomycin	1	2	0.5 – 64	1	1	1	2
Daptomycin	2	4	0.5 – 16	2	2	2	4
Clindamycin	0.125	64	0.03 – 64	0.125	0.1875	0.125	64

MIC50 = min conc to inhibit growth of 50% of isolates. MIC90 = min conc to inhibit growth of 90% of isolates. MRSA = methicillin resistant S. aureus. MSSA = methicillin susceptible S. aureus

MIC daily variability[2]

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12
Daptomycin Cannabidiol 26x fold increase
An increase in MIC over time
8
shows MRSA can develop
4 resistance to the drug
1.5x fold increase
-
Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
MIC (µg/mL)
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Repeat challenge experiments demonstrate that MRSA bacteria form resistance to commonly-used antibiotics such as daptomycin, but not easily to synthetic CBD

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1. Based on testing conducted by the University of Queensland – BOT data on file 2. Based on an average of 8 replicates (University of Queensland – BOT data on file)

www.botanixpharma.com

ANTIMICROBIAL

Unique mechanism of action – bactericidal

Novel mechanism of action with unique ability to rapidly kill bacteria without allowing resistance to develop

Mupirocin – targets only protein synthesis[1]

CBD – MRSA bacteria dead within 10 minutes[2]

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Control
CBD
(1xMIC)
CBD
(2xMIC)
CBD
(5xMIC)
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Control
CBD
(1xMIC)
CBD
(2xMIC)
CBD
(5xMIC)
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Control
CBD
(1xMIC)
CBD
(2xMIC)
CBD
(5xMIC)
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Control
CBD
(1xMIC)
CBD
(2xMIC)
CBD
(5xMIC)
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CBD – affects all macromolecular pathways[1]

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1. Based on testing conducted by HD Biosciences – BOT data on file 2. Based on testing conducted by Linnaeus Bioscience – BOT data on file

www.botanixpharma.com

ANTIMICROBIAL

Novel Mechanism of Action Confirmed

The time-lapse shows CBD causes rapid permeabilization of the bacterial membrane and cell death

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S.aureus treated with 2.5% methanol (negative control) [1] S.aureus treated with synthetic cannabidiol1
Staph bacteria treated
with negative control
Bacteria are not
affected over 120
mins
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Staph bacteria treated
with synthetic CBD
Green staining indicates
uptake of dye and
disintegration of
bacteria
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1. S. aureus grown at room temperature on an agarose pad containing 0.25µM SYTOX-Green. Phase images were collected every five minutes for 120 minutes

www.botanixpharma.com

Clinical data for BTX 1801 and implications for dermatology

ANTIMICROBIAL

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Strict QIDP criteria:
 Requires provision of a
detailed package of data
 Must be a novel product
 Must treat a serious or life
threatening illness
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BTX 1801 – First CBD-based program to receive QIDP

FDA QIDP creates multiple commercial benefits

Exclusivity

Priority

Fast track

5 additional years of regulatory exclusivity on top of the standard 5 years

Eligible for an expedited six-month review period (rather than 12 months)

Enables more frequent communication with the FDA during development

Up to 10 years of sales where generics cannot enter the market

Accelerating the FDA review process reduces time to market

FDA guidance throughout development de-risks clinical trials

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www.botanixpharma.com

ANTIMICROBIAL

BTX 1801: Phase 2a Clinical Study Successfully Completed

Study update

Study design

• Phase 2a study completed in 4Q CY20

• Positive top-line data announced 1Q CY21

• Study evaluated safety and local tolerability of 2 formulations to decolonise Staph from the nose of healthy adults

• Phase 2a study supports rapid progression into pivotal studies for FDA registration

• FDA ‘fast-track’ status application for BTX 1801 to be pursued post IND filing

• Double-blind, vehicle-controlled Phase 2a clinical study

• 4 dose groups: 66 healthy volunteers:

• BTX 1801 Formulation A

• BTX 1801 Formulation B

• Vehicle A

• Vehicle B

• Sites: s ingle Australian site

• Patients: adults: 18 years and older with positive nasal SA

• Treatment: twice daily treatment for a 5-day period

• Primary endpoints : safety and local tolerability, proportion of volunteers carrying Staph / MRSA at Day 12

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www.botanixpharma.com

ANTIMICROBIAL

Phase 2a study: Successful at eradicating Staph[1]

BTX 1801 met study end points

• Safe and well tolerated at doses up to 20% drug active

• All 66 participants successfully completed the BTX 1801 study

• Safety &  No severe adverse events reported[2]

• tolerability

• Efficacy of ointment and gel formulations demonstrated at primary endpoint of Day 12

• Eradication rates as high as 76.2% at Day 7, with eradication effects

• Efficacy extending through to Day 28, despite no treatment after Day 5

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1. The incidence of adverse events was low, mild in severity and occurred at similar rates across the different treatment groups with no severe events reported

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1. Data announced 3 February 2021

www.botanixpharma.com

ANTIMICROBIAL

Phase 2a study data: staph eradication World first human data demonstrating synthetic CBD has clinical utility as an antimicrobial agent

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BTX 1801 Ointment: Staph eradication rates (% of participants) [1] BTX 1801 Gel: Staph eradication rates (% of participants) [1]
80% 80%
5 day 76.2% 5 day
treatment treatment
68.8%
period period
60% 60%
40% 40%
38.1%
27.8% 27.8%
25.0%
23.8%
20% 20%
18.8%
16.7% 16.7%
12.5% 12.5%
0% 0%
0 5 7 12 28 0 5 7 12 28
Days Days
BTX 1801 Ointment Combined Vehicle Groups BTX 1801 Gel Combined Vehicle Groups
Staph eradication rates (% of participants) Staph eradication rates (% of participants)
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1. Data announced 3 February 2021

www.botanixpharma.com

ANTIMICROBIAL

Phase 2a study data: context

Destiny Pharma (XF-73): Staph eradication rates (% of participants)[1]

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80%
5 day
treatment
period
60%
41.7%
40%
20%
0% 0.0%
0 5 6 14 28
Days
Destiny Pharma (XF-73 in 4% gel)
Staph eradication rates (% of participants)
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• Destiny XF-73 study examined eradication at day 6 (i.e 1 day after treatment period) and Day 14 (9 days after treatment period)

• Like most comparative studies, Destiny XF-73 study included full body chlorhexidine wash during the 5-day treatment period to remove reservoirs of bacteria (helps prevents recolonisation)

• BTX 1801 Phase 2a study did not include this wash protocol

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Yendewa et al. A two-part phase 1 study to establish and compare the safety and local tolerability of two nasal formulations of XF-73 for the decolonisation of Staphylococcus aureus: A previously investigated 0.5mg/g viscosified gel formulation versus a modified formulation. Journal of Global Antimicrobial Resistance 2020; 21: 171-180

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www.botanixpharma.com

ANTIMICROBIAL

Significant upside potential– Multiple AMR Opportunities

• Dialysis related infections from catheter usage

• Awarded Innovation Connection Grant[2] to accelerate the medicinal chemistry program

• C. Diff (Clostridium Difficile) causes diarrhea and colitis

• Medicinal chemistry program being conducted in collaboration with the University of Queensland

• N. Gonorrhoeae (Gonorrhea) re-emerging STD with significant AMR challenges

• Targeting creation of new synthetic analogs to improve the efficacy and bioavailability of “natural” cannabinoids

• N. meningitidis ( Meningitis) particular risk for infants

• New analogs have a unique structure and activity profile and are patentable as new chemical entities

• Legionella pneumophila (Legionnaires disease) severe form of pneumonia  Potential in multiple The safety and efficacy profile of synthetic cannabinoids creates multiple future opportunities

• Potential in multiple human and animal health applications

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1. No Time to Wait: Securing the future from drug-resistant infections. Report to the Secretary-General of the United Nations (2019) available at https://www.who.int/antimicrobialresistance/interagency-coordination-group/IACG_final_report_EN.pdf?ua=1

2. See ASX announcement ‘Botanix receives grant for synthetic cannabidiol analog program’, October 2019

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www.botanixpharma.com

ANTIMICROBIAL

Potential for synthetic CBD in dermatology – Safe and effective antimicrobial and anti-inflammatory

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Impetigo Cellulitis Folliculitis Acne
Corynebacterium
Streptococcus Bacillus subtilis S. Aureus S. epidermis MRSA. Cutibacterium
minutissimum
Erysipelas Dermatitis SSI and ulcers Erythrasma
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www.botanixpharma.com

Other clinical programs for synthetic CBD in dermatology

DERMATOLOGY

BTX 1702: Phase 1b Rosacea Study: commencing 1H 2021

Study design

 Four dose groups, ~120 patients:

 Endpoints:

• BTX 1702 high dose - twice daily: 40 patients

  • Safety and tolerability

• BTX 1702 low dose - twice daily: 40 patients

• Vehicle - twice daily: 40 patients

• Sites: ~12 dermatology sites across Australia and NZ

• Patients: adults (18+ years) with moderate to severe papulopustular rosacea

• Treatment period: 8 weeks

• Screening: facial photos with Canfield imaging

• Change in inflammatory lesion counts from baseline at days 15, 29 and 57

• Proportion of patients with Investigator’s Global Assessment (IGA) treatment success

• Change in Clinician’s Erythema Assessment (CEA) scale

• – Imaging and patient reported outcomes

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www.botanixpharma.com

DERMATOLOGY

BTX 1503: Successful End-of-Phase 2 FDA Meeting

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Study update
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Sizable acne prescription market
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• End of Phase 2 meeting with FDA successfully completed

The global acne market expected to reach US$7bn by 2024[2]

• FDA highlighted excellent safety profile of BTX 1503, and allowed several waivers for studies that are typically required for dermatology drug registration

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8m [3]
Oral acne 12m [3]
BOT US$4.2bn
(40%)
Topical acne
focus market
(60%)
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• Co-primary efficacy endpoints[1] agreed for Phase 3 studies

• Confirmed drug development plan to support registration of BTX 1503 for treatment of moderate and severe acne

• Planning underway for Phase 3 clinical studies to be informed by completion of BTX 1702 Phase 1b study and lifting of COVID-19 restrictions

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1. Co-primary efficacy endpoints: (1) Absolute change from baseline in inflammatory and absolute change from baseline in non-inflammatory lesion at Week 12; (2) Proportion of patients with an Investigators Global Assessment (IGA) of “clear” or “almost clear” and at least a 2-grade improvement in IGA from baseline at Week 12

2. Global Market Insights

3. Number of prescriptions

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www.botanixpharma.com

NEAR-TERM CATALYSTS

Executing on Key Near-Term Milestones

• Antimicrobial: BTX 1801 Phase 2a study completion

• Positive results announced

• Rosacea: BTX 1702 Phase 1b study start

• Targeting study start in 1H CY2021

• Acne: BTX 1503 planning for Phase 3 clinical studies

• Pending completion of BTX 1702 Phase 1b clinical study

• Strong cash position ~A$26.0m As at 31 December 2020 (including R&D tax return ~A$6. 9m)

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www.botanixpharma.com

DISCLAIMER

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 release the views as of the date hereof. The that press represent Company’s Company anticipates 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 statements should not be relied as the views as of date to the date forward-looking upon representing Company’s any subsequent hereof.

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www.botanixpharma.com

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General enquiries Botanix Pharmaceuticals Corporate communications +61 8 6555 2945 investors@botanixpharma.com

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www.botanixpharma.com