BOTANIX PHARMACEUTICALS LTD — Investor Presentation 2021

Mar 15, 2021

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16 March 2021

Botanix presenting at ASX Small and Mid-Cap Conference

Philadelphia PA and Sydney Australia, 16 March 2021: Clinical stage cannabinoid company Botanix Pharmaceuticals Limited (ASX:BOT, “Botanix” or “the Company”) is pleased to announce Vince Ippolito, President and Executive Chairman, will be presenting at the ASX Small and Mid-Cap Conference, held on 16 to 17 March 2021.

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 event is free to attend, and investors are invited to register here. 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 CY2021. 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

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
ASX Small
and Mid-Cap
Conference
March 2021
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www.botanixpharma.com

Investment Highlights

Pharmaceutically focused

Leading pharmaceutical company leveraging unique delivery technology (Permetrex ™️ ) and the 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 of CBD 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 launch of Phase 1b rosacea study, progression of 1801 antimicrobial platform and Phase 3 acne study

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

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WORLD-CLASS TEAM

World-Class Team

Board of Directors

Executive

Management

& Advisers

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Vince Ippolito

Dr Bill Bosch

Matt Callahan

Dr Stewart Washer

President and Executive Chairman

Executive Director

Executive Director

Director

• ❖ COO of Anacor and Medicis with 17 years at Novartis

• ❖ Serial founder and ex-investment director of two venture capital firms in life sciences

• ❖ Currently a board member of Orthocell, Cynata Therapeutics and Emyria

• ❖ 20+ years experience in pharma industry

• ❖ Former CSO of iCeutica Inc. and

• ❖ 20+ years of experience in medical tech, biotech and agrifood

• ❖ More than 30 years experience in pharma with 20+ years within dermatology

• ❖ Developed 4 products through FDA approval and launch

• ❖ Co-inventor of SoluMatrix™, a drug delivery technology and NanoCrystal® Technology

Anthony Robinson

Dr Joyce Rico

Dr Clarence Young

Lynda Berne

Dr Ira Lawrence

Chief Medical Officer

Vice President of Development

Head of Commercial

MD, FACP

MD, MBA, FAAD

• ❖ Recently Chief Medical Officer at ❖ Recently Vice President at Velicept Therapeutics Advicenne

• ❖ Founder of BAL Pharma Consulting

• ❖ Recently CMO for Novan Pharmaceuticals

  • ❖ 30+ years of senior level leadership experience within the global pharmaceutical and medical device industries

• ❖ Experience as Board Member for the Society of Investigative Dermatology, VP Medical Affairs at Astellas

• ❖ Senior leadership roles at Iroko ❖ Senior leadership roles at ❖ 13 years senior leadership roles Pharmaceuticals, Novartis and Aquestive Therapeutics, in pharmaceuticals industry GlaxoSmitheKline Intrommune and Shire Pharmaceuticals

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PHARMA FOCUSED

Advanced Pipeline

BTX 1503 Acne

BTX 1801 Antimicrobial

BTX 1702

Rosacea

Ph 1

Ph 1b

Ph 2

Ph 3

Status

Planning underway for Phase 3 clinical studies

Positive Phase 2a results, finalising clinical development plan

Phase 1b study to commence in 2Q CY2021 Ongoing project work and internal development

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PHARMA FOCUSED

Permetrex[TM] : Proprietary skin delivery technology Makes new types of topical products[1] that deliver very high doses of drug into the layer of the skin without using permeation enhancers, preservatives, or irritating levels of alcohol / petrol derivatives

Initial application

Target drug is incorporated in Permetrex™ formulation which spreads easily over skin surface Epidermis Dermis

Evaporation of solvent Delivery into the skin Volatile majority of the formulation evaporates Rapid change in concentration of the drug as a – leaving a minority of highly concentrated result of evaporation, drives drug into the skin drug solution on the skin surface and is designed not to leave excess excipients on the surface

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Permetrex[TM] is utilised in Botanix synthetic CBD pipeline products and to improve delivery or other drugs in development with partners

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1. Topical dosage forms include: solutions, creams, gels, ointments, foams or pastes

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 cannabidiol to be:

• ✓ 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 (MRSA - “Superbugs”)

• ✓ MRSA bacteria do not develop resistance[1]

• ✓ Potential for widespread use across human and animal health

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

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Anti-microbial resistance background and BTX 1801 clinical program

ANTIMICROBIAL

Antimicrobial Resistance is a Fast-Growing Problem…

…with No Innovation in Over Three Decades

Global forecast deaths by 2050[1 ] (p.a.)

Number of antibiotic classes discovered or patented[2]

10.0m

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Without new innovative solutions, antimicrobial resistance (AMR) could emerge as the leading cause of death

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8.2m
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1.4m 1.5m
1.2m
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Traffic Diarrhoeal accidents disease

Diabetes Cancer AMR

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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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1. Tackling Drug Resistant Infections Globally Final Report and Recommendations (2016), The Review on Antimicrobial Resistance

2. 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

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ANTIMICROBIAL

BTX 1801: nasal decolonisation staph aureus Phase 2a study

Study design

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

• ❖ 4 dose groups: 66 healthy volunteers:

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Safety & tolerability

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

  - ✓ All 66 participants successfully completed the BTX 1801 study

  - ✓ No severe adverse events reported[1]

• 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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Efficacy

• ✓ 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 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

www.botanixpharma.com

ANTIMICROBIAL

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

BTX 1801 Ointment: Staph eradication rates (% of participants)[1]

BTX 1801 Gel: Staph eradication rates (% of participants)[1]

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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

Significant Upside Potential– Multiple AMR Opportunities

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• ❖ Dialysis related infections from catheter usage

• ❖ Skin structure infections diabetic ulcers and wounds

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

• ❖ Skin infections – impetigo and bacterial folliculitis

Drug resistant diseases could cause up to 10m deaths each year by 2050[1]

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

• ❖ N. Gonorrhoeae

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

• ❖ Meningitis

• ❖ Legionnaires disease

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

Top-line data and additional information from the BTX 1801 ✓ Potential in multiple study will further inform development strategies for the The safety and efficacy profile of synthetic cannabinoids creates multiple future opportunities applications antimicrobial platform

• ✓ 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

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

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ANTIMICROBIAL

Implications for 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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Dermatology clinical programs

DERMATOLOGY

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BTX 1702: Impact of Rosacea and Significant Market Opportunity

A rapidly growing market: Rosacea market projected to grow to US$2.6bn by 2025[3]

❖ Papulopustular rosacea is a chronic skin disease

characterised by redness (inflammation) and acnelike-break-outs[1]

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US$2.6bn
US$1.9bn
2020 2025
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Anticipated to register CAGR of ~6.8%[3] over the forecast period

❖ Patients diagnosed with Rosacea tend to have higher incidences[2] of:

Depression

• ❖ Affects ~5.5% of the global population[4] , ~430m individuals

Social anxiety

• ❖ 85% of patients are over 30 years old[5]

Embarrassment

• ❖ There are currently over 16m Americans affected[6] by the illness, with ~5m medical treatment prescriptions[7] in the US alone

Decreased quality of life

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1. Blount BW, Pelletier AL. Am Fam Physician. 2002;66:435-440.; 2. Moustafa F. J Am Acad Dermatol. 2014;71:973-980; 3. Grandview Research. www.Grandview research.com; 4. Gether L, et al. Br J Dermatol. 2018;179:282-289; 5. Aimee Two, et al, JAAD, Volume 72, Issue 5, May 2015; 6. National Rosacea Society. www.rosacea.org; 7. Symphony Health Solutions, PHAST

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DERMATOLOGY

BTX 1702: Phase 1b Rosacea Study Commencing 2Q CY2021

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Study design
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❖ 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

  - 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

• ❖ Screening: facial photos with Canfield imaging

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DERMATOLOGY

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

Study update

Large and growing acne market

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• ✓ End of Phase 2 meeting with FDA successfully completed

22m total prescriptions in 2019 growing ~5% year-on-year[2] US$5.1bn in sales in 2019[2]

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

• ✓ Co-primary efficacy endpoints[1] agreed for Phase 3 studies

>2m p.a. active, diagnosed acne patients under HCP care[3]

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

~40m to ~50m acne sufferers[4] (~10m mod-to-severe)

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

60% of acne patients are managed by 5K HCPs[5]

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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. Symphony Health Solutions, METYS, data ending December 2019 – weighted

3. Symphony Health Solutions, MAT, ending April 2019

4. AAD. Acne Stats and Facts. https://www.aad.org/media/stats-numbers 5. Symphony Health Solutions, IDV Vantage, February 2019

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NEAR-TERM CATALYSTS

Executing on Key Near-Term Milestones

❖ Antimicrobial: BTX 1801 Phase 2a study successful completion Positive results announced and finalising clinical progression plans

❖ Rosacea: BTX 1702 Phase 1b study start Targeting study commencement in 2Q CY2021

• ❖ Acne: BTX 1503 planning for Phase 3 clinical studies Pending the completion of BTX 1702 Phase 1b clinical study

• Strong cash position ~A$26m As at 31 December 2020 (including R&D tax return)

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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