BOTANIX PHARMACEUTICALS LTD — Capital/Financing Update 2022

Oct 12, 2022

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13 October 2022

Positive BTX 1702 Phase 1b/2 Clinical Study for Rosacea

Key highlights

• Positive data achieved from BTX 1702 Phase 1b/2 randomised, double blind, vehicle-controlled rosacea clinical study

• 10% BTX 1702 dose showed statistically significant results in the FDA designated endpoint of reduction in inflammatory lesions when compared to vehicle

• Both the 10% and 20% BTX 1702 doses showed clinically meaningful results

• Efficacy for the BTX 1702 active arms continued to improve at each time point assessed

• No serious adverse events were observed

• Review of photo evidence from the clinical study demonstrates significant reduction of redness in target patients and reduction in visible lesions

Philadelphia and Phoenix US, 13 October 2022 : Clinical dermatology company, Botanix Pharmaceuticals Limited (ASX: BOT, “Botanix” or “the Company”), is pleased to announce positive data from its BTX 1702 Phase 1b/2 papulopustular rosacea clinical study (“the Study”).

A summary of the Study design and endpoints is included in a presentation attached to this press release. A webinar to discuss the Study results will be held at 8am Perth time this morning and the Zoom details are at the end of this release .

The BTX 1702 10% gel dose of the study achieved statistical significance in the FDA designated endpoint of reduction in inflammatory lesions (absolute reduction, p=0.02 and percentage reduction, p=0.03) and also approached statistical significance for the investigator’s global assessment “IGA for papules and pustules” (grade of 0 or 1 at day 57, p=0.059 and 2 grade improvement from baseline, p=0.059).

The BTX 1702 10% gel dose was also found to be very safe and well tolerated when compared to Permetrex vehicle (control) gel. The BTX 1702 20% dose was not superior to the 10% dose, but was safe and well tolerated and provides a significant safety margin for the target 10% dose. Efficacy of both the 10% and 20% BTX 1702 doses increased at each time point measured during the 8-week Study.

Botanix President and Executive Chair Vince Ippolito said : “We are very pleased with the outcomes of this Study and the statistically significant performance of the 10% BTX 1702 synthetic CBD dose against the Permetrex  vehicle alone.

“Going into this Study, we wanted to push the dose of synthetic CBD to test the safety and efficacy boundaries in this serious form of rosacea and this has been successfully achieved. The outcomes show that the drug is safe at high doses, but also very effective at the lowest tested dose.”

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Study Design and Endpoints

The BTX 1702 Phase 1b/2 clinical study was a randomised, double blind, vehicle-controlled study in patients with moderate to severe papulopustular rosacea. The Study was designed to investigate the safety and tolerability of BTX 1702 in adults over an 8-week treatment period, with two different concentrations of BTX 1702 tested along with a vehicle (control) arm. The Study enrolled 133 patients in 16 dermatology clinical sites across Australia and New Zealand. Patients were randomised into 3 separate treatment groups consisting of BTX 1702 10% gel (n=45) applied twice daily, BTX 1702 20% gel (n = 45) applied twice daily and vehicle gel (control n= 43) applied twice daily. Patients aged 18 to 65 years old with moderate to severe papulopustular rosacea that met the relevant eligibility and inclusion criteria were enrolled in the Study with 84% of the patient population comprising females and 16% males.

The primary endpoints for the Study were safety and tolerability. Additionally, several exploratory efficacy endpoints were evaluated, including: absolute reduction and percent change, from baseline in inflammatory lesions; the proportion of patients achieving at least clear or almost clear, and a 2- grade improvement from baseline on the 5-grade Investigator’s Global Assessment (IGA) scale and the change in the Clinician’s Erythema Assessment (CEA) scale. Endpoints were assessed at baseline and completion of the 8-week treatment period (day 57) and for some endpoints, also at days 15 and 29 of the Study.

Study results

There were no serious adverse events observed during the Study and all arms (vehicle gel, 10% and 20% BTX 1702 gel) were safe and well tolerated. There were no serious adverse events and most adverse events that did occur, were localised and mild in nature. Patients enrolled in the 10% BTX 1702 arm experienced no burning and stinging, while patients enrolled in the vehicle and 20% BTX 1702 arms experienced some minor burning and stinging (less than 5%).

For the exploratory efficacy endpoints, both doses of BTX 1702 showed clinically positive results, with the 10% showing greater results, being statistically significant compared to vehicle, for reductions in inflammatory lesion counts and improvement in investigator’s global assessment (IGA) endpoints. As outlined in the attached presentation, improvements were seen at each time point measured in the Study of the efficacy endpoints.

A summary of the exploratory efficacy endpoints at the end of 8 weeks (Day 57) is set out below in Table 1.

Exploratory Efficacy Endpoints – Full Analysis Set

Table 1.	Table 1.	Table 1.	Table 1.
Exploratory Efficacy Endpoints – Full Analysis Set
	Vehicle (control)	10% BTX 1702	20% BTX 1702
Absolute reduction in inflammatory lesion count on Day 57	-12.8	-17.7 (p=0.02)	-16.9 (p=0.04)

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Percentage reduction in inflammatory lesion count on Day 57	-26.3%	-44% (p=0.03)	-32.2% (p=0.47)
IGA Success (Grade of 0 or 1 on Day 57)	9.3%	24.4% (p=0.059)	22.2% (p=0.09)
IGA Success (2-point improvement on Day 57)	9.3%	24.4% (p=0.059)	24.4% (p=0.059)
Success as measured by a CEA grade of 0 or 1 on Day 57	15.4%	23.8% (p=0.34)	14% (p=0.85)
Success as measured by a 2-grade improvement of CEA grade at Day 57	15.4%	23.8% (p=0.34)	14% (p=0.85)

IGA = Investigator’s Global Assessment scale (none, mild, moderate, severe) CEA = Clinician’s Erythema Assessment

Botanix medical adviser and former Chief Medical Officer of Medicis Pharmaceutical Corporation,

Dr Ira Lawrence commented : “To achieve this level of inflammatory lesion reduction and improvement in both IGA and CEA within 8 weeks is very exciting, particularly with such an excellent safety profile.

“There is the potential for even greater efficacy if the treatment period is extended to 12 weeks duration, especially if the efficacy continues to improve, as it did at each time point assessed in this study, and could represent the possibility of best-in-class performance with BTX 1702.”

Based on the results from the Study, the Company believes that the 10% BTX 1702 dose is the superior formulation with the most attractive safety and efficacy profile to take into further clinical development and has the potential to be the best-in-class treatment for papulopustular rosacea. The higher 20% BTX 1702 dose produced some safety and tolerability issues not seen in the 10% dose and the efficacy observed was not superior to the 10% BTX 1702 dose.

Available data from competitive products that have published efficacy outcomes after 8 weeks of treatment, suggests that 10% BTX 1702 is comparable in lesion reduction and IGA improvement at the same point in time, with a possible improvement in safety and tolerability.[1] Separately, the reduction in redness, as measured by the CEA outcome compares very favourably with products designed to reduce redness.[2]

1 See Prescribing information for https://www.galderma.com/us/sites/default/files/2019-01/Soolantra_Cream_PI.pdf and - https://www.galderma.com/us/sites/default/files/2022 03/Epsolay_PI.pdf as an example

2 See Prescribing Information for https://www.rhofade.com/_assets/pdf/Rhofade-PI_201-11-13.pdf as an example

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Rosacea market opportunity

The market for treatments for rosacea (including papulopustular) is expected to reach US$2.6 billion by 2025 and is growing at a CAGR of 6.8%.[3] Rosacea affects more than 430 million people worldwide and the global incidence among adults is estimated at 5.5% with the majority of patients consisting of women over the age of 35 years.[4] There are currently more than 16 million Americans affected by the illness with approximately 5 million medical treatment prescriptions in the US alone each year.[5]

There is currently a need for new rosacea treatments and BTX 1702 has the potential combine reduction in inflammatory lesions, antimicrobial effects and general improvement in skin condition in a single product.

Botanix will review the full data set for the Study once the final clinical study report is completed and the Company has had the opportunity to engage with the FDA on the development program.

1204A canine dermatitis pilot study complete

Botanix also confirms that the 1204A canine dermatitis pilot study has completed, and that an initial review of the data from the study suggests that a significant number of dogs enrolled in the study did not meet the specific inclusion criteria and as a result, the Company may not gain useful efficacy data from the study. The 1204A active arms appear to safe and well tolerated in the study and Botanix will continue to review the study, to establish if any additional insights are possible to be gained from this pilot study.

Valuable pipeline addition pending FDA approval for Sofpironium Bromide

The success of the BTX 1702 study significantly adds to the Botanix pipeline of dermatology products and with the recent submission of Sofpironium Bromide for FDA approval, helping to accelerate Botanix’s transition to a revenue generating dermatology company.

Botanix has begun building its commercial capability and is preparing for the important mid-cycle review with FDA for Sofpironium Bromide which occurs 6 months after filing of the NDA. The Company continues to review other opportunities to further bolster its pipeline with additional late stage or revenue producing dermatology products, that can be acquired for modest cost and which contribute to profitability and value.

3 Grand View research January 2019

4 Gether L, et al. Br J Dermatol. 2018;179:282-289;

5 National Rosacea Society. www.rosacea.org; and Symphony Health Solutions, PHAST

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Zoom Call Details:

Oct 13, 2022 08:00 AM Perth time Topic: BTX 1702 Rosacea Data Discussion

Please click the link below to join the webinar: https://us02web.zoom.us/j/82793897592?pwd=U3dOKzJnU3BRL0pxNEpsM0xLcnhzdz09

Webinar ID: 827 9389 7592 Passcode: 764915 International numbers available: https://us02web.zoom.us/u/ksLhVY2Y5

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 (US) 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, filed for FDA approval in Q3 CY2022 with approval expected in Q3 2023. The Company also has a pipeline of other products in late-stage clinical studies for the treatment of moderate to severe rosacea (successful Phase 1b/2 study in 4Q 2022), dermatitis and acne respectively. Botanix is also developing a topical 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 (Permetrex[TM] ) 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

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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, the Company’s ability to obtain marketing approvals for is product candidates, the expected timing and/or results of regulatory approvals and the outcome and effects of Sofpironium Bromide and the market for Sofpironium Bromide. 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.

Not an offer in the United States

This announcement has been prepared for publication in Australia and may not be released to US wire services or distributed in the United States. This announcement does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States or any other jurisdiction. Any securities described in this announcement have not been, and will not be, registered under the US Securities Act of 1933 and may not be offered or sold in the United States except in transactions exempt from, or not subject to, the registration requirements under the US Securities Act and applicable US state securities laws.

BTX 1702 Rosacea Clinical Data

October 2022

Successful Phase 1b/2 study

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BTX 1702 Rosacea Clinical Study

Statistically significant data and clear superiority of BTX 1702 to vehicle

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Positive Phase 1b/2 study

Randomised, double blind, controlled Phase 1b/2 clinical study in 133 subjects, with moderate to severe papulopustular rosacea

Safe and well tolerated

No serious adverse events in any arm of the study, with the 10% BTX 1702 active arm showing superior safety and tolerability

Clinically relevant improvements Both 10% and 20% BTX 1702 active arms showed clinically meaningful improvements across all efficacy endpoints

Statistical significance Improvements in reduction in inflammatory lesions was statistically significant for 10% target dose

Highlights Permetrex™performance Permetrex™technology enabled formulation of very high doses and successful delivery into the skin for efficacy and safety results

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BTX 1702: Rosacea Phase 1b/2
design and endpoints
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Study Details

• Three dose groups - 133 patients:

• BTX 1702 high dose - twice daily (BID): 45 patients

• BTX 1702 low dose - twice daily (BID): 45 patients

• Permetrex™Vehicle - twice daily (BID): 43 patients

Primary Endpoints

Safety and tolerability:

• Adverse events

• Cutaneous (Topical Application) Tolerability measures

Sites: 16 dermatology sites across Australia and NZ

Patients: Adults (18 - 65 years) with moderate to severe papulopustular rosacea

Treatment Period: 8 weeks

Inclusion Criteria

• Moderate to severe papulopustular rosacea on the face

• At least 15 inflammatory lesions (papules/pustules)

• Rosacea severity of moderate (3) or severe (4) on a 5-point Investigator Global Assessment (IGA) scale

Secondary Endpoints

• Percent change in inflammatory lesion counts (ILC) from baseline at days 15, 29 and 57

• Absolute change in inflammatory lesion counts (ILC) from baseline at days 15, 29 and 57

• Change in Investigator’s Global Assessment (IGA) treatment success from baseline at days 29 and 57 (2-point change and number ‘clear’ or ‘almost clear’)

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

• Clinician’s Erythema Assessment (CEA) scale of moderate (3) or severe (4)

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All doses of BTX 1702 were
Safety and
safe and very well tolerated
Tolerability
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• All treatment arms (vehicle 10% and 20%) were very well tolerated

• No treatment related serious adverse events reported

• Most common (but not serious) adverse event was

• local to the application site

• Patients in the 10% BTX 1702 arm reported no burning or stinging whatsoever, with only 5% in the 20% arm reporting minor burning and stinging

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Efficacy endpoint – change in
inflammatory lesion count (ILC) Clinically meaningful results with 10%
BTX 1702 also statistically significant
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Absolute Change in Inflammatory Lesion Counts (ILC) by Visit

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Baseline Day 15 Day 29 Day 57
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Percentage Change in Inflammatory Lesion Counts (ILC) by Visit

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Baseline Day 15 Day 29 Day 57
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When compared to vehicle, the 10% BTX 1702 formulation showed statistically significant reductions in both the absolute (p=0.02) and percent (p=0.03) changes in inflammatory lesion counts

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Efficacy endpoint – Investigators
Global Assessment for papules
Clinically meaningful improvement
and pustules (IGA-PP) in all BTX 1702 active arms
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Success (%) as Measured by
an IGA-PP Grade of 0 or 1
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Baseline Day 29 Day 57
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Success (%) as Measured by an IGA-PP* 2 Grade Improvement

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Baseline
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Day 29 Day 57
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IGA-PP scale is 0 – clear, 1 – almost clear, 2 – Mild, 3 – Moderate, 4 - Severe

Both the 10% and 20% BTX 1702 formulations showed clinically meaningful reductions in IGA-PP compared to vehicle

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Efficacy endpoint –
change in Clinician’s Erythema
Clinically meaningful results with
Assessment (CEA) strong trend for 10% BTX 1702
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Success (%) as Measured by an CEA Grade of 0 or 1 Visit Day v Baseline

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Baseline Day 15 Day 29 Day 57
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Success (%) as Measured by a 2-Grade Improvement CEA Grade Visit Day v Baseline

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Baseline Day 15 Day 29 Day 57
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CEA scale is 0 – clear, 1 – almost clear, 2 – Mild , 3 – Moderate, 4 – Severe

The 10% BTX 1702 formulation showed clinically meaningful reductions in CEA compared to vehicle

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Example patient images from
Canfield image capture
Clear visual improvements and key
tool for future studies
technology
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Baseline

Day 57

Baseline

Day 57

Reduction in inflammatory lesions and improvements in redness, shown for moderate and severe patient examples

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BTX 1702: high impact of rosacea
on patients and significant
market opportunity
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rosacea •Papulopustular is a highly visible chronic skin disease

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

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

Depression Social Anxiety Embarrassment Decreased quality of life

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

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US $2.6bn
Anticipated to register CAGR
of ~6.8% [3] over the forecast
US $1.9bn
period
2020 2025
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• Affects ~5.5% of the global population[4] , ~430m individuals , women are more likely to be affected than men

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

• Currently over 16m Americans affected[6] by rosacea, with ~5m medical treatment prescriptions[7] in the US alone

• Active treatment seekers looking for new solution to rosacea

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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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Summary

10% BTX 1702 dose showed excellent safety and efficacy outcomes

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Outstanding results

Both BTX 1702 arms showed clinically meaningful, and in some cases, statistically significant results

10% BTX 1702 dose to be progressed Efficacy and safety of the 10% dose achieved and demonstrated safety margin provided by the higher 20% dose

Validates synthetic CBD platform

Choice to test higher doses than in previous studies validated with improved efficacy versus vehicle and no new safety signals Efficacy is improving at all time points Potential for further efficacy improvements with longer treatment period

Opens up pathway for acne program Rosacea outcomes in similar disease opens up higher dose options for pivotal acne studies

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Important Notice & Disclaimer

1. Summary information

This presentation has been prepared by Botanix Pharmaceuticals Ltd (“Botanix”) and contains summary information about Botanix and the business conducted by it which is current as at the date of this presentation (“Presentation”) (unless otherwise indicated).

The information in this Presentation is general in nature and does not purport to be accurate nor complete, nor does it contain all of the information that an investor may require in evaluating a possible investment in Botanix, nor does it contain all the information which would be required in a disclosure document or prospectus prepared in accordance with the requirements of the Corporations Act 2001 (Cth). It has been prepared by Botanix with due care but no representation or warranty, express or implied, is provided in relation to the accuracy, reliability, fairness or completeness of the information, opinions or conclusions in this Presentation by Botanix or any other party.

The information in this Presentation remains subject to change without notice. Reliance should not be placed on information or opinions contained in this Presentation, and Botanix does not have any obligation to finalise, correct or update the content of this Presentation. Certain data used in this Presentation has been obtained from research, surveys or studies conducted by third parties, including industry or general publications. To the maximum extent permitted by law, Botanix is not responsible for updating, nor undertakes to update, this Presentation. It should be read in conjunction with Botanix’s other periodic and continuous disclosure announcements lodged with the ASX, which are available at www2.asx.com.au or at https://botanixpharma.com/category/asx-releases/.

2. Not an offer

Neither this Presentation nor any of its contents will form the basis of any understanding, proposal, offer, invitation, contract or commitment. 3. Industry data

Certain market and industry data used in connection with or referenced in this Presentation has been obtained from public filings, research, surveys or studies made or conducted by third parties, including as published in industry-specific or general publications. Neither Botanix nor its advisers, or their respective representatives, have independently verified any such market or industry data.

4. Financial data

All dollar values are in United States dollars ($ or US$) unless otherwise stated. Amounts, totals and change percentages are calculated on whole numbers and not the rounded amounts presented. 5. Forward-looking statements and forecasts

This Presentation contains certain “forward-looking statements” and comments about future matters. Forward-looking statements can generally be identified by the use of forward-looking words such as, “expect”, “anticipate”, “likely”, “intend”, “should”, “could”, “may”, “predict”, “plan”, “propose”, “will”, “believe”, “forecast”, “estimate”, “target” “outlook”, “guidance” and other similar expressions and include, but are not limited to, 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. Indications of, and guidance or outlook on, future earnings or financial position or performance are also forward-looking statements. You are cautioned not to place undue reliance on forward-looking statements. Any such statements, opinions and estimates in this Presentation speak only as of the date hereof, are preliminary views and are based on assumptions and contingencies subject to change without notice, as are statements about market and industry trends, projections, guidance and estimates. Forward-looking statements are provided as a general guide only. The forward-looking statements contained in this Presentation are not indications, guarantees or predictions of future performance and involve known and unknown risks and uncertainties and other factors, many of which are beyond the control of Botanix, and may involve significant elements of subjective judgement and assumptions as to future events which may or may not be correct.

Any such forward looking statements are also based on assumptions and contingencies which are subject to change and which may ultimately prove to be materially incorrect, as are statements about market and industry trends, which are based on interpretations of current market conditions. Investors should consider the forward looking statements contained in this Presentation in light of those disclosures and not place undue reliance on such statements (particularly in light of the current economic climate and significant volatility, uncertainty and disruption caused by the COVID-19 pandemic). The forward looking statements in this Presentation are not guarantees or predictions of future performance and may involve significant elements of subjective judgment, assumptions as to future events that may not be correct, known and unknown risks, uncertainties and other factors, many of which are outside the control of Botanix.

Except as required by law or regulation, Botanix undertakes no obligation to finalise, check, supplement, revise or update forward-looking statements or to publish prospective financial information in the future, regardless of whether new information, future events or results or other factors affect the information contained in this Presentation.

6. No liability

The information contained in this document has been prepared in good faith by Botanix. Neither Botanix, nor any of its advisers or any of their respective affiliates, related bodies corporate, directors, officers, partners, advisers, employees and agents have authorised, permitted or caused the issue, lodgement, submission, dispatch or provision of this Presentation in a final form and none of them makes or purports to make any binding statement in this Presentation and there is no statement in this Presentation which is based on any statement by them. To the maximum extent permitted by law, Botanix and its advisers, affiliates, related bodies corporate, directors, officers, partners, employees and agents:

expressly disclaims any and all liability, including, without limitation, any liability arising out of fault or negligence, for any loss arising from the use of or reliance on information contained in this document including representations or warranties or in relation to the accuracy or completeness of the information, statements, opinions, forecasts, reports or other matters, express or implied, contained in, arising out of or derived from, or for omissions from, this document including, without limitation, any estimates or projections and any other financial information derived therefrom, whether by way of negligence or otherwise; and

expressly exclude and disclaim all liabilities in respect of, make no representations regarding, any part of this Presentation and make no representation or warranty as to the currency, accuracy, adequacy, reliability or completeness or fairness of any statements, estimates, options, conclusions or other information contained in this Presentation.

Operations: 3602 Horizon Drive, Suite 160 King of Prussia PA 19406

Corporate Office: D2, 661 Newcastle Street Leederville W. Australia 6007

Authorised for release by Vince Ippolito, Executive Chairman

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