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BOTANIX PHARMACEUTICALS LTD — Investor Presentation 2021
May 4, 2021
64551_rns_2021-05-04_a7fdb3b6-c53e-4472-8745-301e3307369e.pdf
Investor Presentation
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5 May 2021
Updated investor presentation and conference call
Philadelphia PA and Perth Australia, 5 May 2021 : Clinical dermatology and antimicrobial company, Botanix Pharmaceuticals Limited (ASX:BOT, “Botanix” or “the Company”), is pleased to release an updated investor presentation and provide details for an investor conference call to be held at 11am AEST on Friday, 7 May 2021.
The attached updated investor presentation provides an update on the key clinical development programs, including the progression of BTX 1801 antimicrobial platform and BTX 1702 rosacea study that recently received ethics approval.
Botanix will hold an investor conference call hosted by Vince Ippolito, President and Executive Chairman, and Matt Callahan, Executive Director at 11am AEST on Friday, 7 May 2021. Investors can pre-submit questions to be answered at the end of the call, when registering through the link below.
Conference call details:
Date: Friday, 7 May 2021 Time: 11:00am AEST
Registration details:
Participants are encouraged to pre-register for the conference call. Upon registration, participants will receive a unique pin granting fast-track access to the conference call and the opportunity to submit questions to Botanix management team.
https://s1.c-conf.com/diamondpass/10013700-s0ecot.html
Release authorised by
Vince Ippolito
President and Executive Chairman
About Botanix Pharmaceuticals
Botanix Pharmaceuticals Limited (ASX:BOT) is a dermatology focused 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 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. Botanix has an exclusive license to use a proprietary drug delivery system (Permetrex) for direct skin delivery of active pharmaceuticals in all skin
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diseases, which it utilises in its existing development programs and is being explored with 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 plans for an upcoming Phase 2b study. For the dermatology platform, the Company has received ethics approval to commence its Phase 1b rosacea study and following a successful meeting with the FDA, the Company has confirmed a drug development plan for the BTX 1503 acne program to support registration. To learn more please visit: https://www.botanixpharma.com/
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 [email protected] [email protected] [email protected]
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.
Investor Presentation May 2021
www.botanixpharma.com
Botanix: leader in topical drug development
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Pharmaceutical focus
Topically driven
Significant markets
World-class team
Near-term catalysts
Leveraging novel skin delivery technology (Permetrex ™ ) and novel drug mechanisms of action, including cannabidiol (CBD)
Targeting key dermatology and antimicrobial indications with topical treatments that are safe, well tolerated and validated by clinical efficacy
Pipeline targeting multi-billion dollar markets with no new products approved by FDA in 20-30 years in these indications
World-class and experienced team with significant dermatology and antimicrobial drug track record and development expertise
Multiple upcoming catalysts including completion of Phase 1b rosacea study, Phase 2b antimicrobial study and assessment of new indications for rapid development
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www.botanixpharma.com
Corporate
Corporate overview
Trading information
| Corporate overview Trading information |
|
|---|---|
| Share Price ( 4 May 2021) | A$0.084 |
| 52 week low / high | A$0.037 / A$0.190 |
| Shares outstanding | 973,142,074 |
| Market capitalisation | A$80.8 |
| Cash (31 March 2021) | A$23.3m |
| Debt (31 March 2021) | - |
| Enterprise value | A$57.5 |
Substantial shareholders
| Shareholder | % |
| Matt Callahan – Founder and Executive Director | 7.27% |
| Caperi Pty Ltd – Co-founder | 6.12% |
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Source: IRESS
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Share price performance (last 12 months)
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Price (A$) Volume (m)
$0.20 90
80
$0.16
70
60
$0.12
50
40
$0.08
30
20
$0.04
10
$0.00 0
May-20 Aug-20 Nov-20 Feb-21
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www.botanixpharma.com
World class team
World-class team
Board of Directors
Executive
Management & Advisers
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Vince Ippolito
President and Executive Chairman
-
COO of Anacor and Medicis with 17 years at Novartis
-
More than 30 years experience in pharma with 20+ years within dermatology
Dr Clarence Young
Chief Medical Oficer
-
Recently Chief Medical Officer at Velicept Therapeutics
-
Senior leadership roles at Iroko Pharmaceuticals, Novartis and GlaxoSmitheKline
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Matt Callahan
Executive Director
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Serial founder and ex-investment director of two venture capital firms in life sciences
-
Developed 4 products through FDA approval and launch
Anthony Robinson
Vice President of Development
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Recently Vice President at Advicenne
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Senior leadership roles at Aquestive Therapeutics, Intrommune and Shire Pharmaceuticals
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Dr Bill Bosch
Executive Director
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20+ years experience in pharma industry
-
Co-inventor of SoluMatrix™drug delivery technology and NanoCrystal® Technology
Lynda Berne
Head of Commercial
-
Founder of BAL Pharma Consulting
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13 years senior leadership roles in pharmaceuticals industry
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Dr Stewart Washer
Director
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Currently a board member of Orthocell, Cynata Therapeutics and Emyria
-
20+ years of experience in medical tech, biotech and agrifood
Dr Ira Lawrence
Advisor
- 30+ years of senior level leadership experience within the global pharmaceutical and medical device industries
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www.botanixpharma.com
Pharmaceutical focus
Advanced pipeline
BTX 1801 Antimicrobial
BTX 1702
Rosacea
BTX 1503
Acne
Ph 1
Ph 1b
Ph 2
Ph 3
Status
Positive Phase 2a results 1Q 2021, Phase 2b planned for 4Q 2021
First patients enrolled 2Q 2021
Planning underway for Phase 3 clinical studies
Actively assessing new target indications for rapid clinical development
Ongoing project work and internal development
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www.botanixpharma.com
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Topically driven
Permetrex[TM] : unique skin delivery technology fuels pipeline Delivers high doses of drug into the layers of the skin without using permeation enhancers, preservatives, or irritating levels of alcohol / petroleum derivatives
Initial application
Evaporation of solvent
Target drug is incorporated in Permetrex™ Volatile majority of the formulation evaporates formulation which spreads easily over skin – leaving a minority of highly concentrated surface drug solution on the skin surface Epidermis Dermis
Epidermis
Delivery into the skin
Rapid change in concentration of the drug as a result of evaporation, drives drug into the skin and is designed not to leave excess excipients on the surface
Permetrex[TM] is utilised in Botanix pipeline products and improves delivery for other drugs in development[1]
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- Topical dosage forms include: solutions, creams, gels, ointments, foams or pastes
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www.botanixpharma.com
Topically driven
Independent comparative analysis of CBD delivered
Amount of CBD permeated through skin (time elapsed 48 hours)[1]
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60
50
40
~5x more than closest
comparator product
30
~3x more than closest
20 comparator product
10
-
Epidermis Dermis
BTX 1503 Product 1 Product 2 Product 3 Product 4 Product 5
Delivered dose in mg/cm2
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Relative to the closest comparator, Permetrex[TM] delivers >5 times as much CBD to the epidermis and >3 times as much CBD to the dermis - significantly more than other creams and gels
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- For further details on these tests – see BOT ASX release on 26/02/19. Products purchased from internet websites of respective vendors and tested by independent laboratory testing service Tioga Research. HPLC analysis of CBD content compared labeled CBD or cannabinoid content to Tioga test results.. Botanix data on file.
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www.botanixpharma.com
Significant markets
Our products target markets with significant annual revenue
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Antimicrobial
Specialised / Rosacea 100k patients
Dermatologists $0.5bn
16M patients
sales [2]
$1.9bn
sales [1]
US
Prescriber Acne
Base
50M patients
$5.1bn
sales [3]
General
Practitioners
Preclinical Phase1 Phase2 Phase3
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Stage of Clinical Development
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-
Grandview Research. www.Grandview research.com
-
Using GSK Bactroban Nasal Pricing/BTX 1801 pricing to be developed following analyses of potential impact on healthcare system; assumes 5% YOY pricing following product approval/launch Symphony Health Solutions, METYS, data ending December 2019 – weighted
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www.botanixpharma.com
Pharmaceutical focused
Synthetic cannabinoids are well suited to treat skin diseases and infections
Botanix’s studies show synthetic CBD to:[1]
-
Be safe and well tolerated
-
Have broad anti-inflammatory properties
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Have a strong and consistent impact on lesions
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Kill Staph aureus
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Avoid bacteria from developing resistance
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Have potential for widespread use across human and animal health
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See ASX announcement “Antimicrobial Platform Update and Launch of BTX 1801 Study” (13 March 2020) and The Antimicrobial Potential of Cannabidiol, Communications Biology 4, Article number: 7 (2021) Blaskovich, M et al
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www.botanixpharma.com
BTX 1801 development update
Antimicrobial
Antimicrobial resistance is a with no fast-growing problem, innovation in over three decades
Global forecast deaths by 2050[1 ] (p.a.)
Number of antibiotic classes discovered or patented[2]
10.0m
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 Traffic Diarrhoeal Diabetes Cancer AMR accidents disease
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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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Tackling Drug Resistant Infections Globally Final Report and Recommendations (2016), The Review on Antimicrobial Resistance 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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www.botanixpharma.com
Antimicrobial
BTX 1801 has remarkable activity against bacteria without inducing resistance
MIC daily variability[1]
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26x fold increase from Day 1
8 An increase in MIC over time
shows MRSA can develop
resistance to the drug
4
1.5x fold increase from Day 1
-
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
Days
Daptomycin Cannabidiol
MIC (µg/mL)
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Repeat challenge experiments demonstrate that MRSA bacteria develop resistance to commonly-used antibiotics such as daptomycin, but not easily to synthetic CBD
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- The Antimicrobial Potential of Cannabidiol, Communications Biology 4, Article number: 7 (2021) Blaskovich, M et al
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www.botanixpharma.com
Antimicrobial
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BTX 1801 Phase 2a study: clinical efficacy demonstrated
Safe and generally well tolerated at doses of active drug up to 20% All 66 participants successfully Safety & completed the BTX 1801 study tolerability No severe adverse events reported[1] Efficacy of ointment and gel formulations demonstrated for primary endpoint at 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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-
BTX 1801 Phase 2a Clinical Study - BOT data on file
-
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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www.botanixpharma.com
Antimicrobial
Phase 2a study data: Staph aureus eradication
BTX 1801: Staph aureus eradication rates (% of participants)[1]
Study observations
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80% Significant eradication of Staph aureus 2 days after
5 day 76.2%
1 completion of treatment period
treatment
68.8%
period Large difference between active groups / vehicle control
60%
After 7 days of no treatment with BTX 1801 – significant %
2
of subjects maintained eradication of Staph aureus
40%
38.1%
27.8%
25.0%
23.8% After 23 days of no treatment with BTX 1801 – significant %
20% 3
16.7% 18.8% of subjects maintained eradication of Staph aureus
12.5%
•
The BTX 1801 Phase 2a study did not include a full body chlorhexidine
0%
wash, that has been used in other clinical studies to remove bacterial
0 5 7 12 28
reservoirs in other parts of the body (that recolonize the nose)
Days • Bacterial detection was with high accuracy PCR testing rather than less
BTX 1801 Ointment BTX 1801 Gel Combined Vehicle Groups accurate culture methods
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-
After 7 days of no treatment with BTX 1801 – significant % of subjects maintained eradication of Staph aureus
-
After 23 days of no treatment with BTX 1801 – significant % of subjects maintained eradication of Staph aureus
-
Bacterial detection was with high accuracy PCR testing rather than less accurate culture methods
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First human data demonstrating clinical utility of synthetic CBD as an antimicrobial agent
BTX 1801 Phase 2a Clinical Study Data announced 3 February 2021
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www.botanixpharma.com
Antimicrobial
Haemodialysis patients with central venous catheters at risk of bloodstream infections
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Haemodialysis
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Rationale for
selection
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Significant health risks
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-
Replicates the functions of the kidneys in patients with kidney failure, by using a machine to filter and clean the blood
-
Frequent use of catheters or inserting of needles to access the bloodstream puts patients at high risk of bloodstream infections
-
Infection is a leading cause of death with 20% to 40% of haemodialysis patients eventually dying from an infection[1]
-
Studies have found that risks for central venous catheter-related complications were as high as 30% and 38%, at 1 and 2 years respectively[2]
-
The central venous catheter population (approx. 160,000 patients) is responsible for more than 70% of blood infections in the total dialysis population[2]
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-
-
‘Mortality in dialysis patients: analysis of the causes of death’, Mailloux LU, Bellucci AG, Wilkes BM, Napolitano B, Mossey RT, Lesser M, Bluestone PA. AJKD. 1991 Sep;18(3):326-35 ‘Complications From Tunneled Hemodialysis Catheters: A Canadian Observational Cohort Study’, (2019) Poinen, K. et al AJKD Volume 73 Issue 4 Pages 467-475
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www.botanixpharma.com
Antimicrobial
Health system impact of haemodialysis infections
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Patients
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~US$32k
US$1bn
~60%
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Hospitals
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of Staph aureus–related hospital admissions occur within the first year of the initiation of dialysis therapy[1]
Mean cost (per episode) of treating Staph aureus blood stream infections, including readmissions and outpatient costs[1]
Estimated annual cost of treating bacteraemia in haemodialysis patients with central venous catheters[2]
US$734m
13 days
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Government
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11.8%
Average length of stay for the index admission[1]
Market for nasal decolonisation of haemodialysis patients at risk of blood stream infection by 2030[3]
of patients were readmitted within 12 weeks of hospitalisation related to Staph aureus infections[1]
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‘Clinical and Economic Outcomes of Staphylococcus aureus Septicemia in ESRD Patients Receiving Hemodialysis’, Nissenson A et al, American Journal of Kidney Diseases, Vol 46, No 2 (August), 2005: pp 301-308 ‘Following CDC Protocols Cuts Dialysis Bloodstream Infection in Half’, CDC, May 2013, https://www.cdc.gov/media/releases/2013/p0513-dialysis-infections.html Using GSK Bactroban Nasal Pricing/BTX 1801 pricing to be developed following analyses of potential impact on healthcare system; assumes 5% YOY pricing following product approval/launch
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www.botanixpharma.com
Antimicrobial
BTX 1801: rapid clinical development
Next Study
Phase 1 Phase 2b Safe and delivers Effective at killing Staph aureus synthetic cannabidiol over 3 months, with three times effectively weekly treatment of the nose
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Phase 2a
Phase 3
BTX 1801 effectively kills BTX 1801 is effective at killing Staph aureus after 5 days of Staph aureus for up to 12 continuous treatment months, with three times weekly treatment of the nose
FDA incentives provide accelerated development and increase exclusivity
- Extra 5 years (total of 8 years) exclusivity from generic competition
QIDP[1] status
-
Attractive economic benefits from FDA approval
-
Following IND submission, allows increased
-
Fast track consultation with FDA status De-risks clinical trials and accelerates
-
De-risks clinical trials and accelerates development pathway
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LPAD [2]
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- Allows smaller, fewer and / or shorter clinical trials for FDA approval
status
Botanix plans to apply for all three programs to accelerate development, reduce clinical costs and increase exclusivity
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- QIDP: Qualified Infections Disease Product 2. LPAD: Limited Population Pathway for Antimicrobial and Antifungal Drugs
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www.botanixpharma.com
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 ὋɨʐʝΉ[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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- 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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www.botanixpharma.com
Dermatology
BTX 1702: Phase 1b rosacea study start
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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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www.botanixpharma.com
Dermatology
BTX 1503: Successful End-of-Phase 2 FDA Meeting and preparation for Phase 3
Study update
Sizable acne prescription market
-
End of Phase 2 meeting with FDA successfully completed
-
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
-
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 in the USA
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22m total prescriptions in 2019 growing ~5% year-on-year[2]
US$5.1bn in sales in 2019[2]
>2m p.a. active, diagnosed acne patients under HCP care[3]
~40m to ~50m acne sufferers[4] (~10m mod-to-severe)
60% of acne patients are managed by 5K HCPs[5]
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- 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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www.botanixpharma.com
Corporate
Executing on key clinical milestones
Antimicrobial: positive BTX 1801 Phase 2a study results Positive results announced and Phase 2b planned start 4Q 2021
Rosacea: BTX 1702 Phase 1b study start Recruitment currently underway
-
Acne : BTX 1503 planning for Phase 3 clinical studies
-
Pending the completion of BTX 1702 Phase 1b clinical study
New indications: topical treatments Actively assessing new indications for rapid clinical development
- Strong cash position A$23.3m As at 31 March 2021
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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
General enquiries
Botanix Pharmaceuticals Corporate communications +61 8 6555 2945 [email protected]
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www.botanixpharma.com